
Durvalumab is an immune checkpoint inhibitor that targets programmed death-ligand 1 (PD-L1), enhancing T-cell activation and anti-tumour immune responses. A new indication has recently been added to its product information, alongside an expansion of its Pharmaceutical Benefits Scheme (PBS) listing.
Durvalumab is now indicated for perioperative treatment of gastric and gastroesophageal junction cancer (GC/GOJC). This approval is based on positive results from the MATTERHORN trial, where the addition of durvalumab to standard FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) significantly improved event-free survival compared with chemotherapy alone.
From 1 April 2026, two additional clinical criteria were added to the PBS for durvalumab:
- Limited-stage small cell lung cancer (LS-SCLC) in patients whose disease has not progressed following platinum-based chemoradiation therapy.
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- This is the first immunotherapy to be PBS-listed in this setting and addresses a major unmet need, given the high relapse rates (~70% within five years).
- The listing is supported by results from the ADRIATIC trial, which demonstrated significant improvements in overall survival and progression-free survival with adjuvant durvalumab compared with placebo.
- Muscle invasive bladder cancer
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- The NIAGARA trial demonstrated that perioperative durvalumab plus neoadjuvant chemotherapy was associated with significant improvements in event-free survival and overall survival compared with neoadjuvant chemotherapy alone.
These developments highlight the expanding role of durvalumab across multiple tumour types and stages.
References:
- Behrouzi R, Blackhall F. State of the art in treatment of small cell lung cancer. Ther Adv Med Oncol. 2025; 17: 17588359251363518.
- Imfinzi® (durvalumab) Australian approved product information. Macquarie Park: AstraZeneca. Approved January 2026.
- Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, et al. Perioperative durvalumab in gastric and gastroesophageal junction cancer. N Engl J Med. 2025 Jul 17;393(3):217-230.Bottom of Form
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