At a Glance
MajesTEC-3 — the TL;DR
Design: Randomized phase 3, Tec-Dara (SC teclistamab + SC daratumumab) vs DPd/DVd, relapsed/refractory MM after 1–3 prior lines (ASH 2025 LBA-6; NEJM).
PFS: Median not reached vs 18.1 mo — HR 0.17 (95% CI 0.12–0.23, P<0.0001). KOLs: "unprecedented."
OS: 36-month 83.3% vs 65.0% — HR 0.46 (95% CI 0.32–0.65, P<0.0001).
By risk (36-mo PFS): ~87% (std) / ~78% (high) with Tec-Dara vs ~37% / ~12% (ASH 2025 slide); benefit consistent across HRCA subgroups (HR 0.15–0.22).
Safety: infection risk is the key issue — routine monthly IVIG and infection prevention emphasized.
Regulatory: FDA approved March 5, 2026 for relapsed/refractory myeloma after ≥1 prior line (incl. a proteasome inhibitor and an immunomodulatory agent) — Tecvayli + Darzalex Faspro (Johnson & Johnson).
Sponsor / drugs: Johnson & Johnson — teclistamab (Tecvayli) + daratumumab (Darzalex Faspro).
IMS 2026 Update
New at IMS 2026: Competing-Risk and Cure-Model Analyses
Two oral presentations at the 23rd International Myeloma Society Annual Meeting (Glasgow, September 23–26, 2026) re-analysed the MajesTEC-3 dataset: OA-49, a competing-risk analysis presented by Luciano J. Costa (@End_myeloma), and OA-58, a mixture cure model presented by Niels W.C.J. van de Donk. Neither reports new trial follow-up — both re-examine the existing 34.5-month data cut.
How to read this section
The Tec-Dara regimen itself is FDA approved (March 5, 2026) — see the FDA section above. The IMS 2026 analyses below are exploratory, post-hoc and model-based analyses of the same ~34.5-month data cut already reported at ASH 2025 and in the NEJM. They were not pre-specified endpoints, they carry no regulatory status, and they do not extend or alter the approved indication.
In particular, “statistical cure fraction” and “functional cure” are statistical modelling constructs — a model’s estimate of the proportion of patients whose long-term mortality would match a matched general population — not an observed clinical outcome, and not a claim that any individual patient has been cured. The projected median survival figures are extrapolations far beyond the observed follow-up and will change as the trial matures.
OA-49 · Competing-risk analysis — what is actually driving the survival benefit (L.J. Costa et al.)
Progression-free survival bundles two mutually exclusive events — disease progression and non-relapse mortality (NRM, death without prior progression) — so it cannot show which of them is driving outcomes. This analysis separated them using cumulative incidence of progression (CIP) and NRM as competing risks, plus a time-stratified Cox model of overall survival.
Tec-Dara produced a 90% reduction in the cumulative incidence of disease progression (sHR 0.10; 95% CI 0.07–0.16; P<0.0001), with progressions becoming uncommon after roughly 6 months. NRM was not meaningfully different between the arms (36-month NRM 10.2% vs 9.0%; sHR 1.16; 95% CI 0.69–1.98; P=0.5668). Deaths in the first 10 months were comparable (29 vs 29), after which the survival curves separated sharply. (IMS 2026 OA-49 slides; J&J press release, Sept 23 2026; 34.5-month median follow-up — same data cut as ASH 2025 LBA-6 / NEJM.)
OS benefit driven by suppression of progression, not by lower NRMSource: Johnson & Johnson press release, September 23, 2026 (IMS 2026 abstracts OA-49 / OA-58) · presentation slides posted by @AuclairDan and @hhashmi87Time-stratified Cox analysis of overall survival (OA-49)
| Period | OS hazard ratio, Tec-Dara vs DPd/DVd (95% CI) | Reading |
|---|---|---|
| Overall (intent-to-treat) | 0.46 (0.32–0.65), P<0.0001 | 54% lower risk of death overall |
| First 10 months | 1.08 (0.64–1.81) | No difference; 29 deaths in each arm |
| After 10 months | 0.22 (0.13–0.38) | 78% lower risk of death |
Competing-risk endpoints at 36 months (OA-49)
| Endpoint | Tec-Dara | DPd/DVd | sHR (95% CI) |
|---|---|---|---|
| Cumulative incidence of disease progression | 90% relative reduction with Tec-Dara | 0.10 (0.07–0.16), P<0.0001 | |
| Non-relapse mortality, 36 mo | 10.2% | 9.0% | 1.16 (0.69–1.98), P=0.5668 |
| Non-relapse mortality events, n | 28 | 26 | — |
| — adverse-event related | 19 | 16 | — |
| — infections and infestations | 12 (11 within 6 mo) | 4 (2 within 6 mo) | — |
OA-58 · Mixture cure model — projecting a “functional cure” fraction (N.W.C.J. van de Donk et al.)
A mixture cure model was fitted to the MajesTEC-3 survival data to estimate a statistical cure fraction — the modelled proportion of patients with no excess long-term mortality relative to a matched general population. Under the best-fit model the estimate was 86.6% (95% CI 81–91) for Tec-Dara versus 0% (95% CI 0–53) for DPd/DVd; across the seven parametric models tested the range was 84.4–86.8% versus 0–51.3%. The model projects a median overall survival of 18.5 years with Tec-Dara versus 4.9 years with DPd/DVd, against a matched general-population estimate of 21.1 years. (IMS 2026 OA-58 slides; J&J press release, Sept 23 2026; modelled from the 34.5-month data cut.)
This is a projection, not an observed result: median survival of 18.5 years is extrapolated from under three years of follow-up, the wide confidence interval on the comparator arm (0–53%) reflects real uncertainty, and no patient in MajesTEC-3 has been followed anywhere near long enough to confirm cure.
