AstraZeneca’s chief product in the cancer treatment segment, Imfinzi, has not met the primary endpoint in a phase 3 trial aimed at establishing its effectiveness as an adjuvant therapy to enhance disease-free survival in early-stage lung cancer patients, the company revealed. Imfinzi is a human monoclonal antibody that does not have toxicity to normal cells and works by preventing a tumor from hiding from the immune system, thereby boosting the body’s capacity to fight cancer compared to chemotherapy.
This trial, termed ADJUVANT BR.31 Phase III, aimed to evaluate the use of Imfinzi in the postoperative adjuvant setting for 1,415 patients with more or less Stage III NSCLC after complete resection with or without chemotherapy. This therapy is used alongside the main treatment given to the patient to treat cancer, with the primary aim of minimizing the chances of cancer recurrence. Disease-free survival refers to the time during which the patient does not experience cancer again.
Susan Galbraith, AstraZeneca’s Executive Vice President of Oncology Research and Development, said that the company is disappointed with the ADJUVANT BR.31 results. Lung cancer is one of the most prominent types of cancer responsible for many deaths worldwide, and NSCLC is the most common type of lung cancer. Despite the use of adjuvant chemotherapy and radical surgery for operable lung cancer, a significant number of patients experience disease relapse, even in cases of complete tumor resection.
This result is a complete reversal from a trial conducted in April, where Imfinzi showed a survival advantage in a phase three trial of patients diagnosed with early-stage SCLC, fulfilling two of the trial’s primary measures. The ADJUVANT BR.31 Phase III study was a randomized, double-blind clinical trial conducted by the Canadian Cancer Trials Group, with recruitment across Canada, the USA, Australia, Europe, and parts of Asia.
Imfinzi sales amounted to $4.24 billion last year. Pembrolizumab was first approved by the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of bladder cancer. It was more recently approved for the treatment of mid-NSCLC in 2018 and extensive-SCLC in March 2020.
The loss in this final-stage trial is a heavy blow to AstraZeneca, especially because the company has found Imfinzi effective in earlier trials for other forms of lung cancer. The company stated that it will continue to focus on identifying more treatment methods with Imfinzi and other solutions to successfully fight different forms of cancer.
