AbbVie said that its investigational multiple myeloma treatment etentamig significantly improved response rates and progression-free survival in a Phase 3 trial, cutting the risk of disease progression or death by 60% compared with standard available therapies.

 

The results from the CERVINO trial mark a significant potential advance for patients with relapsed or refractory multiple myeloma who have already been exposed to three major classes of treatment.

 

Etentamig produced an objective response rate of 74%, compared with 45.7% for investigator-selected standard therapies. The treatment also reduced the risk of progression or death by 60%, with a progression-free survival hazard ratio of 0.40.

 

Both were dual primary endpoints of the trial, and the differences were statistically significant, AbbVie said.

 

The study enrolled 393 patients who had received a median of three prior lines of therapy. After a median follow-up of 11.4 months, the 12-month overall survival rate was 87.9% with etentamig versus 72.0% with standard available therapies.

 

The safety results could prove equally important as AbbVie seeks to position etentamig as a treatment that can be administered beyond highly specialized cancer centers.

 

With a single step-up dose followed by monthly dosing, cytokine release syndrome (CRS) occurred in 28.3% of patients receiving the step-up dose, with most cases being grade 1. No grade 3 or higher CRS events were reported.

 

Only one patient experienced immune effector cell-associated neurotoxicity syndrome, or ICANS, and that case was grade 1.

 

Serious infections remained an issue: grade 3/4 infections occurred in 27.7% of patients receiving etentamig, compared with 19.2% in the standard-therapy group. However, fatal infections were less frequent with etentamig, occurring in 1.5% of patients versus 3.1% with standard therapies.

 

Treatment-related discontinuations were also lower with etentamig, at 3.6% versus 9.6%.

 

"In this heavily pre-treated, triple-class exposed patient population, etentamig delivered clinically meaningful improvements in progression-free survival and response rates, alongside a manageable safety profile characterized by predominantly low-grade cytokine release syndrome," said Peter Voorhees, Chief, Plasma Cell Disorders Division at Atrium Health Levine Cancer Institute and an investigator on the CERVINO study. 

 

"Together, with its administration and dosing schedule, these findings support etentamig's role as a BCMA-targeted bispecific treatment option for multiple myeloma patients, with the potential to provide access across a range of treatment settings beyond specialized treatment centers and into outpatient and community-based settings."

 

The findings come as physicians continue to grapple with the complications and logistical demands associated with newer multiple myeloma therapies, including BCMA-directed bispecific antibodies and CAR-T treatments. CRS, neurotoxicity and infections can require intensive monitoring and specialized infrastructure, potentially limiting access in community settings.

 

Etentamig is designed as a second-generation BCMA x CD3 bispecific T-cell engager. Its monthly dosing schedule after a single step-up dose is intended to offer a more convenient treatment approach.

 

"The Phase 3 CERVINO results support the scientific approach behind etentamig and demonstrate the value of designing therapies that address both the biology of multiple myeloma and the practical needs of patients and providers through a manageable safety profile, a convenient dosing schedule and the potential for treatment in outpatient and community-based care settings," said Daejin Abidoye, vice president and therapeutic area head, oncology, solid tumor and hematology, AbbVie. 

 

"These results underscore our confidence in etentamig and our broader multiple myeloma strategy, which explores complementary T-cell engagers, targeted small molecules and rational combinations designed to address distinct disease mechanisms and patient needs over time."

 

The results triggered an early disclosure of the trial after an Independent Data Monitoring Committee recommended unblinding the study following the first planned efficacy interim analysis.

 

AbbVie said it will discuss the CERVINO findings with global regulatory authorities to determine the next steps for etentamig. The drug remains investigational and has not been approved by regulatory authorities.