Modelled statistical cure fraction 86.6% (95% CI 81–91) — exploratorySource: Johnson & Johnson press release, September 23, 2026 · presentation slides posted by @HadidiSamer and @RahulBanerjeeMD · reported by @Myeloma_SocietyMixture cure model estimates (OA-58) — modelled, not observed
| Model output | Tec-Dara | DPd/DVd |
|---|---|---|
| Statistical cure fraction, best-fit model (95% CI) | 86.6% (81–91) | 0% (0–53) |
| Statistical cure fraction, range across 7 tested models | 84.4–86.8% | 0–51.3% |
| Projected median overall survival | 18.5 years | 4.9 years |
| Matched general-population reference | 21.1 years | |
IMS 2026 presentation slides
[Slide 1 - MajesTEC-3: PFS (Primary Endpoint)]
36-mo PFS: Tec-Dara 83.4% (median NR) vs DPd/DVd 29.7% (median 18.1 months)
HR 0.17 (95% CI 0.12–0.23); P<0.0001. Median follow-up: 34.5 months
Tec-Dara led to a PFS plateau around 6 months, with >90% of patients at 6 months estimated to sustain such a benefit at 3 years
Costa LJ, et al. N Engl J Med. 2026;394(8):739–752. Presented by LJ Costa at the 23rd International Myeloma Society (IMS) Annual Meeting; September 23–26, 2026; Glasgow, Scotland
---
[Slide 2 - MajesTEC-3: Cumulative Incidence of Progression]
With NRM as a competing risk, CIP was substantially lower with Tec-Dara. Progression: Tec-Dara 24/291 (18 with subsequent death) vs DPd/DVd 171/296 (72 with subsequent death)
36-mo CIP rate: Tec-Dara 8.7% vs DPd/DVd 62.1%. sHR 0.10 (95% CI 0.07–0.16); nominal P<0.0001
Tec-Dara substantially reduced CIP versus DPd/DVd; progression is uncommon with 90% reduction versus DPd/DVd
---
[Slide 3 - MajesTEC-3: Non-Relapse Mortality]
With CIP as a competing risk, NRM was similar between treatments. Deaths without progression: Tec-Dara 28/291 (19 due to AEs) vs DPd/DVd 26/296 (16 due to AEs)
36-mo NRM rate: Tec-Dara 9.0% vs DPd/DVd 10.2%. sHR 1.16 (95% CI 0.69–1.98); nominal P=0.5668
No meaningful difference between Tec-Dara and DPd/DVd in NRM
---
[Slide 4 - MajesTEC-3: OS]
36-mo OS: Tec-Dara 83.3% (median NR) vs DPd/DVd 65.0% (median NR)
HR 0.46 (95% CI 0.32–0.65); P<0.0001. Median follow-up: 34.5 months
Tec-Dara significantly improved OS versus DPd/DVd, with an estimated 83% of patients alive at 3 years
Costa LJ, et al. N Engl J Med. 2026;394(8):739–752. Presented by LJ Costa at the 23rd International Myeloma Society (IMS) Annual Meeting; September 23–26, 2026; Glasgow, Scotland
[Slide 1 - MajesTEC-3: Table 1 — LS Mean Change From Baseline in PRO Scores at C37D1]
Tec+Dara (n=78) vs DPd/DVd (n=35): MySIm-Q Symptom −0.10 (−0.20, 0.01) vs 0.03 (−0.11, 0.17); Impact −0.30 (−0.41, −0.19) vs −0.14 (−0.29, 0.01)
EORTC QLQ-C30 (n=72 vs n=32): GHS 5.4 (2.6, 8.3) vs 0.26 (−3.7, 4.2); Pain −9.7 (−13.8, −5.6) vs −5.1 (−11.1, 0.8); Fatigue −5.0 (−9.0, −0.9) vs 2.1 (−3.7, 7.9); Physical function 5.1 (2.5, 7.8) vs −0.6 (−4.2, 3.0)
EQ-5D-5L VAS: 5.3 (3.0, 7.5) vs 2.9 (−0.1, 5.9)
---
[Slide 2 - MajesTEC-3: Figure 1 — Proportion of Patients With Meaningful Change From Baseline at C37D1]
MySIm-Q and EORTC QLQ-C30, Tec+Dara (n=78) vs DPd/DVd (n=35), % meaningful improvement/no change/worsening:
Symptom: 22/64/14 vs 20/54/26. Impact: 24/60/15 vs 20/57/23
GHS: 36/46/18 vs 25/41/34. Pain: 49/39/13 vs 34/28/28. Fatigue: 39/38/24 vs 41/19/41. Physical function: 28/61/11 vs 22/59/19
[Slide 1 - OA-49, slide 5]
Why Competing-Risk Analyses Matter in MajesTEC-3
- NRM and disease progression are mutually exclusive components of PFS
- NRM: Death without prior progression, irrespective of cause
- NRM and disease progression are also "competing events," requiring separation
- A patient who experiences 1 event can no longer experience the other event
- Competing-risk analyses (cumulative incidence of progression [CIP] and NRM) are needed to accurately assess what is driving patient survival in MajesTEC-3
Flow: Alive/on study -> 2 possible routes: Disease progression (counted toward CIP) -> Subsequent therapy -> Death | OR Death without prior progression (counted toward NRM)
Banner: Competing-risk analyses help to separate "deaths after progression" from "deaths without prior progression"
---
[Slide 2 - OA-49, slide 9]
MajesTEC-3: Causes of Non-Relapse Mortality
NRM was primarily due to AEs in both treatment groups
- AEs were primarily infections and infestations, occurring most commonly within 6 months of treatment initiation
- Tec-Dara: 12; 11 <=6 months
- DPd/DVd: 4; 2 <=6 months
- Infection prophylaxis was recommended per protocol, with IgRT and antimicrobial use reinforced as experience and guidelines evolved
- Supportive RWE and IMWG guidelines recommend IgRT prophylaxis for the reduction of high-grade infections with BCMA-targeting BsAbs
[Table: NRM, n | Tec-Dara (n=28) | DPd/DVd (n=26)]
AE-related | 19 | 16
Infections and infestations | 12 | 4
General disorders and administration-site conditions | 2 | 4
Respiratory, thoracic, and mediastinal disorders | 2 | 3
Nervous system disorders | 1 | 2
Hepatobiliary disorders | 1 | 1
Cardiac disorders | 1 | 0
Immune system disorders | 1 | 0
Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 0 | 1
Gastrointestinal disorders | 0 | 1
PD without IRC-determined progression | 2 | 8
Other | 7 | 2
Banner: Infection-related NRM may be reduced through diligent use of established IgRT and antimicrobial prophylaxis protocols
---
[Slide 3 - OA-49, slide 13]
MajesTEC-3: Time-Stratified Cox Analysis of OS
>10 months: HR, 0.22 (95% CI, 0.13-0.38)
<=10 months: HR, 1.08 (95% CI, 0.64-1.81)
Overall: HR, 0.46 (95% CI, 0.32-0.65); P<0.0001
Deaths within first 10 months were comparable: 29 Tec-Dara vs 29 DPd/DVd
Cause of death within first 10 months (curve cross):
- Tec-Dara: AEs (n=18), PD (n=5), "Other" (n=6)
- DPd/DVd: AEs (n=8), PD (n=20), "Other" (n=1)
Footnote: Of 18 AE deaths, 12 were infections.
