UPDATED: Merck ends Keytruda trial early with data to challenge Opdivo in bladder cancer

Keytruda packaging

Merck has cut short its Phase III trial of checkpoint inhibitor Keytruda in advanced bladder cancer, saying it hit its endpoint, and so is moving on to present the data to regulators. This is particularly good news for the drugmaker since it is playing catch-up to competitors Roche and Bristol-Myers Squibb for this condition.

The Kenilworth, NJ-based Merck said today that independent Data Monitoring Committee recommended ending the trial after the anti-PD-1 therapy met the primary endpoint of overall survival in patients with previously treated advanced urothelial cancer compared to chemotherapy using one of three treatments.

The randomized trial of 542 patients pitted Keytruda against paclitaxel, docetaxel or vinflunine in patients in whom the cancer has recurred or progressed following platinum-based chemotherapy and had coprimary endpoints of overall survival and progression-free survival.

“The results of Keynote-045 represent a major breakthrough....We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world,” Roger Perlmutter, who heads Merck’s R&D efforts, said today in a statement.

The results will provide a boost for Merck in its efforts to chase down its competitors in this arena. Roche’s Tecentriq burst onto the immuno-oncology stage in May with an FDA approval in bladder cancer for patients who’ve failed on platinum-based chemotherapy. At the ASCO meeting in June, Roche offered Phase II study data that 24% of cisplatin-ineligible bladder cancer patients saw their tumors shrink on Tecentriq.

Bristol-Myers, which had won an FDA breakthrough designation for Opdivo in bladder cancer, late Friday said the the FDA had accepted for priority review its application for Opdivo for previously treated patients with an advanced form of bladder cancer.

Since the immuno-oncology drugs premiered on the scene in 2014, Keytruda and Opdivo have been battling back and forth to be the go-to treatment in a variety of cancers. Merck pointed out today that its development program includes 360 clinical trials on more than 30 tumor types, including nearly 200 trials that combine Keytruda with other cancer treatments. Of course, BMS is doing much the same thing.

Opdivo had generally been seen as leading the race, with higher peak sales numbers having been attached to it than Keytruda, but it stumbled badly recently when it failed to meet its endpoint as a first-line monotherapy for lung cancer.  Keytruda, meanwhile, has won a breakthrough designation for first-line treatment, setting up a multibillion-dollar opportunity to steal market share from Opdivo. Roche earlier this week also received a green light from U.S. regulators in the second-line space for lung cancer, adding more competition there.

- read the Merck release
- here's the BMS release 

Related Articles:
UPDATED: Merck's Keytruda posts 24% response rate in PhII bladder cancer study
Bristol nabs Opdivo 'breakthrough' in bladder cancer--and gears up for Roche showdown
Roche's Tecentriq scores lung cancer nod, setting up 3-way battle with Merck, BMS
Still no Opdivo benefit in subgroup breakdown of Bristol's first-line NSCLC flop
BMS loses its lung cancer lead to Merck as Opdivo data comes up short

Editor's Note: The story was updated with the fact that the FDA today accepted Bristol-Myers Squibb's application for use of Opdivo in advanced bladder cancer.