GSK's BCMA-Targeted ADC Blenrep Achieves Second Pivotal Phase III Victory, Bolstering U.S. Reintroduction Prospects

GSK reported on Thursday that its antibody-drug conjugate Blenrep targeting BCMA achieved a second Phase III clinical victory, strengthening the prospects for the return of this anticancer drug to the U.S. market.

FDA Accelerated Approval of Blenrep (belantamab mafodotin) in 2020 for the Treatment of Fourth-Line Multiple Myeloma. However, the Antibody-Drug Conjugate (ADC) Failed in the Confirmatory Phase III Trial in November 2022., leading the FDA to require GlaxoSmithKline (GSK) to withdraw the drug from the U.S. market later that month.Withdrawn. Since then, the pharmaceutical company has continued to study earlier patients, which could potentially bring the product back to life.

GSK Reveals, a trial named DREAMM-7 reached its primary endpoint in November 2023 andShared more data. Now, the company reports the success of DREAMM-8, a head-to-head clinical trial comparing a Blenrep-based regimen with the standard of care for second-line and later multiple myeloma.

All 302 patients received pomalidomide plus dexamethasone (PomDex) treatment. The researchers randomly assigned participants to receive either Blenrep or bortezomib (a molecule sold under the name Velcade), added to the PomDex backbone.

In a pre-specified interim analysis, the progression-free survival in the Blenrep cohort was significantly longer than that in the control group, prompting the independent data monitoring committee to recommend unblinding the data early. GSK has not yet shared any data but stated that the Blenrep regimen "significantly extended the time to disease progression or death compared to the standard-of-care regimen."

The company also reported a positive overall survival (OS) trend favoring Blenrep. At the interim analysis, the OS endpoint was not statistically significant, but this may change as the data matures.

GSK may next submit an application for Blenrep to return to the U.S. market, planning to discuss data from two successful Phase III clinical trials with regulatory authorities.

If GSK's Blenrep is launched, it will face fierce competition from BCMA-directed CAR-T cell therapies and T-cell engagers, which are already competing with molecules targeting other pathways for market share in multiple myeloma.

If GSK can overcome these challenges, Blenrep could help the company surpass its current mid-term forecasts. The pharmaceutical company's January...Raised the sales target for 2031 but excluded Blenrep from its outlook.After GSK withdrew it from the U.S., the product's sales last yearDropped to 36 million pounds (46 million US dollars).

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