Merck Phase 3 Kidney Cancer Combo Data in NEJM, at ASCO GU

• JAVELIN Renal 101 shows significant improvement in progression-free survival with a hazard ratio of 0.69 in patients regardless of PD-L1 expression
• US FDA has granted Priority Review to BAVENCIO plus INLYTA for patients with advanced renal cell carcinoma
• Data at 2019 Genitourinary Cancers Symposium reinforce consistency of PFS and ORR benefits across broad population of patients with advanced RCC, including all prognostic risk groups, and show increased time to progression on next-line therapy

Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the publication of results from an interim analysis of the pivotal JAVELIN Renal 101 trial online in the New England Journal of Medicine.¹The combination of BAVENCIO^® (avelumab) and INLYTA^®(axitinib)* significantly extended median progression-free survival (PFS) by more than five months compared with SUTENT^® (sunitinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC), irrespective of PD-L1 expression (HR: 0.69 [95% CI: 0.56-0.84]; BAVENCIO+INLYTA: 13.8 months [95% CI: 11.1-NE]; SUTENT: 8.4 months [95% CI: 6.9-11.1]; p

‘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,’ said Robert J. Motzer, M.D., Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center, New York, US, and principal investigator for JAVELIN Renal 101. ‘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.’

Additional data presented today at the 2019 Genitourinary Cancers Symposium reinforce the consistency of the PFS and ORR results across patient subgroups, including patients with favorable, intermediate and poor prognoses as well as those with PD-L1-positive or negative tumors. In subgroup analyses, approximately two-thirds of patients with favorable risk (66% of patients using the Memorial Sloan Kettering Cancer Center risk model and 68% with the International Metastatic Renal Cell Carcinoma Database Consortium risk model) achieved a complete or partial response with BAVENCIO+INLYTA. Median PFS for these patients is not yet estimable. BAVENCIO+INLYTA also extended median PFS2, defined as the time from randomization to disease progression on next-line therapy (HR: 0.56 [95% CI: 0.42-0.74]; NE [95% CI: 19.9-NE] vs. 18.4 months [95% CI: 15.7-23.6]) and increased median duration of response by more than four months (95% CI: 2.9-5.1) in the overall population.

https://www.marketscreener.com/MERCK-KGAA-436395/news/Merck-Pivotal-Phase-III-Data-for-BAVENCIO-avelumab-Plus-INLYTA-axitinib-in-Advanced-Renal-Ce-28022994/