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CERVINO Trial

CERVINO (NCT06158841) is AbbVie’s global Phase 3 trial of etentamig (ABBV-383) — an investigational second-generation BCMA×CD3 bispecific T-cell engager dosed monthly after a single step-up dose — versus standard available therapies in triple-class exposed relapsed/refractory multiple myeloma. Presented in the IMS26 plenary session (Friday, Sept 25, 2026, Glasgow): dual primary endpoints met — ORR 74.0% vs 45.7%, PFS HR 0.40; OS immature.

Phase III · NCT06158841 Triple-class exposed R/R multiple myeloma BCMA×CD3 bispecific · monthly dosing Presented at IMS26 Plenary (Sept 25, 2026) ⚠ Investigational · not approved
See the IMS26 Plenary Data
At a Glance

CERVINO Key Takeaways

Design

Global, Phase 3, multicenter, randomized, open-label: etentamig monotherapy (IV every 4 weeks from initiation, after a single step-up dose) versus investigator’s choice of standard available therapies, in adults with relapsed/refractory multiple myeloma after ≥2 prior lines including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. Prior BCMA-targeted therapy excluded; ECOG ≤2. 393 patients at data cutoff; median 3 prior lines. ClinicalTrials.gov NCT06158841

Result — topline Sept 3, full data at IMS26 plenary Sept 25, 2026

Dual primary endpoints met at the first planned efficacy interim analysis (median follow-up 11.4 months, data cutoff June 10, 2026); the Independent Data Monitoring Committee recommended unblinding. ORR 74.0% (95% CI 67.25–79.97) vs 45.7% (38.59–52.91), p<0.0001. PFS HR 0.40 (95% CI 0.29–0.54), p<0.0001, consistent across pre-specified subgroups — median PFS not reached vs 6.2 months. AbbVie topline announcement · Full plenary data →

Overall survival — immature

12-month OS 87.9% vs 72.0% (HR 0.48; 95% CI 0.29–0.77; nominal p=0.0012) — the pre-specified efficacy boundary for OS was not crossed at this data cutoff. (AbbVie press release, Sept 3, 2026.)

Regulatory

⚠ Etentamig is investigational and not approved by any regulatory authority. Presented at the plenary session, 23rd International Myeloma Society Annual Meeting, Sept 25, 2026, Glasgow.

Live From Glasgow

IMS26 Plenary — September 25, 2026

CERVINO was presented in the Friday plenary session (3–5pm, Hall 5). Dr. Samer Al Hadidi live-tweeted the full data deck from the room, slide by slide — reproduced below in order, with OCR text for every slide. Data cutoff for this presentation: June 10, 2026. No new AbbVie press release with additional figures had posted as of this update, so these plenary slides are the most complete public source for CERVINO’s full dataset right now.

Primary endpoints, presented

ORR 74.0% vs 45.7% (difference 28.3%, 95% CI 18.48–37.46; P<0.0001); ≥CR 40% vs 7%, ≥VGPR 63% vs 20%. Median PFS not reached with etentamig vs 6.2 months with SAT (HR 0.40, 95% CI 0.29–0.54; P<0.0001); 12-month PFS 62.1% vs 28.4%. Median follow-up 11.4 months (data cutoff June 10, 2026).
Source: Dr. Samer Al Hadidi, live from the IMS26 plenary, Sept 25, 2026

Duration of response, MRD & overall survival

Median DoR not reached with etentamig vs 10.2 months with SAT (HR 0.31); 12-month DoR 79.6% vs 48.1%. MRD negativity among ≥CR patients: 89.1% vs 25.0% at 10-5, 82.8% vs 12.5% at 10-6. Early OS signal: 12-month OS 87.9% vs 72.0% (HR 0.48, 95% CI 0.29–0.77; nominal P=0.0012) — the pre-specified OS efficacy boundary (P=0.000017) was not crossed, so OS remains immature. Non-relapse mortality 5.1% vs 9.8%.

Safety, in full

Grade 5 (fatal) TEAEs 2.6% vs 5.7%. CRS was 39.5% across all etentamig-treated patients, 28.3% among single-step-up-dose recipients (n=113, no grade ≥3), and 0% among the subset who also received prophylactic tocilizumab (n=22). ICANS 3.6% (0.9% with single step-up dose). Infections (any grade) 69.7% vs 59.1%; dose discontinuation for AEs 3.6% vs 14.0%.

