Roche's Atezolizumab Receives Priority Review Designation in China for First-Line Treatment of NSCLC

Text: Jia Yi

On September 29, the Center for Drug Evaluation (CDE) announced its intention to include the new marketing application for atezolizumab in the priority review and approval process (Acceptance Number: JXSS2000033), on the grounds that it “meets the criteria for drugs eligible for conditional approval.” The indicated use is: monotherapy for the first-line treatment of patients with PD-L1-positive, EGFR/ALK-negative metastatic non-small cell lung cancer (NSCLC).

Atezolizumab is an anti-PD-L1 monoclonal antibody developed by Genentech, a member of the Roche Group. By blocking the interaction of PD-L1 with its receptors PD-1 and B7-1 (also known as CD80), this agent reverses immunosuppression in the tumor microenvironment and alleviates T-cell exhaustion, thereby promoting the activation, proliferation, and cytotoxic activity of tumor-specific T cells to achieve tumor cell clearance.

Atezolizumab was first approved in China in February 2020, with the indication of combination chemotherapy for first-line treatment of extensive-stage small cell lung cancer. According to the Insight database, there are currently three marketing applications for this drug under review and approval. Prior to its inclusion in the priority review this time, its indication for first-line treatment of advanced unresectable hepatocellular carcinoma had also been included in the priority review in February.

The Insight database shows that there are currently 30 clinical trials of atezolizumab underway in China, with 19 of them already in Phase III. The indications under investigation involve various types of cancer. Although only small cell lung cancer has been approved in China so far, the FDA has previously approved multiple indications including bladder cancer, advanced/metastatic non-small cell lung cancer, triple-negative breast cancer, small cell lung cancer, and hepatocellular carcinoma.

Source: Insight Database (http://db.dxy.cn/v5/)

Furthermore, according to information disclosed by Roche, the first-line treatment indication for non-small cell lung cancer (NSCLC) included in this marketing application was granted Priority Review by the U.S. FDA in February of this year. This designation was based on the results of the IMpower110 study (Registration No.: NCT02409342).

IMpower110 is a randomized, open-label Phase III clinical trial designed to evaluate the efficacy and safety of atezolizumab as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC), compared with chemotherapy (cisplatin or carboplatin plus pemetrexed or gemcitabine). The study enrolled a total of 572 treatment-naïve patients without ALK or EGFR gene mutations.

The study results demonstrated that atezolizumab was superior to chemotherapy in terms of progression-free survival (PFS), overall survival (OS), and safety. Among patients with high PD-L1 expression, the median OS was 20.2 months with atezolizumab versus 13.1 months with chemotherapy; the median PFS was 8.1 months in the atezolizumab group compared to 5.0 months in the chemotherapy group.

High PD-L1 expression is defined as: PD-L1 expression in tumor cells ≥50%, or PD-L1 expression in tumor-infiltrating immune cells ≥10%, or wild-type.