We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Roche (RHHBY) Late-Stage Study for ES-SCLC Fails to Meet Goal
Read MoreHide Full Article
Roche (RHHBY - Free Report) announced disappointing results from the phase III SKYSCRAPER-02 study in extensive-stage small-cell lung cancer (ES-SCLC). The study did not meet its co-primary endpoint of progression-free survival.
SKYSCRAPER-02 is a global phase III, randomized, placebo-controlled and double-blinded study evaluating the investigational anti-TIGIT immunotherapy tiragolumab in combination with cancer immunotherapy Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial (first-line) treatment for people with ES-SCLC.
The co-primary endpoint of overall survival was not met at its interim analysis and is not likely to reach statistical significance at the planned final analysis either.
Tiragolumab is a novel immune checkpoint inhibitor with an intact Fc region. Tecentriq is approved in the United States, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer (NSCLC), SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma.
Tecentriq generated sales of CHF 3.3 billion in 2021 as sales increased in all regions, most notably in Japan, primarily due to the growth in the treatment of hepatocellular carcinoma.
Per the company, Tecentriq was the first cancer immunotherapy to show a survival benefit in ES-SCLC (phase III IMpower133 study).
We remind investors that tiragolumab was granted Breakthrough Therapy Designation by the FDA in 2021 for the initial treatment of PD-L1-high metastatic NSCLC, based on the results of the phase II CITYSCAPE study.
Meanwhile, the phase III SKYSCRAPER-01 trial is ongoing to confirm the CITYSCAPE results. Roche has initiated five phase III trials, including NSCLC (SKYSCRAPER-01, SKYSCRAPER-03), ES- SCLC (SKYSCRAPER-02), oesophageal cancers (SKYSCRAPER-07, SKYSCRAPER-08) and multiple early trials in various tumor types in the past two years.
Roche’s stock has gained 23.7% in the past year compared with the industry’s growth of 25.9%.
Image Source: Zacks Investment Research
Roche’s performance in 2021 was impressive on the back of the diagnostics division, which maintained its stellar performance on strong demand for COVID-19 tests. The pharmaceuticals business also recovered from COVID-19 disruptions. Strong demand for Hemlibra (hemophilia), Ocrevus (multiple sclerosis), Tecentriq (cancer), Evrysdi (spinal muscular atrophy) and Phesgo (cancer) drove growth.
However, the outlook indicated that sales will slow down in 2022 year over year due to reduced demand for its COVID-19 drugs and diagnostics.
The consensus estimate for Vertex’s 2022 earnings has increased 19 cents over the past 60 days to $14.52. Shares of VRTX have gained 16.4% in the year so far.
Loss estimates for VYGR have narrowed to $1.35 from $2.20 for 2022 in the past 60 days. Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed the same once.
Loss estimates for KLDO have narrowed to $1.64 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Roche (RHHBY) Late-Stage Study for ES-SCLC Fails to Meet Goal
Roche (RHHBY - Free Report) announced disappointing results from the phase III SKYSCRAPER-02 study in extensive-stage small-cell lung cancer (ES-SCLC).
The study did not meet its co-primary endpoint of progression-free survival.
SKYSCRAPER-02 is a global phase III, randomized, placebo-controlled and double-blinded study evaluating the investigational anti-TIGIT immunotherapy tiragolumab in combination with cancer immunotherapy Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial (first-line) treatment for people with ES-SCLC.
The co-primary endpoint of overall survival was not met at its interim analysis and is not likely to reach statistical significance at the planned final analysis either.
Tiragolumab is a novel immune checkpoint inhibitor with an intact Fc region. Tecentriq is approved in the United States, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer (NSCLC), SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma.
Tecentriq generated sales of CHF 3.3 billion in 2021 as sales increased in all regions, most notably in Japan, primarily due to the growth in the treatment of hepatocellular carcinoma.
Per the company, Tecentriq was the first cancer immunotherapy to show a survival benefit in ES-SCLC (phase III IMpower133 study).
We remind investors that tiragolumab was granted Breakthrough Therapy Designation by the FDA in 2021 for the initial treatment of PD-L1-high metastatic NSCLC, based on the results of the phase II CITYSCAPE study.
Meanwhile, the phase III SKYSCRAPER-01 trial is ongoing to confirm the CITYSCAPE results. Roche has initiated five phase III trials, including NSCLC (SKYSCRAPER-01, SKYSCRAPER-03), ES- SCLC (SKYSCRAPER-02), oesophageal cancers (SKYSCRAPER-07, SKYSCRAPER-08) and multiple early trials in various tumor types in the past two years.
Roche’s stock has gained 23.7% in the past year compared with the industry’s growth of 25.9%.
Image Source: Zacks Investment Research
Roche’s performance in 2021 was impressive on the back of the diagnostics division, which maintained its stellar performance on strong demand for COVID-19 tests. The pharmaceuticals business also recovered from COVID-19 disruptions. Strong demand for Hemlibra (hemophilia), Ocrevus (multiple sclerosis), Tecentriq (cancer), Evrysdi (spinal muscular atrophy) and Phesgo (cancer) drove growth.
However, the outlook indicated that sales will slow down in 2022 year over year due to reduced demand for its COVID-19 drugs and diagnostics.
Roche currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Vertex Pharmaceuticals (VRTX - Free Report) , Voyager Therapeutics (VYGR - Free Report) and Kaleido Biosciences . All three carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The consensus estimate for Vertex’s 2022 earnings has increased 19 cents over the past 60 days to $14.52. Shares of VRTX have gained 16.4% in the year so far.
Loss estimates for VYGR have narrowed to $1.35 from $2.20 for 2022 in the past 60 days. Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed the same once.
Loss estimates for KLDO have narrowed to $1.64 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.