First immunotherapy maintenance treatment approved in advanced bladder cancer

Pharma News: The approval of a new treatment option for Australian patients with locally advanced or metastatic urothelial carcinoma (UC), the most common type of bladder cancer, has been announced by Merck Healthcare and Pfizer Australia.

The Therapeutic Goods Administration (TGA) approved BAVENCIO (avelumab), the only PD-1/L1 drug for first-line maintenance treatment of patients with locally advanced or metastatic urothelial UC whose disease has not progressed with first-line platinum-based induction chemotherapy.

This approval is based on the JAVELIN Bladder 100 study that demonstrated BAVENCIO plus best supportive care extended median overall survival by 50% and reduce the risk of death by 31% vs best supportive care alone following first-line chemotherapy.

“The approval of BAVENCIO represents the most significant change in the treatment paradigm for urothelial carcinoma in the past 30 years,” said Professor Howard Gurney, Director of Clinical Trials for the Faculty of Medicine and Health Sciences at Macquarie University, and an Australian investigator in the JAVELIN 100 Bladder trial.

“Australian prescribers and patients will now have an immunotherapy option in first-line maintenance therapy for locally advanced and metastatic UC.”

BAVENCIO received a positive recommendation for PBS listing from the Pharmaceutical Benefits Advisory Committee at its March 2021 meeting, and Merck and Pfizer are working towards achieving PBS listing.

At ASCO 2021, Merck is presenting new BAVENCIO analyses from the Phase III JAVELIN Bladder 100 study demonstrating consistent survival benefit of BAVENCIO as first-line maintenance treatment across key subgroups including those defined by the treatment-free interval from the end of chemotherapy to the start of maintenance, disease stage, site of metastasis, or genomic subtype. These data further reinforce the role of BAVENCIO for patients with advanced UC that have not progressed on 1L platinum-containing chemotherapy.

BAVENCIO is included in the recently updated National Comprehensive Cancer Network (NCCN) international guidelines (April 2021) as a preferred first-line therapy (Category 1) for locally advanced or metastatic UC following gemcitabine and cisplatin or carboplatin. The European Society for Medical Oncology (ESMO) provided a magnitude of clinical benefit scale (MCBS) score of 4. This score refers to the product having a substantial benefit for patients.

In Australia, 3,098 new cases of bladder cancer were diagnosed in 2020 (more than three quarters of which were in men) and there were 1,016 deaths. Urothelial cancer is the most common form of bladder cancer, accounting for approximately 80-90% of cases. Studies show an average 5-7% of UC cases are locally advanced or metastatic at diagnosis.

BAVENCIO for the first-line maintenance treatment of patients with locally advanced or metastatic UC is also approved in the USA, EU, UK, Canada, Israel, Argentina, Brazil, Lebanon, Japan and the UAE.

Merck and Pfizer have initiated a BAVENCIO Patient Access Program (PAP), which provides eligible patients with locally advanced or metastatic urothelial carcinoma with access to treatment at no cost until disease progression or PBS reimbursement, whichever comes first.

BAVENCIO is currently approved and PBS-listed in Australia for the treatment of the aggressive skin cancer metastatic Merkel cell carcinoma (mMCC); and is approved in advanced renal cell carcinoma (aRCC) with a positive PBAC recommendation received in March 2021.