AstraZeneca’s PD-L1 inhibitor failed to significantly improve disease-free survival in patients with non-small cell lung cancer, but hit its primary endpoint in a late-stage trial in muscle-invasive bladder cancer.
AstraZeneca announced Tuesday that its PD-L1 inhibitor Imfinzi (durvalumab) did not meet its primary endpoint in the Phase III ADJUVANT BR.31 study in early stage non-small cell lung cancer.
Without revealing specific data, AstraZeneca said that Imfinzi was unable to significantly improve disease-free survival versus placebo in patients with stage IB to IIIA non-small cell lung cancer (NSCLC) following complete tumor resection. The pharma noted that it will share data from ADJUVANT BR.31 at a future scientific meeting.
Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, in a statement said that the pharma is “disappointed” by these results. Nevertheless, Imfinzi has established itself as an important cancer therapy and has “helped change the treatment landscape” in lung cancer, with several positive late-stage findings in patients in the earlier stages of the disease, according to Galbraith.
The pharma will continue its lung cancer development program for Imfinzi, which is currently the global standard of care and the only FDA-approved immunotherapy in the curative-intent setting for patients with stage III NSCLC who had not progressed following chemoradiotherapy. AstraZeneca is running the PACIFIC-4 trial in inoperable or unresectable stage I toII NSCLC, and the PACIFIC-5, -8 and -9 studies in stage III disease.
In November 2023, PACIFIC-2 failed to meet its primary endpoint. The trial combined Imfinzi with chemoradiotherapy (CRT), which was unable to significantly improve progression-free survival versus CRT alone in patients with stage III NSCLC.
Last month, AstraZeneca suffered another NSCLC loss when its Daiichi Sankyo-partnered antibody-drug conjugate datopotamab deruxtecan failed to yield significant overall survival benefits in the Phase III TROPION-Lung01 trial.
Meanwhile, AstraZeneca on Tuesday also reported that Imfinzi cleared the Phase III NIAGARA study in muscle-invasive bladder cancer (MIBC). The PD-1 inhibitor, when combined with chemotherapy, induced a “statistically significant and clinically meaningful improvement” in event-free and overall survival as compared with neoadjuvant chemotherapy.
The pharma again did not provide specific data for the MIBC study in its announcement, but promised to present its findings at an upcoming medical congress. AstraZeneca will also share its results with global regulatory authorities “to bring this regimen with the potential to transform the standard of care to patients as soon as possible,” Galbraith said.
In both the NSCLC and MIBC studies, Imfinzi’s safety profile closely matched what had been established in prior trials, with no new signals of concern. In NIAGARA, Imfinzi did not increase the discontinuation rate and patients were still able to complete surgery.
Initially approved in May 2017 for advanced bladder cancer, Imfinzi is a PD-L1 inhibitor that blocks the cancer cells’ ability to evade the immune system and boosts the body’s anti-cancer activity. The treatment has since picked up several other oncology indications, including certain types of biliary tract cancer and NSCLC.
The FDA last week cleared the use of Imfinzi for primary advanced or recurrent mismatch repair-deficient endometrial cancer.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
