publication date: Oct. 19, 2018
Keytruda-Inlyta combination improved OS and PFS in front line for advanced, metastatic RCC
The pivotal phase III KEYNOTE-426 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), Pfizer’s tyrosine kinase inhibitor, met both primary endpoints of overall survival and progression-free survival in the first-line treatment of advanced or metastatic renal cell carcinoma.
Based on the first interim analysis by the independent Data Monitoring Committee, the Keytruda plus Inlyta combination resulted in statistically significant and clinically meaningful improvements in OS and PFS, compared to sunitinib monotherapy.
The study also met the key secondary endpoint of objective response rate, with significant improvements for the Keytruda and Inlyta combination compared with sunitinib monotherapy. Results for OS, PFS and ORR were consistent regardless of PD-L1 expression and across all risk groups.
The safety profile of Keytruda and Inlyta in this trial was generally consistent with that observed in previously reported studies for each therapy. These results will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
“This marks the first time that combination treatment with an anti-PD-1 therapy has achieved the dual primary endpoints of overall survival and progression-free survival as first-line therapy in advanced renal cell carcinoma,” said Roger Perlmutter, president, Merck Research Laboratories. “We are very grateful to the investigators and patients for their involvement in this important study, the results of which will be filed with global regulatory authorities in the near future.”
KEYNOTE-426 is a randomized, double-arm, phase III trial (ClinicalTrials.gov, NCT02853331) evaluating the safety and efficacy of KEYTRUDA in combination with Inlyta as first-line treatment for advanced or metastatic RCC compared to sunitinib. The … Continue reading Keytruda-Inlyta combination improved OS and PFS in front line for advanced, metastatic RCC
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