SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY), announced positive results for Tecentriq from the Phase III study, OAK. The study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival or OS compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer or NSCLC whose disease progressed on or after treatment with platinum-based chemotherapy.
Adverse events were consistent with what has been previously observed for Tecentriq.
Genentech said it looks forward to presenting full results at an upcoming medical meeting in 2016.
The FDA granted Breakthrough Therapy Designation or BTD for Tecentriqfor the treatment of people with PD-L1 (programmed death-ligand 1) positive NSCLC whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor).
Genentech's Biologics License Application or BLA for NSCLC was granted Priority Review with an action date of October 19, 2016.
Genentech has eight Phase III lung studies underway evaluating TECENTRIQ alone or in combination with other treatments in people with early and advanced stages of lung cancer.
A total of 1,225 patients were enrolled and randomized 1:1 to receive either docetaxel (75 mg/m2 intravenous infusion) or Tecentriq (1200 mg intravenous infusion) every three weeks. Treatment on Tecentriqcontinued as long as patients experienced clinical benefit as assessed by the investigator or until unacceptable toxicity. The primary efficacy analysis was based on the first 850 randomized patients, and the secondary efficacy analysis will include all 1,225 randomized patients.
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