The trial, called ATALANTE (NCT02891824), was designed to test Tecentriq versus placebo as a maintenance therapy for patients who first responded to platinum-based chemotherapy but relapsed after six months or more.
The trial was unveiled June 4 at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in a presentation titled “ATALANTE (ENGOT-ov29): A randomized, double-blinded, phase III study of atezolizumab versus placebo in patients with late relapse of epithelial ovarian, fallopian tube, or peritoneal cancer treated by platinum-based chemotherapy and bevacizumab.”
Ovarian cancer cells are known to express molecules at their surface that work as “off switches” of the immune system, guarding cancer from attacks. Immunotherapies that target these molecules could, therefore, enhance the responses of ovarian cancer patients.
Genentech‘s Tecentriq binds to one such molecule, called the programmed death-1 (PD-1) receptor. By preventing the ligand PD-L1 from binding to PD-1, the medicine keeps immune cells active and able to fight cancer.
Avastin, also developed by Genentech, is a therapy that interferes with the tumor’s blood supply, which is key to a tumor’s ability to grow and spread to other parts of the body. Evidence suggests Tecentriq and Avastin act synergistically to enhance the immune system’s response to ovarian cancer cells.
Avastin is approved in Europe in combination with platinum-based chemotherapy for the treatment of advanced ovarian cancer. It is used as an induction therapy to eliminate cancer, and as a maintenance therapy to prevent it from returning.
ATALANTE was designed to determine if adding Tecentriq to Avastin and platinum-based chemotherapy could increase the time a patient lives without the disease worsening compared to Avastin and chemotherapy alone.
The trial will enroll 405 patients whose disease returned six months or more after their last platinum-based chemotherapy regimen. All patients must have a tumor biopsy and receive tests for PD-L1 levels when entering the study.
Participants randomly will be assigned Tecentriq or a placebo at a 2:1 ratio; for each patient receiving placebo, two will be given Tecentriq.
In addition to progression-free survival – the trial’s primary goal – researchers will assess overall survival, patient-reported outcomes, and frequency of adverse events.
The trial is now recruiting in Austria and France. For more information, visit the trial’s website.
The U.S. Food and Drug Administration is reviewing a supplemental Biologics License Application for Avastin in combination with chemotherapy as a frontline treatment for women with advanced ovarian cancer. A decision is expected by June 25.