Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

Brief summary public domain (ClinicalTrials.gov)

The purpose of this study of MCS110 with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.

Detailed description public domain (ClinicalTrials.gov)

Combined treatment with MCS110 and PDR001 was expected to result in Tumor-associated macrophages (TAM) depletion, enhanced T-cell activation and synergistic antitumor activity in the clinical setting. This study was a Phase Ib/II, multi-center, open label study starting with a Phase Ib dose escalation part followed by a Phase II part. MCS110 and PDR001 were administered i.v. Q3W until the patient experienced unacceptable toxicity, progressive disease as per irRC and/or treatment was discontinued at the discretion of the investigator or the patient. Patients were not to discontinue treatment based on progressive disease per Response evaluation criteria in solid tumors (RECIST) v1.1. During the Phase Ib part of the study, cohorts of patients were treated with increasing doses of MCS110 and PDR001 every 3 weeks until a Recommended Phase 2 Dose (RP2D) was determined for this treatment combination. To assure that the combination RP2D did not exceed the Maximum tolerated dose (MTD), the combination MCS110 and PDR001 dose escalation was guided by a Bayesian logistic regression model (BLRM) with overdose control (EWOC) principle based on dose limiting toxicity data in the context of available safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) information. Once the MTD and/or RP2D was declared, additional patients were enrolled in the Phase II part in order to assess the preliminary anti-tumor activity of MCS110 in combination with PDR001 in anti-PD1/PD-L1-naive triple negative breast cancer (TNBC), pancreatic (PC), endometrial carcinoma (EC) and anti PD1/PD-L1-resistance melanoma (ME).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety [From start of treatment to a maximum timeframe of 116.4 weeks for phase Ib]. Count Of Participants, Participants. Adverse events (AEs) - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 6; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 12; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 12; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 13; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 6; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 11. Adverse events - Treatment-related - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 6; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 12; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 11; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 8; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 6; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 8. Serious Adverse Events (SAEs) - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 3; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 4; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 4; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 7; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 2; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 5. SAEs - Treatment-related - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 1; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 2; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1. Fatal SAEs - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 2; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0. Fatal SAEs - Treatment-related - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0. AEs leading to discontinuation - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 2; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1. AEs leading to discontinuation - Treatment-related - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase II : Overall Response Rate (ORR) - Per RECIST v1.1 [4 years]. Number, Percentage of participants (90% Confidence Interval). Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 5 (0.3 to 21.6); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 0 (0.0 to 13.9); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 9.5 (1.7 to 27.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 0 (0.0 to 13.9).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean [4 years]. Mean, Percentage of participants (90% Confidence Interval). Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 6.7 (0.8 to 17.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): NA (NA to NA) [Bayesian inference of Clinical Benefit Rate was measured for this arm instead - see Bayesian inference of Clinical Benefit Rate - per RECIST v1.1- mean results]; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 10.8 (2.6 to 23.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 0.8 (0 to 4.5).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1 [4 years]. Number, Percentage of participants (90% Confidence Interval). Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 20 (7.1 to 40.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 0 (0.0 to 13.9); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 9.5 (1.7 to 27.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 10.0 (1.8 to 28.3).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean [4 years]. Mean, Percentage of participants (90% Confidence Interval). Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): NA (NA to NA) [Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per RECIST v1.1 - mean results]; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 0.8 (0 to 4.5); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): NA (NA to NA) [Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per RECIST v1.1 - mean results]; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): NA (NA to NA) [Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per RECIST v1.1 - mean results].

