Merck issued the following announcement on Feb. 11.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new combination and monotherapy data from the company’s broad immuno-oncology research program in genitourinary cancers – renal, prostate and bladder − will be presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in San Francisco from February 14-16. Survival data from the pivotal Phase 3 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 (RCC) will be presented for the first-time (Abstract #543). In October 2018, Merck announced that KEYNOTE-426 met both primary endpoints of overall survival (OS) and progression-free survival (PFS), and the key secondary endpoint of objective response rate (ORR). Data released today 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 KEYTRUDA 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.
“Merck is pursuing a broad clinical program in advanced cancers of the kidney, prostate and bladder with the goal of advancing new treatment options for patients afflicted by historically difficult to treat malignancies,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “The improvement in survival achieved with KEYTRUDA in combination with axitinib for the first-line treatment of advanced renal cell carcinoma, which will be described in detail at the ASCO GU meeting, underscores this commitment.”
More than 20 abstracts across Merck’s oncology portfolio – across RCC, prostate cancer, non-muscle invasive bladder cancer (NMIBC) and urothelial carcinoma – have been accepted for presentation. Select data highlights at ASCO GU include:
Renal Cell Carcinoma
Abstract #543 Oral Presentation: Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for locally advanced or metastatic renal cell carcinoma (mRCC): phase III KEYNOTE-426 study. T. Powles. Saturday, Feb. 16. 2:00 p.m.-3:30 p.m. PST.
Abstract #546 Oral Presentation: First-line pembrolizumab (pembro) monotherapy for advanced non-clear cell renal cell carcinoma (nccRCC): Results from KEYNOTE-427 cohort B. D. McDermott. Saturday, Feb. 16. 2:00 p.m.-3:30 p.m. PST.
Abstract #145 Rapid Abstract Session: KEYNOTE-365 cohort A: Pembrolizumab (pembro) plus olaparib in docetaxel-pretreated patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC). E. Yu. Thursday, Feb. 14. 4:35 p.m.-5:30 p.m. PST.
Abstract #170 Poster Session: KEYNOTE-365 cohort B: Pembrolizumab (pembro) plus docetaxel and prednisone in abiraterone (abi) or enzalutamide (enza)-pretreated patients (pts) with metastatic castrate resistant prostate cancer (mCRPC). C. Massard. Thursday, Feb. 14. 11:30 a.m.-1:00 p.m. and 5:30 p.m.-6:30 p.m. PST.
Abstract #171 Poster Session: KEYNOTE-365 cohort C: Pembrolizumab (pembro) plus enzalutamide (enza) in abiraterone (abi)-pretreated patients (pts) with metastatic castrate resistant prostate cancer (mCRPC). P. Fong. Thursday, Feb. 14. 11:30 a.m.-1:00 p.m. and 5:30 p.m.-6:30 p.m. PST.
Abstract #216 Poster Session: Pembrolizumab for metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel: Updated analysis of KEYNOTE-199. E. Antonarakis. Thursday, Feb. 14. 11:30 a.m.-1:00 p.m. and 5:30 p.m.-6:30 p.m. PST.
Abstract #TPS340 Poster Session: PROPEL: A randomized, phase III trial evaluating the efficacy and safety of olaparib combined with abiraterone as first-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). N. Clarke. Thursday, Feb. 14. 11:30 a.m.-1:00 p.m. and 5:30 p.m.-6:30 p.m. PST.
Abstract #350 Welcome and General Session: KEYNOTE-057: Phase II trial of Pembrolizumab (pembro) for patients (pts) with high-risk (HR) nonmuscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG). A. Balar. Friday, Feb. 15. 7:55 a.m.-9:25 a.m. PST.
Abstract #433 Poster Session: Association between stromal/TGF-β/EMT gene expression signature and response to pembrolizumab monotherapy in cisplatin-ineligible patients with locally advanced (unresectable) or metastatic urothelial carcinoma. P. Grivas. Friday, Feb. 15. 12:15 p.m.-1:45 p.m. and 5:15 p.m.- 6:15 p.m. PST.
For more information, including a complete list of abstract titles and presentation dates and times for Merck’s oncology portfolio, please visit the ASCO GU website at https://gucasym.org/program.
Original source can be found here.