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FDA Approves atezolizumab with nab-paclitaxel, Carboplatin for Metastatic NSCLC

December 09, 2019 By americanpharmaceuticalreview

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

Efficacy was evaluated in IMpower130 (NCT02367781), a multicenter, randomized (2:1), open-label trial in patients with stage IV non-squamous NSCLC who had received no prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor, if appropriate. The trial randomized 724patients (ITT) to receive atezolizumab, paclitaxel protein-bound, and carboplatin, followed by single-agent atezolizumab or to receive paclitaxel protein-bound and carboplatin, followed by maintenance pemetrexed at the investigator’s discretion (control).

The primary efficacy outcome measures were progression-free survival (PFS) by RECIST v1.1 and overall survival (OS) in the subpopulation of patients documented to have no EGFR or ALK genomic tumor aberrations (ITT-WT). In the primary analysis population (ITT-WT, N=681), the estimated median PFS was 7.2 months (95% CI: 6.7, 8.3) for the atezolizumab arm compared to 6.5 months (95% CI: 5.6, 7.4) for the control arm(HR 0.75; 95% CI: 0.63, 0.91; p=0.0024). Median OS were 18.6 months (95% CI: 15.7, 21.1) and 13.9 months (95% CI: 12.0, 18.7), respectively (HR 0.80; 95% CI: 0.64, 0.99; p=0.0384). 

The most common adverse reactions (reported in ≥ 20% of patients) of atezolizumab when administered in combination with other antineoplastic drugs in patients with NSCLC and SCLC were fatigue/asthenia, nausea, alopecia, constipation, diarrhea, and decreased appetite.

The recommended atezolizumab dose for this use is 1200 mg as an intravenous infusion every 3 weeks. When atezolizumab is administered on the same day as chemotherapy, atezolizumab should be given first.

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