Roche Holdings RHHBY announced disappointing results from a late-stage study on immune-oncology drug, Tecentriq, for the indication of ovarian cancer.
The phase III IMagyn050 study showed that the addition of Tecentriq 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.
Nevertheless, data for the overall survival (OS) co-primary endpoint are currently immature and follow-up will continue until the next planned analysis.
Positive results from the study would have supported a potential approval of the combination in this indication, which is the 8th most commonly occurring cancer in women worldwide, with nearly 300,000 new cases diagnosed each year.
Tecentriq sales came in at CHF644 million in the first quarter. Meanwhile, Roche is also evaluating the drug in multiple ongoing and planned phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. These include studies evaluating the drug both alone and in combination with other drugs.
However, the drug faces stiff competition from Merck’s MRK Keytruda and Bristol-Myers’ BMY Opdivo. Other PD-L1 inhibitors available in the market include AstraZeneca’s AZN Imfinzi.
Roche’s stock has gained 10.8% in the year so far against the industry’s decline of 0.5%.
Separately, the company announced results from the second interim analysis of the phase IIIb STASEY study, which reinforces the safety profile of hemophilia drug, Hemlibra (emicizumab). STASEY is a single-arm, multicenter, open-label, phase IIIb clinical study where patients received Hemlibra for an average of 50.9 weeks.
Hemlibra is already approved to treat patients with hemophilia A with factor VIII inhibitors and those without factor VIII inhibitors in more than 70 countries worldwide, including the United States, the EU and Japan.
The results show that Hemlibra was effective with no new safety signals identified in adults and adolescents with hemophilia A with factor VIII inhibitors. The data reinforce the safety profile of Hemlibra as characterized in the phase III HAVEN clinical program.
Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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