FDA approves Tecentriq for new lung cancer indication
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The FDA expanded the approval of atezolizumab to include adjuvant treatment of certain patients with non-small cell lung cancer.
The approval applies to use of the agent after resection and platinum-based chemotherapy for patients with stage II to stage IIIA NSCLC whose tumors have PD-L1 expression on at least 1% of tumor cells.
Atezolizumab (Tecentriq, Genentech/Roche), an anti-PD-L1 monoclonal antibody, is approved in the United States for multiple lung cancer indications. It also is approved for treatment of certain patients with melanoma, hepatocellular carcinoma and urothelial carcinoma.
The FDA based approval in part on results of the randomized phase 3 IMpower010 trial, which included 1005 patients with stage IB to stage IIIA NSCLC who underwent complete tumor resection and cisplatin-based adjuvant chemotherapy.
Researchers randomly assigned patients to 1,200 mg atezolizumab every 3 weeks for 16 cycles or best supportive care.
DFS in the primary efficacy analysis population — composed of 476 patients with stage II to stage IIIA NSCLC with PD-L1 expression on at least 1% of tumor cells — served as the major efficacy outcome.
Results showed a statistically significant DFS improvement in the atezolizumab group (median, not reached vs. 35.3 months; HR = 0.66; 95% CI, 0.5-0.88).
A prespecified secondary subgroup analysis of patients with stage II to stage IIIA disease who had PD-L1 expression on at least 50% of tumor cells showed an even greater DFS benefit with atezolizumab (HR = 0.43; 95% CI, 0.27-0.68).
The most common adverse events reported among atezolizumab-treated patients included increases in 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 FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems) as a companion diagnostic to identify patients with NSCLC who may benefit from adjuvant treatment with atezolizumab.
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