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Roche's Lung Cancer Drug Alecensa Meets Primary Endpoint
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Roche Holdings (RHHBY - Free Report) announced that the global, randomized phase III study, ALEX, on lung cancer drug Alecensa met its primary endpoint as an initial (first-line) treatment. Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with Pfizer’s (PFE - Free Report) Xalkori in patients suffering from anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
We remind investors that Alecensa was granted accelerated approval by the FDA in Dec 2015 for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant to Xalkori. Roche is conducting the ALEX study to convert the current accelerated approval of Alecensa in patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to Xalkori to a full approval as an initial treatment.
Meanwhile, this is the second phase III trial to show that Alecensa was better as an initial treatment compared to Xalkori. The FDA also has granted Alecensa Breakthrough Therapy Designation (BTD) for advanced ALK-positive NSCLC without prior treatment with an ALK inhibitor.
Roche expects to present full data from the study later at an upcoming medical meeting.
Roche’s share price shows that the company has outperformed the Zacks classified industry year to date. The stock rallied 11.1% compared to the Large Cap Pharmaceuticals industry’s gain of 5.7%.
We remind investors that Novartis (NVS - Free Report) is also evaluating Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK+positive as detected by an FDA-approved test.
Roche has a strong presence in the oncology market. The company dominates the breast cancer space with strong demand for HER2 franchise drugs like Herceptin, Perjeta and Kadcyla. We are also impressed by the company's efforts to develop its portfolio beyond oncology into immunology. New drug launches, such as Tecentriq, Cotellic and Alecensa boosted sales and are expected to continue to do so in the upcoming quarters as well.
Zacks Rank & Stock to Consider
Roche currently sports a Zacks Rank #1 (Strong Buy).
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 60 days. The company posted a positive earnings surprise in all the four trailing quarters with an average beat of 291.54%.
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Roche's Lung Cancer Drug Alecensa Meets Primary Endpoint
Roche Holdings (RHHBY - Free Report) announced that the global, randomized phase III study, ALEX, on lung cancer drug Alecensa met its primary endpoint as an initial (first-line) treatment. Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with Pfizer’s (PFE - Free Report) Xalkori in patients suffering from anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
We remind investors that Alecensa was granted accelerated approval by the FDA in Dec 2015 for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant to Xalkori. Roche is conducting the ALEX study to convert the current accelerated approval of Alecensa in patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to Xalkori to a full approval as an initial treatment.
Meanwhile, this is the second phase III trial to show that Alecensa was better as an initial treatment compared to Xalkori. The FDA also has granted Alecensa Breakthrough Therapy Designation (BTD) for advanced ALK-positive NSCLC without prior treatment with an ALK inhibitor.
Roche expects to present full data from the study later at an upcoming medical meeting.
Roche’s share price shows that the company has outperformed the Zacks classified industry year to date. The stock rallied 11.1% compared to the Large Cap Pharmaceuticals industry’s gain of 5.7%.
We remind investors that Novartis (NVS - Free Report) is also evaluating Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK+positive as detected by an FDA-approved test.
Roche has a strong presence in the oncology market. The company dominates the breast cancer space with strong demand for HER2 franchise drugs like Herceptin, Perjeta and Kadcyla. We are also impressed by the company's efforts to develop its portfolio beyond oncology into immunology. New drug launches, such as Tecentriq, Cotellic and Alecensa boosted sales and are expected to continue to do so in the upcoming quarters as well.
Zacks Rank & Stock to Consider
Roche currently sports a Zacks Rank #1 (Strong Buy).
Another top stock in the healthcare sector is Heska Corp. . You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 60 days. The company posted a positive earnings surprise in all the four trailing quarters with an average beat of 291.54%.
Zacks' Hidden Trades
While we share many recommendations and ideas with the public, certain moves are hidden from everyone but selected members of our portfolio services. Would you like to peek behind the curtain today and view them?
Starting now, for the next month, I invite you to follow all Zacks' private buys and sells in real time from value to momentum...from stocks under $10 to ETF to option movers...from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors. Click here for Zacks' secret trade>>