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Seagen's (SGEN) Breast Cancer Study on Tuksya Combo Meets Goal
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Seagen Inc. announced positive top-line results from its late-stage HER2CLIMB-02 study, evaluating Tuksya (tucatinib) in combination with Roche’s (RHHBY - Free Report) antibody-drug conjugate, Kadcyla (ado-trastuzumab emtansine), for the treatment of breast cancer.
The phase III study is evaluating the Tuksya/Kadcyla combo treatment in patients with unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer, who had received previous treatment with a taxane and trastuzumab.???
The HER2CLIMB-02 study reportedly met its primary endpoint of progression-free survival. The secondary endpoint of overall survival was not yet mature enough to be reported. However, despite the encouraging news, there were reported discontinuation cases in the combination arm of the study due to adverse events, although no new safety signals emerged for the combination drug.
Year to date, shares of Seagen have soared 50.4% against the industry’s 12.6% fall.
Image Source: Zacks Investment Research
The data from the HER2CLIMB-02 study will be presented at an upcoming medical conference. Management also plans to meet with the FDA soon to discuss the study results to determine future steps.
Tuksya, an oral tyrosine kinase inhibitor, was initially approved in April 2020 in combination with Roche's Herceptin (trastuzumab) and Xeloda (capecitabine) and is currently approved in more than 40 countries. The indication for the same includes treatment of adult patients with locally advanced/metastatic HER2-positive breast cancer including those with brain metastases, having received one or more prior anti-HER2-based regimens in the metastatic setting. The combination drug is also currently approved in the EU for the same indication.
Earlier this year, Tuksya was granted accelerated approval in the United States, in combination with Roche’s Herceptin (trastuzumab), to address a new indication. The said indication includes treating adult patients with RASwild-type, HER2-positive unresectable or metastatic colorectal cancer whose disease progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Seagen is currently conducting a confirmatory study, MOUNTAINEER-03, for continued approval in the U.S. market.
SGEN markets Tuksya in collaboration with Merck (MRK - Free Report) . Seagen signed an agreement with Merck in September 2023, which granted MRK exclusive rights to commercialize Tukya in Asia, Middle East and Latin America and other regions. The company, however, withheld rights to commercialize Tuksya in the United States, EU and Canada. Apart from Tuksya, Seagen also has collaboration agreements with Merck to develop other candidates in its pipeline.
Tukysa is also being evaluated in other label-expanding studies. SGEN’s robust development plan for Tuksya includes a phase III HER2CLIMB-05 study, in combination with Roche’s Herceptin and Perjeta (pertuzumab) as frontline maintenance for patients with metastatic HER2-positive breast cancer, along with a couple of other mid-stage studies. Merck is co-funding the said global development plan for Tukysa with Seagen.
Furthermore, the company also reported supporting a late-stage cooperative group study in adjuvant high-risk HER2-positive breast cancer in combination with Kadcyla.
Per Seagen, approximately 300,590 people will be diagnosed with breast cancer in the United States this year, among which 15-20% of breast cancer cases are HER2-positive. Additionally, about 50% of patients with HER2-positive metastatic breast cancer develop brain metastases over time.
In the past 90 days, the Zacks Consensus Estimate for J&J’s 2023 earnings per share has increased from $10.67 to $10.75. During the same period, the estimate for JNJ’s 2024 earnings per share has increased from $11.01 to $11.29. Year to date, shares of JNJ have lost 2.4%.
JNJ beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 5.58%.
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Seagen's (SGEN) Breast Cancer Study on Tuksya Combo Meets Goal
Seagen Inc. announced positive top-line results from its late-stage HER2CLIMB-02 study, evaluating Tuksya (tucatinib) in combination with Roche’s (RHHBY - Free Report) antibody-drug conjugate, Kadcyla (ado-trastuzumab emtansine), for the treatment of breast cancer.
The phase III study is evaluating the Tuksya/Kadcyla combo treatment in patients with unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer, who had received previous treatment with a taxane and trastuzumab.???
The HER2CLIMB-02 study reportedly met its primary endpoint of progression-free survival. The secondary endpoint of overall survival was not yet mature enough to be reported. However, despite the encouraging news, there were reported discontinuation cases in the combination arm of the study due to adverse events, although no new safety signals emerged for the combination drug.
Year to date, shares of Seagen have soared 50.4% against the industry’s 12.6% fall.
Image Source: Zacks Investment Research
The data from the HER2CLIMB-02 study will be presented at an upcoming medical conference. Management also plans to meet with the FDA soon to discuss the study results to determine future steps.
Tuksya, an oral tyrosine kinase inhibitor, was initially approved in April 2020 in combination with Roche's Herceptin (trastuzumab) and Xeloda (capecitabine) and is currently approved in more than 40 countries. The indication for the same includes treatment of adult patients with locally advanced/metastatic HER2-positive breast cancer including those with brain metastases, having received one or more prior anti-HER2-based regimens in the metastatic setting. The combination drug is also currently approved in the EU for the same indication.
Earlier this year, Tuksya was granted accelerated approval in the United States, in combination with Roche’s Herceptin (trastuzumab), to address a new indication. The said indication includes treating adult patients with RASwild-type, HER2-positive unresectable or metastatic colorectal cancer whose disease progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Seagen is currently conducting a confirmatory study, MOUNTAINEER-03, for continued approval in the U.S. market.
SGEN markets Tuksya in collaboration with Merck (MRK - Free Report) . Seagen signed an agreement with Merck in September 2023, which granted MRK exclusive rights to commercialize Tukya in Asia, Middle East and Latin America and other regions. The company, however, withheld rights to commercialize Tuksya in the United States, EU and Canada. Apart from Tuksya, Seagen also has collaboration agreements with Merck to develop other candidates in its pipeline.
Tukysa is also being evaluated in other label-expanding studies. SGEN’s robust development plan for Tuksya includes a phase III HER2CLIMB-05 study, in combination with Roche’s Herceptin and Perjeta (pertuzumab) as frontline maintenance for patients with metastatic HER2-positive breast cancer, along with a couple of other mid-stage studies. Merck is co-funding the said global development plan for Tukysa with Seagen.
Furthermore, the company also reported supporting a late-stage cooperative group study in adjuvant high-risk HER2-positive breast cancer in combination with Kadcyla.
Per Seagen, approximately 300,590 people will be diagnosed with breast cancer in the United States this year, among which 15-20% of breast cancer cases are HER2-positive. Additionally, about 50% of patients with HER2-positive metastatic breast cancer develop brain metastases over time.
Seagen Inc. Price and Consensus
Seagen Inc. price-consensus-chart | Seagen Inc. Quote
Zacks Rank and Stock to Consider
Seagen currently has a Zacks Rank #4 (Sell).
A better-ranked stock in the overall medical sector is J&J (JNJ - Free Report) , 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 90 days, the Zacks Consensus Estimate for J&J’s 2023 earnings per share has increased from $10.67 to $10.75. During the same period, the estimate for JNJ’s 2024 earnings per share has increased from $11.01 to $11.29. Year to date, shares of JNJ have lost 2.4%.
JNJ beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 5.58%.