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Spartalizumab phase 3 combination study fails to meet primary endpoint


Novartis announces their phase 3 study investigating spartalizumab (PDR001) in combination with dabrafenib (Tafinlar) and trametinib (Mekinist) failed to meet its primary endpoint.

Novartis recently announced an update on its phase 3 study (COMBI-i) investigating spartalizumab (PDR001, Novartis) in combination with dabrafenib (Tafinlar, Novartis) and trametinib (Mekinist, Novartis) as a treatment for advanced BRAF V600-mutated melanoma, with the study failing to meet its primary endpoint of investigator-assessed progression-free survival.

“While the COMBI-i trial did not reach its primary endpoint, the study’s findings give us valuable insights into the role the investigational immunotherapy spartalizumab may play in future cancer therapy combinations and underscore the previously established importance of Tafinlar + Mekinist for these patients,” says John Tsai, M.D., head of Global Drug Development and chief medical officer at Novartis.

Spartalizumab, an investigational monoclonal antibody, is designed to work against the human programmed death-1 (PD-1) receptor.

MORE: 5-year follow-up demonstrates long-term benefit of dabrafenib/trametinib for stage 3 melanoma

The COMBI-I study is a phase 3, double-blind, randomized, placebo-controlled trial evaluating anti-PD1 spartalizumab in combination with dabrafenib and trametinib compared to placebo with dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma.1

The company says they plan on continuing to review data from the study and will submit results for presentation at upcoming scientific congresses. They will also continue to investigate and develop spartalizumab at a treatment for various tumor types, according to a press release.1

RELATED: FDA approves Tafinlar with Mekinist for melanoma

“Novartis remains committed to melanoma patients through ongoing research, and we continue to deliver the approved combination therapy Tafinlar + Mekinist to patients around the world. We extend our gratitude to the patients and investigators who participated in the COMBI-i study. Their partnership has expanded our understanding of spartalizumab and its potential role in future cancer treatments,” says Dr. Tsai.


1. Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar® Mekinist® in advanced melanoma. (2020, August 22). Retrieved September 11, 2020, from https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-study-evaluating-investigational-spartalizumab-pdr001-combination-tafinlar-mekinist-advanced-melanoma

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