FDA approves Merck KGaA, Pfizer's Bavencio in combination with Inlyta as first-line RCC treatment

Merck KGaA and Pfizer announced that the FDA approved the anti-PD-L1 therapy Bavencio (avelumab) in combination with the tyrosine kinase inhibitor Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The companies noted that this is the first authorisation of "an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC."

Approval was based on data from the Phase JAVELIN Renal 101 study, with results showing that the combination of Bavencio and Inlyta 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. In the trial, median PFS for Bavencio in combination with Inlyta was 13.8 months versus 8.4 months for Sutent.

Further results from the study showed that the objective response rate (ORR) was doubled in the ITT population from 25.7 percent in the Sutent arm to 51.4 percent for Bavencio in combination with Inlyta. However, with a median follow-up of 19 months, data for the trial's other primary endpoint of overall survival are immature, with the study continuing as planned.

The approval of Bavencio in this indication comes less than a month after the FDA cleared Merck & Co.'s Keytruda (pembrolizumab) in combination with Inlyta as a first-line treatment for patients with advanced RCC. The authorisation was based on findings from the Phase III KEYNOTE-426 trial, with results showing that the combination of Keytruda plus Inlyta cut the risk of death by 47 percent versus Sutent, while the risk of disease progression or death was reduced by 31 percent.

Merck KGaA and Pfizer noted that regulatory filings for Bavencio plus Inlyta in advanced RCC are under way worldwide, including in the EU and Japan. The therapy is also approved in the US for use in adults and children aged 12 and older with metastatic Merkel cell carcinoma, with the product generating global sales of 22 million euros ($25 million) in the first quarter of 2019, up 76.6 percent year-over-year.

For related analysis, read Physician Views Results: Oncologist feedback supports view that Keytruda will become a dominant force in renal cancer.

To read more Top Story articles, click here.