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase Ib: Planned Dose Intensity - MCS110 [Measured up to a max of 112.4 weeks]. Mean, mg/kg/3wks (Standard Deviation). Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0.86 (0.191); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 2.74 (0.386); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 2.66 (0.435); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 4.85 (0.286); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 7.05 (0.594); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 9.47 (1.093).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase Ib: Relative Dose Intensity - MCS110 [Measured up to a max of 112.4 weeks]. Mean, Percentage (Standard Deviation). Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 100 (100); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 100 (100); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 100 (100); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 99.23 (2.774); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 100 (100); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 100 (100).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase Ib: Planned Dose Intensity - PDR001 [Measured up to a max of 112.4 weeks]. Mean, mg/3wks (Standard Deviation). Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 86.09 (19.058); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 91.18 (12.873); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 265.83 (43.528); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 293.59 (16.013); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 282.12 (23.773); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 289.04 (20.329).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase Ib: Relative Dose Intensity - PDR001 [Measured up to a max of 112.4 weeks]. Mean, Percentage (Standard Deviation). Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 100.00 (100.00); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 100.00 (100.00); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 100.00 (100.00); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 100.00 (100.00); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 100.00 (100.00); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 100.00 (100.00).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase Ib: Number of Participants With Dose Reductions [Measured up to a max of 112.4 weeks]. Count Of Participants, Participants. n (%) of participants with no dose reduction- Study drug: MCS110: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 6; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 12; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 12; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 13; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 6; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 9. n (%) of participants with no dose reduction- Study drug: PDR001: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 6; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 12; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 12; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 13; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 6; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 11.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase Ib: Number of Dose Interruptions Per Participant [Measured up to a max of 112.4 weeks]. Mean, Dose interruptions per participant (Standard Deviation). Number of dose interruptions per subject - Study drug: MCS110: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 1.3 (1.97); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0.3 (0.45); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0.3 (0.45); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0.0 (0.0); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0.3 (0.52); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0.1 (0.30). Number of dose interruptions per subject - Study drug: PDR001: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 1.3 (1.97); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0.3 (0.45); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0.3 (0.45); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0.0 (0.0); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0.3 (0.52); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0.1 (0.30).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase Ib: Number of Subjects With at Least One Dose Interruption [Measured up to a max of 112.4 weeks]. Count Of Participants, Participants. Number of subjects with at least one dose interruption - by reason - Adverse Event - MCS110: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 3; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 3; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 3; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 2; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1. Number of subjects with at least one dose interruption - by reason - Adverse Event - PDR001: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 3; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 3; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 3; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 2; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment [the first 2 cycles of study treatment; cycle = 21 days (i.e., at day 42)]. Count Of Participants, Participants. n (%) of subjects with at least one event - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=5): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=9): 1; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=7): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=4): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=4): 1. n (%) Investigations - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=5): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=9): 1; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=7): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=4): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=4): 1. n (%) Blood creatine phosphokinase increased - all grades: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=5): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=9): 1; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=7): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=4): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=4): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase II : Overall Response Rate (ORR) - Per irRC [4 years]. Number, Percentage of participants (90% Confidence Interval). Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 5 (0.3 to 21.6); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 0 (0.0 to 13.9); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 9.5 (1.7 to 27.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 0 (0.0 to 13.9).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib: Overall Response Rate (ORR) [4 years]. Number, Percentage of participants (90% Confidence Interval). Overall Response Rate as per investigator based on RECIST v1.1: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 16.7 (0.9 to 58.2); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0 (0.0 to 22.1); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0 (0.0 to 22.1); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0 (0.0 to 20.6); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0 (0.0 to 39.3); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 9.1 (0.5 to 36.4). Overall Response Rate - as per investigator based on irRC: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 16.7 (0.9 to 58.2); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0 (0.0 to 22.1); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0 (0.0 to 22.1); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0 (0.0 to 20.6); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0 (0.0 to 39.3); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 9.1 (0.5 to 36.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean [4 years]. Mean, Percentage of participants (90% Confidence Interval). Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 6.7 (0.8 to 17.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): NA (NA to NA) [Bayesian inference of Clinical Benefit Rate was measured for this arm instead - see Bayesian inference of Clinical Benefit Rate - per irRC - mean results]; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 10.8 (2.6 to 23.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 0.8 (0 to 4.5).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase 1b: Clinical Benefit Rate (CBR) [4 years]. Number, Percentage of participants (90% Confidence Interval). Clinical Benefit Rate - as per investigator based on RECIST v1.1: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 33.3 (6.3 to 72.9); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 8.3 (0.4 to 33.9); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0 (0.0 to 22.1); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0 (0.0 to 20.6); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0 (0.0 to 39.3); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 18.2 (3.3 to 47.0). Clinical Benefit Rate - as per investigator based on irRC: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 50.0 (15.3 to 84.7); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 8.3 (0.4 to 33.9); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0 (0.0 to 22.1); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 7.7 (0.4 to 31.6); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 33.3 (6.3 to 72.9); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 18.2 (3.3 to 47.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC [4 years]. Number, Percentage of participants (90% Confidence Interval). Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 20.0 (7.1 to 40.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 5.0 (0.3 to 21.6); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 19.0 (6.8 to 38.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 30.0 (14.0 to 50.8).

