Basel, 13 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), 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. Topline safety data indicate that safety for Tecentriq in combination with Avastin, paclitaxel and carboplatin was consistent with the known safety profile of the combination.
“Ovarian cancer remains one of the most aggressive cancers and is difficult to treat in its advanced stages,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
Data for the overall survival (OS) co-primary endpoint are currently immature and follow-up will continue until the next planned analysis. Results from IMagyn050 will be further evaluated in order to inform the Tecentriq gynaecologic development programme. The Tecentriq programme in ovarian cancer and cervical cancers builds on the combination with Avastin, which has helped women with newly diagnosed, advanced or relapsed ovarian and cervical cancers live without their disease getting worse, as demonstrated in results across seven pivotal Phase III trials that involved more than 5,000 women.
Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About the IMagyn050 study
IMagyn050 is a Phase III, multicentre, randomised, double-blind study evaluating the efficacy and safety of Tecentriq in combination with Avastin, paclitaxel and carboplatin compared with placebo plus Avastin, paclitaxel and carboplatin in women with Stage III or IV ovarian cancer who are undergoing neoadjuvant or adjuvant therapy. Patients were randomised 1:1 either before or after tumour reductive surgery. The co-primary endpoints are investigator-determined PFS and OS, both in the intent-to-treat (ITT) population and PD-L1-positive subpopulation. Key secondary endpoints include objective response rate, safety and tolerability, as well as patient-reported improvement in abdominal pain and bloating.
The IMagyn050 study is being conducted in collaboration with The GOG Foundation, Inc. (GOG Foundation) [GOG-3015] and the European Network of Gynaecological Oncological Trial groups (ENGOT) [ENGOT OV-39].
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