Banner: Tec-Dara substantially reduced the risk of death by 78% versus DPd/DVd after 10 months
[Kaplan-Meier curve axis tick labels not transcribed - see the numbers table above (RULE 23)]
---
[Slide 4 - OA-49, slide 14]
Conclusions
- Tec-Dara significantly improved PFS (HR, 0.17) and OS (HR, 0.46) over DPd/DVd in patients with RRMM and 1-3 prior LOTs, with a sustained plateau in survival curves
- With Tec-Dara, progressions became uncommon after 6 months, with an unparalleled reduction in disease progression (sHR, 0.10), which is the leading cause of mortality in RRMM
- There was no meaningful difference in NRM between treatments over time; infection-related NRM occurred with both treatments
- Infections can be better managed now with guideline-based IgRT and antimicrobial prophylaxis
- OS benefit with Tec-Dara versus DPd/DVd was driven by durable disease control without an increase in NRM
- Superior OS with Tec-Dara was supported by RMST and time-stratified Cox analysis (>10 months)
Banner: Tec-Dara's OS benefit is driven by profound suppression of disease progression, while NRM remains comparable over time
References: 1. Costa LJ, et al. N Engl J Med. 2026;394(8):739-752. 2. Mateos MV, et al. Presented at: 67th ASH Annual Meeting and Exposition; December 6-9, 2025; Orlando, FL. Oral LBA-6. 3. Tan CR, et al. Blood Adv. 4. Rodriguez-Otero P, et al. Lancet Oncol. 2024;25(5):e205-e216.
[Slide 1 - OA-58, slide 10]
Model Estimates of Median OS for Tec-Dara
Estimated all-cause survival (MajesTEC-3: ~3yr follow-up) - curves for General population, Tec-Dara, DPd/DVd
[Estimated median survival]
General population | 21.1 years
Tec-Dara | 18.5 years
DPd/DVd | 4.9 years
Banner: The model projects substantially longer median OS with Tec-Dara, approaching the matched general-population estimate
Footnotes: Median follow-up: 34.5 months. Determined using the best-fit relative survival MCM. Determined using the best-fit survival model without cure.
---
[Slide 2 - OA-58, slide 11]
Model Estimates of Mortality Risk With Tec-Dara
- Across tested models, estimated statistical cure fractions were consistently high with Tec-Dara, and low with DPd/DVd
[Table: Statistical cure fraction, % | Tec-Dara | DPd/DVd]
Best-fit model (95% CI) | 86.6 (81-91) | 0 (0-53)
Range across tested models | 84.4 to 86.8 | 0 to 51.3
Relative survival chart: Statistical cure fraction 86.6% (Tec-Dara plateau); DPd/DVd curve declines toward 0
Banner: ~87% of patients treated with Tec-Dara are estimated to have no excess long-term mortality risk on top of the general population by best-fit models
Footnotes: Tested models analyzed survival related to excess risk in the uncured fraction using 7 classical parametric models including exponential, Weibull, lognormal, loglogistic, Gompertz, gamma, and generalized gamma. Results from the Gompertz function were excluded for Tec-Dara because it resulted in a non-zero ceiling in excess mortality due to the shape parameter being negative. Best-fit models were selected according to statistical goodness of fit criteria; MCMs applied the exponential function for Tec-Dara OS and DPd/DVd OS. Profile-likelihood 95% CIs shown here; these replace the Wald CIs reported in the abstract and typically provide more accurate coverage.
IMS 2026 coverage on X
#IMS2026 How to approach first relapse by @DrRakeshPopat https://t.co/3uXrSIgjY7
422 impressions9 likes2026-09-23
Never a good time to be a myeloma patient but this is the best it has ever been!
Remarkable results in early relapse setting!
@mvmateos #IMS26 https://t.co/rNUviKkXc5
359 impressions8 likes2026-09-23
#IMS26 Worth highlighting since pts with MM often aged 70+. We don't need OS plateau if myeloma remains in remission & no excess long-term mortality versus general population.
Excellent 'functional cure' MajesTEC-3 data for tec-dara - I hope time-limited BsAb can replicate!
320 impressions9 likes2026-09-24
#IMS26 Elegant (post hoc) MajesTEC-3 analysis by @End_myeloma
Unlike other myeloma drugs, I bet real-world tec-dara OS will look *better* than MajesTEC-3 did.