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Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean [4 years]. Mean, Percentage of participants (90% Confidence Interval). Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): NA (NA to NA) [Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per irRC - mean results]; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 5.6 (0.4 to 15.3); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): NA (NA to NA) [Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per irRC - mean results]; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): NA (NA to NA) [Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per irRC - mean results].

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Phase 1b and Phase II: Progression Free Survival Based on Investigator Assessment as Per RECIST v1.1 and Per Immune Related Response Criteria (irRC) - Using Kaplan-Meier Method - Median [Up to year 4]. Median, months (90% Confidence Interval). Median PFS - per RECIST v1.1: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 1.5 (1.1 to 14.8); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 1.3 (1.3 to 2.7); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 1.3 (0.8 to 1.3); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 1.1 (0.6 to 1.3); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 1.3 (0.5 to 4.0); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1.2 (0.6 to 2.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1.6 (1.4 to 2.8); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 1.3 (1.2 to 1.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 1.3 (1.2 to 1.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 2.4 (1.4 to 3.7). Median PFS - per iiRC: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 8.2 (1.2 to 25.8); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 2.2 (1.3 to 2.7); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 1.3 (0.9 to 1.3); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 1.0 (0.5 to 1.3); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 1.3 (0.5 to 16.8); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1.2 (0.7 to 2.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1.6 (1.4 to 2.8); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 1.3 (1.2 to 1.5); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 1.3 (1.2 to 1.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 3.7 (1.4 to 4.2).

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Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median [Up to year 4]. Median, months (90% Confidence Interval). Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 12.3 (3.1 to 26.6); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 9.6 (3.8 to 12.2); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 4.2 (1.5 to 7.9); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 2.8 (1.2 to 3.8); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 22.8 (1.1 to 26.8); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 5.7 (1.2 to 8.2); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 8.9 (5.6 to 16.6); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 2.6 (1.8 to 5.0); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 11.7 (9.2 to 14.6); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 19.7 (9.2 to 20.3).

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Phase 1b and Phase II: Duration of Response (DOR) [4 years]. Median, days (Full Range). Duration of response(days) - based on RECIST v1.1: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 372.0 (372 to 372); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): NA (NA to NA) [The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.]; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): NA (NA to NA) [The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.]; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): NA (NA to NA) [The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.]; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): NA (NA to NA) [The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.]; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 155.0 (155.0 to 155.0); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 169 (169 to 169); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): NA (NA to NA) [The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.]; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 328.5 (194 to 463); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): NA (NA to NA) [The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.]. Duration of response(days) - based on irRC: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 372.0 (372.0 to 372.0); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): NA (NA to NA) [The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.]; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): NA (NA to NA) [The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.]; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): NA (NA to NA) [The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.]; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): NA (NA to NA) [The median is not available because there was an insufficient number of participan

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Phase 1b and Phase II: Disease Control Rate (DCR) [4 years]. Number, Percentage (90% Confidence Interval). Disease Control Rate - as per investigator based on RECIST v1.1: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 33.3 (6.3 to 72.9); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 8.3 (0.4 to 33.9); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0 (0.0 to 22.1); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 15.4 (2.8 to 41.0); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 16.7 (0.9 to 58.2); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 18.2 (3.3 to 47.0); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 20.0 (7.1 to 40.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 0 (0.0 to 13.9); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 19.0 (6.8 to 38.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 35.0 (17.7 to 55.8). Disease Control Rate as per investigator based on irRC: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 50.0 (15.3 to 84.7); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 8.3 (0.4 to 33.9); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0 (0.0 to 22.1); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 15.4 (2.8 to 41.0); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 33.3 (6.3 to 72.9); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 18.2 (3.3 to 47.0); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 20.0 (7.1 to 40.1); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 5.0 (0.3 to 21.6); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 19.0 (6.8 to 38.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 45.0 (25.9 to 65.3).

