Atezolizumab Receives FDA Approval as Adjuvant Treatment After Lung Cancer Surgery

On October 15, 2021, atezolizumab (Tecentriq, Genentech, Inc.) immunotherapy received FDA approval after platinum-based chemotherapy as postoperative adjuvant (protective) treatment for patients with stage 2 – 3A, or early-stage, non-small cell lung cancer (NSCLC) whose tumor cells have a PD-L1 level of ≥ % 1. With this development, atezolizumab became the first immunotherapy approved by the FDA for this operable non-small cell lung cancer.

At the same time, the FDA also approved the VENTANA PD-L1 (SP263) assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to select patients with NSCLC for adjuvant treatment with Tecentriq.

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Lung Cancer Causes, Symptoms, and Treatment

PD-L1 level

Non-Small Cell Lung Cancer (NSCLC)

FDA Approval Based on the IMpower010 Study

IMpower010, a randomized, multicenter, open-label clinical trial, enrolled patients with NSCLC from stage 1B (tumors ≥ 4 cm) to stage 3A. Patients underwent complete surgical tumor resection (removal), followed by cisplatin-based adjuvant chemotherapy. Then 1005 patients were randomly assigned in a 1:1 ratio to one of two arms. The experimental arm received 1200 mg of atezolizumab every 3 weeks for 16 cycles, while the control arm received best supportive care.

The study’s main efficacy outcome measure for 476 patients with stage II-IIIA NSCLC whose tumor cells had PD-L1 expression ≥1% was disease-free survival.

Results

• Median disease-free survival was not reached in patients in the atezolizumab arm (95% CI: 36.1, not reached), compared with 35.3 months in the best supportive care arm (95% CI: 29.0, not reached).
• Adding atezolizumab immunotherapy as adjuvant maintenance treatment reduced the risk of cancer recurrence by 44% (HR 0.66; 95% CI: 0.50, 0.88; p =0.004).
• In a prespecified secondary subgroup analysis of patients with PD-L1 TC ≥ %50 stage 2-3A NSCLC, the HR for disease-free survival was 0.43 (95% CI: 0.27, 0.68).
• In an exploratory subgroup analysis of patients with PD-L1 TC 1-49% stage 2-3A NSCLC, the HR for disease-free survival was 0.87; (95% CI: 0.60, 1.26).

The most common (≥ 10%) side effects associated with atezolizumab use, including laboratory abnormalities, were increased aspartate aminotransferase (ALT), creatinine, hyperkalemia, rash, cough, hypothyroidism, fever, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, joint pain, and itching.

For this indication, the recommended atezolizumab dose is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for up to 1 year.