On September 23, 2026 Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, reported new data from the Phase 3 MajesTEC-3 study showing sustained disease control and survival with TECVAYLI (teclistamab-cqyv) plus DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who had received 1-3 prior lines of therapy. 1,2

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Using a relative survival mixture cure model (MCM) and actual progression-free survival (PFS) and overall survival (OS) data from the trial, statistical modeling estimated that ~87% of patients treated with TECVAYLI plus DARZALEX FASPRO (Tec-Dara) may experience a mortality risk and projected life expectancy similar to an age-matched general population.1 Modeling further predicted that median overall survival with Tec-Dara would be nearly four-fold longer than with the standard of care (SOC) comparator in the study, dexamethasone with pomalidomide or bortezomib (DPd/DVd). These data help to illustrate to what extent treatment with TECVAYLI plus DARZALEX FASPRO as early as second line may reshape survival expectations in multiple myeloma.1

In the MajesTEC-3 study, TECVAYLI plus DARZALEX FASPRO significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years.3 A post hoc analysis showed that Tec-Dara reduced the risk of cumulative incidence of disease progression by 90% versus SOC, with no significant difference in non-relapse mortality over time between the treatment arms.2 These data (Abstract #OA-58 and Abstract #OA-49) will be presented in two oral sessions at the International Myeloma Society (IMS) Annual Meeting.

Expert and company perspectives emphasize the potential for durable, long-term disease control

"These findings underscore how consequential treatment choice at first relapse can be in shaping a patient’s long-term trajectory," said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham.* "The sustained disease control observed with TECVAYLI plus DARZALEX FASPRO is changing expectations for what treatment can achieve in relapsed or refractory multiple myeloma, moving beyond just delaying the next relapse toward the possibility of durable long-term disease control."

"The continued analyses of the unprecedented MajesTEC-3 trial challenge long-held expectations of what may be possible in multiple myeloma," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "Our ambition is to build on this progress by fundamentally changing the long-term trajectory of multiple myeloma and, ultimately, creating a future in which this disease is no longer defined as incurable."

Model-based analysis projects potential long-term survival outcomes

The MajesTEC-3 study evaluated TECVAYLI plus DARZALEX FASPRO versus investigator’s choice of daratumumab SC plus DPd/DVd in patients with RRMM who had received one to three prior lines of therapy.3 In this analysis, a relative survival mixture cure model was applied to patients treated with TECVAYLI plus DARZALEX FASPRO (n=291) and DPd/DVd (n=296) to assess whether long-term disease control could translate into outcomes approaching those of the general population.1 Best-fit models estimated cure fractions of 86.6% (95% confidence interval [CI], 81–91) for OS with the combination, compared with 0% (95% conCI, 0–53) with DPd/DVd, with substantially greater uncertainty in the DPd/DVd estimates.1 Model projected remaining life expectancy was 18.5 years with the combination, nearly four times the 4.9 years projected with DPd/DVd and approaching 21.1 years for the matched general population.1

Reduced disease progression drives survival benefit

A separate post hoc analysis provided further insight into the survival benefit observed in MajesTEC-3.2 At 36 months, the cumulative incidence of disease progression was 8.7% with TECVAYLI plus DARZALEX FASPRO, versus 62.1% with DPd/DVd, representing a 90% reduction in the risk of disease progression (subdistribution hazard ratio [sHR]=0.10; 95% CI, 0.07–0.16; P<0.0001).2 The 36-month OS rate was 83.3% versus 65.0%, respectively (hazard ratio [HR]=0.46; 95% CI, 0.32–0.65; P<0.0001).2 There was no significant difference in non-relapse mortality between treatment groups, with 36-month rates of 10.2% with TECVAYLI plus DARZALEX FASPRO and 9.0% with DPd/DVd (sHR=1.16; 95% CI, 0.69–1.98; P=0.5668).2

There was no difference in OS through 10 months (HR=1.08; 95% CI, 0.64–1.81).2 Beyond 10 months, OS favored TECVAYLI plus DARZALEX FASPRO, with a 78% reduction in the risk of death versus DPd/DVd (HR=0.22; 95% CI, 0.13–0.38).2 A prespecified restricted mean survival time analysis also confirmed a significant OS benefit, with a difference of 2.15 months (P=0.0088).2

Together, these analyses provide complementary evidence supporting the long-term benefit observed with TECVAYLI plus DARZALEX FASPRO. While the MCM analysis suggests the potential for highly durable disease control to extend overall survival for patients with multiple myeloma relative to the general population, the competing risk analysis helps explain these outcomes by demonstrating a profound reduction in disease progression without a significant increase in non-relapse mortality. MajesTEC-3 is ongoing, and continued follow-up will assess whether observed outcomes confirm these model-based predictions.

About the MajecTEC-3 study

MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab SC versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients with relapsed/refractory multiple myeloma who have received 1–3 prior lines of therapy. The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD)-negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety. The MajesTEC-3 study is a part of the MajesTEC clinical program, which includes exploring the potential of teclistamab as a combination regimen.

About multiple myeloma

Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.4 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.5 Multiple myeloma is the second most common blood cancer worldwide.6 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.7 People living with multiple myeloma have a 5-year survival rate of 59.8%.8 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.9,10 In recent years, overall survival has improved from years to decades, with effective treatment options now available across every stage and line of therapy.

(Press release, Johnson & Johnson, SEP 23, 2026, View Source [SID1234671027])