What AbbVie Reported
Response & Progression-Free Survival
At the first planned efficacy interim analysis (n=393; median follow-up 11.4 months), etentamig delivered an objective response rate of 74.0% versus 45.7% with standard available therapies (p<0.0001) and reduced the risk of progression or death by 60% (PFS HR 0.40; 95% CI 0.29–0.54; p<0.0001), with benefit observed across all pre-specified subgroups evaluated. Median PFS values have not been disclosed in the topline release.
ORR 74.0% vs 45.7% · PFS HR 0.40 (AbbVie press release, Sept 3, 2026)
Source: AbbVie topline announcement
Safety (topline, quantified)
AbbVie reported the following with a single step-up dose and monthly (Q4W) dosing from initiation: grade 3/4 infections were higher with etentamig, 27.7% vs 19.2% with standard available therapies, while grade 5 (fatal) infections were lower, 1.5% vs 3.1%. Among patients receiving a single step-up dose, CRS incidence was 28.3%, predominantly grade 1 (23.9%), with no grade 3 or higher events reported. One patient experienced ICANS (0.9%, grade 1), with no grade 2 or higher events. Treatment-emergent adverse event discontinuations were 3.6% vs 9.6%. AbbVie describes this as a “potentially differentiated safety profile”; full safety tables are expected with the IMS 2026 presentation. (AbbVie press release, Sept 3, 2026 — interim analysis.)
How KOLs framed the context
Rajshekhar Chakraborty, MD (Columbia): “Etentamig now joins Teclistamab and Elranatamab as the 3rd BCMA BsAb to report positive RCT data in relapsed/refractory #MultipleMyeloma. Looking forward to full data at #IMS26!” The differentiation debate centers on etentamig’s monthly dosing and single step-up dose versus the approved BCMA bispecifics’ more intensive schedules — and on how bispecifics sequence against BCMA CAR-T.
Design & Endpoints
Design
Global, Phase 3, multicenter, randomized, open-label, parallel-group. 393 patients at data cutoff.
Population
R/R multiple myeloma, ≥2 prior lines incl. PI + IMiD + anti-CD38 (triple-class exposed); prior BCMA-targeted therapy excluded; ECOG ≤2.
Interventions
Etentamig IV every 4 weeks (single step-up dose at initiation) vs investigator’s choice of standard available therapies.
Primary Endpoints
Dual: objective response rate and progression-free survival — both met at the first planned efficacy interim analysis.
The Topline on X
Physician voices
Etentamig now joins Teclistamab and Elranatamab as the 3rd BCMA BsAb to report positive RCT data in relapsed/refractory #MultipleMyeloma. Looking forward to full data at #IMS26! https://t.co/3RQc3wmXPb
New phase 3 multiple myeloma data caught my attention. Etentamig, a BCMA×CD3 bispecific antibody, reportedly produced a 74.0% response rate versus 45.7% with standard therapy and reduced the risk of progression or death by approximately 60%. Encouraging numbers. But what interests me most is where this may eventually fit in the rapidly changing myeloma landscape. We now have CAR-T therapies, bispecific antibodies, and increasingly effective combinations competing for space in the treatment sequence. So the question I keep coming back to is: Not simply, “Does this treatment work?” But, “Which patient should receive which immune therapy, and when?” Durability, infections, CRS, accessibility, quality of life, and what therapies remain available afterward may ultimately matter as much as the initial response rate. These are encouraging phase 3 results. I look forward to seeing the complete dataset and longer follow-up before knowing where etentamig ultimately belongs. This is what makes modern myeloma treatment so fascinating to follow. My interpretation for educational and informational purposes only.
Trade & analyst coverage
🗞️Just in: Topline data from the phase 3 CERVINO trial showed etentamig generated statistically significant improvements in PFS and ORR vs standard therapies in patients with triple-class exposed R/R myeloma #mmsm #oncology Dive into the efficacy and safety highlights: https://t.co/d1NVOD8bv3
🔬 Etentamig surpassed standard therapy in terms of response rate and PFS in the phase 3 CERVINO trial for relapsed/refractory multiple #myeloma. Read more: https://t.co/t7Jfl1ccFG #Hematology #Oncology #ClinicalTrials #Bispecifics
AbbVie’s etentamig has a relatively cleaner safety profile and an administration schedule that could give it an edge over other BCMA-targeting multiple myeloma therapies on the market, according to BMO Capital Markets. https://t.co/NxvPPXhReu
Phase 3 CERVINO results show that etentamig significantly improved response rate and progression-free survival in relapsed/refractory multiple myeloma. 🔹 ORR: 74.0% vs 45.7% 🔹 60% reduction in risk of progression or death 🔹 Overall survival data remain immature Full results will be presented at the International Myeloma Society Annual Meeting on September 25. https://t.co/vAa4DwaVSi
🚨: Topline results from the phase 3 #CERVINO showed that #etentamig clinical outcomes in triple-class exposed relapsed or refractory multiple #myeloma, supporting a potential new #BCMA-directed treatment option. Learn more: https://t.co/J6Bx1BBKQd #medtwitter #onctwitter https://t.co/mJjcdC7DsP
CERVINO Questions
What is the CERVINO trial?
CERVINO (NCT06158841) is a global, Phase 3, multicenter, randomized, open-label study of etentamig (ABBV-383) monotherapy versus investigator's choice of standard available therapies in adults with relapsed/refractory multiple myeloma who received at least two prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody (triple-class exposed). Patients with prior BCMA-targeted therapy were excluded. 393 patients were included at the data cutoff, with a median of three prior lines.
What did the CERVINO topline results show?
Per AbbVie's September 3, 2026 announcement, the study met its dual primary endpoints at the first planned efficacy interim analysis (median follow-up 11.4 months): objective response rate was 74.0% with etentamig versus 45.7% with standard therapies (p<0.0001), and progression-free survival favored etentamig with a hazard ratio of 0.40 (95% CI 0.29-0.54; p<0.0001), consistent across pre-specified subgroups. The Independent Data Monitoring Committee recommended unblinding the study.
Did CERVINO show an overall survival benefit?
Not yet. Twelve-month overall survival was 87.9% with etentamig versus 72.0% with standard therapies (HR 0.48; nominal p=0.0012), but the pre-specified efficacy boundary for OS was not crossed at the data cutoff - OS data remain immature.
What is etentamig?
Etentamig (ABBV-383) is AbbVie's investigational second-generation BCMA x CD3 bispecific T-cell engager. It is engineered with a low-affinity CD3-binding domain to limit cytokine release and a bivalent high-avidity BCMA-binding domain, and is dosed once every four weeks from initiation after a single step-up dose. In the topline announcement AbbVie reported CRS in 28.3% of patients (predominantly grade 1; no grade 3 or higher), grade 3/4 infections in 27.7% vs 19.2% with standard therapies, and grade 5 infections in 1.5% vs 3.1%. It is not approved by any regulatory authority.
When will full CERVINO data be presented?
Full results will be presented in a plenary session at the 23rd International Myeloma Society Annual Meeting, September 23-26, 2026, in Glasgow, Scotland.