Roche RHHBY announced that the late-stage study on immuno-oncology drug Tecentriq for the indication of muscle-invasive urothelial cancer (MIUC) failed.
The phase III, open-label, randomized, controlled study, IMvigor010, is designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq in 809 patients with MIUC, who are at high risk for recurrence following resection. The primary endpoint is disease-free survival (DFS) as assessed by investigator, which is defined as the time from randomization to invasive urothelial cancer recurrence or death.
The study did not meet its primary endpoint of DFS compared to observation in patients with MIUC.
Urothelial cancer is the most common type of bladder cancer and MIUC is a type of urothelial cancer spreads into the muscle of the bladder, ureter or renal pelvis.
Nevertheless, the safety for Tecentriq was consistent with the known safety profile of the drug and no new safety signals were identified.
Tecentriq is approved in the United States and the EU 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 PD-L1-positive metastatic triple-negative breast cancer.
A potential label expansion in additional indications will boost sales of the drug further.
In addition to the ongoing phase III studies in early and advanced bladder cancer, Roche has an extensive development program for Tecentriq, including multiple ongoing and planned phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. The program includes studies evaluating Tecentriq both alone and in combination with other drugs.
Roche’s shares have gained 32.2% in the past year compared with the industry's 17.2% growth.
While the uptake of Tecentriq has been strong, it is currently facing stiff competition from immuno-oncology therapies like Merck’s MRK Keytruda, AstraZeneca’s AZN Imfinzi and Bristol-Myers’ BMY Opdivo in various indications.
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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Click to get this free report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Bristol-Myers Squibb Company (BMY) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research