Why? Because we now know PPx toci, PPx IVIG, etc - early BsAb deaths can be prevented, vs fatal PD with Dara-Pd can't.
281 impressions4 likes2026-09-24
#IMS26 #mmsm Oral- % of functional cure with the use of Tec-Dara @Myeloma_Society
Estimated functional cure of 87% with Tec-Dara showing excellent promise of such therapy.
➡️Future will need time limited therapy (Stop and see what will happen)
➡️Assess cumulative toxicity with longer use of this therapy (infections most imp)- Non relapse mortality will be imp
Future is bright in myeloma
204 impressions2 likes2026-09-23
Niels van de Donk, MD, PhD, spoke abt a mixed cure model to estimate statistical cure fraction - % of pts w/o excess mortality & long-term disease control. In MajesTEC-3, statistical cure fraction w/ Tec-Dara was 86.6% vs 0% w/ DVd or DPd. #IMS26 https://t.co/83OcpeAl2d
199 impressions1 likes2026-09-23
#IMS26 #mmsm Oral MajesTEC-3 post hoc analysis @End_myeloma
➡️ In Tec-Dara, progressions became uncommon after 6 months, with an reduction in disease progression (sHR, 0.10), which is the leading cause of mortality in RRMM https://t.co/jctyzj62b3
109 impressions0 likes2026-09-24
#IMS26 #mmsm Oral MajesTEC-3 post hoc analysis @End_myeloma
➡️Tec-Dara reduced the risk of death by 78% versus DPd/DVd after 10 months with similar early deaths
Better AEs management will help further mitigate higher risk of infection early on
Moving forward this should change to time limited therapy given excellent results and depth of response
69 impressions0 likes2026-09-24
Very interesting Competing-Risk analysis of MajesTEC-3 presented by @End_myeloma at #IMS26 . Tec-Dara OS benefit driven by suppression of disease progression while NRM remains comparable over time. https://t.co/nxIZ0GDYk6
122 impressions2 likes2026-09-24
@End_myeloma on MajesTEC-3 competing-risk analysis at #IMS26: Tec-Dara vs DPd/DVd in RRMM, 1–3 prior LOTs
• Progression sHR 0.10
• NRM similar (28 vs 26)
• OS HR 0.22 after 10 mo
Early infection deaths → IgRT + antimicrobial prophylaxis is a must. #mmsm @Myeloma_Society https://t.co/J9QwgmmdCZ
93 impressions2 likes2026-09-24
A question I get asked constantly: can we actually cure myeloma now? MajesTEC-3 remodeled with a mixture cure model shows Tec-Dara's survival curves plateauing (PFS HR 0.17, OS HR 0.46 vs DPd/DVd) — a real signal of a functional cure fraction in RRMM. #RRMM #mmsm #IMS2026
38 impressions0 likes2026-09-23
Who's Talking
KOL Leaders Discussing MajesTEC-3
Presented by Prof. María-Victoria Mateos (@mvmateos), ASH 2025 LBA-6. Other voices ranked by total impressions among physicians discussing the trial.
Conference Slides
Key Slides & Data
[Slide 1]
MajesTEC-3: PFS by Number of Expandedᵃ HRCAs
0 HRCAs
1 HRCA
≥2 HRCAs
Estimated
Estimated
Estimated
36-mo PFS rate
36-mo PFS rate
36-mo PFS rate
100
100
100
90.1%
Tec-Dara,
0 HRCAs
82.0%
80
80
Tec-Dara,
80
76.4%
1 HRCA
Tec-Dara,
% surviving without progression
>2 HRCAs
60
60
60
40
31.9%
40
40
30.7%
DPd/DVd,
0 HRCAs
DPd/DVd,
20
Tec-Dara, n=52
20
Tec-Dara, n=105
1 HRCA
20
Tec-Dara, n=64
13.7%
DPd/DVd, n=55
DPd/DVd. n=111
DPd/DVd, n=69
DPd/DVd,
HR, 0.12 (95% CI, 0.04-0.30)
HR, 0.19 (95% CI, 0.11-0.32)
HR, 0.16 (95% CI, 0.08-0.29)
>2 HRCAs
0
0
0
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45
Months
Months
Months
No. at risk
No. at risk
No. at risk
Tec-Dara
52
50
46
45
45
45
44
44
44
43
42
28
15
8
3
0
Tec-Dara 105 93 87 84 84 82 81 79 79 78 78 54 34 13 3 0 0
Tec-Dara
64 54 52 49 49 47 46 45 44 43 41 26 19 6 3 0
DPd/DVd
55
51
46
39
34
32
32
29
26
22
19
12
8
3
0
0
DPd/DVd 111 97 82 71 61 55 49 47 44 41 34 20 10 7 2 1 0
DPd/DVd
69 56 47 39 34 29 22 17 13 11 11 7 1 1 1 0
Tec-Dara consistently improved PFS vs DPd/DVd, including in patients with ultra high-risk RRMM
PHRCA number is defined as the number of abnormalities present from the following: del(17p). t(4;14), t(14;16), amp(1q21). or gain(1q21).
