Linvoseltamab-gcpt

beast01/Getty Images AbbVie’s etentamig has a relatively cleaner safety pro an administration schedule that could give it an edge over other BCMA-targeting multiple myeloma therapies on the market, according to BMO Capital Markets. AbbVie’s investigational anti-BCMA bispecific T cell engager significantly cut the risk of disease progression or death in a late-stage multiple myeloma study. In the Phase 3 CERVINO trial, AbbVie’s asset, dubbed etentamig, showed a 60% progression-free survival (PFS) benefit versus standard available therapies, according to a news release on Thursday . The study enrolled 421 patients with relapsed or refractory multiple myeloma (RRMM) who had undergone at least two prior lines of therapy. Aside from PFS, etentamig also hit CERVINO’s other primary endpoint of objective response rate. A monthly course of etentamig elicited treatment response in 74% of patients, as opposed to 45.7% in the control arm. The CERVINO readout was presented at the 23rd International Myeloma Society Annual Meeting in Scotland. These findings point to the “clear efficacy” of etentamig in RRMM patients, BMO Capital Markets wrote to investors on Thursday. But what could set AbbVie’s asset apart in the market, the analysts continued, is its “potentially differentiated administration profile.” Etentamig makes use of a single step-up dose, after which the drug can be given once every four weeks. Meanwhile, Johnson & Johnson’s Tecvayli —a similar BCMA-targeting bispecific T cell engager that won its first multiple myeloma nod in 2022—requires two step-up doses before transitioning to a weekly then biweekly schedule. Patients only graduate to monthly frequency after 25 weeks. A more recent competitor, Regeneron’s Lynozyfic , similarly requires two step-up doses and requires weekly and biweekly injections before patients transition to a monthly schedule. Lynozyfic was approved in July 2025 and is also a bispecific T cell engager that targets BCMA. Safety also appears to be an edge for etentamig, BMO said. AbbVie reported a 28.3% rate of cytokine release syndrome, which the analysts called “relatively low.” Most of these episodes were grade 1, with no case reaching grade 3 or above. There was only one patient who developed immune effector cell-associated neurotoxicity syndrome (ICANS), which was rated grade 1, AbbVie said. “Collectively, the data position etentamig as a potentially attractive BCMA option that could expand use beyond large academic centers and into community settings,” BMO noted. AbbVie plans to bring CERVINO’s data to global regulatory authorities to determine a path forward for etentamig, though the pharma hasn’t yet provided a specific timeline for a submission. Cancer 5 Therapies Moving the Multiple Myeloma Space Forward A “significant number of patients” could see a cure for multiple myeloma within the next two decades, one expert told BioSpace . Here are five therapies that could change the treatment paradigm. March 9, 2026 · 8 min read · Tristan Manalac Read more

AbbVie's investigational BCMA×CD3 bispecific etentamig (ABBV-383) has delivered a Phase III win in multiple myeloma, potentially giving the late entrant a foothold in an increasingly crowded class.In the CERVINO trial, etentamig produced a 74% objective response rate versus 45.7% with investigator's choice of standard available therapies and reduced the risk of disease progression or death by 60% in patients with triple-class exposed relapsed/refractory multiple myeloma. The study met both primary endpoints of response rate and progression-free survival, prompting an independent monitoring committee to recommend unblinding the trial at its first planned efficacy interim analysis.Overall survival (OS) at 12 months also favoured etentamig at 87.9% versus 72%, though AbbVie said the prespecified efficacy boundary for OS had not been crossed at the data cutoff.The trial enrolled 421 patients who received at least two prior lines of therapy, including exposure to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody. They were randomised to receive etentamig administered once every four weeks or investigator's choice of standard available therapies, including Kyprolis (carfilzomib) plus dexamethasone, Empliciti (elotuzumab) plus pomalidomide and dexamethasone, or Xpovio (selinexor) plus bortezomib and dexamethasone.Dosing, safety advantages?The results put etentamig on track to become a potential fourth BCMA×CD3 bispecific on the market, following Johnson & Johnson's Tecvayli (teclistamab), Pfizer's Elrexfio (elranatamab) and Regeneron's Lynozyfic (linvoseltamab).However, AbbVie is betting dosing convenience might be a key differentiator. Etentamig is administered following a single step-up dose and then every four weeks right from the start of treatment."Etentamig is going to be fourth to market…However, [with the marketed bispecifics] we are now admitting fewer patients for the ramp-up [step-up], and we are not sticking to the FDA dosing schedule; we usually still use them once a week for two months and then once every other week for four months," noted one key opinion leader (KOL) in a recent FirstWord report (see – KOL Insight - Multiple Myeloma). "Nevertheless, etentamig could still gain traction because an FDA-approved label of once-a-month administration right from the start could have an advantage," the KOL said.Another highlighted that etentamig's structure "is different because the Fc region has been silenced, and so the safety profile, in principle, is better than that of the other bispecifics in terms of CRS (cytokine release syndrome)."Among patients receiving the single step-up dose in the CERVINO study, CRS occurred in 28.3%, predominantly grade 1, with no grade 3 or higher cases; grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in one patient (0.9%), with no grade 2 or higher events.Grade 3/4 infections were more common with etentamig than standard therapies (27.7% vs. 19.2%), but grade 5 infections were half as frequent (1.5% vs. 3.1%).Treatment-related adverse-event discontinuations were also lower with etentamig than standard therapies, at 3.6% versus 9.6%. AbbVie says the profile could potentially allow treatment to move beyond specialised centres and into outpatient and community settings.Early-stage data based on 82 evaluable patients presented at last year's American Society of Hematology (ASH) meeting showed etentamig plus pomalidomide and dexamethasone produced an 81% response rate. CRS occurred in 37% of patients after receiving the etentamig target dose, with events either grade 1 or 2 and no grade ≥3 events. Two deaths, due to influenza and worsening renal failure, were possibly related to etentamig treatment.Full CERVINO results will be presented at the International Myeloma Society (IMS) annual meeting later this month.