From the sponsor

AbbVie Oncology Medical Affairs: “Happening now at #IMS26 plenary session, Dr. Peter Voorhees presents the first efficacy and safety results from phase 3 CERVINO study in relapsed or refractory multiple myeloma (RRMM). #MultipleMyeloma #RRMM View the IMS program here: https://t.co/bnTtnqlXZz https://t.co/cu6sjRvH1A”
@AbbVieUSOncMed, IMS26, Sept 25, 2026

Plenary slide deck — live-tweeted by Dr. Samer Al Hadidi (@HadidiSamer)

Multiple Myeloma Hub @MM_Hub · Sep 25
Primary results — Voorhees plenary presentation
ORR, PFS, OS & CRS — official IMS26 plenary slides
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CERVINO — ORR 74.0% (etentamig) vs 45.7% (SAT), P<0.0001Click to enlargeCERVINO — PFS: HR 0.40, 12-month PFS 62.1% (etentamig) vs 28.4% (SAT)Click to enlargeCERVINO — OS: HR 0.48, 12-month OS 87.9% (etentamig) vs 72.0% (SAT)Click to enlargeCERVINO — CRS 39.5% overall, 0% with single SUD + prophylactic tocilizumabClick to enlarge
[Slide 1 - CERVINO: ORR] Median (range) follow-up: 11.4 (0.5–24.3) months ORR: Etentamig 74.0% (≥CR 40%, VGPR 23%, PR 11%) vs SAT (N=197) 45.7% (≥CR 7%, VGPR 14%, PR 25%); P<0.0001; difference 28.3 (95% CI 18.48–37.46) ≥VGPR: 63% (etentamig) vs 20% (SAT) Etentamig demonstrated substantially higher ORR and ≥CR Data cutoff: June 10, 2026 --- [Slide 2 - CERVINO: PFS] Median (range) follow-up: 11.4 (0.5–24.3) months 12-month PFS: Etentamig 62.1% (mPFS: NR) vs SAT 28.4% (mPFS: 6.2 months) HR 0.40 (95% CI 0.29–0.54); P<0.0001 At 11.4 months median follow-up, Etentamig reduced the risk of disease progression or death by 60%, with twice as many patients being progression-free at 12 months vs SAT --- [Slide 3 - CERVINO: OS] Median (range) follow-up: 11.4 (0.5–24.3) months 12-month OS: Etentamig 87.9% (mOS: NR) vs SAT 72.0% (mOS: NR) HR 0.48 (95% CI 0.29–0.77); P=0.0012 NRM: 5.1% (etentamig) vs 9.8% (SAT). Infection NRM: 1.5% vs 3.1%. Relapse mortality: 9.2% vs 15.0% 75% of SAT-treated patients receiving post-study therapy received a T-cell engager or CAR T-cell therapy At 12 months, almost 90% of patients on Etentamig were still alive --- [Slide 4 - CERVINO: CRS (Etentamig arm)] CRS incidence: All (N=195) 39.5% (Grade 1: 27%, Grade 2: 11%, Grade 3: 1%); Single SUD (n=113) 28.3% (Grade 1: 24%, Grade 2: 4%); Single SUD + ppx tocilizumab (n=22) 0% CRS and ICANS (Etentamig arm): All (N=195) CRS 77 (39.5%) — Grade 1: 53 (27.2%), Grade 2: 22 (11.3%), Grade 3: 2 (1.0%); Median time to CRS onset 17.6h, resolution 8.5h; CRS recurrence 1 (0.5%). ICANS 7 (3.6%) — Grade 1: 3, Grade 2: 3, Grade 3: 1 Etentamig’s unique design with low CD3 affinity enables a predictable CRS profile, potentially supporting broad implementation across diverse treatment settings
Samer Al Hadidi, MD,MS,FACP @HadidiSamer · 2026-09-25
Design & comparator arms
Etentamig IV, single step-up dose, stop after 2 years vs Kd / SVd / EloPd
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CERVINO / IMS26 — Design & comparator arms (1)Click to enlargeCERVINO / IMS26 — Design & comparator arms (2)Click to enlarge
[Slide 1] CERVINO study design summary. Etentamig: IV, given less often, with one single step-up dose (SUD) given prior to full dose. Patients can stop therapy after 2 years. Comparator arm (SAT, standard available therapy): Kd (carfilzomib + dexamethasone), SVd (selinexor + bortezomib + dexamethasone), and EloPd (elotuzumab + pomalidomide + dexamethasone) - EloPd not commonly used in the US currently. Data cutoff: June 10, 2026. --- [Slide 2] CERVINO baseline characteristics table. Etentamig (N=196) vs SAT (N=197): median age 69 vs 70 years; Triple-class exposed 196 (100%) vs 197 (100%); Triple-class refractory 101 (51.5%) vs 103 (52.3%); median prior lines of therapy 3 (range 2-10) vs 3 (range 1-8); North America (US only) 24 (12.2%) vs 33 (16.8%); high cytogenetic risk 41 (20.9%) vs 51 (25.9%). CERVINO enrolled a diverse population with a substantial proportion treated in non-academic settings, reflecting today's clinical practice.
Samer Al Hadidi, MD,MS,FACP @HadidiSamer · 2026-09-25
Patient disposition, ORR & PFS (primary endpoints)
ORR 74.0% vs 45.7% (P<0.0001) · mPFS NR vs 6.2 mo, HR 0.40 (P<0.0001)
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CERVINO / IMS26 — Patient disposition, ORR & PFS (primary endpoints) (1)Click to enlargeCERVINO / IMS26 — Patient disposition, ORR & PFS (primary endpoints) (2)Click to enlargeCERVINO / IMS26 — Patient disposition, ORR & PFS (primary endpoints) (3)Click to enlargeCERVINO / IMS26 — Patient disposition, ORR & PFS (primary endpoints) (4)Click to enlarge
