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GSK to Withdraw Blenrep From U.S. Market on FDA Request

GSK GSK announced that it has initiated the process of withdrawing the U.S. marketing authorization for anti-BCMA therapy, Blenrep, following a request by the FDA. The FDA’s request came after the failure of GSK’s phase III confirmatory study, DREAMM-3. As the result of the withdrawal, GSK will stop selling Blenrep in the U.S. market.

Blenrep (belantamab mafatotin) was granted accelerated approval as a monotherapy for relapsed or refractory multiple myeloma (RRMM) patients who had received at leastfour prior therapies in 2020 based on the results of the DREAMM-2 overall response rate. The four prior therapies should include an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

The final approval was contingent upon a confirmed clinical benefit from a randomized phase III study. However, in November, GSK announced that the DREAMM-3 study on Blenrep in patients with RRMM failed to meet its primary endpoint of progression-free survival (PFS), thereby failing to meet the FDA Accelerated Approval regulations.

GSK’s stock has declined 38.6% this year so far compared with a decrease of 19.9% for the industry.

 

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The head-to-head DREAMM-3 study evaluated Blenrep (belantamab mafodotin) monotherapy versus pomalidomide in combination with low-dose dexamethasone (PomDex) in RRMM patients. In the study, the median progression-free survival was 11.2 months for belantamab mafodotin, which was longer than seven months for PomDex. Secondary endpoints included overall response rate (ORR), duration of response (DOR) and overall survival (OS). ORR was 41% for belantamab mafodotin and 36% for PomDex. DOR rates at 12 months were 76.8% and 48.4% for belantamab mafodotin and PomDex, respectively. At the time of the primary analysis, the OS data had only achieved 37.5% overall maturity. The median OS was 21.2 and 21.1 months for belantamab mafodotin and PomDex, respectively.

GSK said additional trials within the DREAMM clinical trial program would continue. Data from DREAMM-7 and DREAMM-8 phase III studies are expected in the first half of 2023. These additional studies are evaluating belantamab mafodotin in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy.

Blenrep is also approved in Europe. The drug’s sales rose 28% at constant exchange rate in the first nine months of 2022. Access to Blenrep in Europe remains unaffected.

Zacks Rank & Stocks to Consider

GSK currently has a Zacks Rank #3 (Hold).

Some better-ranked large drugmakers include Vertex Pharmaceuticals VRTX, Merck MRK and Gilead Sciences GILD, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vertex Pharmaceuticals’ stock has risen 46.3% this year. Estimates for Vertex’s 2022 earnings have gone up from $14.21 to $14.61 per share, while those for 2023 have increased from $15.18 to $15.60 per share over the past 30 days.

Vertex has a four-quarter earnings surprise of 3.16%, on average.

Estimates for Merck’s 2022 earnings have increased from $7.30 per share to $7.38, while the same for 2023 has increased from $7.20 per share to $7.34 in the past 30 days. Merck’s stock is up 39.5% in the year-to-date period.

Merck beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 16.07%, on average.

Estimates for Gilead’s 2022 earnings per share have increased from $6.56 per share to $7.09 per share, while that for 2023 have increased from $6.51 per share to $6.79 per share in the past 30 days. Gilead’s stock is up 17.3% in the year-to-date period.

Gilead beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 0.36%, on average.

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