The approval marks the first time the FDA has approved a checkpoint inhibitor for the treatment of advanced renal cell cancer.
The U.S. Food and Drug Administration (FDA) approved the first checkpoint inhibitor treatment for advanced renal cell carcinoma (RCC). Late Tuesday, the FDA approved a combination of Bavencio (avelumab) and Inlyta (axitinib) for the first-line treatment of advanced RCC patients.
The combination treatment was a collaboration between Merck KGaA, Darmstadt, Germany and Pfizer, two long-time partners in the development of cancer treatments. The approval was based on the results from the Phase III JAVELIN Renal 101 study. In that study, the combination treatment significantly improved median progression-free survival (PFS) compared with Pfizer’s Sutent (sunitinib) by more than five months in the intent-to-treat (ITT) patient population. Median PFS for the combination therapy was 13.8 months, compared to median PFS of 8.4 months for Sutent. The ITT population included patients regardless of PD-L1 expression and across International Metastatic Renal Cell Carcinoma Database prognostic risk groups, the companies said.
Trial data also showed that the objective response rate (ORR) was doubled in the ITT population who received the combination of Bavencio and Inlyta. With a median overall survival (OS) follow-up of 19 months, data for the trial’s other primary endpoint of OS were immature, with 27 percent of deaths in the ITT population and the trial is continuing as planned, the companies said. Trial data did show there were some safety issues. Serious adverse reactions occurred in 35 percent of patients who received the combination treatment. The incidence of major adverse cardiovascular events was higher in the group who received the combination treatment than in those patients who received Sutent alone.
RCC is the most common form of kidney cancer. It is a type of cancer where PD-L1 expression may contribute to inhibition of the immune response against the tumor. It is also a highly vascular tumor, in which vascular endothelial growth factor (VEGF) plays a key role. Approximately 20-30 percent of patients are first diagnosed with RCC at the advanced stage, and 30 percent of patients treated for an earlier stage go on to develop metastases, the companies noted. About half of patients living with advanced RCC do not go on to receive additional treatment after first-line therapy.
Andy Schmeltz, head of Pfizer Oncology, said the approval of the combination of Bavencio and Inlyta builds on the company’s “long heritage in bringing innovation to the RCC community with the hopes of making a significant and meaningful impact on the lives of patients.”
Merck KGaA’s Rehan Verjee, president of the company’s U.S. subsidiary EMD Serono, said the company is privileged to be able to bring a first-line treatment for patients with advanced RCC.