[Slide 1] CERVINO patient disposition (CONSORT). Screened N=498, failed screening n=105, randomized (ITT) n=393. Etentamig n=196 (received 195); SAT n=197 (received 193). Discontinued Etentamig n=79; remain on Etentamig n=117. Discontinued SAT n=142; remain on SAT n=55 - twice as many patients remained on Etentamig vs SAT. Primary reason for discontinuation: progressive disease 61 (31.1%) Etentamig vs 100 (50.8%) SAT; AEs 7 (3.6%) vs 19 (9.6%). AE-related discontinuation under 5% reinforces Etentamig's favorable tolerability. Data cutoff: June 10, 2026. --- [Slide 2] CERVINO primary endpoint ORR (International Myeloma Working Group criteria, independent review). Etentamig ORR 74.0% (>=CR 40%, VGPR 23%, PR 11%; >=VGPR 63%) vs SAT 45.7% (>=CR 7%, VGPR 14%, PR 25%; >=VGPR 20%). Difference 28.3% (95% CI 18.48-37.46), P<0.0001. Median follow-up 11.4 (0.5-24.3) months. Etentamig demonstrated substantially higher ORR and >=CR. --- [Slide 3] CERVINO primary endpoint PFS (Kaplan-Meier). HR 0.40 (95% CI 0.29-0.54), P<0.0001. Median PFS: Etentamig not reached (NR); SAT 6.2 months. 12-month PFS rate: 62.1% Etentamig vs 28.4% SAT. At 11.4 months median follow-up, Etentamig reduced the risk of disease progression or death by 60%, with twice as many patients progression-free at 12 months vs SAT. Data cutoff: June 10, 2026.
Samer Al Hadidi, MD,MS,FACP @HadidiSamer · 2026-09-25
PFS subgroups, duration of response & MRD, overall survival
12-mo OS 87.9% vs 72.0% (HR 0.48, P=0.0012) · MRD<10⁻⁵ 89.1% vs 25.0%
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CERVINO / IMS26 — PFS subgroups, duration of response & MRD, overall survival (1)Click to enlargeCERVINO / IMS26 — PFS subgroups, duration of response & MRD, overall survival (2)Click to enlargeCERVINO / IMS26 — PFS subgroups, duration of response & MRD, overall survival (3)Click to enlarge
[Slide 1] CERVINO PFS forest plot by subgroup - benefit favors Etentamig across all subgroups evaluated: sex (male HR 0.53, female HR 0.29), age <65y HR 0.59 / >=65y HR 0.32, age <75y HR 0.46 / >=75y HR 0.27, race (White HR 0.36, Black/African American HR 0.23, Asian HR 0.58), region (North America US-only HR 0.29, Europe HR 0.39), baseline ISS I/II HR 0.37 vs III HR 0.57, ECOG PS 0 HR 0.44 / >=1 HR 0.37, academic HR 0.42 / non-academic site HR 0.39, high cytogenetic risk HR 0.35 / standard risk HR 0.43, prior lines <=2 HR 0.36 / 3 lines HR 0.41 / >=4 lines HR 0.45, double-refractory HR 0.43 / triple-refractory HR 0.39. --- [Slide 2] CERVINO duration of response (DoR) and MRD negativity. DoR: HR 0.31 (95% CI 0.18-0.53); median DoR not reached with Etentamig vs 10.2 months with SAT; 12-month DoR rate 79.6% vs 48.1%. Median time to response: 1.12 months Etentamig vs 1.58 months SAT. MRD negativity among evaluable >=CR patients: at MRD<10^-5, 89.1% (Etentamig, n=64) vs 25.0% (SAT, n=8); at MRD<10^-6, 82.8% vs 12.5%. Etentamig achieved deeper, more durable responses than SAT, supporting its potential for sustained remission. --- [Slide 3] CERVINO secondary endpoint overall survival (early signal, immature). HR 0.48 (95% CI 0.29-0.77), P=0.0012 (prespecified efficacy boundary for OS, P=0.000017, was NOT crossed at this data cutoff). 12-month OS 87.9% Etentamig vs 72.0% SAT; median OS not reached in either arm. Non-relapse mortality 5.1% vs 9.8%; infection-related non-relapse mortality 1.5% vs 3.1%; relapse mortality 9.2% vs 15.0%. 75% of SAT-treated patients who received post-study therapy went on to a T-cell engager or CAR-T therapy. At 12 months, almost 90% of patients on Etentamig were still alive.
Samer Al Hadidi, MD,MS,FACP @HadidiSamer · 2026-09-25
Safety — TEAEs, CRS & ICANS
CRS 28.3% (single SUD), 0% with prophylactic tocilizumab (n=22) · Grade 5 AEs 2.6% vs 5.7%
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CERVINO / IMS26 — Safety — TEAEs, CRS & ICANS (1)Click to enlargeCERVINO / IMS26 — Safety — TEAEs, CRS & ICANS (2)Click to enlargeCERVINO / IMS26 — Safety — TEAEs, CRS & ICANS (3)Click to enlargeCERVINO / IMS26 — Safety — TEAEs, CRS & ICANS (4)Click to enlarge
[Slide 1] CERVINO treatment-emergent adverse events (TEAEs), Etentamig (N=195) vs SAT (N=193). Any TEAE 97.9% vs 95.3%; Grade 3/4 70.8% vs 59.6%; Grade 5 (fatal) 2.6% vs 5.7% - roughly half the fatal AE rate with Etentamig. Neutropenia 46.7% vs 23.3%. CRS (among SUD recipients, N=113): 28.3%, no grade 3 or higher. ICANS 0.9%, no grade 2+. Infections any grade 69.7% (grade 3/4 27.7%, grade 5 1.5%) vs 59.1% (grade 3/4 19.2%, grade 5 3.1%). Serious TEAEs 51.8% vs 40.4%. Dose discontinuation due to AEs 3.6% vs 14.0%. Etentamig redefines anti-BCMA BsAb safety with low CRS and severe infection rates and a >=50% reduction of fatal AEs and fatal infections vs SAT. --- [Slide 2] CERVINO CRS incidence and management by step-up dosing strategy. All patients (N=195): CRS 39.5% (Grade 1 27%, Grade 2 11%, Grade 3 1%). Single step-up dose (SUD) subgroup (n=113): CRS 28.3% (Grade 1 24%, Grade 2 4%, Grade 3 0%). Single SUD plus prophylactic tocilizumab (n=22): CRS 0%. Median time to CRS onset 17.6 hours (single SUD 20.9 hrs); median time to CRS resolution 8.5 hours (single SUD 6.0 hrs). CRS recurrence after Cycle 1: 0.5%. ICANS 3.6% overall (single SUD 0.9%). Etentamig's unique design with low CD3 affinity enables a predictable CRS profile, potentially supporting broad implementation across diverse treatment settings.

