AstraZeneca said interim results in a Phase III PACIFIC trial of Imfinzi (durvalumab), a human monoclonal antibody developed with MedImmune, AstraZeneca's biologics research and development arm, were positive.
The randomized trial evaluated Imfinzi versus a placebo in patients with unresectable Stage III non-small cell lung cancer (NSCLC) who had already undergone standard platinum-based chemotherapy with radiation therapy.
“These are highly encouraging results for patients with locally advanced lung cancer for whom surgery is not an option," AstraZeneca Executive Vice President of Global Medicines Development and Chief Medical Officer Sean Bohen said in an AstraZeneca elease. "We look forward to working with regulatory authorities around the world to bring Imfinzi to lung cancer patients as soon as possible. Alongside this, we continue to explore Imfinzi’s full potential as monotherapy as well as in combination with tremelimumab and other medicines in areas of continued unmet need across multiple types of cancer.”
The interim analysis revealed that the study had met the progression free survival (PFS) endpoint.
The current long-term prognosis and survival rate for Stage III NSCLC patients is poor, the release said. NSCLC affected approximately 100,000 patients in 2016 and approximately half have unresectable tumors.