The European Commission (EC) has approved Keytruda (pembrolizumab) for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, according to the therapy’s maker, Merck, known as MSD outside the United States and Canada.
The approval includes adults who received prior platinum-based chemotherapy and adults who are ineligible for Platinol-based chemotherapy.
“This approval of Keytruda is important for patients with advanced urothelial carcinoma,” Roger Dansey, senior vice president and therapeutic area head of oncology late-stage development at Merck Research Laboratories, said in a press release. “Our focus is now on working with health authorities in Europe to ensure access for these patients as quickly as possible.”
The EC’s decision was based on data from two ongoing clinical studies: the KEYNOTE-045 Phase 3 trial (NCT02256436) and KEYNOTE-052 Phase 2 trial (NCT02335424).
KEYNOTE-045 is a multicenter, placebo-controlled, randomized study that included 542 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-based chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy.
Patients were randomized to receive either Keytruda every three weeks or the investigator’s choice of chemotherapy. Chemotherapy regimens included Taxol (paclitaxel), Taxotere (docetaxel), or the investigational drug vinflunine.
Results showed that Keytruda treatment reduced the risk of death by 27% compared with the other treatment regimens. Median overall survival for those receiving Keytruda was 10.3 months, while it was 7.4 months in the chemotherapy group.
KEYNOTE-052 is a multicenter trial that included 370 patients with locally advanced or metastatic urothelial carcinoma who were not eligible for Platinol-containing chemotherapy. Participants received Keytruda once every three weeks for up to 24 months, unless they presented signs of treatment-related toxicity.
After a follow-up of 9.5 months, 29% of patients had responded to the treatment, with 7% achieving complete remission. At the time, more than half of the patients who responded had not seen their disease progress, and researchers were unable to determine the median duration of response and progression-free survival.
“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, MD, PhD, group leader for experimental systemic therapy of urogenital cancers at the 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,” he added.
