AbbVie’s bispecific T-cell engager (BiTE) therapy, etentamig, has been shown to positively impact progression-free survival (PFS) in a Phase III trial in relapsed or refractory multiple myeloma (R/R MM) – positioning the therapy to take a portion of the market share held by Johnson & Johnson’s Tecvayli (teclistamab).
In the Phase III CERVINO study (NCT06158841), AbbVie pitted its BCMA x CD3-targeting therapy against multiple regimens incorporating standard available therapies – including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 therapy, in patients with R/R MM.
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During the trial, a once-monthly intravenous dose of etentamig triggered an objective response rate (ORR) in 74% of patients, marking a significant improvement over the 45.7% ORR observed in the control group. The drug also offered significant improvements to PFS and 12-month overall survival (OS) rates compared with the control arm.
On top of these promising efficacy outcomes, once-monthly treatment with etentamig was linked to a safety profile that AbbVie touts as “potentially differentiated” from current offerings, as there were fewer deaths linked to infections (1.5%) in the etentamig group than in the standard therapeutic arm (3.1%). The drug also provoked low levels of a common BiTE side effect, cytokine release syndrome (CRS), with a majority of the 23.9% of patients who had it experiencing it at Grade 1.
Following the positive outcome of the CERVINO study, AbbVie plans to share these results with global regulatory authorities, which will help the company determine the next steps for etentamig.
Multiple myeloma market continues to heat up
AbbVie debuts this data as the multiple myeloma space is in the throes of a targeted therapeutic revolution, with advanced modalities increasingly making their way into the treatment paradigm.
This means that, if etentamig were to secure approval in R/R MM, it would face stiff competition from J&J’s marketed BCMA x CD3 BiTE therapy, Tecvayli. While currently approved for use in the fourth line or beyond, recent data suggest its use could benefit patients as early as second line.
However, AbbVie hopes that etantamig may offer differential benefit characterised by its favourable safety, administration and dosing schedule compared with currently available therapies.
“In this heavily pre-treated, triple-class exposed patient population, etentamig delivered clinically meaningful improvements in PFS and response rates, alongside a manageable safety profile characterised by predominantly low-grade cytokine release syndrome,” commented CERVINO investigator, Dr Peter Voorhees.
According to Voorhees, the drug’s administration and dosing schedule could also prime the drug to be used across a range of treatment settings outside of the traditional specialist centers – moving care into outpatient and community settings as issues around access to cancer treatment remain a significant issue for patients.
If etentamig were to secure the regulatory green light, it would enter a market that GlobalData forecasts will be worth $29bn in 2032 across the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China).
GlobalData is the parent company of Clinical Trials Arena.