How KOLs reacted, live from the plenary floor

Physician reactions posted within minutes of the presentation — Rajkumar (Mayo), Banerjee (Fred Hutch), Hashmi (MUSC), Mian (McMaster), Zanwar (Mayo), Kansagra, Moreno de Gusmão (São Paulo), and Tenorio Feixas (Royal Free NHS).

Vincent Rajkumar
Vincent Rajkumar@VincentRK

First RCT results of Etentamig (BCMA bispecifc antibody) presented at Plenary Session #IMS26 @Myeloma_Society @PlasmaCellPete @myelomaMD 60 mg fixed dose every 4 weeks makes this the easiest bispecific to administer. Impressive PFS benefit in relapsed refractory myeloma with at least 2 prior lines of therapy. See thread for more details.

1.0K views28 likes15 RT2026-09-25
Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP@RahulBanerjeeMD

#IMS26 CERVINO plenary (pronounced 🪑 + 🇪🇸 🍷) by @PlasmaCellPete - Part 2. PPx toci is very clearly the way to go with any BsAb, and here it works quite well. Etentamig has low CD3 affinity like Velcro for T cells (credit @myelomatips ), which may explain part of this. https://t.co/cwkTM8opZO

418 views7 likes2 RT2026-09-25
Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP@RahulBanerjeeMD

#IMS26 CERVINO plenary (pronounced 🪑 + 🇪🇸 🍷) by @PlasmaCellPete Excellent results for BCMA BsAb therapy in early lines of R/R myeloma, this time with etentamig. It turns out we may be able to get to Q4W BsAb dosing as soon as C2D1! https://t.co/iUdr4jmZTn