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Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety [From start of treatment to a maximum timeframe of 92.4 weeks for phase II.]. Count Of Participants, Participants. Adverse events - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 20; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 20; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 21; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 20. Adverse events - Treatment-related - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 16; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 15; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 17; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 19. SAEs - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 8; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 14; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 8; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 7. SAEs - Treatment-related - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 4; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 4; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 1. Fatal SAEs - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 1. Fatal SAEs - Treatment-related - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 0. AEs leading to discontinuation - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 2. AEs leading to discontinuation - Treatment-related - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 1. AEs leading to dose adjustment / interruption - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 11; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 4; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 8; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 11. AEs requiring additional therapy - all grades: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W

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Phase Ib and Phase II: Immunogenicity MCS110 [4 years]. Number, Participants. Baseline positive: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 1; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 1; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 1; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 0. Baseline negative: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 6; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 11; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 11; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 12; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 6; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 11; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 19; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 19; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 17; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 18. Baseline missing: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 4; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 2. Baseline positive, on treatment persistent positive: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 0. Baseline positive, on treatment only last positive: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 1; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0; Ph II:

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Phase Ib and Phase II: Immunogenicity PDR001 [4 years]. Number, Participants. Baseline positive: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 2; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 1; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 2; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 1; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 2; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 1. Baseline negative: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 6; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 10; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 11; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 10; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 5; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 8; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 18; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 17; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 19; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 19. Baseline missing: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 1; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 2; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 2; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 0. Baseline positive, on treatment persistent positive: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 1; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 1; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 0. Baseline positive, on treatment only last positive: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 1; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0; Ph II:

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Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf [cycle 1 (day 21) and cycle 4 (day 84)]. Mean, day*ng/mL (Standard Deviation). AUClast (day*ng/mL) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 46900 (9080); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 343000 (142000); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 249000 (93400); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 490000 (149000); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 909000 (233000); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1090000 (231000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1200000 (507000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 1090000 (352000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 1120000 (440000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 1270000 (335000). AUCinf (day*ng/mL) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 50100 (11600); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 383000 (178000); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 330000 (73400); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 560000 (177000); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 1020000 (336000); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 988000 (116000). AUClast (day*ng/mL) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 41000 (22800); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 213000 (92200); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 232000 (99300); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 710000 (171000); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 1520000 (353000); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1200000 (1030000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1200000 (389000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 918000 (102000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 1010000 (337000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 1240000 (499000). AUCinf (day*ng/mL) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 42300 (21900); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 260000 (73500); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 253000 (114000); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 619000 (NA) [SD is not applicable for an analysis with 1 participant]; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 769000 (NA) [SD is not applicable for an analysis with 1 participant].

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Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf [cycle 1 (day 21) and cycle 4 (day 84)]. Mean, day*ug/mL (Standard Deviation). AUClast (day*ug/mL) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 229 (68.3); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 271 (53.8); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 651 (322); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 604 (309); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 581 (147); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 450 (135); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 825 (402); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 782 (264); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 764 (311); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 782 (307). AUCinf (day*ug/mL) - cycle 1 - day 21: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 274 (NA) [SD is not applicable for an analysis with 1 participant]; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 610 (NA) [SD is not applicable for an analysis with 1 participant]; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 747 (NA) [SD is not applicable for an analysis with 1 participant]; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 710 (NA) [SD is not applicable for an analysis with 1 participant]. AUClast (day*ug/mL) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 369 (26.4); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 330 (182); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 1020 (526); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 2020 (1170); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 954 (179); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 718 (288); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1170 (388); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 1330 (555); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 1660 (283); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 1260 (533). AUCinf (day*ug/mL) - cycle 4 - day 84: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 196 (NA) [SD is not applicable for an analysis with 1 participant].

