Nov 2021: The Food and Drug Administration has approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumours contain PD-L1 expression on less than 1% of tumour cells, as assessed by an FDA-approved test.
The VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) was also authorised by the FDA today as a companion diagnostic device for selecting patients with NSCLC for adjuvant treatment with Tecentriq.
Disease-free survival (DFS) was the key efficacy outcome measure, as determined 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 tumour cells (PD-L1 1% TC). In the atezolizumab arm, median DFS was not reached (95 percent CI: 36.1, NE) compared to 35.3 months (95 percent CI: 29.0, NE) in the BSC arm (HR 0.66; 95 percent CI: 0.50, 0.88; p=0.004).
The DFS HR was 0.43 in a pre-specified secondary subgroup analysis of patients with PD-L1 TC 50% stage II-IIIA NSCLC (95 percent CI: 0.27, 0.68). The DFS HR was 0.87 in an exploratory subgroup study of patients with PD-L1 TC 1-49 percent stage II-IIIA NSCLC (95 percent CI: 0.60, 1.26).
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, were the most common (ten percent) adverse reactions in patients receiving atezolizumab, including laboratory abnormalities.
For this indication, the recommended atezolizumab dose is 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks for up to a year.