According to findings from the phase 1b JAVELIN Renal 100 trial in the USA, the combination of Bavencio (avelumab) – a PD-L1 inhibitor – and Inlyta (axitinib) – a VEGF inhibitor – had a response rate of 58.2 percent in patients with advanced renal cell carcinoma (RCC).

The JAVELIN Renal 100 study (currently recruiting in the UK as of the date of this post) included 55 patients with advanced clear-cell RCC. Patients had a median age of 60 years (range, 42-76), no prior systemic therapy for advanced RCC, and an ECOG performance status up to 1.
Over 95 percent of patients had favorable or intermediate risk per MSKCC criteria. Patients had one (45.5 percent), two (41.8 percent) or three (12.7 percent) metastatic sites. In the dose-finding stage of the study, patients received a lead-in dose of Inlyta of 5 mg orally twice daily for seven days, followed by 10 mg/kg of Bavencio IV every two weeks plus Inlyta at 5 mg orally twice a day.
In the dose-expansion phase, patients could receive the same regimen as the dose-finding phase, or just start with 10 mg/kg of Bavencio IV every two weeks plus Inlyta at 5 mg orally twice a day. Fifty-four of 55 patients received the combination, with 1 patient never receiving Inlyta. At the April 13, 2017, data cutoff, treatment was ongoing in 30 patients receiving Inlyta and 31 patients receiving Inlyta.
The median duration of Bavencio treatment was 36.5 weeks, and the median duration of Inlyta treatment was 34 weeks. Thirty-one patients had at least one dose reduction of Inlyta, and 10 patients had at least 1 dose escalation of Inlyta.
Thirty-two patients had confirmed responses, including three CRs, and 29 PRs. An additional patient still receiving therapy had an unconfirmed response. Eleven patients had stable disease, 10 had progressive disease, and two were not evaluable. In 20 of 32 responders, the response occurred at the time of the first tumor assessment, and responses were ongoing in 24 of the responders. Late responses occurred, as well. “Six patients had a late response — on or after week 18 –– and five of these patients remain on treatment,” said Choueiri. – Read the full story HERE  Our Glossary Of Terms may help when reading this article