publication date: Feb. 15, 2019

Clinical Roundup

Keytruda + Inlyta improves OS, PFS and ORR vs. Sunitinib in RCC

Merck announced new combination and monotherapy data from the company’s immuno-oncology research program in genitourinary cancers will be presented at the 2019 Genitourinary Cancers Symposium in San Francisco Feb. 14-16.

Survival data from the pivotal phase III KEYNOTE-426 trial with Keytruda, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced or metastatic renal cell carcinoma will be presented for the first-time (Abstract #543).

In October 2018, Merck announced that KEYNOTE-426 met both primary endpoints of overall survival  and progression-free survival, and the key secondary endpoint of objective response rate. Data from the first interim analysis showed Keytruda in combination with axitinib, when compared to sunitinib, significantly improved OS, reducing the risk of death by nearly half, (HR 0.53 [95% CI 0.38-0.74]; P=0.0001), as well as PFS (HR 0.69 [95% CI 0.57-0.84]; P=0.0001) and ORR (59.3% vs. 35.7%; P=0.0001).

Results across OS, PFS and ORR were consistent across all IMDC risk groups and regardless of PD-L1 expression. Treatment-related adverse events were grade 3-5 in 62.9 percent of patients in the Keytryda and axitinib arm vs 58.1 percent in the sunitinib arm and led to regimen discontinuation in 6.3 percent vs 10.1 percent of patients in those arms, respectively. Full results from KEYNOTE-426 will be presented at the meeting.

KEYNOTE-426 is a randomized, double-arm, phase III trial (, NCT02853331) evaluating the safety and efficacy of Keytruda in combination with axitinib as first-line treatment for advanced or metastatic RCC compared to sunitinib.

The dual primary endpoints of the study were OS and PFS, and the … Continue reading Keytruda + Inlyta improves OS, PFS and ORR vs. Sunitinib in RCC

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