KEYTRUDA now registered for bladder cancer

KEYTRUDA® (pembrolizumab) is now registered by Medsafe for the treatment of patients with advanced urothelial carcinoma (a type of bladder cancer).¹

Urothelial carcinoma, the most common type of bladder cancer, starts in the urothelial cells that line the inside of the bladder. In 2014, 437 New Zealanders were diagnosed with bladder cancer,² and around 70% of those diagnosed were men. ²

Paul Smith, MSD New Zealand Director says, “Medsafe has now registered KEYTRUDA for advanced urothelial carcinoma patients who have received prior platinum-containing chemotherapy, as well as adults with advanced urothelial carcinoma, who are not eligible for cisplatin-containing chemotherapy.”¹

Chemotherapy has long been the standard of care for newly diagnosed patients with advanced bladder cancer; however, around half of patients may not be well enough to receive this type of treatment.³

The Medsafe approval in previously treated patients was based on results for KEYTRUDA versus chemotherapy in the KEYNOTE-045 trial. Nearly double the number of KEYTRUDA patients responded to treatment (57) versus the chemotherapy patients (31) ⁴ and 7% ⁵ of patients had a complete response meaning their cancer was undetectable. In addition, 68% of the patients who responded were continuing to respond at 12 months compared to 35% of the chemotherapy patients. ⁴

The Medsafe approval for untreated patients who were ineligible for cisplatin-containing chemotherapy was based on the KEYNOTE-052 trial; where patients received KEYTRUDA every three weeks.⁶ This trial demonstrated an overall response rate of 24 % ⁶ and 5% of patients had their cancer completely disappear.⁶

Paul Smith says, “Despite advances, there remain limited treatment options for patients with advanced bladder cancer, so it is very exciting to have a new treatment option for these difficult-to-treat patients.

“Our focus is on working with PHARMAC to ensure patients gain access to KEYTRUDA as quickly as possible. Patients wanting to access KEYTRUDA now should seek advice from their cancer specialist about the options that may benefit them.

“MSD currently has a large immuno-oncology clinical development programme in bladder cancer, with 29 trials involving KETYRUDA alone or in combination with other medicines^{.” 7}

KEYTRUDA, which was funded for advanced melanoma last year, also has three registrations for advanced non-small cell lung cancer and a registration for classical Hodgkin’s Lymphoma in New Zealand.¹