BMS PBS listing expands first-line treatment in advanced bladder cancer

Bristol Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), has been added to the Pharmaceutical Benefits Scheme (PBS) for the first-line treatment of unresectable or metastatic urothelial carcinoma (bladder cancer), in combination with cisplatin and gemcitabine.

The PBS listing is underpinned by results from the Phase 3 CheckMate 901 clinical trial, which demonstrated that the addition of Opdivo to the standard of care chemotherapy led to improved clinical outcomes.

At a median follow-up of 33.6 months, the combination therapy showed statistically significant improvements in primary efficacy endpoints. Median overall survival (OS) increased to 21.7 months compared to 18.9 months with chemotherapy alone (p=0.02) while median progression-free survival (PFS) also improved, reaching 7.9 months versus 7.6 months (p=0.001).

“Being diagnosed with urothelial carcinoma can be incredibly challenging for patients and their families, particularly for patients with unresectable or metastatic disease,” said Adam Lynch, CEO of BEAT Bladder Cancer Australia. “Today, together with the patient community, we welcome this Opdivo PBS listing for this patient group. It is so encouraging to see these treatment advances in bladder cancer where there were previously so few options.”

Owen Smith, General Manager of Bristol Myers Squibb Australia/New Zealand, said “With the PBS listing, we’re pleased to be able to offer Opdivo for use in combination with cisplatin and gemcitabine, followed by Opdivo monotherapy, to cisplatin-eligible patients for first-line treatment of unresectable or metastatic urothelial carcinoma.

“This is a welcome additional treatment option for this patient population and reinforces our goal of delivering new options to patients living with difficult-to-treat cancers.”

Urothelial carcinoma is the most common form of bladder cancer, which ranks as the 11th most commonly diagnosed cancer in Australia. In 2023, an estimated 3,121 new cases were diagnosed nationally.

While the majority of bladder cancers are detected early, around 5% of patients present with metastatic disease at initial diagnosis. Furthermore, recurrence is common – approximately half of patients relapse following cystectomy, with risk dependent on tumour stage and nodal involvement.

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