‘Significant breakthrough’ as first adjuvant immunotherapy is PBS listed for gastro-oesophageal cancers

Pharma News: The first adjuvant immunotherapy reimbursed for resected oesophageal cancer (OC) or gastro-oesophageal junction cancer (GOJC) in patients who have received neoadjuvant chemoradiotherapy (CRT) will be listed on the Pharmaceutical Benefits Scheme (PBS) effective 1 April.

BMS’ Opdivo (nivolumab) PBS listing is supported by positive data from the Phase 3 CheckMate 577 trial in which Opdivo treatment in OC and GOJC patients following trimodality therapy (neoadjuvant CRT and complete surgical resection) doubled disease-free survival (DFS) compared to placebo. The median DFS in Opdivo-treated patients was 22.4 months compared to 11.0 months in the placebo group.

According to Medical Oncologist, Professor Stephen Clarke OAM, GenesisCare North Shore, the reimbursement of the first adjuvant immunotherapy option for this patient group represents a significant breakthrough in gastro-oesophageal cancer care.

“While patients who present with operable disease can have trimodality therapy, disease recurrence is common. There is a particularly high risk of recurrence for the up to 75% of patients whose tumours do not show a complete therapeutic response. In the absence of adjuvant treatment options, clinicians have historically used a ‘wait and watch’ approach after treatment failure in the neo-adjuvant setting,” said Prof Clarke.

“The reimbursement of an adjuvant immunotherapy option for this patient population is welcomed news and represents a significant milestone in addressing this high clinical unmet need.”

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Gastro-oesophageal cancers are a heterogenous group encompassing distinct histologic and genomic subtypes that can arise in the oesophagus, stomach or the junction between these organs. Patients with gastro-oesophageal cancers typically face significant quality of life impacts due to impaired physical activity, fatigue, insomnia, mental health decline, and pain.

In 2022, approximately 2,572 Australians were newly diagnosed with stomach cancer (including a subset of GOJC), with 1,146 Australians dying of the disease. For OC, these numbers were estimated at 1,725 new cases and 1,394 deaths in 2022.

Medical Director of Bristol-Myers Squibb Australia and New Zealand, Dr Melinda Munns, said the company is committed to leading innovative science in earlier stages of cancer with the goal of disrupting the course of the disease.

“The listing follows from the reimbursement for Opdivo in later stages of gastro-oesophageal cancer. BMS was the first company to bring checkpoint inhibitors to patients with oesophagogastric cancer, and we are pleased to be the first to bring adjuvant therapy to Australian patients with oesophageal or gastro-esophageal junction cancers who continue to face a high unmet need.

“Recurrence often marks the transition from curable to incurable disease and represents a life-altering event for patients. We believe intervening in earlier stages of cancer may interrupt this trajectory, helping patients live longer and with a higher quality of life as we work toward a cure,” said Dr Munns.

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