AstraZeneca secures first PBS listing for rare gastrointestinal cancer in over a decade

Pharma News: AstraZeneca’s immunotherapy drug, Imfinzi (durvalumab), has been granted reimbursement on the Pharmaceutical Benefits Scheme (PBS) starting December 1, 2023, heralding a leap in the treatment landscape for adult patients diagnosed with locally advanced or metastatic biliary tract cancer. This marks the first treatment breakthrough in combating this rare cancer in over a decade.

Biliary tract cancer encompasses a cluster of rare and aggressive cancers that manifest in the bile ducts and gallbladder. Approximately 1,300 Australians confront this diagnosis each year, with roughly 70% receiving the devastating news at an advanced stage. Survivability is dire, with only one in five patients surpassing the five-year mark post-diagnosis. Until now, the primary therapy for this patient group has been limited to chemotherapy.

Professor Niall Tebbutt, Director of Medical Oncology at the Olivia Newton-John Cancer Wellness and Research Centre, voiced his perspective on this development, stating, “The PBS inclusion of Imfinzi [in combination with chemotherapy (gemcitabine plus cisplatin)] for advanced biliary cancer provides an important treatment option for patients with this rare and aggressive type of gastrointestinal cancer. Imfinzi is the first immunotherapy for the treatment of biliary cancer, and it is exciting to now have reimbursed access to this treatment for Australian patients.”

The approval stems from the outcomes of the TOPAZ-1 Phase III trial, demonstrating that Imfinzi combined with chemotherapy decreased the risk of death by 24% compared to chemotherapy alone (p<0.05). Notably, the overall survival (OS) was 12.9 months versus 11.3 months with chemotherapy alone. More than two times as many patients were estimated to be alive at two years versus chemotherapy alone (23.6% versus 11.5%). These promising results spanned diverse subgroups, regardless of disease status, tumour location, or PD-L1 expression.

Ben McDonald, Country President of AstraZeneca Australia and New Zealand, underscored the significance of this milestone. He stated “AstraZeneca is proud to be able to address the significant unmet need of patients living with this rare and aggressive gastrointestinal cancer. We are pleased that the Government continues to support innovative medicines that help to reduce the burden of disease, regardless of how rare or aggressive the cancer is, and improve the quality of life for hundreds of Australian patients.”

Doug Hawkins, CEO of Pancare Foundation, hailed the inclusion of Imfinzi on the PBS as a beacon of hope for patients diagnosed with this challenging and rare cancer. He emphasised “This is wonderful news for patients living with locally advanced or metastatic biliary tract cancer as there has been limited progress in new therapies over the past decade. Pancare Foundation welcomes any new therapy that offers patients greater choice regarding treatment that aims to provide them with more time with their families.”

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