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NSCLC: AstraZeneca’s durvalumab meets PFS endpoint

AstraZeneca Global R&D centre and corporate HQ, Cambridge, UK – illustration of proposed design, subject to planning consent © Herzog & de Meuron

AstraZeneca’s anti PD-L1 antibody durvalumab has met the co-primary endpoint in non-small cell lung cancer (NSCLC) in a Phase III trial vs placebo. OS data were not yet available. 

In an interim analysis, durvalumab (MEDI4736) met the endpoint of progression free survival (PFS) in a patient population not stratified for PD-L1 expression. According to AZ, the results demonstrated a favourable benefit/risk profile. In the PACIFIC trail, AZ enrolled 983 stage III NSCLC patients who had not progressed following platinum-based chemotherapy plus radiation therapy. Patients received AZ’s antibody for 12 months. The company is preparing regulatory submission to the FDA. 

“These are highly encouraging results for patients with locally-advanced lung cancer for whom surgery is not an option“, said AZ’s CEO Sean Bohen. “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 news came after AZ’s competitor Merck & Co. received market approval for its PD-L1 antibody pembrolizumab plus chemotherapy as first-line treatment in the lucrative indication.

Durvalumab has been recently approved to treat metastatic bladder cancer after chemotherapy failed. Additionally, the antibody, which binds to PD1 and CD80, is being tested as first-line treatment monotherpay of patients with NSCLC in two further Phase III trials and is being tested in combination with AZ’s anti-CTLA4 antibody tremelimumab in three Phase III trials in patients with urothelial bladder cancer,  SCLC and HNSCC.