Spartalizumab is an investigational monoclonal antibody under a development programme evaluating the immunotherapy across various tumour types
Novartis India headquarters HITEC City, Hyderabad. (Credit: Laldharwaja/Wikipedia.)
Phase 3 COMBI-i clinical trial, evaluating Novartis’ investigational immunotherapy spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) did not meet the primary endpoint.
The drug did not improve the progression-free survival in untreated patients with unresectable (Stage-3C) or metastatic (Stage-4) BRAF V600 mutation-positive cutaneous melanoma, as assessed by the investigator.
Novartis global drug development head and chief medical officer John Tsai said: “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.
“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.”
Spartalizumab is an investigational monoclonal antibody studied across various tumour types
Spartalizumab is an investigational monoclonal antibody designed to target the human programmed death-1 (PD-1) receptor and is currently under a development programme evaluating the immunotherapy across various tumour types.
Tafinlar and Mekinist are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma, metastatic NSCLC, anaplastic thyroid cancer (ATC).
COMBI-i is a randomised, double-blind, placebo-controlled, Phase 3 clinical trial that evaluated the combination of anti-PD1 spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) compared with the combination of placebo with Tafinlar and Mekinist.
The COMBI-i trial was conducted in three parts, and the current results are from of third part of the clinical trial.
The Swiss drugmaker said that the investigators will continue the review of COMBI-i study data, and is committed to exploring new uses for spartalizumab as immunotherapy for the treatment of various cancers.