Keytruda approved for bladder cancer in Europe, first to prove survival benefit

Merck Sharp & Dohme’s Keytruda has been approved in Europe for metastatic urothelial carcinoma, a move which helps it catch up with its immunotherapy rivals.

However, while BMS’ Opdivo and Roche’s Tecentriq beat MSD (known as Merck in the US) to approval in Europe earlier this year, Keytruda is the first to show superior overall survival versus chemotherapy in patients who have failed earlier treatment.

This could give it a major advantage, especially over Tecentriq, which in May failed to show superior overall survival (OS) in its key phase 3 trial.

Keytruda is now approved for use as monotherapy in locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for cisplatin-containing chemotherapy.

In the Keynote 045 study, Keytruda showed a 27% reduction in the risk of death compared to chemotherapy – with 155 events (57%) observed in the Keytruda arm, compared to 179 events (66%) in the chemotherapy arm.  The median OS was 10.3 months with Keytruda compared to 7.4 months  in the chemotherapy arm.

Dr Roger Dansey

Dr Roger Dansey

“This approval of Keytruda is important for patients with advanced urothelial carcinoma,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “Our focus is now on working with health authorities in Europe to ensure access for these patients as quickly as possible.”

“Despite advances, there remain limited treatment options available to patients with locally advanced or metastatic urothelial carcinoma who are either not eligible to receive cisplatin-containing chemotherapy – which is platinum-based and currently the standard of care – or for those patients whose cancer returns after receiving prior platinum-containing chemotherapy,” said professor Ronald de Wit, M.D., Ph.D., group leader experimental systemic therapy of urogenital cancers, Erasmus MC Cancer Institute.

“It is exciting that with this approval of Keytruda, we now also have a new treatment option for patients previously treated with platinum-containing chemotherapy that has shown a clinically meaningful and improved overall survival benefit versus chemotherapy in this difficult-to-treat population.”

The median duration of response for patients treated with the immunotherapy had not yet been reached (range: 1.6+ to 15.6+ months), compared to 4.3 months (range: 1.4+ to 15.4+ months) in the chemotherapy arm.

However there are limits to Keytruda’s benefits in bladder cancer, with the trial showing a response rate in just 21% of patients, though this was significantly higher than the 7% seen with chemotherapy.

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