11
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
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[Slide 2]
MajesTEC-3: PFS by Functional High-Risk Statusᵃ
Estimated
100
36-mo PFS rate
89.9%
Tec-Dara, not FHR
after 1 prior LOT
% surviving without progression
80
77.3%
Tec-Dara, FHR after 1 prior LOT
60
40
35.9%
&
DPd/DVd, not FHR
Not FHR after 1 prior LOT: Tec-Dara, n=82; DPd/DVd, n=94
after 1 prior LOT
20
HR, 0.11 (95% CI, 0.05-0.23)
0%
FHR after 1 prior LOT: Tec-Dara, n=26; DPd/DVd, n=20
DPd/DVd, FHR after 1 prior LOT
HR, 0.22 (95% CI, 0.08-0.62)
0
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
Months
No. at risk
Tec-Dara, not FHR after 1PL
82
78
78
77
77
74
74
72
71
70
69
46
30
15
3
0
0
DPd/DVd, not FHR after 1PL
94
86
73
65
59
53
47
45
39
38
36
24
13
7
2
1
0
Tec-Dara, FHR after 1PL
26
20
18
18
18
17
17
17
17
16
16
8
6
2
1
0
0
DPd/DVd, FHR after 1 PL
20
16
14
12
12
11
10
9
8
5
4
1
0
0
0
0
0
Tec-Dara substantially prolonged PFS vs DPd/DVd in patients with FHR MM,
surpassing inferior outcomes historically seen with traditional therapies¹
1PL, 1 prior LOT; MM, multiple myeloma. *Functional high-risk status defined as patients with 1 prior LOT and progressive disease within 18 months of ASCT or start of initial therapy. 1. Banerjee R, et al. Frontiers Oncol.
2023;13:1240966.
13
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
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[Slide 3]
MajesTEC-3: PFS By Risk Status (ITT)
Tec-Dara
DPd/DVd
Events
Median
Events
Median
n/N
n/N
HR (95% CI)
PFS (mo)
PFS (mo)
Functional high risk
5/26
NE
14/20
23.2
0.22 (0.08-0.62)
Non-functional high risk
8/82
NE
57/94
20.8
0.11 (0.05-0.23)
Prespecified std. risk
15/126
NE
84/145
24.7
0.16 (0.09-0.27)
Prespecified high risk
20/104
NE
78/104
14.4
0.15 (0.09-0.25)
Expanded std. riskᵇ
5/52
NE
34/55
24.2
0.12 (0.04-0.30)
Expanded high riskb
30/169
NE
122/180
15.8
0.18 (0.12-0.26)
1 HRCA
17/105
NE
69/111
17.9
0.19 (0.11-0.32)
≥2 HRCAs
13/64
NE
53/69
14.4
0.16 (0.08-0.29)
0.01
0.1
1
10
Tec-Dara better DPd/DVd better
Tec-Dara consistently improved PFS vs DPd/DVd regardless of disease biology
CI, confidence interval; HR hazard ratio; ITT, intent-to-treat; NE, not estimable; Std., standard Prespecified standard risk: none of del(17p), t(4;14), or t(14;16). Prespecified high risk: >1 of del(17p), t(4;14), or t(14;16). Expanded
standard risk: none of del(17p), t(4;14), t(14;16), amp(1q21), or gain(1q21). Expanded high risk: >1 of del(17p), t(4;14), t(14;16), amp(1q21), or gain(1q21).
6
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
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[Slide 4]
MajesTEC-3: PFS by Number of Expandedᵃ HRCAs
0 HRCAs
1 HRCA
≥2 HRCAs
Estimated
Estimated
Estimated
36-mo PFS rate
36-mo PFS rate
36-mo PFS rate
100
100
100
90.1%
Tec-Dara,
0 HRCAs
82.0%
80
80
Tec-Dara,
80
76.4%
1 HRCA
Tec-Dara,
% surviving without progression
>2 HRCAs
60
60
60
40
31.9%
40
40
30.7%
DPd/DVd,
0 HRCAs
DPd/DVd,
20
Tec-Dara, n=52
20
Tec-Dara, n=105
1 HRCA
20
Tec-Dara, n=64
13.7%
DPd/DVd, n=55
DPd/DVd. n=111
DPd/DVd, n=69
DPd/DVd,
HR, 0.12 (95% CI, 0.04-0.30)
HR, 0.19 (95% CI, 0.11-0.32)
HR, 0.16 (95% CI, 0.08-0.29)
>2 HRCAs
0
0
0
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45
Months
Months
Months
No. at risk
No. at risk
No. at risk
Tec-Dara
52
50
46
45
45
45
44
44
44
43
42
28
15
8
3
0
Tec-Dara 105 93 87 84 84 82 81 79 79 78 78 54 34 13 3 0 0
Tec-Dara
64 54 52 49 49 47 46 45 44 43 41 26 19 6 3 0
DPd/DVd
55
51
46
39
34
32
32
29
26
22
19
12
8
3
0
0
DPd/DVd 111 97 82 71 61 55 49 47 44 41 34 20 10 7 2 1 0
DPd/DVd
69 56 47 39 34 29 22 17 13 11 11 7 1 1 1 0
Tec-Dara consistently improved PFS vs DPd/DVd, including in patients with ultra high-risk RRMM
PHRCA number is defined as the number of abnormalities present from the following: del(17p). t(4;14), t(14;16), amp(1q21). or gain(1q21).
11
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 5]
MajesTEC-3: PFS by Functional High-Risk Statusᵃ
Estimated
100
36-mo PFS rate
89.9%
Tec-Dara, not FHR
after 1 prior LOT
% surviving without progression
80
77.3%
Tec-Dara, FHR after 1 prior LOT
60
40
35.9%
&
DPd/DVd, not FHR
Not FHR after 1 prior LOT: Tec-Dara, n=82; DPd/DVd, n=94
after 1 prior LOT
20
HR, 0.11 (95% CI, 0.05-0.23)
0%
FHR after 1 prior LOT: Tec-Dara, n=26; DPd/DVd, n=20
DPd/DVd, FHR after 1 prior LOT
HR, 0.22 (95% CI, 0.08-0.62)
0
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
Months
No. at risk
Tec-Dara, not FHR after 1PL
82
78
78
77
77
74
74
72
71
70
69
46
30
15
3
0
0
DPd/DVd, not FHR after 1PL
94
86
73
65
59
53
47
45
39
38
36
24
13
7
2
1
0
Tec-Dara, FHR after 1PL
26
20
18
18
18
17
17
17
17
16
16
8
6
2
1
0
0
DPd/DVd, FHR after 1 PL
20
16
14
12
12
11
10
9
8
5
4
1
0
0
0
0
0
Tec-Dara substantially prolonged PFS vs DPd/DVd in patients with FHR MM,
surpassing inferior outcomes historically seen with traditional therapies¹
1PL, 1 prior LOT; MM, multiple myeloma. *Functional high-risk status defined as patients with 1 prior LOT and progressive disease within 18 months of ASCT or start of initial therapy. 1. Banerjee R, et al. Frontiers Oncol.
