An analysis of interim data from a Phase III study evaluating AstraZeneca’s anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) Imfinzi™ (durvalumab) in non-small-cell lung cancer (NSCLC) indicates that the trial has already met one of its primary endpoints.

The planned analysis of data from the PACIFIC Study showed that therapy with the anticancer antibody led to statistically significant and clinically meaningful progression-free survival (PFS) when used as sequential treatment in patients with locally advanced, unresectable NSCLC that had not progressed following platinum-based chemotherapy and radiation therapy.

The PACIFIC study is also evaluating overall survival (OS) as a primary endpoint, which AstraZeneca says will be assessed as the trial progresses. The initial PACIFIC data will be presented at a forthcoming medical meeting.

The positive study data come less than 2 weeks after FDA granted Imfinzi accelerated approval for use in previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC), and just a couple of days after the U.K. drug maker reported the failure of its anti-interleukin-13 (anti-IL-13) mAb tralokinumab in a Phase III asthma study.

“These are highly encouraging results for patients with locally advanced lung cancer for whom surgery is not an option,” commented Sean Bohen, M.D., Ph.D., evp for global medicines development and CMO at AstraZeneca.”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.”

Earlier this week, Merck KGaA and Pfizer won accelerated approval for the anti-PD-L1 mAb Bavencio® (avelumab) as a treatment for previously treated mUC patients, while Roche reported the failure of its anti-PD-L1 mAb Tecentriq® (atezolizumab) in a Phase III urothelial cancer study. Tecentriq had already been granted accelerated approval by FDA for the mUC indication.

The Phase III MYSTIC and PEARL trials are separately evaluating Imfinzi as first-line monotherapy for patients with NSCLC. The antibody is also undergoing Phase III assessment in combination with the CTLA-4, or cytotoxic T-lymphocyte-associated protein 4, checkpoint inhibitor tremelimumab, in the Phase III MYSTIC, NEPTUNE, and POSEIDON trials.


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