Novartis' melanoma combo fails in PhIII

Novartis has announced that its investigational immunotherapy spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) failed to improve progression-free survival in patients with advanced melanoma.

The Phase III COMBI-i trial did not meet primary endpoint for patients with advanced BRAF V600-mutated melanoma compared to when the combination was compared to Tafinlar (dabrafenib) and Mekinist (trametinib) 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 plus Mekinist for these patients,” said John Tsai, 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.”

The company said it 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 also stressed that it “remains committed” to exploring new uses for immunotherapy in cancer treatment, including the ongoing development of spartalizumab, across a range of tumour types.

Kesimpta approval

In more positive news for the firm, US regulators have approved Kesimpta (ofatumumab) as the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis (RMS).

Approval was based on two Phase III ASCLEPIOS studies demonstrating significant reductions in risk of relapses, confirmed disability progression and brain lesions.

Kesimpta may halt new disease activity in RMS patients as shown in a post hoc analysis, with 47.0% and 87.8% of patients treated with Kesimpta achieving no evidence of disease activity (NEDA-3) within the first (0–12 months) and second year (12–24 months) of treatment, respectively, the firm noted.

“MS is a complex disease, and response to disease modifying treatment will vary among individuals,” said Bruce Bebo, executive vice president of Research at the National MS Society. “This makes it important to have a range of treatments available with different mechanisms of action and routes of administration. We are pleased to have an additional option approved for the treatment of relapsing forms of MS.”