160 views2 likes1 RT2026-09-25
Ankit kansagra
Ankit kansagra@kansagraMD

Impressive safety; tolerability while maintaining efficacy for BCMA directed bispecifics. Congratulations @PlasmaCellPete and the CERVINO team ! https://t.co/qKgIj04y92

151 views2 likes2 RT2026-09-25
Saurabh Zanwar
Saurabh Zanwar@ZanwarSaurabh

#IMS26 Plenary presentation for CERVINO demonstrates clear superiority of TCEs over SOC! 👏👏@PlasmaCellPete @myelomaMD et al. 12-mo PFS of 62.1% with Etentamig vs. 28.4% with control (Kd, SVd, EloPd) OS showing encouraging trend as well! Surely no more non TCE control arms in this setting going forward! What’s different with Etentamig vs. other BCMA bispecifics: Etentamig with its silenced fc tail offers longer administration intervals and lower CRS rates from lower CD3-binding affinity Prophylactic toci is the way to go! Key for community uptake

118 views2 likes1 RT2026-09-25
Pablo Tenorio Feixas
Pablo Tenorio Feixas@ptenfei

Dr Peter Voorhees presenting phase 3 CERVINO at #IMS26: etentamig, a monthly BCMA×CD3 bispecific, versus investigator’s choice of Kd, SVd or EloPd (n= 393) with triple-class-exposed, BCMA-naïve RRMM. Median 3 prior lines; over half triple-class refractory. 🧵 @Myeloma_Society https://t.co/Ww2j52yuCK

78 views1 likes0 RT2026-09-25
Hira Mian
Hira Mian@HiraSMian

Congratulations to the CERVINO team! Great agents with lower toxicity and more convenient for pts. Also great trial design with an ability to stop after 24 months if sustained cr > 12 months #IMS26

72 views1 likes0 RT2026-09-25
Hamza Hashmi
Hamza Hashmi@hhashmi87

CERVINO (Etentamig Phase 3) @PlasmaCellPete on 🎯#IMS26: CERVINO Ph3: Etentamig superior to SAT (EPD, SVD, KD) in heavily pre-treated triple-class exposed RRMM 💡ORR 74% vs 45%, PFS at 12m NR (60%) vs 6m, OS benefit signal despite many SAT pts receiving TCRT at relapse 💡CRS 28% with SUD, 0% rates with ppx toci!! 💡Severe Infections were 28% despite many pts not receiving IVIG #MultipleMyeloma #MMsm #BCMA @Myeloma_Society

60 views0 likes1 RT2026-09-25
Pablo Tenorio Feixas
Pablo Tenorio Feixas@ptenfei

The CERVINO trial met all primary endpoints: - ORR: 74.0% vs 45.7% - ≥CR: 40% vs 7% - PFS: HR 0.40 - 12-month PFS: 62.1% vs 28.4% The PFS benefit was consistent across prespecified subgroups. Impressive efficacy in a heavily pretreated population! 👏 @Myeloma_Society #IMS26 https://t.co/czBBgYIEhH

54 views0 likes1 RT2026-09-25
Breno Moreno de Gusmão
Breno Moreno de Gusmão@morenodegusmao

#LBA-01 CERVINO (Ph3): Etentamig vs investigator-choice SAT in triple-class exposed, BCMA-naive RRMM (n=393). ORR 74% vs 46% (P<0.0001). PFS HR 0.40, median NR vs 6.2mo. 12-mo OS 87.9% vs 72% (early signal). CRS 39.5%, mostly low-grade. #mmsm #IMS2026

52 views0 likes1 RT2026-09-25
Pablo Tenorio Feixas
Pablo Tenorio Feixas@ptenfei

Responses also appeared deeper and more durable: - 12-month DoR was 79.6% vs 48.1%, while median DoR was not reached with etentamig. - Among evaluable patients achieving ≥CR, MRD negativity reached 89.1% at 10-5 and 82.8% at 10-5. - Early OS signal also favoured etentamig. #IMS26 @Myeloma_Society

33 views0 likes0 RT2026-09-25
Pablo Tenorio Feixas
Pablo Tenorio Feixas@ptenfei

Of note, I think it such a practical and modern design is most appropriate: - Monthly dosing from the start - Outpatient initiation allowed - Inclusion of non-academic centres from inception - Option to stop after 24 cycles for patients sustaining ≥CR for at least 12 months Definitely one to follow! ⚡️ #IMS26 @Myeloma_Society