2023;13:1240966.
13
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 6]
MajesTEC-3: PFS By Risk Status (ITT)
Tec-Dara
DPd/DVd
Events
Median
Events
Median
n/N
n/N
HR (95% CI)
PFS (mo)
PFS (mo)
Functional high risk
5/26
NE
14/20
23.2
0.22 (0.08-0.62)
Non-functional high risk
8/82
NE
57/94
20.8
0.11 (0.05-0.23)
Prespecified std. risk
15/126
NE
84/145
24.7
0.16 (0.09-0.27)
Prespecified high risk
20/104
NE
78/104
14.4
0.15 (0.09-0.25)
Expanded std. riskᵇ
5/52
NE
34/55
24.2
0.12 (0.04-0.30)
Expanded high riskb
30/169
NE
122/180
15.8
0.18 (0.12-0.26)
1 HRCA
17/105
NE
69/111
17.9
0.19 (0.11-0.32)
≥2 HRCAs
13/64
NE
53/69
14.4
0.16 (0.08-0.29)
0.01
0.1
1
10
Tec-Dara better DPd/DVd better
Tec-Dara consistently improved PFS vs DPd/DVd regardless of disease biology
CI, confidence interval; HR hazard ratio; ITT, intent-to-treat; NE, not estimable; Std., standard Prespecified standard risk: none of del(17p), t(4;14), or t(14;16). Prespecified high risk: >1 of del(17p), t(4;14), or t(14;16). Expanded
standard risk: none of del(17p), t(4;14), t(14;16), amp(1q21), or gain(1q21). Expanded high risk: >1 of del(17p), t(4;14), t(14;16), amp(1q21), or gain(1q21).
6
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
[Slide 1]
MajesTEC-3: PFS By Risk Status (ITT)
Tec-Dara
DPd/DVd
Events
Median
Events
Median
n/N
PFS (mo)
n/N
HR (95% CI)
PFS (mo)
Functional high risk
5/26
NE
14/20
23.2
0.22 (0.08-0.62)
Non-functional high risk
8/82
NE
57/94
20.8
0.11 (0.05-0.23)
Prespecified std. risk
15/126
NE
84/145
24.7
0.16 (0.09-0.27)
Prespecified high risk
20/104
NE
78/104
14.4
0.15 (0.09-0.25)
Expanded std. riskᵇ
5/52
NE
34/55
24.2
0.12 (0.04-0.30)
Expanded high riskᵇ
30/169
NE
122/180
15.8
0.18 (0.12-0.26)
1 HRCA
17/105
NE
69/111
17.9
0.19 (0.11-0.32)
≥2 HRCAs
13/64
NE
53/69
14.4
0.16 (0.08-0.29)
0.01
0.1
1
10
Tec-Dara better DPd/DVd better
Tec-Dara consistently improved PFS vs DPd/DVd regardless of disease biology
CI, confidence interval; HR hazard ratio; ITT. intent-to-treat; NE, not estimable; Std., standard "Prespecified standard risk: none of del(17p). 1(4;14), or 1(14;16). Prespecified high risk: >1 of del(17p). t(4;14). or t(14;16). Expanded
standard risk: none of del(17p). t(4;14). t(14;16), amp(1q21). or gain(1q21). Expanded high risk: >1 of del(17p). t(4;14). t(14;16). amp(1q21). or gain(1q21).
6
Presented by R Banenee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14. 2026: Stockholm. Sweden
---
[Slide 2]
MajesTEC-3: PFS by Prespecifieda Cytogenetic Risk
Estimated
100
36-mo PFS rate
87.4%
Tec-Dara, std. risk
% surviving without progression
80
Tec-Dara, high risk
77.7%
60
40
37.1%
DPd/DVd, std. risk
Std. risk: Tec-Dara, n=126; DPd/DVd, n=145
20
HR, 0.16 (95% CI, 0.09-0.27)
High risk: Tec-Dara, n=104; DPd/DVd, n=104
11.5%
DPd/DVd, high risk
HR, 0.15 (95% CI, 0.09-0.25)
0
4
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
Months
No. at risk
Tec-Dara, std. risk
126
116
108
105
105
104
103
102
101
99
97
64
36
17
6
0
0
DPd/DVd, std. risk
145
131
115
99
87
82
78
73
69
62
53
34
20
10
2
1
0
Tec-Dara, high risk
104
89
86
82
82
79
77
75
74
73
71
47
31
10
3
0
0
DPd/DVd. high risk
104
85
71
61
53
45
35
30
24
20
18
10
2
2
1
0
0
Tec-Dara demonstrated superior PFS vs DPd/DVd regardless of
cytogenetic risk and mirroring the overall study effect (HR 0.17)¹
"Prespecified standard risk: none of del(17p). t(4;14). or t(14;16). Prespecified high risk: 21 of del(17p). t(4;14). or t(14;16).
