Durvalumab Improves Overall Survival in Stage 3 Non-Small Cell Lung Cancer

Durvalumab, an FDA-approved immunotherapy, met its second primary endpoint of overall survival in the phase 3 PACIFIC trial for stage 3 non-small cell lung cancer.

Durvalumab (Imfinzi) improved overall survival (OS) in patients with unresectable stage 3 non-small cell lung cancer (NSCLC) whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy, according to results from a phase 3 study.

AstraZeneca and MedImmune announced the positive results for the phase 3 PACIFIC trial, in which durvalumab met the second of 2 primary endpoints by showing statistically significant OS benefit compared with placebo.

Durvalumab binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

In May 2017, durvalumab met its first primary endpoint of progression-free survival (PFS) by demonstrating a median improvement of 11.2 months compared with placebo, according to the press release. Durvalumab is currently approved in the United States and Canada for the treatment of patients with unresectable stage 3 NSCLC who had not progressed following platinum-based chemoradiation therapy.

Before the trial, the standard of care for stage 3 NSCLC was chemotherapy and radiation therapy followed by active surveillance to monitor for progression.

“The readout of positive overall survival data at the interim analysis of the PACIFIC trial provides additional compelling evidence of the clinical benefit that Imfinzi can offer patients in this earlier stage of lung cancer,” Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at AstraZeneca, said in the press release. “We look forward to sharing these results with Health Authorities to support ongoing regulatory interactions and to update the Imfinzi label with these important data.”

According to the press release, durvalumab is also being tested as a monotherapy and in combination with chemotherapy, radiation therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal antibody, as a first-line treatment for patients with NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer, and other solid tumors.

Reference

Imfinzi significantly improves overall survival in the phase III PACIFIC trial for unresectable stage II non-small cell lung cancer [news release]. AstraZeneca’s website. 2018. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2018/imfinzi-significantly-improves-overall-survival-in-the-phase-iii-pacific-trial-for-unresectable-stage-iii-non-small-cell-lung-cancer-25052018.html. Accessed May 25, 2018.