Roche announced that its phase 3 IMpower150 study determined that the combination of drug atezolizumab (Tecentriq) to bevacizumab (Avastin) with the chemotherapy drugs paclitaxel and carboplatin showed a significant reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy in the first-line treatment of patients with non-small cell lung cancer (NSCLC).
A phase 3 study showed that the addition of Roche’s immunotherapy drug atezolizumab (Tecentriq) to bevacizumab (Avastin) plus chemotherapy delayed lung cancer progression in the initial treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC).
Roche announced that the phase 3 IMpower150 study met its co-primary endpoint of progression-free survival (PFS). They determined that the combination of Tecentriq and Avastin with the chemotherapy drugs paclitaxel and carboplatin demonstrated a significant reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy in the first-line treatment of patients with NSCLC.
“We are extremely encouraged by these results and will submit these data to health authorities globally with the goal of bringing a potential new standard of care for the initial treatment of lung cancer,” said Sandra Horning, MD, Chief Medical Officer and head of global product development, Roche, in a statement. “In addition to first-line NSCLC, we are testing the ability of Tecentriq and Avastin to enhance the potential of the immune system to combat a broad range of other cancers.”
The IMpower150 study is a multicenter, open-label, randomized, controlled phase 3 study assessing the efficacy and safety of Tecentriq in combination with carboplatin and paclitaxel with or without Avastin in people with stage IV non-squamous NSCLC who have not been previously treated with chemotherapy.
The study enrolled 1202 patients, but those with anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) mutations were excluded from the primary intention-to-treat (ITT) analysis. The patients were randomized 1:1:1 to receive Tecentriq plus carboplatin and paclitaxel (Arm A), Tecentriq and Avastin plus carboplatin and paclitaxel (Arm B), or Avastin plus carboplatin and paclitaxel (Arm C, control arm).
During the treatment-induced phase, patients in arm A received Tecentriq intravenously at 1200 mg on day 1 of a 3-week treatment cycle for 4 or 6 cycles. Patients continued to receive treatment until loss of clinical benefit or disease progression.
Patients in Arm B received induction treatment of Tecentriq at 1200 mg plus Avastin at 15 mg per kg intravenously in combination with infusion of carboplatin and paclitaxel on day 1 of a 3-week treatment cycle or 4 or 6 weeks. Patients continued treatment with the Tecentriq—Avastin regimen until disease progression or loss of clinical benefit/disease progression.
Patients in Arm C received induction treatment with Avastin administered intravenously at 15 mg per kg plus intravenous infusion of carboplatin and paclitaxel on day 1 of a 3-week treatment cycle for 4 or 6 cycles. Treatment with Avastin alone continued until disease progression.
Results showed that the Tecentriq—Avastin regimen with paclitaxel and carboplatin demonstrated a significant reduction in the risk of disease worsening or death compared with Avastin plus paclitaxel and carboplatin.
While the initial observations for the co-primary endpoint of overall survival (OS) are encouraging, the data are not fully mature, and the next OS analysis is expected in the first half of 2018, said Roche in a statement.