The Phase III COMBI-i study evaluating the immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar (dabrafenib) and Mekinist (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival, Swiss pharma giant Novartis (NOVN: VX) announced on Saturday.
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.
Tafinlar, a BRAF inhibitor, and Mekinist, a MEK inhibitor, are already approved to treat BRAF V600-mutant melanoma, generating sales of $737 million in the first half of 2020. Spartalizumab is an experimental PD-1-blocking agent.
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