Astra’s Pacific expansion plan hits the rocks

AstraZeneca’s plan to expand Imfinzi’s established use in unresectable pre-metastatic lung cancer took a hit today with the failure of the Pacific-2 trial, in which the drug on top of chemoradiation was compared versus chemoradiation alone in stage III disease. Imfinzi is already established in stage III NSCLC patients who are in response after chemoradiation, based on the Pacific trial, and Pacific-2 was the group’s first pivotal study aiming to move into an earlier use. Several other trials, including with combos, continue in similar settings. Astra is separately hoping for better things from volrustomig, its conditional anti-CTLA-4 x PD-1 bispecific MAb. Having at ESMO revealed hopes of a therapeutic window being found for this project, Astra is now starting a fourth pivotal trial: Evolve-HNSCC will enrol 1,145 patients with unresected head and neck cancer who are in response to chemoradiotherapy, and compare volrustomig versus observation, measuring PFS in patients with PD-L1-positive tumours as its primary endpoint. Volrustomig’s other phase 3 trials, Evolve-Cervical and Evolve-Lung02, are already recruiting respectively 1,000 and 900 patients in the ovarian cancer maintenance and <50% PD-L1-expressing front-line NSCLC settings, while Evolve-Meso will start enrolling 600 mesothelioma patients later this month.

Pivotal trials of Imfinzi in unresectable, pre-metastatic NSCLC

Source: OncologyPipeline.