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GSK Blenrep Combos for Multiple Myeloma Accepted for EU Review
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GSK plc (GSK - Free Report) announced that the European Medicines Agency (EMA) has accepted its marketing authorization application (MAA) seeking approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma (RRMM) for review.
The MAA seeks the approval of Blenrep in combination with J&J’s (JNJ - Free Report) Velcade (bortezomib) plus dexamethasone (BorDex) or Bristol Myers’ Pomalyst (pomalidomide) plus dexamethasone (PomDex) for the myeloma indication in the EU. Per GSK, the advisory committee to the EMA is scheduled to begin the review process soon to make a recommendation to the regulatory body regarding the potential authorization of the Blenrep combo therapy for RRMM in the EU.
The MAA for the Blenrep combo was supported by interim results from the phase III DREAMM-7 and DREAMM-8 studies, both of which met their primary endpoints of progression-free survival (PFS). In both studies, statistically significant and clinically meaningful improvements in PFS were observed for Blenrep combinations compared with standard care in RRMM patients.
Specifically, the DREAMM-7 study compared Blenrep/BorDex combo to J&J’s Darzalex (daratumumab) and BorDex combo, while the DREAMM-8 study compared Blenrep in combination with PomDex to J&J’s Velcade in combination with PomDex.
A positive trend was observed for a key secondary endpoint of overall survival (OS) in both phase III studies. However, such a trend was notstatistically significant at the time of the interim analysis, and follow-up for OS is ongoing.
Additionally, GSK reported clinically meaningful improvements in all secondary efficacy endpoints in the studies, including deeper and more durable responses compared with standard care combinations. The safety and tolerability of Blenrep combinations in these studies were generally consistent with the known profiles of the individual agents.
Year to date, shares of GSK have gained 6.2% against the industry’s 3% decline.
Image Source: Zacks Investment Research
We remind investors that Blenrep was initially granted accelerated approval in the United States as a monotherapy for RRMM patients who had received at least four prior therapies in 2020, based on the results of the DREAMM-2 study’s overall response rate. The drug was also approved in the EU for the same indication on a conditional basis.
The final approval of the drug was contingent upon a confirmed clinical benefit from a randomized phase III study.
However, in November 2022, Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or refractory multiple myeloma. The study failed to meet its primary endpoint of PFS, thereby failing to meet the FDA’s Accelerated Approval regulations.
Consequently, Blenrep monotherapy as a treatment for RRMM was also withdrawn from the EU market.
The acceptance of the latest filing for Blenrep combinations to treat RRMM in the EU instills GSK’s hope of bringing the drug back to the European market for the patients soon, given the high unmet need.
MM is one of the most common forms of blood cancer, which is treatable but not curable. Per GSK, more than 180,000 new cases are diagnosed globally every year, with around 50,000 of these in the EU. As MM often becomes resistant to existing treatments, ongoing research into new therapies is essential.
In the past 60 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 39.4%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, shares of RAPT have plunged 86.8%.
RAPT’s earnings beat estimates in two of the trailing four quarters and missed twice, the average surprise being 3.19%.
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GSK Blenrep Combos for Multiple Myeloma Accepted for EU Review
GSK plc (GSK - Free Report) announced that the European Medicines Agency (EMA) has accepted its marketing authorization application (MAA) seeking approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma (RRMM) for review.
The MAA seeks the approval of Blenrep in combination with J&J’s (JNJ - Free Report) Velcade (bortezomib) plus dexamethasone (BorDex) or Bristol Myers’ Pomalyst (pomalidomide) plus dexamethasone (PomDex) for the myeloma indication in the EU. Per GSK, the advisory committee to the EMA is scheduled to begin the review process soon to make a recommendation to the regulatory body regarding the potential authorization of the Blenrep combo therapy for RRMM in the EU.
The MAA for the Blenrep combo was supported by interim results from the phase III DREAMM-7 and DREAMM-8 studies, both of which met their primary endpoints of progression-free survival (PFS). In both studies, statistically significant and clinically meaningful improvements in PFS were observed for Blenrep combinations compared with standard care in RRMM patients.
Specifically, the DREAMM-7 study compared Blenrep/BorDex combo to J&J’s Darzalex (daratumumab) and BorDex combo, while the DREAMM-8 study compared Blenrep in combination with PomDex to J&J’s Velcade in combination with PomDex.
A positive trend was observed for a key secondary endpoint of overall survival (OS) in both phase III studies. However, such a trend was notstatistically significant at the time of the interim analysis, and follow-up for OS is ongoing.
Additionally, GSK reported clinically meaningful improvements in all secondary efficacy endpoints in the studies, including deeper and more durable responses compared with standard care combinations. The safety and tolerability of Blenrep combinations in these studies were generally consistent with the known profiles of the individual agents.
Year to date, shares of GSK have gained 6.2% against the industry’s 3% decline.
Image Source: Zacks Investment Research
We remind investors that Blenrep was initially granted accelerated approval in the United States as a monotherapy for RRMM patients who had received at least four prior therapies in 2020, based on the results of the DREAMM-2 study’s overall response rate. The drug was also approved in the EU for the same indication on a conditional basis.
The final approval of the drug was contingent upon a confirmed clinical benefit from a randomized phase III study.
However, in November 2022, Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or refractory multiple myeloma. The study failed to meet its primary endpoint of PFS, thereby failing to meet the FDA’s Accelerated Approval regulations.
Consequently, Blenrep monotherapy as a treatment for RRMM was also withdrawn from the EU market.
The acceptance of the latest filing for Blenrep combinations to treat RRMM in the EU instills GSK’s hope of bringing the drug back to the European market for the patients soon, given the high unmet need.
MM is one of the most common forms of blood cancer, which is treatable but not curable. Per GSK, more than 180,000 new cases are diagnosed globally every year, with around 50,000 of these in the EU. As MM often becomes resistant to existing treatments, ongoing research into new therapies is essential.
GSK PLC Sponsored ADR Price and Consensus
GSK PLC Sponsored ADR price-consensus-chart | GSK PLC Sponsored ADR Quote
Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Annovis Bio (ANVS - Free Report) and RAPT Therapeutics, Inc. (RAPT - Free Report) . While ANVS currently sports a Zacks Rank #1 (Strong Buy), RAPT carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 39.4%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, shares of RAPT have plunged 86.8%.
RAPT’s earnings beat estimates in two of the trailing four quarters and missed twice, the average surprise being 3.19%.