Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01584648 | Melanoma | Progression-Free Survival (PFS) as Assessed by the Investigator From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years) | Dabrafenib + Placebo | 8.8 Months |
| Dabrafenib + Trametinib | 10.2 Months | |||
| NCT01597908 COMBI-v | Melanoma | Overall Survival (OS) From the date of randomization until date of death due to any cause (up to approximately 6 years) | Dabrafenib Plus Trametinib | 26.0 Months |
| Vemurafenib | 17.8 Months | |||
| NCT01682083 COMBI-AD | Melanoma | Percentage of Participants With Relapse-free Survival (RFS) Events Approximately 4 years | Dabrafenib and Trametinib Combination Therapy | 3 Participants |
| Dabrafenib and Trametinib Combination Therapy | 163 Participants | |||
| Dabrafenib and Trametinib Combination Therapy | 43 Participants | |||
| Dabrafenib and Trametinib Combination Therapy | 229 Participants | |||
| Dabrafenib and Trametinib Placebos | 149 Participants | |||
| Dabrafenib and Trametinib Placebos | 35 Participants | |||
| Dabrafenib and Trametinib Placebos | 247 Participants | |||
| Dabrafenib and Trametinib Placebos | 1 Participants | |||
| NCT01682083 COMBI-AD | Melanoma | Relapse-free Survival (RFS) Approximately 4 years | Dabrafenib and Trametinib Combination Therapy | NA Months |
| Dabrafenib and Trametinib Placebos | 16.6 Months | |||
| NCT02224781 | Melanoma | 2-year Overall Survival (OS) assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry | Arm A (Immunotherapy) | 0.683 Proportion of participants |
| Arm B (BRAF Inhibitor Therapy) | 0.541 Proportion of participants | |||
| NCT02967692 COMBI-i | Melanoma | Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days | Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD | 1.2 Percentage Marker Area (±2.43 Standard Deviation) |
| Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD | 0.4 Percentage Marker Area (±3.22 Standard Deviation) | |||
| NCT02967692 COMBI-i | Melanoma | Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days | Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD | 2.7 Percentage of positive tumor cells (±7.63 Standard Deviation) |
| Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD | 1.7 Percentage of positive tumor cells (±13.05 Standard Deviation) | |||
| NCT02967692 COMBI-i | Melanoma | Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1 Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3) | Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD | 16.2 Months |
| Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD | 12.0 Months | |||
| NCT02967692 COMBI-i | Melanoma | Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs) Up to 8 weeks (Part 1) | Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD | 1 Participants |
| NCT03551626 COMBI-APlus | Melanoma | Composite Rate of Pyrexia Related Events Baseline up to 12 months | Dabrafenib+Trametinib | 7.6 Percentage of participants |
| NCT04940052 | — | Progression Free Survival (PFS) From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years | Dabrafenib Placebo Plus Trametinib Placebo | 3.7 Months |
| Dabrafenib Plus Trametinib | 12.8 Months |