Phase III COMBI-i study of PDR 001 + Tafinlar + Mekinist fails to meet primary endpoint in melanoma.- Novartis

Novartis announced that the Phase III COMBI-i study evaluating the investigational immunotherapy PDR 001 (spartalizumab), in combination with the targeted therapies Tafinlar (dabrafenib) and Mekinist (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival. The trial was conducted among untreated patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600 mutation-positive cutaneous melanoma, compared to Tafinlar + Mekinist alone. Novartis and the COMBI-i study investigators will continue to review the data to learn more from the results, which are expected to be submitted for presentation at a future medical meeting. Novartis remains committed to exploring new uses for immunotherapy in cancer treatment, including the ongoing development of spartalizumab, across a range of tumor types. COMBI-i was a randomized, double-blind, placebo-controlled, Phase III study comparing the combination of anti-PD1 spartalizumab with Tafinlar (dabrafenib) and Mekinist (trametinib) versus the combination of placebo with Tafinlar and Mekinist. The study was conducted among previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma. The COMBI-i study was conducted in three parts. Results reported are from part 3 of the trial.