On October 15, 2021, the FDA approved a new indication for atezolizumab (Tecentriq; Genentech) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small-cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥1% of tumor cells, as determined by an FDA-approved test.
On the same day, the FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems) as a companion diagnostic test to identify appropriate patients with early-stage NSCLC and PD-L1 expression for adjuvant treatment with atezolizumab.
This new indication is based on results of the IMpower010 trial of patients with stage IB to IIIA NSCLC. Patients in this trial, who had complete removal of their tumors by surgery and received cisplatin-based adjuvant chemotherapy, were randomized to receive atezolizumab injection every 3 weeks for 16 cycles or best supportive care.
The main efficacy end point measure was disease-free survival (DFS) as assessed by the investigator in the primary efficacy analysis population (N = 476) of patients with stage II-IIIA NSCLC with PD-L1 expression on ≥1% of tumor cells. In patients treated with atezolizumab, the median DFS was not reached and was an average of 35.3 months in patients who received best supportive care.
The most common (≥10%) AEs in patients receiving atezolizumab, including laboratory abnormalities, were increased aspartate aminotransferase, blood creatinine, and alanine aminotransferase; as well as hyperkalemia, rash, cough, hypothyroidism, pyrexia, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, arthralgia, and pruritus.
The recommended atezolizumab dose for this indication is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for up to 1 year.