AbbVie's cancer TCE etentamig hits the mark in myeloma

AbbVie has reported positive results with T-cell engager (TCE) etentamig in relapsed or refractory multiple myeloma, a key programme in the company's expansion into the oncology sector.

Interim data from the 393-patient phase 3 CERVINO trial of etentamig (ABBV-383), a bispecific CD3 and BCMA-directed TCE, showed that the drug met both its efficacy objectives with a simple, once-monthly dosing schedule that could make it an attractive alternative to other drugs in the class.

Current FDA-approved CD3xBCMA bispecifics – Johnson & Johnson's Tecvayli (teclistamab), Pfizer's Elrexfio (elranatamab), and Regeneron's Lynozyfic (linvoseltamab) – require more step-up doses in the first week of treatment and need weekly dosing thereafter.

In CERVINO, etentamig achieved an objective response rate (ORR) of 74%, compared to just under 46% for the control group treated with standard regimens for relapsed or refractory multiple myeloma in patients treated with at least two prior lines of therapy.

The TCE also cut the risk of disease progression or death by 60% compared to the investigator-selected therapies, and there was a trend towards improved overall survival (OS) at the 12-month mark, coming in at 87.9% and 72%, respectively.

AbbVie is also pointing to a "potentially differentiated safety profile" for etentamig, including a low rate of cytokine release syndrome (CRS), which is a recognised side effect of TCE and CAR-T therapies for multiple myeloma.

The company's head of oncology, solid tumour, and haematology, Daejin Abidoye, said the 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."

AbbVie has been pushing into new areas like oncology and neuroscience after coming under pressure in its core immunology and inflammation (I&I) therapeutic category following the patent expiry for Humira (adalimumab), which made $22 billion a year at peak, but which has now succumbed to biosimilar competition.

While newer I&I medicines like Skyrizi (risankizumab) and Rinvoq (upadacitinib) have plugged the gap with blockbuster sales, AbbVie has taken steps to diversify and reduce its reliance on the sector.

AbbVie has said it plans to submit regulatory applications for etentamig later this year, and analysts have suggested it could be a future blockbuster with $1 billion-plus in annual sales, despite being a late entrant into an increasingly crowded multiple myeloma market.