5 views0 likes0 RT2026-09-25
Pablo Tenorio Feixas
Pablo Tenorio Feixas@ptenfei

@Myeloma_Society Safety and TEAEs profile are also reassuring: - Single step-up dose: 28.3% CRS, mostly grade 1; no grade ≥3 - ICANS: 0.9% - Grade 3/4 infections: 27.7% vs 19.2% - Grade 5 infections: 1.5% vs 3.1% - AE-related discontinuation: 3.6% vs 9.6% https://t.co/FI1smEdiEa

3 views0 likes0 RT2026-09-25

Cross-trial context

Saurabh Zanwar @ZanwarSaurabh · 2026-09-23
Cross-trial context: Phase 3 immunotherapy in early relapse (Dr. Maria-Victoria Mateos, IMS26)
Forest plot places CERVINO (PFS HR 0.40) alongside CARTITUDE-4, DREAMM-7/8, MajesTEC-3/9, MonumenTAL-3/6
View Post
CERVINO / IMS26 — Cross-trial context: Phase 3 immunotherapy in early relapse (Dr. Maria-Victoria Mateos, IMS26)Click to enlarge
[Slide 1] Phase 3 evidence has moved inmune therapy into early relapse [Table: STUDY | COMPARISON | forest plot (FAVOURS EXPERIMENTAL / FAVOURS CONTROL) | PFS HR | OS HR] CARTITUDE-4 | Cilta-cel vs DPd/PVd | PFS HR 0.29 | OS HR 0.55 DREAMM-7 | BVd vs DVd | PFS HR 0.41 | OS HR 0.58 DREAMM-8 | BPd vs PVd | PFS HR 0.52 | OS HR 0.77 MajesTEC-3 | Tec-Dara vs DPd/DVd | PFS HR 0.17 | OS HR 0.46 MonumenTAL-3 | Tal-DP vs DPd | PFS HR 0.28 | OS HR 0.47 (MonumenTAL-3) | Tal-D vs DPd | PFS HR 0.33 | OS HR 0.51 MajesTEC-9 | Teclistamab vs PVd/Kd | PFS HR 0.29 | OS HR 0.60 MonumenTAL-6 | Tal-Tec vs EPd/PVd | PFS HR 0.11 | OS HR NR (MonumenTAL-6) | Tal-Pom vs EPd/PVd | PFS HR 0.27 | OS HR NR CERVINO | Etentamig vs investigator's choice | PFS HR 0.40 | OS HR NR RANDOMIZED PHASE 3 TRIALS WITHOUT PUBLIC NUMERICAL HRs MagnetisMM-5 | Elranatamab +/- Dara vs DPd | Positive top-line result; no numerical data reported [Forest plot x-axis tick labels largely illegible]

See KOL Pulse’s full IMS26 conference coverage →

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Topline Results

What AbbVie Reported

Response & Progression-Free Survival

At the first planned efficacy interim analysis (n=393; median follow-up 11.4 months, data cutoff June 10, 2026), 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. As presented in full at the IMS26 plenary (Sept 25, 2026): median PFS was not reached with etentamig versus 6.2 months with standard therapies, and 12-month PFS was 62.1% vs 28.4%.
ORR 74.0% vs 45.7% · mPFS NR vs 6.2 mo, HR 0.40
Source: AbbVie topline announcement, Sept 3, 2026 · Full plenary data →

Safety (full plenary data)

As presented at IMS26: any-grade TEAEs 97.9% vs 95.3%; Grade 3/4 70.8% vs 59.6%; Grade 5 (fatal) 2.6% vs 5.7%. Among patients receiving a single step-up dose (n=113), CRS incidence was 28.3%, with no grade 3 or higher events; among the subset who also received prophylactic tocilizumab (n=22), CRS was 0%. ICANS occurred in 3.6% overall (0.9% with single step-up dose), no grade 2 or higher. Any-grade infections were 69.7% vs 59.1%; dose discontinuations for AEs were 3.6% vs 14.0%. AbbVie’s Sept 3 topline release described this as a “potentially differentiated safety profile”; the full safety tables above are from the IMS26 plenary presentation, Sept 25, 2026.

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.

Study Design

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.

Design facts per ClinicalTrials.gov NCT06158841 and the AbbVie announcement. All efficacy figures are from the sponsor topline release (first planned efficacy interim); full data land at IMS 2026.

Launch Coverage

KOL & Media Coverage

Two distinct windows, kept separate: the Sept 3–4 topline announcement, and the Sept 21–25 IMS26 conference window. IMS26 physician reactions are featured above in “How KOLs reacted” — not repeated here.

IMS26 window — Patient advocacy, sponsor & trade coverage

Non-physician coverage: patient advocacy, sponsor announcements, and trade press.

