Merck, Pfizer intend to file Bavencio, Inlyta combo

The pivotal Phase III JAVELIN Renal 101 study evaluated immunotherapy Bavencio (avelumab) in combination with tyrosine kinase inhibitor Inlyta (axitinib), compared with Pfizer’s Sutent (sunitinib) as first-line therapy for patients with advanced renal cell carcinoma (RCC).

A planned interim analysis by an independent Data Monitoring Committee has confirmed a statistically significant improvement in progression-free survival (PFS) for patients treated with the combination whose tumors had PD-L1+ expression greater than 1% (primary objective), as well as in the entire study population regardless of PD-L1 tumor expression (secondary objective).

The study will continue as planned to the final analysis for the other primary endpoint of overall survival (OS), the firms said, but noted that they plan to file the combination in the US as well as initiate discussions with other health authorities given the strength of the PFS data.

"We are encouraged by these data which illustrate the impact of Bavencio in combination with Inlyta as a potential first-line treatment for people with advanced RCC, a serious and life-threatening cancer," said Luciano Rossetti, executive vice president, global head of R&D at the Biopharma business of Merck.

"They also support our firm belief in the promise of combining Bavencio with currently approved therapies and novel agents, a strong focus of the overall Javelin clinical development program."

Late last year the combination was awarded breakthrough status in the US based on data from the JAVELIN 100 trial, which showed it induced a response in 58.2% of patients with advanced RCC.

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