Date: 25-Aug-2020

Novartis Phase III COMBI-i Study Evaluating Spartalizumab In Combo With Tafinlar And Mekinist Fails To Meet Primary Endpoint

Novartis announced that the phase III COMBI-i study evaluating the investigational 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. 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.

“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,” said John Tsai, MD, head of global drug development and chief medical officer, Novartis. “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.”

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 today are from part 3 of the trial.

Spartalizumab is an investigational monoclonal antibody directed against the human programmed death-1 (PD-1) receptor. Its development programme continues investigating the immunotherapy across a range of tumor types.

Tafinlar and Mekinist are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma: That has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable); and that has a certain type of abnormal “BRAF” (V600E or V600K mutation-positive) gene.

Tafinlar and Mekinist are prescription medicines that can be used in combination to help prevent melanoma that has a certain type of abnormal “BRAF” gene from coming back after the cancer has been removed by surgery.

Tafinlar and Mekinist are prescription medications that can be used in combination to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic NSCLC), and that has a certain type of abnormal “BRAF V600E” gene.

Tafinlar and Mekinist are prescription medications that can be used in combination to treat a type of thyroid cancer called anaplastic thyroid cancer (ATC): That has spread to other parts of the body and you have no satisfactory treatment options; and that has a certain type of abnormal “BRAF” gene.

Tafinlar, in combination with Mekinist, should not be used to treat people with wild-type BRAF melanoma. Mekinist should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma and it did not work or is no longer working.