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FDA approves Tecentriq-based combination for first-line treatment of lung cancer
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The FDA approved atezolizumab in combination with bevacizumab, paclitaxel and carboplatin for first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer.
The atezolizumab (Tecentriq, Genentech)-based regimen is indicated for patients without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The recommended dose of atezolizumab is 1,200 mg intravenously for 60 minutes every 3 weeks.
“This Tecentriq regimen has demonstrated a significant survival benefit in the initial treatment of metastatic nonsquamous non-small cell lung cancer,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “[The] approval supports our combination approach for Tecentriq in lung cancer and our vision to develop medicines that improve outcomes for patients with this complex disease.”
The approval was based on the phase 3, randomized IMpower150 study that enrolled 1,202 patients receiving first-line treatment for metastatic nonsquamous NSCLC.
Of those, 87% (1,045) did not have EGFR or ALK genomic tumor aberrations.
Researchers randomly assigned patients to receive six cycles of one of the following regimens:
- Atezolizumab, carboplatin, paclitaxel and bevacizumab (Avastin, Genentech);
- Atezolizumab, carboplatin and paclitaxel; or
- Carboplatin, paclitaxel and bevacizumab (control arm).
Endpoints of the study included PFS and OS determined by an independent review facility, as well as safety in the intent-to-treat population.
Among patients who did not have EGFR or ALK genomic tumor aberrations, the median OS was 19.2 months those assigned the four-drug regimen and 14.7 months for those assigned carboplatin, paclitaxel and bevacizumab (HR = 0.78; 95% CI, 0.64-0.96).
The median PFS was 8.5 months for patients receiving the four-drug regimen and 7 months for those in the control arm (HR = 0.71; 95% CI, 0.59-0.85).
Overall response rates were 55% among patients receiving the four-drug regimen — which included a 4% complete response rate — and 42% among patients in the control group. Median duration of response was 10.8 months (95% CI, 8.4-13.9) with the four-drug regimen and 6.5 months (95% CI, 5.6-7.6) with the control regimen.
Researchers reported no differences in PFS and OS between the three-drug regimen group and the control group.
Adverse events occurring among 20% or more of patients who received the four-drug regimen included fatigue, hair loss, nausea, diarrhea, constipation, decreased appetite, arthralgia, hypertension and neuropathy.
Fifteen percent of patients discontinued atezolizumab due to adverse events, the most common of which was pneumonitis (1.8%).
Among 364 patients who received the four-drug regimen, 36% (n = 132) developed antibodies to atezolizumab. Of those, 83% developed the antibodies before the second dose.
Patients who tested positive for antibodies had lower systemic atezolizumab exposure than those who didn’t. The presence of the antibodies did not affect the incidence of adverse events.
In an exploratory analysis, researchers observed similar HRs for OS among patients with antidrug antibodies (HR = 0.69; 95% CI, 0.44-1.07) and without antidrug antibodies (HR = 0.64; 95% CI, 0.46-0.9).