AstraZeneca’s Lung Cancer Drug Scores First FDA Approval
An FDA approval for AstraZeneca’s Imfinzi has now rolled in just in time to allow the firm to capitalize on the virgin market marking a competitive advantage in the lung cancer treatment field over Merck KGaA & Pfizer, who received rejections for a similar treatment.
Lung cancer is the second most common type of cancer and the leading cause of cancer death, with an estimated 155,870 lung cancer deaths in the US in 2017. About 80% to 85% of lung cancers are non-small cell lung cancer.
Globally, approximately 30 percent of patients with NSCLC present with stage III disease. These individuals typically receive a combination of chemotherapy and radiotherapy, but only around 15 percent of them are still alive after five years.
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80. This prevents the tumors from evading the immune system.
The green light – which had been expected following positive clinical data last year – gives AstraZeneca a chance to intervene earlier in lung cancer, distinguishing it from rivals that have approval for tackling advanced or metastatic disease.
The approval
was based on the positive progression-free survival data from the Phase III PACIFIC trial. In the trial, which involved 713 participants, Imfinzi showed an 11.2 month improvement in median progression-free survival─16.8 months compared to 5.6 months on placebo.Investigator in the PACIFIC trial Dr Scott Antonia said: “Until now, treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression. The PACIFIC trial data supporting today’s approval of Imfinzi will change how we treat these patients.”
Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy. Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.”
Scott J. Antonia, MD, Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and investigator in the PACIFIC trial, said: “Until now, treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression. The PACIFIC trial data supporting today’s approval of Imfinziwill change how we treat these patients.”
