Roche (RHHBY - Free Report) 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 - Free Report) Keytruda, AstraZeneca’s (AZN - Free Report) Imfinzi and Bristol-Myers’ (BMY - Free Report) 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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Roche (RHHBY - Free Report) 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 - Free Report) Keytruda, AstraZeneca’s (AZN - Free Report) Imfinzi and Bristol-Myers’ (BMY - Free Report) 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.
Zacks Top 10 Stocks for 2020
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2020?
Last year's 2019 Zacks Top 10 Stocks portfolio returned gains as high as +102.7%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
Access Zacks Top 10 Stocks for 2020 today >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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