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Gilead (GILD) Ends Myelodysplastic Syndromes Study on Magrolimab
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Gilead Sciences (GILD - Free Report) announced the discontinuation of the late-stage ENHANCE study, a trial investigating the potential of magrolimab as a treatment for higher-risk myelodysplastic syndromes (MDS).
The ENHANCE study was a phase III randomized, double-blind trial evaluating the combination of magrolimab and azacitidine as a first-line treatment for higher-risk myelodysplastic syndromes (HR-MDS).
Magrolimab is a novel immunotherapy being developed in several hematologic cancers and solid tumor malignancies.
HR-MDS is a condition characterized by abnormal blood cell production in the bone marrow. This life-threatening disease has been lacking newly approved treatments for almost two decades.
The study enrolled more than 500 patients who were randomized to receive magrolimab in combination with azacitidine or azacitidine monotherapy.
The decision to discontinue the ENHANCE study was based on a planned analysis that indicated futility in achieving the study's primary endpoints, which were focused on complete response and overall survival. Secondary endpoints included duration of response, transfusion independence, progression-free survival, and time to transformation to acute myeloid leukemia, among others.
While the safety data were consistent with the known profile of magrolimab and typical adverse events seen in this patient population, the study was discontinued due to futility based on a planned analysis.
Gilead's research strategy now shifts toward ongoing trials of magrolimab in solid tumors and two pivotal studies — ENHANCE-2 in acute myeloid leukemia (AML) with TP53 mutations and ENHANCE-3 in first-line, unfit AML.
The candidate was previously granted Breakthrough Therapy designation for magrolimab for the treatment of newly diagnosed MDS.
The FDA had placed a partial clinical hold in 2022 on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms but the hold was subsequently removed.
The acquisition of Forty Seven, Inc. added its investigational lead product candidate, magrolimab, to Gilead’s immuno-oncology research and development portfolio.
Shares of Gilead have lost 6.1% in the year so far compared with the industry’s decline of 10%.
Image Source: Zacks Investment Research
Gilead is looking to diversify in the lucrative oncology space. The oncology business put up a stellar performance in the first quarter, fueling its top line.
The Cell Therapy franchise, comprising Yescarta and Tecartus, also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in relapsed or refractory (R/R) large B-Cell lymphoma and Tecartus in R/R acute lymphoblastic leukemia and mantle cell lymphoma.
The uptake of the breast cancer drug Trodelvy has been strong as well.
Earlier, Gilead entered into a strategic collaboration with Arcellx, Inc. (ACLX - Free Report) to co-develop and co-commercialize CART-ddBMCA, a late-stage clinical asset in development for the treatment of multiple myeloma.
However, Arcellx recently announced that the FDA placed a clinical hold on its iMMagine-1 program, designed to evaluate the lead program, CART-ddBCMA, for treating adult patients with relapsed or refractory multiple myeloma. The hold was placed on Jun 16 after a patient died.
The Zacks Consensus Estimate for Alkermes’ 2023 earnings has increased from 29 cents to $1.27 in the past 60 days. Earnings estimates for 2024 have increased from $1.73 to $2.08 in the past 60 days. ALKS beat estimates in three of the last four quarters and met the mark on one occasion, the average surprise being 90.83%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for 2024 loss per share has narrowed from 46 cents to 38 cents. ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.
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Gilead (GILD) Ends Myelodysplastic Syndromes Study on Magrolimab
Gilead Sciences (GILD - Free Report) announced the discontinuation of the late-stage ENHANCE study, a trial investigating the potential of magrolimab as a treatment for higher-risk myelodysplastic syndromes (MDS).
The ENHANCE study was a phase III randomized, double-blind trial evaluating the combination of magrolimab and azacitidine as a first-line treatment for higher-risk myelodysplastic syndromes (HR-MDS).
Magrolimab is a novel immunotherapy being developed in several hematologic cancers and solid tumor malignancies.
HR-MDS is a condition characterized by abnormal blood cell production in the bone marrow. This life-threatening disease has been lacking newly approved treatments for almost two decades.
The study enrolled more than 500 patients who were randomized to receive magrolimab in combination with azacitidine or azacitidine monotherapy.
The decision to discontinue the ENHANCE study was based on a planned analysis that indicated futility in achieving the study's primary endpoints, which were focused on complete response and overall survival. Secondary endpoints included duration of response, transfusion independence, progression-free survival, and time to transformation to acute myeloid leukemia, among others.
While the safety data were consistent with the known profile of magrolimab and typical adverse events seen in this patient population, the study was discontinued due to futility based on a planned analysis.
Gilead's research strategy now shifts toward ongoing trials of magrolimab in solid tumors and two pivotal studies — ENHANCE-2 in acute myeloid leukemia (AML) with TP53 mutations and ENHANCE-3 in first-line, unfit AML.
The candidate was previously granted Breakthrough Therapy designation for magrolimab for the treatment of newly diagnosed MDS.
The FDA had placed a partial clinical hold in 2022 on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms but the hold was subsequently removed.
The acquisition of Forty Seven, Inc. added its investigational lead product candidate, magrolimab, to Gilead’s immuno-oncology research and development portfolio.
Shares of Gilead have lost 6.1% in the year so far compared with the industry’s decline of 10%.
Image Source: Zacks Investment Research
Gilead is looking to diversify in the lucrative oncology space. The oncology business put up a stellar performance in the first quarter, fueling its top line.
The Cell Therapy franchise, comprising Yescarta and Tecartus, also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in relapsed or refractory (R/R) large B-Cell lymphoma and Tecartus in R/R acute lymphoblastic leukemia and mantle cell lymphoma.
The uptake of the breast cancer drug Trodelvy has been strong as well.
Earlier, Gilead entered into a strategic collaboration with Arcellx, Inc. (ACLX - Free Report) to co-develop and co-commercialize CART-ddBMCA, a late-stage clinical asset in development for the treatment of multiple myeloma.
However, Arcellx recently announced that the FDA placed a clinical hold on its iMMagine-1 program, designed to evaluate the lead program, CART-ddBCMA, for treating adult patients with relapsed or refractory multiple myeloma. The hold was placed on Jun 16 after a patient died.
Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Alkermes (ALKS - Free Report) and Anixa Biosciences (ANIX - Free Report) . Alkermes sports a Zacks Rank #1 (Strong Buy), while Anixa carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Alkermes’ 2023 earnings has increased from 29 cents to $1.27 in the past 60 days. Earnings estimates for 2024 have increased from $1.73 to $2.08 in the past 60 days. ALKS beat estimates in three of the last four quarters and met the mark on one occasion, the average surprise being 90.83%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for 2024 loss per share has narrowed from 46 cents to 38 cents. ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.