Thalidomide

Analysis shows ~87% of patients treated with TECVAYLI ® plus DARZALEX FASPRO ® as early as second line were estimated to have comparable mortality risk to the general population A separate analysis shows the survival benefit was driven by a 90% reduction in the risk of multiple myeloma progression versus standard of care, with no significant difference in rates of non-relapse mortality Johnson & Johnson is advancing a differentiated multiple myeloma portfolio designed to deliver deeper, more durable disease control and improve long-term outcomes for patients RARITAN, N.J. , Sept. 23, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced 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 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% CI, 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; P400 mg/dL. Neutropenia - TECVAYLI can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), decreased neutrophils occurred in 88% of patients, with Grade 3 or 4 decreased neutrophils in 70%. Febrile neutropenia occurred in 6% of patients. Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI based on severity. Hypersensitivity and Other Administration Reactions - TECVAYLI can cause both systemic administration-related and local injection-site reactions. Systemic Reactions - In patients who received the recommended TECVAYLI dosage in the clinical trials (monotherapy and combination therapy trials; N=448), 2.5% of patients experienced systemic administration reactions, which included recurrent pyrexia and rash. Local Reactions - In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), injection-site reactions occurred in 37% of patients, with Grade 1 injection-site reactions in 29% and Grade 2 in 9%. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity. Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient. Advise pregnant patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose. ADVERSE REACTIONS The most common adverse reactions (≥20%) in patients who received TECVAYLI monotherapy were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common adverse reactions (≥20%) in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj were hypogammaglobulinemia, upper respiratory tract infection, CRS, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis, and weight decreased. The most common Grade 3 to 4 laboratory abnormalities (≥20%) with TECVAYLI (as monotherapy or in combination with daratumumab and hyaluronidase-fihj) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. Please read full Prescribing Information , including Boxed WARNING, for TECVAYLI. DARZALEX FASPRO ® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS DARZALEX ® (daratumumab) is indicated for the treatment of adult patients with multiple myeloma: In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma: In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI) In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent IMPORTANT SAFETY INFORMATION DARZALEX ® ANDDARZALEX FASPRO ® : CONTRAINDICATIONS DARZALEX ® and DARZALEX FASPRO ® are contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase (for DARZALEX FASPRO ® ), or any of the components of the formulations. WARNINGS AND PRECAUTIONS DARZALEX ® : Infusion-Related Reactions DARZALEX ® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX ® . Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision. When DARZALEX ® dosing was interrupted in the setting of autologous stem cell transplant (ASCT) (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX ® , the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX ® following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4: 1%) injection-site reactions were injection site erythema and injection site rash. In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%. These local reactions occurred a median of 6 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO ® . Monitor for local reactions and consider symptomatic management. DARZALEX ® and DARZALEX FASPRO ® : Infections DARZALEX ® and DARZALEX FASPRO ® can cause serious, life-threatening, or fatal infections. In patients who received DARZALEX ® in a pooled safety population (N=2066), serious infections, including opportunistic infections, occurred in 22.6% of patients, Grade 3 or 4 infections occurred in 24.3%, and fatal infections occurred in 1.2%. The most common (≥2%) types of serious infection reported were pneumonia (11%), upper respiratory tract infection (4%), sepsis (3%), and bronchitis (2%). In patients who received DARZALEX FASPRO ® in a pooled safety population including patients with smoldering multiple myeloma and light chain (AL) amyloidosis (N=1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%. The most common type of serious infection reported was pneumonia (8.5%). Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX ® or DARZALEX FASPRO ® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. DARZALEX ® and DARZALEX FASPRO ® : Neutropenia and Thrombocytopenia DARZALEX ® and DARZALEX FASPRO ® may increase neutropenia and thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX ® or DARZALEX FASPRO ® until recovery of neutrophils or for recovery of platelets. In lower body weight patients receiving DARZALEX FASPRO ® , higher rates of Grade 3-4 neutropenia were observed. DARZALEX ® and DARZALEX FASPRO ® : Interference With Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX ® and DARZALEX FASPRO ® . Type and screen patients prior to starting DARZALEX ® and DARZALEX FASPRO ® . DARZALEX ® and DARZALEX FASPRO ® : Interference With Determination of Complete Response Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein. DARZALEX ® and DARZALEX FASPRO ® : Embryo-Fetal Toxicity Based on the mechanism of action, DARZALEX ® and DARZALEX FASPRO ® can cause fetal harm when administered to a pregnant woman. DARZALEX ® and DARZALEX FASPRO ® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX ® or DARZALEX FASPRO ® and for 3 months after the last dose. The combination of DARZALEX ® or DARZALEX FASPRO ® with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy. DARZALEX ® : ADVERSE REACTIONS The most frequently reported adverse reactions (incidence ≥20%) with DARZALEX ® were upper respiratory infection, neutropenia, infusion-related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX ® are neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia. DARZALEX FASPRO ® : ADVERSE REACTIONS In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO ® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, sleep disorder, headache, rash, renal impairment, motor dysfunction, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, musculoskeletal pain, decreased appetite, urinary tract infection, abdominal pain, upper respiratory tract infection, peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, dizziness, bruising, and COVID-19. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX FASPRO ® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin. Please click here to read full Prescribing Information for DARZALEX ® . Please click here to read full Prescribing Information for DARZALEX FASPRO ® . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at  or at  . Follow us at  @JNJInnovMed . Caution Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to TECVAYLI ®  (teclistamab-cqyv) and DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at  ,  ,  or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Footnote * 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, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Effelterre T, et al. Projecting Functional Cure in Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM) in the MajesTEC-3 Study of Teclistamab-Daratumumab (Tec-Dara) Using a Mixture Cure Model. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 23, 2026; Glasgow, Sweden. 2 Costa L, et al. Overall Survival, Progression and Non-Relapse Mortality With Teclistamab Plus Daratumumab (Tec-Dara) vs Dara-Based Triplets in Relapsed/Refractory Multiple Myeloma (RRMM): MajesTEC-3 Post Hoc Analysis. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 24, 2026; Glasgow, Sweden. 3 MajesTEC-3, NCT05083169. A Phase 3 Randomized Study Comparing Teclistamab + Subcutaneous Daratumumab (Tec-Dara) Versus Daratumumab SC + Pomalidomide + Dexamethasone (DPd) or Daratumumab SC + Bortezomib + Dexamethasone (DVd). Accessed September 2026 4 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol . 2020;95(5):548-567. 5 National Cancer Institute. Plasma cell neoplasms. Accessed September 2026.  6 City of Hope. Multiple myeloma: Causes, symptoms & treatments. 2022. Accessed September 2026.  7 International Agency for Research on Cancer (World Health Organization). Multiple myeloma fact sheet. 2024. Accessed September 2026.  8 SEER Explorer: An interactive website for SEER cancer statistics. Surveillance Research Program, National Cancer Institute. Accessed September 2026.  9 American Cancer Society. What is multiple myeloma? Accessed September 2026.  10 American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. Accessed September 2026.  11 Kazandjian D. Multiple myeloma epidemiology and survival: a unique malignancy.  J Clin Oncol.  2018;36(15):1479-1487.  12 Johnson & Johnson. U.S. FDA approves TECVAYLI ®  (teclistamab-cqyv), the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma. Accessed September 2026.  13 DARZALEX FASPRO ®  U.S. Prescribing Information. 2025. Horsham, PA: Janssen Biotech, Inc. 14 DARZALEX ®  U.S. Prescribing Information. 2022. Horsham, PA: Janssen Biotech, Inc. View original content to download multimedia: SOURCE Johnson & Johnson

Analysis showed ~87% of patients treated with TECVAYLI ® ▼ plus daratumumab as early as second line were estimated to have comparable mortality risk to the general population 1 A separate analysis shows the survival benefit was driven by a 90% reduction in the risk of multiple myeloma progression versus standard of care, with no significant difference in rates of non-relapse mortality 2 BEERSE, Belgium, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson, a worldwide leader in multiple myeloma, today announced new data from the Phase 3 MajesTEC-3 study showing sustained disease control and survival with TECVAYLI ® (teclistamab) plus daratumumab in patients with relapsed or refractory multiple myeloma (RRMM) who had received 1-3 prior lines of therapy. In an analysis to be presented in Abstract #OA-58, statistical modelling estimated that more than 85% of patients treated with teclistamab plus daratumumab may experience a mortality risk and projected life expectancy similar to an age-matched general population. 1 The analysis used a relative survival mixture cure model (MCM) and actual progression-free survival (PFS) and overall survival (OS) data from MajesTEC-3. 