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Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast [cycle 1 (day 21) and cycle 4 (day 84)]. Mean, ng/mL (Standard Deviation). Cmax (ng/mL) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 17400 (1870); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 58800 (16900); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 56700 (17800); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 96900 (28600); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 122000 (17100); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 186000 (54000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 158000 (44800); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 130000 (38400); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 134000 (64900); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 151000 (42500). Clast (ng/mL) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 1120 (795); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 1290 (2760); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 6600 (6370); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 9130 (11500); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 15100 (9070); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 28700 (27800); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 33000 (21300); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 12900 (10700); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 24500 (20100); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 17500 (11400). Cmax (ng/mL) -- cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 13500 (5580); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 53000 (9790); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 48900 (14100); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 76400 (24000); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 176000 (19800); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 189000 (29400); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 159000 (39800); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 152000 (58000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 128000 (42600); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 147000 (38300). Clast (ng/mL) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 510 (457); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 5700 (10300); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 3490 (2410); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 7350 (5870); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 45100 (12400); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 34100 (29800); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 57600 (45000); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 33300 (42600);

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast [cycle 1 (day 21) and cycle 4 (day 84)]. Mean, ug/mL (Standard Deviation). Cmax (ug/mL) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 24 (9.52); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 29.5 (6.56); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 73.4 (22.3); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 77 (24.3); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 76.6 (36.8); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 64.2 (20.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 94.5 (27.4); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 75.3 (23.9); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 80.2 (24); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 70.3 (21.6). Clast (ug/mL) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 7.73 (2.97); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 7.24 (2.95); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 19.4 (11.7); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 26.4 (11.8); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 22.7 (12.8); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 17.2 (8.67); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 34.5 (13.3); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 24 (12); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 22.8 (9.44); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 24.4 (14.6). Cmax (ug/mL) -- cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 29.5 (9.3); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 36.8 (10.5); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 126 (54.6); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 153 (22.6); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 92 (22.1); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 85.9 (16.8); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 123 (56.8); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 127 (7); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 122 (23.6); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 108 (23.4). Clast (ug/mL) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 10.7 (2.25); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 14.5 (8.47); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 65.1 (37.6); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 71 (6.65); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 47.5 (25.7); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 35.6 (14.7); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 81.4 (43.6); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 62.1 (9.93); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 48.8 (20.6); Ph II: MCS110 7.5

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Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax [cycle 1 (day 21) and cycle 4 (day 84)]. Median, hour (Full Range). Tmax (h) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 2.02 (1.5 to 2.08); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 1.92 (0.5 to 23.7); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 2.08 (1.5 to 22.2); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 2.13 (1.92 to 24); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 2.06 (2 to 24.4); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 2.04 (1.92 to 26.2); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 2.01 (0.5 to 162); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 2.08 (1.92 to 2.28); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 2.09 (2 to 163); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 2.08 (1.5 to 188). Tmax (h) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 2 (2 to 2); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 2.05 (0.5 to 2.08); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 2.03 (2 to 23.7); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 13 (2.02 to 24); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 2 (2 to 20.8); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 2.03 (1.98 to 21.3); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 2 (1.92 to 2.12); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 2.02 (1.98 to 2.08); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 2.04 (2 to 2.12); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 2.05 (2 to 2.13).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax [cycle 1 (day 21) and cycle 4 (day 84)]. Median, hour (Full Range). Tmax (h) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 11.5 (1.48 to 26); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 2.08 (1.5 to 25.5); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 1.53 (1 to 26.5); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 1.57 (1.5 to 22.3); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 1.53 (0.983 to 25.8); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1.52 (1.5 to 22.8); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1.5 (1 to 168); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 1.5 (0.5 to 3.22); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 1.5 (1.42 to 166); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 1.5 (1.45 to 624). Tmax (h) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 1.52 (1.5 to 22.4); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 1.53 (0 to 23.7); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 1.2 (0 to 1.5); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 1.57 (1.55 to 1.58); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 1.5 (1.5 to 3.42); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 1.45 (1.43 to 2.92); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1.53 (1.5 to 165); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=19): 1.47 (1.42 to 1.48); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=20): 1.54 (1.48 to 1.62); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 1.5 (1.43 to 1.67).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 [cycle 1 (day 21) and cycle 4 (day 84)]. Median, day (Full Range). T1/2 (day) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 1.5 (1.25 to 2.38); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 2.16 (1.68 to 6.71); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 3.3 (1.85 to 5.32); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 3.48 (1.73 to 7.82); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 6.35 (2.17 to 8.05); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 4.36 (2.25 to 6.62). T1/2 (day) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 1.77 (1.23 to 1.81); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 1.53 (1.03 to 2.49); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 4.08 (1.41 to 4.26); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 6.32 (6.32 to 6.32); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 4.82 (4.82 to 4.82).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 [cycle 1 (day 21) and cycle 4 (day 84)]. Median, day (Full Range). T1/2 (day) - cycle 1 - day 21: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 8.14 (8.14 to 8.14); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 7.71 (7.71 to 7.71); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 7.13 (7.13 to 7.13); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 7.33 (7.33 to 7.33). T1/2 (day) - cycle 4 - day 84: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 7.81 (7.81 to 7.81).

