Roche Group member Genentech has secured approval from the US Food and Drug Administration (FDA) for its Tecentriq (atezolizumab) in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
Tecentriq monoclonal antibody has been approved in combination with carboplatin and etoposide as a first-line treatment for adults with ES-SCLC.
The approval was based on data from the phase III IMpower133 study, which demonstrated that the monoclonal antibody in combination with chemotherapy enabled people live significantly longer compared against chemotherapy alone in the intention-to-treat (ITT) population.
The combination significantly decreased the risk of disease worsening or death compared to chemotherapy alone, said the company.
IMpower133 is a phase III, multicenter, double-blinded, randomized placebo-controlled study designed to assess the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) against chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve adults with ES-SCLC.
The study recruited 403 people and randomized equally (1:1) to secure Tecentriq in combination with carboplatin and etoposide in arm A, as well as placebo in combination with carboplatin and etoposide in arm B or control arm.
Tecentriq is designed to bind with PD-L1 protein. It is being developed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells to block, enabling to block its interactions with both PD-1 and B7.1 receptors. Tecentriq may enable the re-activation of T cells through blocking PD-L1.
Tecentriq, in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), was also approved as the first-line treatment for adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
In addition, the FDA approved Tecentriq to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.
Roche chief medical officer and global product development head Dr Sandra Horning said: “Tecentriq is the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer, which is especially difficult to treat.
“Until now, there have been limited treatment advances for this disease, and we are excited to bring a potential new standard of care to patients that has been shown to improve survival compared to chemotherapy.”