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Roche's (RHHBY) Tecentriq Meets Primary Goal in Lung Cancer Study
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Roche (RHHBY - Free Report) announced that a late-stage stage study evaluating its immuno-oncology drug, Tecentriq (atezolizumab), met its primary endpoint of disease-free survival (DFS) at the interim analysis in patients living with lung cancer.
Per the company, Tecentriq, which is already approved for various forms of lung cancer, has become the first cancer immunotherapy to help patients with resectable early lung cancer live longer without their cancer returning.
The phase III IMpower010 study randomized 1,005 patients with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or best supportive care (BSC).
The results showed that Tecentriq demonstrated a statistically significant improvement in DFS as an adjuvant therapy following surgery and chemotherapy in all randomized stage II-IIIA patients with non-small cell lung cancer (NSCLC) when compared with BSC.
Moreover, the magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population.
The study will continue with planned analyses of DFS in the overall intent-to-treat (ITT) population, which at the time of analysis did not cross the threshold, and overall survival (OS) data, which were immature at the time of the interim analysis. The safety for Tecentriq was consistent with its known safety profile and no new safety signals were identified.
Tecentriq is currently approved for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). The drug also has four approved indications in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is also approved for certain types of metastatic urothelial cancers, PD-L1-positive metastatic triple-negative breast cancer and hepatocellular carcinoma.
Roche is also evaluating Tecentriq in multiple ongoing and planned phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
Approval in additional indications will boost sales of the drug, which raked in CHF 2.7 billion in 2020, up 55% year over year.
Roche’s stock has lost 6% in the year so far compared with the industry’s decline of 1.1%.
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 and Bristol-Myers’ (BMY - Free Report) Opdivo in various indications. AstraZeneca’s (AZN - Free Report) Imfinzi is also approved for some of these indications.
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Roche's (RHHBY) Tecentriq Meets Primary Goal in Lung Cancer Study
Roche (RHHBY - Free Report) announced that a late-stage stage study evaluating its immuno-oncology drug, Tecentriq (atezolizumab), met its primary endpoint of disease-free survival (DFS) at the interim analysis in patients living with lung cancer.
Per the company, Tecentriq, which is already approved for various forms of lung cancer, has become the first cancer immunotherapy to help patients with resectable early lung cancer live longer without their cancer returning.
The phase III IMpower010 study randomized 1,005 patients with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or best supportive care (BSC).
The results showed that Tecentriq demonstrated a statistically significant improvement in DFS as an adjuvant therapy following surgery and chemotherapy in all randomized stage II-IIIA patients with non-small cell lung cancer (NSCLC) when compared with BSC.
Moreover, the magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population.
The study will continue with planned analyses of DFS in the overall intent-to-treat (ITT) population, which at the time of analysis did not cross the threshold, and overall survival (OS) data, which were immature at the time of the interim analysis. The safety for Tecentriq was consistent with its known safety profile and no new safety signals were identified.
Tecentriq is currently approved for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). The drug also has four approved indications in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is also approved for certain types of metastatic urothelial cancers, PD-L1-positive metastatic triple-negative breast cancer and hepatocellular carcinoma.
Roche is also evaluating Tecentriq in multiple ongoing and planned phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
Approval in additional indications will boost sales of the drug, which raked in CHF 2.7 billion in 2020, up 55% year over year.
Roche’s stock has lost 6% in the year so far compared with the industry’s decline of 1.1%.
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 and Bristol-Myers’ (BMY - Free Report) Opdivo in various indications. AstraZeneca’s (AZN - Free Report) Imfinzi is also approved for some of these indications.
Roche currently carries a Zacks Rank #5 (Strong Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Last year's 2020 Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. 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.
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