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Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL [cycle 1 (day 21) and cycle 4 (day 84)]. Mean, L/h/kg (Standard Deviation). CL (L/h/kg) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0.000863 (0.000158); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 0.000388 (0.000181); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0.000394 (0.0000833); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0.000407 (0.000131); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0.000338 (0.000117); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0.000427 (0.0000558). CL (L/h/kg) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0.00117 (0.000549); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 0.000523 (0.000199); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0.000315 (0.000218); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0.000337 (NA) [Not Evaluable]; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0.000541 (NA) [Not Evaluable].

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Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL [cycle 1 (day 21) and cycle 4 (day 84)]. Mean, L/h (Standard Deviation). CL (L/h) - cycle 1 - day 21: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 0.0152 (NA) [Not Evaluable]; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0.0205 (NA) [Not Evaluable]; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0.0167 (NA) [Not Evaluable]; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0.0176 (NA) [Not Evaluable]. CL (L/h) - cycle 4 - day 84: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 0.0213 (NA) [Not Evaluable].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz [cycle 1 (day 21) and cycle 4 (day 84)]. Mean, L/kg (Standard Deviation). Vz (L/kg) - cycle 1 - day 21: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0.0486 (0.00989); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 0.0334 (0.00783); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0.0423 (0.00875); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0.051 (0.0206); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 0.0651 (0.0201); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0.065 (0.0267). Vz (L/kg) - cycle 4 - day 84: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0.0684 (0.0407); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 0.0294 (0.0128); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 0.045 (0.0308); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 0.0736 (NA) [Not Evaluable]; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 0.0904 (NA) [Not Evaluable].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz [cycle 1 (day 21) and cycle 4 (day 84)]. Mean, Liters (L) (Standard Deviation). Vz (L) - cycle 1 - day 21: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 4.28 (NA) [Not Evaluable]; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 5.47 (NA) [Not Evaluable]; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 4.13 (NA) [Not Evaluable]; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 4.47 (NA) [Not Evaluable]. Vz (L) - cycle 4 - day 84: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=11): 5.76 (NA) [Not Evaluable].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) [cycle 4 (day 84)]. Mean, Ratio of AUC (Standard Deviation). Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=3): 0.789 (0.232); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0.744 (0.307); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=4): 0.833 (0.0739); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=2): 1.14 (0.0991); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=3): 1.37 (0.278); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=3): 1.04 (0.731); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=4): 0.712 (0.205); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=3): 0.829 (0.177); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=4): 0.723 (0.315); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=12): 0.987 (0.35).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) [cycle 4 (day 84)]. Mean, Ratio of AUC (Standard Deviation). Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=3): 1.48 (0.17); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 1.15 (0.522); Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=4): 1.14 (0.176); Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=2): 1.89 (0.84); Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=3): 1.85 (0.348); Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=3): 1.5 (0.848); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=5): 1.08 (0.235); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=3): 1.56 (0.593); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=4): 2.05 (0.156); Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=13): 1.54 (0.664).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Phase Ib and Phase II: All Collected Deaths [For ontreatment deaths: up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II. For total deaths: up to 3.8 years]. Number, Participants. Total Deaths: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 6; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 12; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 10; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 12; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 4; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 10; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 11; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 19; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 14; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 11. On-treatment Deaths: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W (n=6): 0; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W (n=12): 1; Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W (n=12): 4; Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W (n=13): 4; Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W (n=6): 1; Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W (n=11): 4; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC (n=20): 1; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC (n=20): 3; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC (n=21): 0; Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME (n=20): 2.