Phase 3 IMagyn050 trial did not meet the primary endpoint of progression-free survival (PFS) for the treatment of women with advanced-stage ovarian cancer
Roche Diagnostics administration and R&D buildings. (Credit: F. Hoffmann-La Roche Ltd.)
Roche’s announced that its Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), paclitaxel and carboplatin has failed to treat ovarian cancer in Phase 3 IMagyn050 trial.
The clinical trial has not met the primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced-stage ovarian cancer.
Swiss pharmaceutical firm said that the safety data for Tecentriq in combination with Avastin, paclitaxel and carboplatin was consistent with the known safety profile of the combination.
Roche chief medical officer and global product development head Levi Garraway said: “Ovarian cancer remains one of the most aggressive cancers and is difficult to treat in its advanced stages.
“While we are disappointed by these results, we remain committed to improving outcomes for women living with this disease and are pleased that Avastin remains a key component in the treatment of front-line ovarian cancer.”
Phase 3 IMagyn050 trial evaluated Tecentriq plus Avastin, paclitaxel and carboplatin
IMagyn050 is a Phase 3, multicentre, randomised, double-blind study designed to evaluate the efficacy and safety of Tecentriq in combination with Avastin, paclitaxel and carboplatin, versus placebo plus Avastin, paclitaxel and carboplatin.
The study enrolled women with Stage III or IV ovarian cancer who are undergoing neoadjuvant or adjuvant therapy and randomised the subjects to either before or after tumour reductive surgery.
Tecentriq is a monoclonal antibody that binds with PD-L1 protein, expressed on tumour cells and tumour-infiltrating immune cells, to block its interactions with PD-1 and B7.1 receptors, and activates T-cells.
Investigator-determined PFS and OS, both in the intent-to-treat (ITT) population and PD-L1-positive subpopulation include the co-primary endpoints of the study.
Also, objective response rate, safety and tolerability, along with patient-reported improvement in abdominal pain and bloating constitute the secondary endpoints.
Roche is conducting the IMagyn050 study in collaboration with The GOG Foundation, and the European Network of Gynaecological Oncological Trial groups (ENGOT).
The overall survival (OS) data for the co-primary endpoint are underway, and the company is planning to continue the follow-up until the planned further analysis. IMagyn050 results will be further evaluated for use in the Tecentriq gynaecologic development programme.