Oncologist hails PBS listing in bladder cancer as ‘potential new standard of care’

Pharma News: From 1 August, high-risk patients with the most common form of bladder cancer will have access to a new treatment option through the Pharmaceutical Benefits Scheme (PBS).

Bristol Myers Squibb’s Opdivo (nivolumab), a PD-1 binding immune checkpoint inhibitor, is now reimbursed for patients with muscle-invasive urothelial carcinoma (MIUC) who have previously received platinum-containing neoadjuvant chemotherapy and are at high risk of recurrence following radical resection.

Urothelial carcinoma is the most prevalent type of bladder cancer, with a five-year survival rate of approximately 57%.

Dr Lewis Au, Medical Oncologist at Peter MacCallum Cancer Centre, welcomed the PBS listing, saying “Based on the CheckMate 274 study, Opdivo is shown to extend disease-free survival for high-risk MIUC patients after radical surgery and has the potential to become a new standard of care option in this setting.”

The results of the Phase 3 CheckMate 274 trial demonstrated that Opdivo reduced the risk of disease recurrence or death by 30% compared to placebo in high-risk MIUC patients. Patients treated with Opdivo remained disease-free for a median of 21.0 months, compared to 10.9 months for the placebo arm.

Currently, the standard of care for MIUC patients includes neoadjuvant cisplatin-containing combination chemotherapy followed by radical surgery. However, patients with residual disease after radical surgery are at a high risk of metastatic recurrence, underscoring the need for new treatment options that can extend disease-free survival and reduce the likelihood of recurrence.

Dr Au also emphasised, “While this reimbursement marks a significant step forward, it’s important that oncologists and urologists work together to ensure conversations around multi-disciplinary care and all options are considered in early stages of disease management.”

Adam Lynch, Chief Executive Officer of BEAT Bladder Cancer Australia, highlighted the benefits of the new listing for patients and their families.

“Receiving a diagnosis of muscle-invasive urothelial carcinoma can be incredibly challenging for patients and their families. Today, alongside the patient community, we welcome this PBS listing of an adjuvant treatment for high-risk MIUC following radical surgery,” said Lynch.

Dr Meredith Edwards, Country Medical Director for BMS Australia and New Zealand, acknowledged the significance of the PBS listing.

“We share this milestone with the wider community and are proud to play a role in delivering access to new treatments,” she stated.

In the PD-1/L1 market, Roche’s Tecentriq, Pfizer’s Bavencio and MSD’s Keytruda all have their clinical wins in different bladder cancer populations. 

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