- Merck & Co. released positive updated data for its KEYNOTE-085 and KEYNOTE -045 Keytruda (pembrolizumab) studies at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.
- In a group of patients with advanced bladder cancer who were not able to have cisplatin treatment (KEYNOTE-052), Keytruda first-line met its primary endpoint, with 25 (7%) of patients having compete responses and 81 (22%) partial responses. After a median follow up of 8 months, 74% of responses were ongoing, and the positive responses were supported by biomarker data.
- In second-line use in recurrent, advanced urothelial cancer (KEYNOTE-045), Keytruda was significantly more effective than chemotherapy with paclitaxel, docetaxel or vinflunine, with an overall survival of 10.3 vs. 7.4 months (p<0.001), with significance lasting longer irrespective of PD-L1 expression. Overall survival was also higher and lasted for longer.
Advanced urothelial bladder cancer is an area of cancer where, historically, there have been few treatment options, and the five-year survival is just 5%. The rise of the checkpoint inhibitors is bringing new hope for these patients, with U.S. approvals and accelerated approvals for Keytruda, Bavencio (avelumab), Imfinzi (durvalumab) and Tecentriq (atezolizumab) just over the past couple of months.
"The updated data at ASCO in previously treated urothelial cancer patients continue to support the overall survival benefit we have observed in the second-line treatment setting and the response rates demonstrated in cisplatin-ineligible patients,” said Roger Dansey, therapeutic area head of oncology late-stage development at Merck Research Laboratories.
The recent failure of Tecentriq (atezolizumab) in bladder cancer calls into question whether all checkpoint inhibitors are the same, as previously thought. Unravelling that possibility will be a challenge, and would be likely to need data from a lot of patients, or even head-to-head studies. However, it could open up new approaches to the development of second-generation checkpoint inhibitors.
Keytruda clinical development is ongoing, with studies looking at more than 30 tumor types in over 500 clinical trials, including more than 300 trials that combine Keytruda with other cancer treatments. In bladder cancer there are 29 monotherapy and combination therapy trials underway.