The combination of Bavencia and Inlyta have significantly expanded median PFS by more than five months compared against Sutent (sunitinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC) in the pivotal Javelin Renal 101 trial. The results are from an interim analysis of the trial.
The phase III Javelin Renal 101 study was designed to assess the combination of Bavencio+Inlyta compared with Sutent in 886 patients with previously untreated advanced RCC.
Bavencio+Inlyta significantly reduced the risk of disease progression or death by 39% in patients with PD-L1-positive tumors, which is a primary endpoint of the study.
This month, the firms also announced that the US Food and Drug Administration (FDA) accepted for priority review the supplemental biologics license application (sBLA) for Bavencio in combination with Inlyta for patients with advanced RCC.
Javelin, which is a clinical development program for avelumab, included around 30 cliniprograms and assessed more than 9,000 patients across over 15 different tumor types.
The tumor types comprise of breast, gastric/gastro-esophageal junction, and head and neck cancers, Merkel cell carcinoma, non-small cell lung cancer and urothelial carcinoma, in addition to RCC.
Bavencio is a human anti-programmed death ligand-1 (PD-L1) antibody, and it demonstrated to release the suppression of the T cell-mediated antitumor immune response in preclinical models by blocking the interaction of PD-L1 with PD-1 receptors.
Merck and Pfizer entered into a strategic alliance to co-develop and co-commercialize Bavencio in November 2014.
Javelin Renal 101 trial principal investigator Dr Robert Motzer said: “There is a significant need for patients with advanced RCC to prolong the time until the disease worsens beyond what tyrosine kinase inhibitors alone offer.
“The magnitude and consistency of PFS and response rates seen thus far across populations in the JAVELIN Renal 101 study suggest that many different types of patients, including those with a favorable prognosis, could potentially derive benefit from this particular combination.”