1. Costa LJ, et al. N Engl J Med. 2026,394(8):739-752.
7
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 3]
MajesTEC-3: MRD-Negative ≥CR by Prespecified
Cytogenetic Risk
MRD-negative ≥CRᵃ (10⁻⁵)
MRD-negative ≥CRᵃ (10⁻⁶)
Tec-Dara
100
100
DPd/DVd
90
OR, 5.08
90
(95% CI, 2.90-8.88)
OR, 12.83
OR, 8.29
80
80
(95% CI, 4.46-15.42)
OR, 21.28
(95% CI, 5.77-28.53)
(95% CI, 7.93-57.14)
MRD-negative ≥CR rate, %
70
62.6
70
57.9
58.9
60
60
54.7
50
50
40
40
30
24.8
30
20
20
14.7
9.7
10
10
5.4
0
0
n=107
n=129
n=95
n=93
n=107
n=129
n=95
n=93
Prespecified std. riskb
Prespecified high riskc
Prespecified std. riskb
Prespecified high riskc
Tec-Dara substantially increased MRD-negative ≥CR rates,
with an MRD-negative ≥CR (10⁻⁶) rate that was 10-fold that of DPd/DVd
OR, odds ratio. "MRD-negative >CR refers to MRD negativity achieved within 3 months prior to achieving CR/sCR or at any time after CR/sCR and before progression or subsequent therapy. Assessed in the MRD NGS primary
analysis set, defined as all randomized patients except those recruited in China (due to China instead utilizing NGF for MRD assessment). Prespecified standard risk: none of del(17p). 1(4;14), or 1(14;16). Prespecified high risk: 21
of del(17p), 1(4;14), or t(14;16).
8
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 4]
MajesTEC-3: MRD-Negative ≥CR by
Functional High-Risk Statusᵃ
MRD-negative ≥CRb (10⁻⁵)
MRD-negative ≥CRb (10⁻⁶)
Tec-Dara
DPd/DVd
100
100
90
OR, 4.47
90
OR, 5.95
80
(95% CI, 2.32-8.60)
OR, 12.75
80
(95% CI, 2.98-11.88)
(95% CI, 1.42-114.40)
MRD-negative ≥CR rate, %
70
70
61.3
58.8
OR, NE
60
60
(95% CI, NE-NE)
50
42.9
50
38.1
40
40
30
26.1
30
19.3
20
20
10
5.6
10
0
0
0
n=80
n=88
n=21
n=18
n=80
n=88
n=21
n=18
Not FHR after 1 prior LOT
FHR after 1 prior LOT
Not FHR after 1 prior LOT
FHR after 1 prior LOT
Tec-Dara consistently increased MRD-negative >CR rates vs DPd/DVd at both 10⁻⁵ and
the more stringent 10⁻⁶ threshold in patients with FHR MM
Functional high-risk status defined as patients with 1 prior LOT and progressive disease within 18 months of ASCT or start of initial therapy. MRD-negative >CR refers to MRD negativity achieved within 3 months prior to achieving
CR/sCR or at any time after CR/sCR and before progression or subsequent therapy. Assessed in the MRD NGS primary analysis set, defined as all randomized patients except those recruited in China (due to China instead utilizing
NGF for MRD assessment).
14
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
[Slide 1]
Teclistamab (RRMM): (Pts) With Relapsed Ratumumab
and Rahul on Cytogenetic
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Service Cirical Athers, SA, Medizinsche Cárdiba, Research d'Hematologie, School Argentina Kink of Center ACT for Hematologic Oncopole Certificate). Johnan Disease, Principal Toubute CBERONG Being France Ching Salamance Beigun Emay Washington, The Salamance Royal Spain Seate Ane Writing M de Cancer inestigición American Cance Haria University Christopher Medical " Chiu, Caigary Luciano Costa's Lina Otaro, . Case
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Göleborg Mediche Titala Cancer Scan Center Chirurgiche, Sweden Clinica Zeole Medicine The University The Athers, Nethertands, Bologra, Greece: to *2. *You Bologra, talk Car Bladipod styoge "Chica Kore, Neueger, Certano, The Natinomya, that Dresdien, Demany PRIN Copentages, Carata Terrary
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Center, Johnson Presented & Johnson, by TN R Ratan Banerjee "Johnson Lie, & France, PA "Cancer Dine Certer University Katara de CIMA, in Into
at the 31st European Hematology Association (EHA) Annual Meeting: June No. 11-14, 2028; - Stockhaim, Sweden
---
[Slide 2]
Rahul
Banerjee
EHA2026
Congress
eha
[Slide 1]
Estimated
36-mo PFS rate
100
87.4%
Tec-Dara, std. risk
80
77.7%
% surviving without progression
Tec-Dara, high risk
60
40
37.1%
DPd/DVd, std. risk
20
11.5%
DPd/DVd, high risk
0
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
Months
Social Signal
Top Tweets
Unprecedented. #ASH25 Tec-Dara in relapsed myeloma. @mvmateos https://t.co/hjxKrGsmH9
62.6K impressions230 likes2025-12-09
This is the one of the most incredible outcome difference I have seen in myeloma: Results of the randomized Majestec-3 trial in myeloma. @mvmateos HR 0.17 !! Late breaker at #ASH25 @ASH_hematology https://t.co/GRCGkQgBjZ
60.1K impressions236 likes2025-11-24
OK here it is. Finally. My #ASH25 algorithm for Relapsed Myeloma: First Relapse. Discussed with @YiLinMDPhD @myelomaMD Give comments. I’m willing to adjust it based on your insights. https://t.co/uP8RFXIKYU
20.7K impressions99 likes2025-12-09
Just out in @NEJM Majestec-3 trial. Tec-Dara in relapsed myeloma. #ASH25 @End_myeloma @mvmateos Link: https://t.co/DnTeuBMsLU More in thread https://t.co/GrYwRuLUIL
16.1K impressions54 likes2025-12-09
#ASH25 #mmsm @ASH_hematology Treatment Refinement in Multiple Myeloma @SLentzsch Reasons why CAR-T should be positioned before BsAbs https://t.co/cYiU44RR7f
16.0K impressions41 likes2025-12-07
