FDA/CDC

Atezolizumab combination regimen approved for advanced non-squamous NSCLC


 

The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations.

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Approval was based on greater overall survival (OS) among patients receiving the four drug combination, compared with patients who did not receive the checkpoint inhibitor but received the other three drugs in the randomized IMpower150 trial.

For the trial, 1,202 patients with metastatic NSq NSCLC were randomized to three arms for first-line treatment:

• atezolizumab, carboplatin, paclitaxel, and bevacizumab (4-drug regimen);

• atezolizumab, carboplatin and paclitaxel (3-drug regimen); or

• carboplatin, paclitaxel, and bevacizumab (control arm).

Among patients with NSq NSCLC without an EGFR or ALK mutation (87%), the estimated median OS was 19.2 months for patients receiving the 4-drug regimen and 14.7 months for those in the control arm (hazard ratio [HR] 0.78; 95% CI: 0.64, 0.96; P = .016), the FDA said in a press statement announcing the approval.

The median progression-free survival was 8.5 months for patients receiving the 4-drug regimen and 7.0 months for those in the control arm (HR 0.71; 95% CI 0.59, 0.85; P = .0002). The overall response rates were 55% in the 4-drug arm and 42% in the control arm. There were no significant differences in OS or final progression-free survival between the 3-drug arm containing atezolizumab and the control arm.

The most common adverse reactions with atezolizumab were fatigue/asthenia, alopecia, nausea, diarrhea, constipation, decreased appetite, arthralgia, hypertension, and neuropathy. Treatment with atezolizumab was discontinued in 15% of patients due to adverse reactions, the most common reason being pneumonitis.

The recommended atezolizumab dose is 1,200 mg intravenously over 60 minutes every 3 weeks, the FDA said.

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