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Roche's (RHHBY) Immunotherapy Gets Breakthrough Therapy Status
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Roche (RHHBY - Free Report) announced that the FDA has granted Breakthrough Therapy Designation (BTD) to tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT in combination with its immuno-oncology drug, Tecentriq (atezolizumab).
The combination has been granted the designation for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations.
The BTD is based on the randomized phase II CITYSCAPE study that showed encouraging efficacy and safety with tiragolumab plus Tecentriq in patients suffering from PD-L1-positive metastatic NSCLC. At an average of 10.9 months follow-up, the combination showed an improvement in the overall response rate (ORR) of 37% versus 21% with only Tecentriq and a 42% reduction in the risk of disease worsening or death (progression-free survival; PFS) compared with Tecentriq alone.
Per the company, CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.
The designation from the FDA accelerates the development and review of medicines intended to treat serious or life-threatening conditions, with preliminary evidence that indicates that these may demonstrate a substantial improvement over existing therapy.
Meanwhile, Roche is evaluating the potential of tiragolumab in a broad development program, which includes randomized trials in metastatic NSCLC (SKYSCRAPER-01 and SKYSCRAPER-06) and small cell lung cancer (SKYSCRAPER-02), as well as an evaluation of tiragolumab in earlier stages, including stage III NSCLC (SKYSCRAPER-03) and locally advanced esophageal cancer (SKYSCRAPER-07).
We note that Roche’s Tecentriq is already approved in the United States, the EU and other regions around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, small cell lung cancer, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and hepatocellular carcinoma.
A potential approval of other drugs will boost Roche’s immunotherapy portfolio. which includes Tecentriq. The target market represents huge potential.
The company’s shares have increased 6.9% in the past year compared with the industry's 3.4% 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 and Bristol-Myers’ (BMY - Free Report) Opdivo in various indications. AstraZeneca’s (AZN - Free Report) Imfinzi is also approved for lung cancer.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
Roche's (RHHBY) Immunotherapy Gets Breakthrough Therapy Status
Roche (RHHBY - Free Report) announced that the FDA has granted Breakthrough Therapy Designation (BTD) to tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT in combination with its immuno-oncology drug, Tecentriq (atezolizumab).
The combination has been granted the designation for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations.
The BTD is based on the randomized phase II CITYSCAPE study that showed encouraging efficacy and safety with tiragolumab plus Tecentriq in patients suffering from PD-L1-positive metastatic NSCLC. At an average of 10.9 months follow-up, the combination showed an improvement in the overall response rate (ORR) of 37% versus 21% with only Tecentriq and a 42% reduction in the risk of disease worsening or death (progression-free survival; PFS) compared with Tecentriq alone.
Per the company, CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.
The designation from the FDA accelerates the development and review of medicines intended to treat serious or life-threatening conditions, with preliminary evidence that indicates that these may demonstrate a substantial improvement over existing therapy.
Meanwhile, Roche is evaluating the potential of tiragolumab in a broad development program, which includes randomized trials in metastatic NSCLC (SKYSCRAPER-01 and SKYSCRAPER-06) and small cell lung cancer (SKYSCRAPER-02), as well as an evaluation of tiragolumab in earlier stages, including stage III NSCLC (SKYSCRAPER-03) and locally advanced esophageal cancer (SKYSCRAPER-07).
We note that Roche’s Tecentriq is already approved in the United States, the EU and other regions around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, small cell lung cancer, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and hepatocellular carcinoma.
A potential approval of other drugs will boost Roche’s immunotherapy portfolio. which includes Tecentriq. The target market represents huge potential.
The company’s shares have increased 6.9% in the past year compared with the industry's 3.4% 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 and Bristol-Myers’ (BMY - Free Report) Opdivo in various indications. AstraZeneca’s (AZN - Free Report) Imfinzi is also approved for lung cancer.
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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