Non-Small Cell Lung Cancer Coverage from Every Angle
Advertisement
Advertisement

FDA Grants Approval to Atezolizumab for Adjuvant Treatment of NSCLC

By: JNCCN 360 Staff
Posted: Monday, October 18, 2021

On October 15, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody atezolizumab (Tecentriq) as an adjuvant treatment after resection and platinum-based chemotherapy for non–small cell lung cancer (NSCLC). Eligible patients would have stage II to IIIA NSCLC with PD-L1 expression on at least 1% of tumor cells, as determined by an FDA-approved test. The FDA simultaneously approved the VENTANA PD-L1 Assay as a companion diagnostic device to select eligible patients with NSCLC for adjuvant treatment with atezolizumab.

The recommended atezolizumab dose for this indication is 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks for up to 1 year. For full prescribing information, visit accessdata.fda.gov.

The FDA approval was based on the multicenter, open-label IMpower010 clinical trial results. The study recruited 1,005 patients with stage IB NSCLC who had complete tumor resection and cisplatin-based adjuvant chemotherapy. Participants were randomly assigned to receive 1,200 mg of atezolizumab every 3 weeks for 16 cycles or best supportive care. The median disease-free survival was not reached in the atezolizumab arm compared with 35.3 months in the best supportive care arm (P = .004). 

A secondary subgroup analysis showed a 0.43 disease-free survival hazard ratio in patients with stage II to IIIA NSCLC and PD-L1 expression of at least 50% of tumor cells. An exploratory subgroup analysis of patients with stage II to IIIA NSCLC and PD-L1 expression of between 1% to 49% of tumor cells showed a disease-free survival hazard ratio of 0.87. The most common (≥ 10%) adverse reactions in patients administered atezolizumab included increased aspartate aminotransferase, blood creatinine, alanine aminotransferase, hyperkalemia, rash, cough, hypothyroidism, pyrexia, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, arthralgia, and pruritus.



By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.