BMS achieves Australian-first with pre-surgery lung cancer PBS listing

On World Lung Cancer Day (1 August), Bristol Myers Squibb’s PD-1 checkpoint inhibitor combined with platinum-based chemotherapy is the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer (NSCLC) to be listed on the Pharmaceutical Benefits Scheme (PBS).

Lung cancer remains the leading cause of cancer deaths in Australia, with an estimated 14,500 Australians diagnosed annually. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases.

The PBS reimbursement of Opdivo (nivolumab) is underpinned by data from the CheckMate 816 clinical trial. With median follow up of 41.4 months, Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death by 32%, demonstrating a landmark three-year event-free survival (EFS) rate of 57% with Opdivo with chemotherapy compared to 43% with chemotherapy alone.

“Up until recently, upfront surgery has been the standard of care for curative intent treatment. Now we have a new option which could potentially enhance surgical outcomes,” stated Associate Professor Gavin Wright, cardiothoracic surgeon at the Victorian Comprehensive Cancer Centre.

Additionally, at three years, 78% of patients treated with neoadjuvant Opdivo and chemotherapy were alive, compared to 64% with chemotherapy alone.

Dr Meredith Edwards, Medical Director at BMS Australia, added “Some patients with resectable NSCLC remain at high risk of recurrence and potentially death from their disease despite receiving definitive surgical treatment.

‘This newly available treatment may help reduce the risk of disease recurrence, progression, and death in resectable NSCLC when given before surgery. The PBS listing of neoadjuvant Opdivo plus chemotherapy means that patients with a higher risk of recurrence have an earlier treatment option to help reduce the risk of relapse post curative-intent surgery.”

Dr Wei-Sen Lam, Head of Service, Medical Oncology at Fiona Stanley Hospital in Perth, WA, highlighted the evolving landscape of early-stage lung cancer management, emphasising the critical role of multi-disciplinary team (MDT) discussions.

“The PBS listing of the neoadjuvant immunotherapy-based regimen signals that all patients with resectable NSCLC, with tumours of 4 cm or larger or with lymph node involvement, should be discussed at the MDT prior to their tumour resection,” said Dr Lam.

Mark Brooke, Chief Executive Officer of Lung Foundation Australia, concluded, “Although we have seen progress in the treatment of earlier-stage non-small cell lung cancer, a significant number of people still face poor outcomes. We are pleased to see the PBS listing of this pre-surgery immunotherapy-based combination, which provides an additional option in the early-stage NSCLC space.”

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