Michel Doepke
Michel Doepke@doepke_michel

$ABBV to Present Phase 3 Etentamig Results and Data from Broad Multiple Myeloma Portfolio at the 2026 International Myeloma Society (IMS) Meeting https://t.co/fyOO8bvf8C

1.7K views5 likes0 RT2026-09-17
Myeloma Patients Europe
Myeloma Patients Europe@MyelomaEurope

Just announced at #IMS26: results from the phase III CERVINO trial. In our interview, Dr Craig Cole explains the benefits of etentamig, an investigational treatment, compared with standard of care combinations in relapsed or refractory myeloma. Watch: https://t.co/MnLJAp4Ayc

65 views1 likes0 RT2026-09-25
AbbVie Oncology Medical Affairs
AbbVie Oncology Medical Affairs@AbbVieUSOncMed

Happening now at #IMS26 plenary session, Dr. Peter Voorhees presents the first efficacy and safety results from phase 3 CERVINO study in relapsed or refractory multiple myeloma (RRMM). #MultipleMyeloma #RRMM View the IMS program here: https://t.co/bnTtnqlXZz https://t.co/cu6sjRvH1A

35 views0 likes1 RT2026-09-25

Topline window (Sept 3–4, 2026) — Physician voices

Raj Chakraborty
Raj Chakraborty@rajshekharucms

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

1.7K views25 likes3 RT2026-09-04
Dr. Alex Ehsan, MD, PhD
Dr. Alex Ehsan, MD, PhD@DrAlexEhsan

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.

11 views0 likes0 RT2026-09-04

Topline window — Trade & analyst coverage

Media and analyst posts, including a BMO Capital Markets view relayed by BioSpace — analyst opinion, not clinical consensus.

Jim Omel
Jim Omel@IMFjimMYELOMA

AbbVie Announces Positive Topline Results from the Phase 3 CERVINO Trial Showing Etentamig Significantly Improved ... https://t.co/jHOXc7WG3F

3.9K views20 likes7 RT2026-09-04
OncLive.com
OncLive.com@OncLive

🗞️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

714 views3 likes2 RT2026-09-03
Targeted Oncology
Targeted Oncology@TargetedOnc

🔬 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

642 views4 likes0 RT2026-09-03
BioSpace
BioSpace@biospace

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

583 views4 likes1 RT2026-09-04
OncoDaily
OncoDaily@oncodaily

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

264 views9 likes0 RT2026-09-03
Oncology Learning Network
Oncology Learning Network@OncLearnNetwork

🚨: 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

103 views0 likes1 RT2026-09-03
Physician Opinions

Key KOL Sentiments — CERVINO

Physician reactions only, verbatim, sentiment read from each post’s own tone. Excludes tweets already reproduced above as slide-deck sources.

