FDA OKs First Anti-PD-L1 Therapy in Combo Regimen for Advanced Kidney Cancer


Avelumab (Bavencio) plus axitinib (Inlyta) is indicated for the first-line treatment of patients with advanced renal cell carcinoma.

Officials with the FDA have approved Pfizer’s avelumab (Bavencio) in combination with axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), according to a press release.

Avelumab, a human anti-programmed death ligand-1 (PD-L1) antibody, blocks the interaction of PD-L1 and PD-1 receptors. In preclinical models, the drug has been shown to release the suppression of T cell-mediated antitumor immune response and induce NK cell-mediated direct tumor cell lysis via antibody-dependent, cell-mediated cytotoxicity in vitro.

With this approval, avelumab is the first anti-PD-L1 therapy approved as part of a combination regimen for advanced RCC, according to the release.

Approximately 20% to 30% of patients are first diagnosed with RCC at an advanced stage and 30% of patients treated for an earlier stage go on to develop metastases, according to Pfizer. The 5-year survival rate for patients with metastatic RCC is approximately 12%. The approval of new treatments in the first-line setting offers much-needed options for patients with advanced disease.

The phase 3 JAVELIN Renal 101 study evaluated the combination therapy in 886 patients with untreated advanced RCC regardless of tumor PD-L1 expression [intent-to-treat (ITT) population]. Compared with sunitinib, the combination significantly improved median progression-free survival by more than 5 months in the ITT population (HR: 0.69 [95% CI: 0.56-0.84].

The objective response rate was doubled in the ITT population with the combination therapy compared with sunitinib (51.4% versus 25.7%, respectively), according to the study. With a median overall survival (OS) follow-up of 19 months, data for the other primary endpoint of OS were immature, with 27% of deaths in the ITT population.

“As we look to continue to improve outcomes for people with advanced RCC, new treatment approaches have the potential to benefit patients,” principal trial investigator Robert J. Motzer, MD, Jack and Dorothy Byrne Chair in Clinical Oncology at Memorial Sloan Kettering Cancer Center, said in a statement. “With today’s FDA approval of avelumab in combination with axitinib, we can now offer patients with advanced RCC a first-line treatment option that combines a PD-L1 immunotherapy with a well-known VEGFR TKI to provide a significant reduction in the risk of disease progression or death and doubling of the response rate compared with sunitinib.”

The JAVELIN clinical development program for avelumab includes at least 30 clinical programs and approximately 10,000 patients across more than 15 different tumor types, including gastric/gastro-esophageal junction cancer, head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer, and urothelial cancer.


FDA approves Bavencio (avelumab) plus Inlyta (axitinib) combination for patients with advanced renal carcinoma [news release]. Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_bavencio_avelumab_plus_inlyta_axitinib_combination_for_patients_with_advanced_renal_cell_carcinoma. Accessed May 15, 2019.

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