FDA Grants Atezolizumab Priority Review as Adjuvant Treatment for Certain Patients With NSCLC

Officials with the FDA have granted priority review to atezolizumab (Tecentriq, Roche) as an adjuvant treatment following surgery and platinum-based chemotherapy for patients with non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%, as determined by an FDA-approved test. According to a press release from Roche, the FDA is reviewing the company’s Biologics License Application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

“New treatment options are urgently needed in early-stage non-small cell lung cancer to help the nearly 50% of people who currently experience a recurrence following surgery,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, in a press release. “Tecentriq is the first cancer immunotherapy to show a clinically meaningful benefit in the adjuvant lung cancer setting, and we’re working closely with the FDA to bring this significant advancement to patients as quickly as possible.”

The application is based on disease-free survival (DFS) results from an interim analysis of the phase 3 IMpower010 study, is the first and only phase 3 study of a cancer immunotherapy to demonstrate positive results in the adjuvant lung cancer setting, according to Roche. The investigators found that treatment with atezolizumab following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death (DFS) by 34% in patients with stage 2-3A NSCLC whose tumors express PD-L1≥1%, compared with best supportive care (BSC).

Safety data for atezolizumab were consistent with its known safety profile, with no new safety signals identified. Follow-up on the IMpower010 trial is set to continue with planned analyses of DFS in the overall intent-to-treat population, including Stage 1B patients, which at the time of analysis did not cross the threshold. Further, the investigators plan to analyze overall survival data, which were immature at the time of interim analysis.

REFERENCE

US FDA grants Priority Review to Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer [news release]. Roche; August 3, 2021. Accessed August 3, 2021. https://www.roche.com/media/releases/med-cor-2021-08-03.htm