Merck and Pfizer get PBAC nod for checkpoint inhibitor in bladder cancer

Pharma News: Merck Healthcare and partner Pfizer Australia received positive recommendations for listing of their checkpoint inhibitor on the Pharmaceutical Benefits Scheme (PBS) for both urothelial carcinoma (UC) and advanced renal cell carcinoma (aRCC) indications following review of submissions at the March 2021 meeting of the Pharmaceutical Benefits Advisory Committee (PBAC).

Bavencio (avelumab), PD-L1 inhibitor, is indicated for locally advanced or metastatic urothelial carcinoma (UC) – the most common form of bladder cancer – in cases where cancer has not progressed after platinum-containing chemotherapy. 

The application was based on the JAVELIN Bladder 100 study demonstrating that BAVENCIO plus best supportive care extended median overall survival (OS) by 50% over best supportive care alone following first-line chemotherapy in patients who had not progressed after first-line treatment.

In a competitive market, Pfizer and Merck’s drug is the only checkpoint inhibitor cleared for the first-line maintenance treatment in UC after induction chemotherapy when compared to MSD’s Keytruda (pembrolizumab), Roche’s Tecentriq (atezolizumab), AstraZeneca’s Imfinzi (durvalumab) and Bristol-Myers Squibb’s Opdivo (nivolumab).

This indication allows anti-tumour treatment to continue for longer, giving UC patients a break from the toxicity of chemotherapy. 

Merck and Pfizer, who formed a global strategic alliance in 2014 to jointly develop and commercialise Bavencio, are currently working with the Government to secure reimbursement through the PBS.