Given the emerging data of MajesTEC-3, here is a table of early BCMA based therapies (combination BCMA (Tec-Dara, Belnrep triplet) and Cilta Cel #ASH25 #mmsm @ASH_hematology Efficacy summary https://t.co/Rxas7bubCm
15.6K impressions111 likes2025-11-24
Finally I found the 10th abstract for #ASH25 🔥🔥🔥 Phase 3 randomized study of teclistamab plus daratumumab versus investigator’s choice of DPd/DVd in Pts with RRMM: majestec-3 1/ 🔥 Practice-changing data in RRMM! MajesTEC-3 is the first phase 3 trial of a BCMA×CD3 bispecific https://t.co/FLt9haCc28
14.7K impressions27 likes2025-11-24
Implications are many: Off-the-shelf, highly active, outpatient-based, community-accessible, T-cell redirecting therapy. Steroid free with a convenient schedule. It will force us to reappraise options in 1-3 LOT. https://t.co/gnVq6bOcxN
13.8K impressions54 likes2025-11-24
Wow its happening.... Cure / long term remission in early relapse MM Dara-Tec vs DPD/DVD -PFS @ 36 mo (HR, 0.17; 95% CI, 0.12-0.23)-83.4% vs 29.7% -OS (HR, 0.46; 95% CI, 0.32-0.65)-83.3% and 65.0% Any grade infections- 96.5% and 84.1% of Tec-Dara and DPd/DVd pts, respectively;
11.5K impressions49 likes2025-11-24
Efficacy in terms of PFS #ASH25 https://t.co/S3noKkLe5y
11.5K impressions11 likes2025-12-09
Efficacy & Safety
Results — What the Data Show
Progression-Free Survival
Median PFS was not reached with Tec-Dara versus 18.1 months with daratumumab-based standard care — a hazard ratio of 0.17 (95% CI 0.12–0.23, P<0.0001), an 83% reduction in the risk of progression or death at nearly three years of follow-up (3-year PFS 83.4% vs 29.7%). Depth of response strongly favored Tec-Dara (≥CR 81.8% vs ~32%; higher MRD-negativity) in this 587-patient randomized trial.
Median PFS NR vs 18.1 mo · HR 0.17Source: ASH 2025 LBA-6 · NEJM · NCT05083169
Overall Survival
At 36 months, overall survival was 83.3% with Tec-Dara versus 65.0% with standard care — HR 0.46 (95% CI 0.32–0.65, P<0.0001), a 54% reduction in the risk of death.
36-mo OS 83% vs 65% · HR 0.46Source: ASH 2025 / ASCO Post
High-Risk Cytogenetics
The PFS benefit was consistent across cytogenetic risk: HR 0.16 with ≥2 high-risk cytogenetic abnormalities (HRCAs), 0.19 with 1 HRCA, and 0.15 in the prespecified high-risk group. Estimated 36-month PFS reached ~87% (standard risk) and ~78% (high risk) with Tec-Dara.
Source: ASH 2025 subgroup slidesSafety & Administration
As a BCMA-directed bispecific combination, infection risk is the central safety consideration. KOLs emphasize close monitoring, routine monthly IVIG, and infection-prevention measures. MajesTEC-3 used a less-frequent, daratumumab-like teclistamab dosing schedule with subcutaneous administration. Cytokine release syndrome occurred in ~60% of patients but was limited to grades 1–2 and resolved.
Source: ASH 2025 · KOL commentaryKOL Sentiment
Physician Sentiment
In the News
Media Coverage
FDA
FDA approves Tecvayli + Darzalex Faspro for R/R myeloma (2L+)
PRESSUnprecedented MajesTEC-3 results support Tec-Dara as potential 2L standard
PRESSTec-Dara Offers Substantial Improvement Over Standard 2L Therapies (LBA-6)
MEDIAMajesTEC-3: 'Unprecedented' Benefit in Previously Treated Myeloma
MEDIAMajesTEC-3: Teclistamab plus Daratumumab in R/R Myeloma
FAQ
Frequently Asked Questions
What is the MajesTEC-3 trial?
A randomized phase 3 trial of teclistamab + daratumumab SC (Tec-Dara) vs daratumumab-based standard care (DPd or DVd) in relapsed/refractory myeloma after 1–3 prior lines, presented at ASH 2025 (LBA-6) and published in the NEJM.
What were the results?
Median PFS not reached vs 18.1 mo (HR 0.17, 95% CI 0.12–0.23, P<0.0001); 36-month OS 83.3% vs 65.0% (HR 0.46).
Is Tec-Dara FDA approved?
Yes. On March 5, 2026 the FDA approved teclistamab + daratumumab hyaluronidase-fihj (Tecvayli + Darzalex Faspro) for relapsed/refractory multiple myeloma after at least one prior line of therapy, based on MajesTEC-3.
What is the main safety concern?
Infection risk; KOLs emphasize close monitoring, routine monthly IVIG, and infection prevention.
Why does it matter?
KOLs called the benefit "unprecedented" and noted it could shift first-relapse standard of care from monotherapy to a bispecific-based combination as early as second line.
Does MajesTEC-3 mean myeloma can now be cured?
No. At IMS 2026 a mixture cure model (abstract OA-58) estimated a statistical cure fraction of 86.6% (95% CI 81-91) with Tec-Dara versus 0% (95% CI 0-53) with DPd/DVd, and a companion competing-risk analysis (OA-49) showed a 90% reduction in disease progression (sHR 0.10) with no meaningful difference in non-relapse mortality. These are exploratory, post-hoc statistical models of the existing 34.5-month data cut, not observed cures: "statistical cure fraction" means the modelled proportion of patients with no excess mortality versus a matched general population. Longer follow-up is required, and no regulatory claim of cure exists.
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. KOL quotes verbatim from public posts; impressions/sentiment from the KOL Pulse database. Efficacy figures verified against ASH 2025 LBA-6, NEJM, and the J&J press release. Last updated September 24, 2026 (IMS 2026 competing-risk and cure-model analyses added).