Dabrafenib (D) and trametinib (T) plus spartalizumab (S) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma...Estimated 2-year and 3-year OS rates were 67.7% (95% CI 61.6‒73.1) and 60.1% (95% CI 53.8‒65.8) with S+D+T vs 61.9% (95% CI 55.6‒67.5) and 52.9% (95% CI 46.6‒58.9) with PBO+D+T, respectively….Results from this landmark 3-year OS analysis from COMBI-i- part 3 was consistent with the primary analysis, while the PBO+D+T showed a higher OS rate than previously observed for D+T alone in COMBI D/V studies, with a longer median follow-up.

Patients received spartalizumab 400 mg intravenously every 4 weeks plus dabrafenib 150 mg orally twice daily and trametinib 2 mg orally... Participants were age ≥ 18 years with unresectable or metastatic BRAF V600-mutant melanoma….The objective response rates were 69% (183 of 267 patients) versus 64% (170 of 265 patients), respectively.

NON-SUPPORTIVE EVIDENCE:...Sparta-DabTram did not significantly improve PFS vs PBO...While OS was not formally tested, median OS was not reached (NR) across tx arms (HR, 0.785). The objective response rate was 69% in the Sparta-DabTram arm….The primary endpoint was not met.

These preliminary results indicate that PDR001 can be combined with D+T with a manageable safety profile and demonstrate promising activity in pts with BRAF V600–mutant melanoma.

...Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation...