Improved Survival Using Imfinzi In Sequential Treatment in NSCLC
Durvalumab (Imfinzi) significantly improved progression-free survival (PFS) when used as a sequential treatment in patients with locally-advanced, unresectable non–small cell lung cancer (NSCLC) who had not progressed following standard care with platinum-based chemotherapy and radiotherapy, meeting the primary endpoint of the phase III PACIFIC trial.
AstraZeneca, the manufacturer of the PD-L1 inhibitor, intends to present these initial findings from the PACIFIC trial at an upcoming medical meeting. The company has also initiated talks with regulatory authorities regarding approval for durvalumab for use in this setting.
“These are highly encouraging results for patients with locally-advanced lung cancer for whom surgery is not an option. 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,” Sean Bohen, MD, PhD, executive vice president, global medicines development, and chief medical officer at AstraZeneca, said in a statement.
The double-blind PACIFIC trial took place at 235 centers in 26 countries and included an “all-comer” patient population who had locally-advanced, unresectable (stage III) NSCLC with no disease progression after concurrent therapy with platinum-based chemotherapy and radiation. Patients were randomized in a 2:1 ratio to durvalumab or placebo. PFS was the primary endpoint, along with overall survival (OS).
An independent data monitoring panel determined at an interim analysis that the study had met the primary PFS endpoint. The benefit/risk profile was also shown to favor the durvalumab arm. OS continues to be evaluated.
Results from the phase II ATLANTIC trial presented late last year at the 17th World Lung Cancer Conference showed that durvalumab demonstrated a clinical benefit in the second-line setting and beyond in heavily pretreated patients with locally advanced or metastatic NSCLC.