Novartis said it its phase-3 trial on immunotherapy spartalizumab, a programmed cell death protein 1 (PD-1) inhibitor, failed to work against BRAF V600E-mutated malignant melanoma.

The company announced on Saturday that the COMBI-I study, evaluating spartalizumab, did not meet the primary endpoint of progression-free survival (PFS).

The COMBI-I trial assessed spartalizumab’s efficacy and safety, in combination with targeted therapies Rafinlar and Meqsel, in patients with unresectable or metastatic BRAF V600 mutation-positive melanoma.

Novartis’ BRAF inhibitor Rafinlar (dabrafenib) and MEK inhibitor Meqsel (trametinib) arrived in Korea in late 2017. They are the standard therapies for BRAF V600E-positive metastatic melanoma, with the insurance benefit for first-line or more advanced treatments.

Novartis was the latecomer in developing PD-1 inhibiting immunotherapy. The company attempted but failed to provide any additional benefit of spartalizumab, in addition to its standard of care.

“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 Rafinlar plus Meqsel for these patients,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis.

Novartis said it would review the data of the COMBI-i trial to continue developing spartalizumab against various types of tumors.

However, a market research firm said Novartis’ trial failure aggravated the company’s lagging PD-1 inhibitor development.

“Whatever the reason for COMBI-i’s failure, Novartis is now left even further behind in the competitive anti-PD-(L)1 space,” said an article of Evaluate Pharma’s Vantage, a provider of pharma market intelligence and news analysis.

The next important data of spartalizumab is expected to come from other melanoma studies, the report noted. In the worst-case scenario, even if Novartis applies for approval for spartalizumab, the phase-3 trial failure could make regulators question the drug’s effect when used alone, it added.

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