AbbVie Inc. (NYSE:ABBV) on Thursday reported topline outcomes from its Phase 3 CERVINO trial evaluating etentamig, an investigational treatment for relapsed or refractory multiple myeloma.
The study demonstrated that the drug outperformed standard therapies, meeting its primary goals for objective response rate and progression-free survival.
Efficacy And Trial Metrics
At a median follow-up of 11.4 months, researchers assessed 393 patients who previously underwent a median of three treatment lines. Patients receiving etentamig achieved a 74% objective response rate, compared to a 45.7% rate for those on standard available therapies.
The investigational drug also significantly enhanced progression-free survival across all evaluated subgroups.
Furthermore, the 12-month overall survival rate reached 87.9% for etentamig, outpacing the 72% rate observed with standard treatments, though the data have not yet crossed the prespecified efficacy boundary.
Favorable Safety Profile And Future Plans
Utilizing a single step-up dose followed by monthly administration, etentamig exhibited a manageable safety profile. Severe grade 3 or 4 infections appeared in 27.7% of the etentamig group versus 19.2% in the standard therapy group.
However, fatal grade 5 infections remained lower for etentamig at 1.5% compared to 3.1% for standard care.
Incidences of cytokine release syndrome stayed low at 28.3%, with no events reaching grade 3 or higher. Only one patient experienced mild neurotoxicity.
Treatment discontinuations due to adverse events stood at just 3.6% for etentamig, contrasting with 9.6% for standard therapies.
Following these strong interim results, the Independent Data Monitoring Committee advised unblinding the study.
The pharmaceutical company will now engage with global regulatory agencies to outline future steps.
ABBV Price Action: AbbVie shares were down 0.31% at $260.89 at the time of publication on Thursday. The stock is approaching its 52-week high of $267.47, according to Benzinga Pro data.
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