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Roche's (RHHBY) Late-Stage Lung Cancer Study Meets Primary Goal
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Roche Holding AG (RHHBY - Free Report) announced that the late-stage study evaluating Alecensa (alectinib) met its primary endpoint of disease-free survival (DFS) in the treatment of early-stage lung cancer.
The prescheduled interim analysis of the phase III ALINA study of Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy compared with platinum-based chemotherapy in people with completely resected stage IB to IIIA anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Per Roche, Alecensa is the first and only ALK inhibitor that reduced the risk of disease progression or death for people with early-stage ALK-positive NSCLC in a phase III study.
The company further reported that the overall survival data was immature at the time of the data readout. However, treatment with Alecensa did not trigger any unexpected safety signals.
RHHBY plans to present results from the late-stage ALINA study at an upcoming medical conference and submit the findings to regulatory bodies across the globe, including the FDA and EU’s European Medicines Agency.
Year to date, shares of Roche have fallen 6.4% against the industry’s 7.4% rise.
Image Source: Zacks Investment Research
Roche’s Alecensa is currently approved in more than 100 countries worldwide as the first-line treatment for advanced ALK-positive NSCLC, including in the United States, EU, Japan and China. Now, based on promising results from the ALINA study, management believes that Alecensa could also play a pivotal role in the early-stage treatment of the disease, where there is a significant unmet need.
If approved, Alecensa can potentially treat the cancer before it has spread, which increases the chances of cure for the patient. Approval of Alecensa in early-stage ALK-positive NSCLC will expand the patient eligibility for this treatment, thereby driving up Roche’s Alecensa sales.
Per Roche, currently half of the total number of people suffering from early-stage lung cancer experience a cancer recurrence following surgery, despite adjuvant chemotherapy. Hence, though there are some innovative immunotherapies for early-stage NSCLC, there are no approved ALK inhibitors for early-stage ALK-positive disease, which is a rare form of NSCLC.
Currently, the standard of care in the frontline treatment of metastatic NSCLC is Merck’s (MRK - Free Report) Keytruda. Keytruda, an anti-PD-1 therapy, is MRK’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 40% of Merck’s pharmaceutical sales.
Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
A couple of better-ranked stocks in the pharma/biotech sector are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 51 cents to 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 35%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has gone up from 62 cents to 78 cents. The estimate for Corcept’s 2024 earnings per share has also improved from 61 cents to 83 cents. Year to date, shares of CORT have climbed 61.1%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Roche's (RHHBY) Late-Stage Lung Cancer Study Meets Primary Goal
Roche Holding AG (RHHBY - Free Report) announced that the late-stage study evaluating Alecensa (alectinib) met its primary endpoint of disease-free survival (DFS) in the treatment of early-stage lung cancer.
The prescheduled interim analysis of the phase III ALINA study of Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy compared with platinum-based chemotherapy in people with completely resected stage IB to IIIA anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Per Roche, Alecensa is the first and only ALK inhibitor that reduced the risk of disease progression or death for people with early-stage ALK-positive NSCLC in a phase III study.
The company further reported that the overall survival data was immature at the time of the data readout. However, treatment with Alecensa did not trigger any unexpected safety signals.
RHHBY plans to present results from the late-stage ALINA study at an upcoming medical conference and submit the findings to regulatory bodies across the globe, including the FDA and EU’s European Medicines Agency.
Year to date, shares of Roche have fallen 6.4% against the industry’s 7.4% rise.
Image Source: Zacks Investment Research
Roche’s Alecensa is currently approved in more than 100 countries worldwide as the first-line treatment for advanced ALK-positive NSCLC, including in the United States, EU, Japan and China. Now, based on promising results from the ALINA study, management believes that Alecensa could also play a pivotal role in the early-stage treatment of the disease, where there is a significant unmet need.
If approved, Alecensa can potentially treat the cancer before it has spread, which increases the chances of cure for the patient. Approval of Alecensa in early-stage ALK-positive NSCLC will expand the patient eligibility for this treatment, thereby driving up Roche’s Alecensa sales.
Per Roche, currently half of the total number of people suffering from early-stage lung cancer experience a cancer recurrence following surgery, despite adjuvant chemotherapy. Hence, though there are some innovative immunotherapies for early-stage NSCLC, there are no approved ALK inhibitors for early-stage ALK-positive disease, which is a rare form of NSCLC.
Currently, the standard of care in the frontline treatment of metastatic NSCLC is Merck’s (MRK - Free Report) Keytruda. Keytruda, an anti-PD-1 therapy, is MRK’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 40% of Merck’s pharmaceutical sales.
Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
Roche Holding AG Price and Consensus
Roche Holding AG price-consensus-chart | Roche Holding AG Quote
Zacks Rank & Stocks to Consider
Roche currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the pharma/biotech sector are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 51 cents to 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 35%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has gone up from 62 cents to 78 cents. The estimate for Corcept’s 2024 earnings per share has also improved from 61 cents to 83 cents. Year to date, shares of CORT have climbed 61.1%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.