An updated analysis of interim results for JAVELIN Renal 101 will be presented at a Presidential Symposium during the annual congress of the European Society for Medical Oncology (ESMO 2018), to be held Oct. 19-23 in Munich.
The phase 3 trial compared avelumab (Bavencio) in combination with axitinib (Inlyta) to sunitinib monotherapy as first-line treatment, in patients with advanced renal cell carcinoma (RCC). Interim analysis results announced by the company in a September press release indicated the combination of immunotherapy and a tyrosine kinase inhibitor showed “a statistically significant improvement in progression-free survival by central review for patients treated with the combination whose tumors had programmed death ligand-1‒positive (PD-L1+) expression greater than 1% (primary objective), as well as in the entire study population regardless of PD-L1 tumor expression (secondary objective).”
An updated analysis of progression-free survival and overall response rates will be presented at ESMO 2018 by Robert J. Motzer, MD of Memorial Sloan Kettering Cancer Center, New York.
A phase 1b study (JAVELIN Renal 100), published in Lancet Oncology, found the safety profile of the combination to be similar to either drug alone.
For the phase 3 trial, more than 800 patients with advanced RCC were randomized to first-line treatment with the combination of avelumab (10 mg/kg IV every 2 weeks) plus axitinib (5 mg orally, twice daily) or monotherapy with sunitinib (50 mg orally once daily, 4 weeks on/2 weeks off). The overall survival results will be presented at the Presidential Symposium 2 on Oct. 21.
This article was updated on 10/15/18 to reflect the fact that interim results will be presented.