Pfizer and Merck reported positive top-line results from the Phase III JAVELIN Renal 101 clinical trial conducted to assess the cominbation of Bavencio (avelumab) and Inlyta (axitinib) as initial therapy for advanced renal cell carcinoma (RCC).
During a planned interim analysis, the combination demonstrated statistically significant improvement in progression-free survival (PFS) for previously untreated patients, compared to Sutent (sunitinib).
This improvement was observed in subjects with programmed cell death ligand-1-positive (PD-L1+) expression greater than 1%, and in the entire study population irrespective of PD-L1 tumour expression.
Bavencio is Merck’s anti-programmed cell death ligand-1 (PD-L1) antibody, while Inlyta is a small molecule tyrosine kinase inhibitor developed by Pfizer.
The combination secured breakthrough therapy designation in the US in December last year for treatment-naïve patients with advanced RCC.
JAVELIN Renal 101 is a global, multi-centre, randomised Phase III trial designed to evaluate the efficacy and safety of the combination in a total of 886 participants.
Data did not reveal any new safety signals. Adverse events for all three drugs were observed to be consistent with previous safety profiles.
Based on these interim results, Pfizer and Merck plan to file a regulatory submission in the US. The JAVELIN Renal 101 trial will continue as planned to the final analysis of overall survival (OS) as the other primary endpoint.
Merck Biopharma business Research & Development global head Luciano Rossetti said: “We are encouraged by this data which illustrates 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.
“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 programme.”
Pfizer and Merck partnered in November 2014 to co-develop and co-commercialise Bavencio.