FDA Grants Approval to Atezolizumab for Adjuvant Treatment of NSCLC
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.
