FDA Approves Frontline Tecentriq Regimen for NSCLC

The Food and Drug Administration has approved Tecentriq (atezolizumab) for use in combination with Avastin (bevacizumab), carboplatin, paclitaxel, the treatment combination known as ABCP, for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).
BY Gina Columbus
PUBLISHED December 06, 2018
The Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) for use in combination with Avastin (bevacizumab), carboplatin, paclitaxel, the treatment combination known as ABCP, for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). This indication excludes patients with EGFR/ALK aberrations.

The approval was based on findings from the phase 3 IMpower150 trial, in which the ABCP regimen reduced the risk of death by 22 percent compared with Avastin and chemotherapy (BCP) in patients with advanced wild-type NSCLC.

Results showed that the median overall survival (OS) with the addition of Tecentriq was 19.2 months compared with 14.7 months in the BCP group. Moreover, the 24-month OS rate with Tecentriq was 43 percent compared with 34 percent for BCP. ABCP also improved median progression-free survival (PFS) by 1.5 months compared with BCP (8.3 vs 6.8 months).

The trial was designed to exclude data for patients with EGFR/ALK-mutated NSCLC from the co-primary endpoints of OS and PFS. Approximately 13 percent of the trials participants were EGFR or ALK-positive. Prior to study entry, these patients had received at least one prior EGFR TKI.

When patients with EGFR/ALK alterations were included in the intent-to-treat population, the median OS with ABCP jumped to 19.8 months compared with 14.9 months for BCP. Better than expected survival was also seen in patients with liver metastases.

Added efficacy for both groups correlated with the addition of the VEGF inhibitor Avastin and Tecentriq. In a separate cohort of the study looking at Tecentriq plus carboplatin and paclitaxel (ACP) there was a less pronounced improvement compared with BCP. In the EGFR/ALK-positive group, the objective response rate (ORR) was 56 percent with ABCP compared with 40 percent with ACP and 41 percent with BCP.

There was a 46 percent reduction in the risk of death with ABCP compared with BCP for patients with liver metastases and a 46 percent reduction in the risk of death for patients with EGFR/ALK-mutated NSCLC. The risk of death was reduced by 15 percent and 18 percent for patients with liver metastases and EGFR/ALK alterations, respectively.

Treatment-related grade 3 or 4 side effects occurred in 43 percent of patients in the ACP group and for 57 percent and 49 percent of those in the ABCP and BCP arms, respectively. Serious adverse events occurred in 39 percent, 44 percent and 34 percent of patients in the ACP, ABCP and BCP groups. The most common grade 3/4 immune-related side effects were rash and hepatitis.

This article was originally published on OncLive, “FDA Approves Frontline Atezolizumab Regimen for NSCLC.”
 
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