KENILWORTH, N.J.—Merck, known as MSD outside of the United States and Canada, is closing October with a spate of good news. The company announced on Oct. 21 that its Phase 3 KEYNOTE-045 trial of Keytruda in patients with previously treated advanced urothelial (bladder) cancer met its primary endpoint of overall survival and was proved superior compared to investigator choice chemotherapy. Keytruda's safety profile in the trial stayed consistent with that seen in previous studies of patients with advanced urothelial cancer. Given the results of a pre-specified interim analysis, an independent Data Monitoring Committee recommended that the trial be stopped early.
The trial is a randomized, pivotal Phase 3 study evaluating KEYTRUDA monotherapy compared to investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with metastatic or locally advanced or unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy. The co-primary endpoints are overall survival and progression-free survival, with secondary endpoints of overall response rate, duration of response and safety.
“The results of KEYNOTE-045 represent a major breakthrough and will be welcome news for patients dealing with previously treated advanced urothelial cancer,” said Dr. Roger M. Perlmutter, president of Merck Research Laboratories, remarked in a press release. “We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world.”
Urothelial carcinoma is the most common type of bladder cancer, and begins in the urothelial cells that line the inside of the bladder. In 2012, roughly 430,000 people worldwide were diagnosed with bladder cancer and 165,000 died from the disease. Merck noted in a press release that for genitourinary cancers, it has the largest immuno-oncology clinical development program in bladder cancer, with 27 trials underway involving Keytruda as monotherapy and in combination, including four registration-enabling studies.
The same day it shared the news regarding KEYNOTE-045, Merck also shared that it had racked up another approval from the FDA when the agency gave the green light for ZINPLAVA (bezlotoxumab) Injection 25 mg/mL. The drug is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years old and up who are receiving antibacterial drug treatment for CDI and are at high risk for recurrence. Merck expects to make ZINPLAVA available in the first quarter of next year.
In other good news for Keytruda, Merck announced that the FDA has approved the drug for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. This makes Keytruda the only anti-PD-1 therapy approved in the first-line treatment setting for this patient population.
“Ketytruda improved survival, compared to traditional chemotherapy, in patients with non-small cell lung cancer whose tumors express high levels of PD-L1,” Perlmutter noted in the announcement. “The approval of KEYTRUDA for the first-line treatment of metastatic non-small cell lung cancer has the potential to change the treatment landscape for these patients.”
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