Phase 3 IMagyn050 Study Does Not Meet Primary Endpoint of PFS

Roche announced that the phase 3 IMagyn050 study demonstrated that the addition of atezolizumab (Tecentriq) to bevacizumab (Avastin), paclitaxel, and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer.

“Ovarian cancer remains one of the most aggressive cancers and is difficult to treat in its advanced stages,” Levi Garraway, MD, PhD, chief medical officer and Head of Global Product Development at Roche. “While we are disappointed by these results, we remain committed to improving outcomes for women living with this disease and are pleased that [bevacizumab] remains a key component in the treatment of front-line ovarian cancer.”

The phase 3, multicenter, randomized, double-blind IMagyn050 study is evaluating the efficacy and safety of atezolizumab in combination with bevacizumab, paclitaxel, and carboplatin compared with placebo plus bevacizumab, paclitaxel, and carboplatin in women with stage III or IV ovarian cancer who are undergoing neoadjuvant or adjuvant therapy. Patients were randomized in a 1:1 fashion either before or after tumor reductive surgery.

The dual primary endpoints are investigator-determined PFS and overall survival (OS), both in the intent-to-treat (ITT) population and a PD-L1-positive subpopulation. Key secondary endpoints include objective response rate (ORR), safety and tolerability, as well as patient-reported improvement in abdominal pain and bloating.

Notably, topline safety data indicated that safety for atezolizumab in combination with bevacizumab, paclitaxel, and carboplatin was consistent with the known safety profile of the combination.

Data for the OS co-primary endpoint are currently immature, and follow-up will continue until the next planned analysis. Moreover, results from IMagyn050 will be further evaluated in order to inform Roche’s atezolizumab gynecologic development program.

The company has an extensive development program for atezolizumab, including multiple ongoing and planned phase 3 studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating the agent both alone and in combination with other medicines.

Atezolizumab is already approved in the US and EU, as well as other countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer. Specifically, in the US, atezolizumab in combination with bevacizumab is approved for individuals with unresectable or metastatic hepatocellular carcinoma.

Reference:

Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer [news release]. Basel. Published July 13, 2020. roche.com/media/releases/med-cor-2020-07-13.htm. Accessed July 13, 2020.