KOLComment (verbatim)Sentiment
Raj Chakraborty 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 Positive
Vincent Rajkumar First RCT results of Etentamig (BCMA bispecifc antibody) presented at Plenary Session #IMS26 @Myeloma_Society @PlasmaCellPete @myelomaMD 60 mg fixed dose every 4 weeks makes this the easiest bispecific to administer. Impressive PFS benefit in relapsed refractory myeloma with at least 2 prior lines of therapy. See thread for more details. Positive
Rahul Banerjee, MD, FACP #IMS26 CERVINO plenary (pronounced 🪑 + 🇪🇸 🍷) by @PlasmaCellPete - Part 2. PPx toci is very clearly the way to go with any BsAb, and here it works quite well. Etentamig has low CD3 affinity like Velcro for T cells (credit @myelomatips ), which may explain part of this. https://t.co/cwkTM8opZO Positive
Rahul Banerjee, MD, FACP #IMS26 CERVINO plenary (pronounced 🪑 + 🇪🇸 🍷) by @PlasmaCellPete Excellent results for BCMA BsAb therapy in early lines of R/R myeloma, this time with etentamig. It turns out we may be able to get to Q4W BsAb dosing as soon as C2D1! https://t.co/iUdr4jmZTn Positive
Ankit kansagra Impressive safety; tolerability while maintaining efficacy for BCMA directed bispecifics. Congratulations @PlasmaCellPete and the CERVINO team ! https://t.co/qKgIj04y92 Positive
Saurabh Zanwar #IMS26 Plenary presentation for CERVINO demonstrates clear superiority of TCEs over SOC! 👏👏@PlasmaCellPete @myelomaMD et al. 12-mo PFS of 62.1% with Etentamig vs. 28.4% with control (Kd, SVd, EloPd) OS showing encouraging trend as well! Surely no more non TCE control arms in this setting going forward! What’s different with Etentamig vs. other BCMA bispecifics: Etentamig with its silenced fc tail offers longer administration intervals and lower CRS rates from lower CD3-binding affinity Prophylactic toci is the way to go! Key for community uptake Positive
Hira Mian Congratulations to the CERVINO team! Great agents with lower toxicity and more convenient for pts. Also great trial design with an ability to stop after 24 months if sustained cr > 12 months #IMS26 Positive
Hamza Hashmi CERVINO (Etentamig Phase 3) @PlasmaCellPete on 🎯#IMS26: CERVINO Ph3: Etentamig superior to SAT (EPD, SVD, KD) in heavily pre-treated triple-class exposed RRMM 💡ORR 74% vs 45%, PFS at 12m NR (60%) vs 6m, OS benefit signal despite many SAT pts receiving TCRT at relapse 💡CRS 28% with SUD, 0% rates with ppx toci!! 💡Severe Infections were 28% despite many pts not receiving IVIG #MultipleMyeloma #MMsm #BCMA @Myeloma_Society Positive
Pablo Tenorio Feixas The CERVINO trial met all primary endpoints: - ORR: 74.0% vs 45.7% - ≥CR: 40% vs 7% - PFS: HR 0.40 - 12-month PFS: 62.1% vs 28.4% The PFS benefit was consistent across prespecified subgroups. Impressive efficacy in a heavily pretreated population! 👏 @Myeloma_Society #IMS26 https://t.co/czBBgYIEhH Positive
Pablo Tenorio Feixas Responses also appeared deeper and more durable: - 12-month DoR was 79.6% vs 48.1%, while median DoR was not reached with etentamig. - Among evaluable patients achieving ≥CR, MRD negativity reached 89.1% at 10-5 and 82.8% at 10-5. - Early OS signal also favoured etentamig. #IMS26 @Myeloma_Society Positive
Pablo Tenorio Feixas Of note, I think it such a practical and modern design is most appropriate: - Monthly dosing from the start - Outpatient initiation allowed - Inclusion of non-academic centres from inception - Option to stop after 24 cycles for patients sustaining ≥CR for at least 12 months Definitely one to follow! ⚡️ #IMS26 @Myeloma_Society Positive
Pablo Tenorio Feixas @Myeloma_Society Safety and TEAEs profile are also reassuring: - Single step-up dose: 28.3% CRS, mostly grade 1; no grade ≥3 - ICANS: 0.9% - Grade 3/4 infections: 27.7% vs 19.2% - Grade 5 infections: 1.5% vs 3.1% - AE-related discontinuation: 3.6% vs 9.6% https://t.co/FI1smEdiEa Positive
Pablo Tenorio Feixas Dr Peter Voorhees presenting phase 3 CERVINO at #IMS26: etentamig, a monthly BCMA×CD3 bispecific, versus investigator’s choice of Kd, SVd or EloPd (n= 393) with triple-class-exposed, BCMA-naïve RRMM. Median 3 prior lines; over half triple-class refractory. 🧵 @Myeloma_Society https://t.co/Ww2j52yuCK Neutral
Breno Moreno de Gusmão #LBA-01 CERVINO (Ph3): Etentamig vs investigator-choice SAT in triple-class exposed, BCMA-naive RRMM (n=393). ORR 74% vs 46% (P<0.0001). PFS HR 0.40, median NR vs 6.2mo. 12-mo OS 87.9% vs 72% (early signal). CRS 39.5%, mostly low-grade. #mmsm #IMS2026 Neutral
Dr. Alex Ehsan, MD, PhD 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. Neutral
FAQ

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 was full CERVINO data presented?

CERVINO was presented in the plenary session at the 23rd International Myeloma Society Annual Meeting, Friday, September 25, 2026, in Glasgow, Scotland. Live coverage from the session reported the same headline figures as AbbVie's September 3 topline release (ORR 74% vs 45.7%; PFS risk reduced 60%; CRS predominantly grade 1) - no formal post-presentation press release with additional numbers had posted as of this page's last update, so the sponsor's topline release remains the source for every stat above.

How does CERVINO's PFS benefit compare to other myeloma trials?

At IMS26, Dr. Maria-Victoria Mateos presented a forest plot of Phase 3 immunotherapy trials in early-relapse myeloma placing CERVINO's PFS HR of 0.40 alongside CARTITUDE-4 (HR 0.29), DREAMM-7 (HR 0.41), DREAMM-8 (HR 0.52), MajesTEC-3 (HR 0.17), MajesTEC-9 (HR 0.29), and MonumenTAL-3/6. CERVINO's OS hazard ratio was not yet reported on that slide (OS remains immature per AbbVie's topline).

Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated September 25, 2026. Every quote verbatim; every design fact sourced to ClinicalTrials.gov or the sponsors’ announcements.

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