KEYNOTE-045 Study Meets Primary Endpoint and Stops Early

Studying pembrolizumab in advanced urothelial cancer

On 21 October 2016, Merck, known as MSD outside the United States and Canada, announced that the phase III, KEYNOTE-045 trial investigating the use of pembrolizumab (KEYTRUDA®), anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival (OS). In this trial, pembrolizumab was superior compared to investigator choice of chemotherapy. Based on a pre-specified interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early.

Pembrolizumabis the first immunotherapy to show improved OS compared with chemotherapy in urothelial cancer. The safety profile of pembrolizumab in this trial was consistent with that observed in previously reported studies involving patients with advanced urothelial cancer.

Results from KEYNOTE-045 will be presented at an upcoming medical meeting.

KEYNOTE-045 is a randomised, pivotal, phase III study (ClinicalTrials.gov, NCT02256436) evaluating pembrolizumab monotherapy compared to investigator choice of chemotherapy ( paclitaxel, docetaxel, vinflunine) in the treatment of patients with metastatic or locally advanced or unresectable (inoperable) urothelial cancer that has recurred or progressed following platinum-based chemotherapy.

The co-primary endpoints are OS and progression-free survival (PFS); secondary endpoints are overall response rate (ORR), duration of response (DOR), and safety.

The study randomised 542 patients to receive pembrolizumab (200 mg every three weeks) or investigator choice of paclitaxel (175 mg/m2 every three weeks), docetaxel (75 mg/m2 every three weeks), or vinflunine (320 mg/m2 every three weeks).

Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. Pembrolizumab is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. Pembrolizumab for injection is supplied in a 100 mg single use vial.

In 2012, approximately 430,000 patients worldwide were diagnosed with bladder cancer and 165,000 died from the disease. The incidence of bladder cancer is elevated in North America, Europe, North Africa, the Middle East, Australia and New Zealand.

The news release of Merck & Co., Inc., Kenilworth, NJ, USA includes “forward-looking statements”.