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GSK's Blenrep Combo Meets PFS Endpoint in Head-to-Head Study
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GSK plc (GSK - Free Report) announced positive data from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III study, which evaluated its anti-BCMA therapy, Blenrep (belantamab mafatotin), for tretaing relapsed/refractory multiple myeloma. The study met its primary endpoint of progression-free survival (PFS).
The data from this study showed that treatment with Blenrep in combination with bortezomib plus dexamethasone (BorDex) led to a statistically significant PFS benefit (extending the time to disease progression or death) as compared to daratumumab plus BorDex – the existing standard of care regimen for relapsed/refractory multiple myeloma.
A strong and clinically meaningful overall survival (OS) trend was also observed and the study now continues for follow up on OS.
GSK plans to present data from this interim efficacy analysis at an upcoming medical conference.
Shares of GSK have increased 1.9% so far this year against the industry’s decline of 22.7%.
Image Source: Zacks Investment Research
We remind investors that Blenrep was granted accelerated approval as a monotherapy for relapsed or refractory multiple myeloma 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 final approval of the drug was contingent upon a confirmed clinical benefit from a randomized phase III study.
However, in November 2022, Blenrep sales were withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or refractory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 FDA’s Accelerated Approval regulations.
Per the company, additional studies within the DREAMM clinical trial program continue. The DREAMM-8 phase III study is evaluating Blenrep in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidomide and dexamethasone. Data from the DREAMM-8 study is expected in the second half of 2024
Though Blenrep is also approved in Europe, the drug’s sales have been significantly impacted owing to its withdrawal from the U.S. markets.
Blenrep sales plunged 67% at constant exchange rate in the first nine months of 2023.
In the past 60 days, estimates for CytomX Therapeutics for 2023 have narrowed from a loss of 37 cents per share to a loss of 10 cents. Meanwhile, estimates for 2024 have narrowed from a loss of 51 cents to a loss of 22 cents. Year to date, shares of CTMX have dipped 15%.
CTMX beat estimates in three of the last four quarters while missing the same on the remaining occasion, delivering an average earnings surprise of 45.44%.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2023 earnings per share (EPS) have improved from $4.98 to $5.33. During the same period, estimates for 2024 EPS have moved up from $4.26 to $4.64. Year to date, shares of LGND have decreased 10%.
LGND outpaced estimates in each of the trailing four quarters, the average earnings surprise being 67.19%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 EPS have jumped from 67 cents to 72 cents. During the same period, estimates for 2024 EPS have ascended to 62 cents from 55 cents. Year to date, shares of PBYI have risen 2.6%.
PBYI outshined estimates in three of the last four quarters while missing once, delivering an average earnings surprise of 76.55%.
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GSK's Blenrep Combo Meets PFS Endpoint in Head-to-Head Study
GSK plc (GSK - Free Report) announced positive data from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III study, which evaluated its anti-BCMA therapy, Blenrep (belantamab mafatotin), for tretaing relapsed/refractory multiple myeloma. The study met its primary endpoint of progression-free survival (PFS).
The data from this study showed that treatment with Blenrep in combination with bortezomib plus dexamethasone (BorDex) led to a statistically significant PFS benefit (extending the time to disease progression or death) as compared to daratumumab plus BorDex – the existing standard of care regimen for relapsed/refractory multiple myeloma.
A strong and clinically meaningful overall survival (OS) trend was also observed and the study now continues for follow up on OS.
GSK plans to present data from this interim efficacy analysis at an upcoming medical conference.
Shares of GSK have increased 1.9% so far this year against the industry’s decline of 22.7%.
We remind investors that Blenrep was granted accelerated approval as a monotherapy for relapsed or refractory multiple myeloma 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 final approval of the drug was contingent upon a confirmed clinical benefit from a randomized phase III study.
However, in November 2022, Blenrep sales were 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 FDA’s Accelerated Approval regulations.
Per the company, additional studies within the DREAMM clinical trial program continue. The DREAMM-8 phase III study is evaluating Blenrep in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidomide and dexamethasone. Data from the DREAMM-8 study is expected in the second half of 2024
Though Blenrep is also approved in Europe, the drug’s sales have been significantly impacted owing to its withdrawal from the U.S. markets.
Blenrep sales plunged 67% at constant exchange rate in the first nine months of 2023.
Zacks Rank & Stocks to Consider
GSK currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are CytomX Therapeutics, Inc. (CTMX - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics for 2023 have narrowed from a loss of 37 cents per share to a loss of 10 cents. Meanwhile, estimates for 2024 have narrowed from a loss of 51 cents to a loss of 22 cents. Year to date, shares of CTMX have dipped 15%.
CTMX beat estimates in three of the last four quarters while missing the same on the remaining occasion, delivering an average earnings surprise of 45.44%.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2023 earnings per share (EPS) have improved from $4.98 to $5.33. During the same period, estimates for 2024 EPS have moved up from $4.26 to $4.64. Year to date, shares of LGND have decreased 10%.
LGND outpaced estimates in each of the trailing four quarters, the average earnings surprise being 67.19%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 EPS have jumped from 67 cents to 72 cents. During the same period, estimates for 2024 EPS have ascended to 62 cents from 55 cents. Year to date, shares of PBYI have risen 2.6%.
PBYI outshined estimates in three of the last four quarters while missing once, delivering an average earnings surprise of 76.55%.