Tecentriq Combination Regimen Approved for Metastatic Non-Squamous NSCLC

The approval was based on data from the IMpower 150 trial, an open-label study involving 1202 patients with stage IV metastatic NSq NSCLC who had not received prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor if appropriate, regardless of PD-L1 or T-effector gene status and ECOG performance status 0 or 1.

The Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab; Genentech), 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.

The approval was based on data from the IMpower 150 trial, an open-label study involving 1202 patients with stage IV metastatic NSq NSCLC who had not received prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor if appropriate, regardless of PD-L1 or T-effector gene status and ECOG performance status 0 or 1. Patients were randomized to receive 1 of the following regimens: Tecentriq + carboplatin and paclitaxel, Tecentriq and bevacizumab + carboplatin and paclitaxel, or bevacizumab + carboplatin and paclitaxel. The major efficacy outcome measures were progression free survival (PFS) and overall survival (OS).

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Results showed that compared with bevacizumab + carboplatin and paclitaxel, OS was significantly longer in the Tecentriq with bevacizumab + chemotherapy arm (median OS: 19.2 months vs 14.7 months; hazard ratio [HR] 0.78, 95% CI, 0.64-0.96; P= .016). Moreover, compared with bevacizumab + chemotherapy, Tecentriq with bevacizumab + carboplatin and paclitaxel reduced the risk of disease progression or death by 29% (PFS: 8.5 months vs 7.0 months; HR 0.71, 95% CI 0.59-0.85; P= .0002).

An overall response rate was observed in 55% of patients treated with Tecentriq and bevacizumab + chemotherapy compared with 42% for those who received bevacizumab + chemotherapy. Complete response was noted in 4% of patients receiving Tecentriq in combination with bevacizumab + chemotherapy; 51% of patients had a partial response. The median duration of response was 10.8 months for the Tecentriq and bevacizumab + chemotherapy group vs 6.5 months for the bevacizumab + chemotherapy arm.

Tecentriq, a programmed death-ligand 1 (PD-L1) blocking antibody is also approved for the treatment of patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. In addition, it is approved for the treatment of urothelial carcinoma.

For more information visit Tecentriq.com.