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First line treatment with atezolizumab plus chemotherapy for advanced NSCLC improved PFS

The combination of anti PD-L1 atezolizumab plus chemotherapy (carboplatin and nab-paclitaxel) has been shown to reduce the risk of disease worsening or death (based on progression-free survival; PFS) compared with chemotherapy alone in the first-line treatment of people with advanced squamous non-small cell lung cancer (NSCLC).

Improved PFS was a co-primary endpoint of the Phase III IMpower131 trial.

IMpower131 is a Phase III, open-label, multicenter, randomized study evaluating the efficacy and safety of atezolizumab in combination with carboplatin and nab-paclitaxel or atezolizumab in combination with carboplatin and paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone in people with stage IV squamous NSCLC who have not been previously treated with chemotherapy.

The study enrolled 1,021 people who were randomized equally (1:1:1) to receive:

  • Atezolizumab plus carboplatin and paclitaxel (Arm A)
  • Atezolizumab plus carboplatin and nab-paclitaxel (Arm B)
  • Carboplatin and nab-paclitaxel (Arm C, control arm)

Safety for the atezolizumab and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.

At this interim analysis a statistically significant overall survival (OS) benefit was not observed and the study will continue as planned.

These data will be presented at an upcoming oncology congress.

“Squamous non-small cell lung cancer is difficult to treat and there have been limited new treatment options over the last few decades,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development at Genentech, a member of the Roche group. “We will share the IMpower131 results with global health authorities and we look forward to seeing more mature overall survival data.”

As per the statistical analysis plan in IMpower131, Arm B (atezolizumab plus carboplatin and nab-paclitaxel) must demonstrate a statistically significant OS result vs. Arm C (carboplatin and nab-paclitaxel), before an analysis between Arm A (atezolizumab plus carboplatin and paclitaxel) and Arm C can be made for PFS and OS.

Source: BusinessWire



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