COMBI-I: Long-Term Overall Survival With Spartalizumab Plus Dabrafenib and Trametinib in BRAF V600-Mutant Advanced Melanoma.

Authors

Antoni Ribas, Caroline Robert, Dirk Schadendorf, Georgina V Long, Hussein Tawbi, Keith Flaherty, Paolo A Ascierto, Paul Nathan, Piotr Rutkowski, Oleg V Leonov, Paul Lorigan, Sorilla Prey, Maristella Saponara, Ana Arance, Caroline Gaudy-Marqueste, Daniil Stroyakovskiy, Celeste Lebbe, Michele Maio, Michele Del Vecchio, Pamela Salman Boghikian, Ralf Gutzmer, Roberta Depenni, Marina Miskic, Mark Russo, Reinhard Dummer

Published in

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. Pages JCO2600528. Aug 12, 2026. Epub Aug 12, 2026.

Abstract

The COMBI-I trial (ClinicalTrials.gov identifier: NCT02967692) evaluating spartalizumab plus dabrafenib and trametinib (sparta-DabTram, n = 267) versus placebo plus dabrafenib and trametinib (placebo-DabTram, n = 265) for BRAF V600-mutant unresectable or metastatic melanoma failed to reach its primary end point of progression-free survival at 24 months. This final analysis reports overall survival (OS) during at least 5 years of extended follow-up. At the end of the trial (August 21, 2024), the median duration of follow-up was 76.9 months (range, 73.7-83.3 months). The median OS was 61.5 months (95% CI, 41.6 to not evaluable) for the sparta-DabTram arm and 41.6 months (95% CI, 30.6 to 56.9) for the placebo-DabTram arm (hazard ratio, 0.760 [95% CI, 0.598 to 0.966]). The safety findings were consistent with the known safety profile for sparta-DabTram. The most common treatment-related adverse event (TRAE) was pyrexia (65.9% v 46.2%, respectively, in the two study arms). Grade ≥3 TRAEs were reported in 57.3% and 36.7% of patients in the two arms, respectively. The combination of sparta-DabTram appears to improve OS compared with dabrafenib and trametinib alone in patients with BRAF V600-mutant metastatic melanoma.

PMID:
42585631
Bibliographic data and abstract were imported from PubMed on 13 Aug 2026.

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