- AstraZeneca’s cancer drug Imfinzi failed in a late-stage trial for non-small cell lung cancer, missing its primary endpoint.
- It recently received FDA approval for Imfinzi in combination with chemotherapy for advanced endometrial cancer.
AstraZeneca, the global science-led biopharmaceutical company, announced on Tuesday that its blockbuster cancer drug, Imfinzi (durvalumab) failed in the late-stage trial for non-small cell lung cancer (NSCLC).
According to the company, the high-level results from the Phase III ADJUVANT BR.31 trial showed that Imfinzi did not meet the statistical significance for the primary endpoint of disease-free survival (DFS) compared to placebo.
The ADJUVANT BR.31 trial is a multicenter, double-blind study that assessed 1,415 patients diagnosed with early-stage (IB-IIIA) non-small cell lung cancer (NSCLC) who underwent complete tumor resection and had PD-L1 expression on 25% or more tumor cells.
“We are disappointed in the ADJUVANT BR.31 results. Imfinzi has helped change the treatment landscape and achieved multiple positive Phase III trials for patients with earlier stages of lung cancer,” said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca.
“We are committed to addressing the remaining unmet need in lung cancer through our broad development programme,” she added.
Lung cancer is the leading cause of cancer death among all sexes, contributing to one-fifth of all cancer mortalities, according to recent reports from WHO. Lung cancer is broadly categorized into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC comprising 80-85% of diagnosed cases.
Imfinzi is a human monoclonal antibody that works by blocking the tumor's ability to evade the immune system and simultaneously enhancing the body's immune response against cancer cells.
Currently, Imfinzi is being used for the treatment of extensive-stage SCLC in combination with a short course of Imjudo (tremelimumab) and chemotherapy for treating metastatic NSCLC.
In addition to its indication in lung cancer, Imfinzi in combination with chemotherapy, has recently received FDA approval for treating adults with primary advanced or recurrent endometrial cancer characterized by mismatch repair deficiency (dMMR).
In other news, AstraZeneca had recently made headlines when it acknowledged that its COVID-19 vaccine, developed in collaboration with Oxford University, might rarely cause blood clotting and low platelet counts post-immunization.
Meanwhile, AstraZeneca's CEO Pascal Soriot projected in a CNBC interview that the drugmaker could nearly double its revenue by 2030. Soriot highlighted the company's strong growth from a large portfolio of existing products, including several blockbusters, and plans to launch another 20 medicines to achieve this goal.
Edited by Harshajit Sarmah
