UK— AstraZeneca, a global, science-led biopharmaceutical company, has announced that its blockbuster cancer drug, Imfinzi, has failed to improve disease-free survival in a late-stage trial aimed at treating a type of early-stage lung cancer.
According to the drugmaker, the ADJUVANT BR.31 Phase III trial, sponsored by the Canadian Cancer Trials Group (CCTG), did not meet the primary endpoint of disease-free survival versus a placebo in early-stage non-small-cell lung cancer (NSCLC) after tumor removal in patients whose tumors express PD-L1 on 25 percent or more tumor cells.
This trial result is a significant setback for AstraZeneca, considering the high expectations placed on Imfinzi’s performance.
Despite this, Imfinzi remains the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy, based on the PACIFIC Phase III trial.
This standing highlights Imfinzi’s critical role in the current treatment landscape for lung cancer.
Furthermore, Imfinzi is under investigation as monotherapy and in combinations in several other early-stage lung cancer settings.
These include medically inoperable or unresected Stage I-II NSCLC (PACIFIC-4) and unresectable Stage III NSCLC (PACIFIC-5, 8, and 9).
Interestingly, the latest results stand in contrast to those published in April. In a separate trial, the Anglo-Swedish drugmaker reported that Imfinzi helped improve survival in patients in the early stages of small-cell, or the aggressive type, of lung cancer, successfully meeting two key trial goals.
This discrepancy between the trial outcomes underscores the complexity and challenges involved in cancer drug development.
Commenting on the recent results, Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, expressed her disappointment with the ADJUVANT BR.31 results.
However, she emphasized that Imfinzi has already played a transformative role in the treatment landscape, achieving multiple positive Phase III trials for patients with earlier stages of lung cancer.
Moreover, Galbraith reaffirmed AstraZeneca’s commitment to addressing the remaining unmet needs in lung cancer treatment through their broad and ongoing development program.
This program aims to explore and expand the therapeutic applications of Imfinzi, ensuring that patients continue to receive innovative and effective treatment options.
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