1 Modelling further predicted that median OS with teclistamab plus daratumumab would be nearly four-fold longer than with the standard-of-care comparator in the study, daratumumab and dexamethasone with either pomalidomide or bortezomib (DPd/DVd). 1 These data help to illustrate to what extent treatment with teclistamab plus daratumumab as early as second line may reshape survival expectations in multiple myeloma. Post-hoc analysis provides insight into the survival benefit In the MajesTEC-3 study, teclistamab plus daratumumab significantly improved OS versus SOC, with an estimated 83% of patients alive at three years. 2 A post hoc analysis (Abstract #OA-49) showed that teclistamab plus daratumumab 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 will be presented in two oral sessions at the International Myeloma Society (IMS) Annual Meeting. Complementary mechanisms of action underpin this immunotherapy doublet Teclistamab and daratumumab work in a complementary manner, with daratumumab modulating the immune system to enhance T-cell fitness and activation, thereby amplifying teclistamab-mediated killing of myeloma cells. 3 Expert and company perspectives emphasise 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 teclistamab plus daratumumab 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.” “Seeing projected life expectancy for patients with relapsed or refractory multiple myeloma potentially approach that of the general population is an exciting and hopeful signal of what may be possible with teclistamab plus daratumumab,” said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Alongside the growing body of positive clinical evidence, these analyses reinforce our convictions that this combination offers a new standard of care – one where outcomes once considered difficult to imagine could become increasingly achievable for patients.” “The continued analyses of the 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. “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 teclistamab plus daratumumab versus investigator’s choice of DPd/DVd in patients with RRMM who had received 1-3 prior lines of therapy. In this analysis, a relative survival MCM was applied to patients treated with teclistamab plus daratumumab (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% CI, 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 teclistamab plus daratumumab 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. At 36 months, the cumulative incidence of disease progression was 8.7% with teclistamab plus daratumumab versus 62.1% with DPd/DVd, representing a 90% reduction in the risk of disease progression (sub-distribution 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 (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 teclistamab plus daratumumab and 9.0% with DPd/DVd (sHR=1.16; 95% CI, 0.69–1.98; p =0.5668). 2 No statistically significant difference in overall survival was observed between the treatment groups during the first 10 months (HR=1.08; 95% CI, 0.64–1.81). 2 After 10 months, overall survival favoured teclistamab plus daratumumab, with a 78% reduction in the risk of death compared with DPd/DVd (HR=0.22; 95% CI, 0.13–0.38). 2 A prespecified restricted mean survival time analysis also supported a significant overall survival benefit, with a difference of 2.15 months during the period analysed ( p =0.0088). 2 Together, these analyses provide complementary evidence supporting the long-term benefit observed with teclistamab plus daratumumab. While the MCM analysis suggests the potential for highly durable disease control to extend OS 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. 1,2 MajesTEC-3 is ongoing, and continued follow-up will assess whether observed outcomes confirm these model-based predictions. About the MajesTEC-3 Study MajesTEC-3 ( NCT05083169 ) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. 3, 4 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. 4 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen. 4 About Teclistamab Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. 5 In August 2026, the EC approved teclistamab in combination with daratumumab for the treatment of patients with RRMM who have received at least one prior therapy, providing a treatment option as early as second line. 6 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. 7 , 8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. 7 Teclistamab is currently being evaluated in several combination studies. 9 ,1 0 ,1 1 ,1 2 To date, more than 30,700 patients have been treated worldwide with teclistamab. 1 3 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: . ▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. 7 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 830,000 patients worldwide. 1 4 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 1 5,16 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training. 1 5 , 1 7 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 1 5 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 1 5 , 17 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 18 Daratumumab may also have an effect on normal cells. 1 5 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 19,20,21,22,23,24,25,26,27,28 For further information on daratumumab, please see the Summary of Product Characteristics at: . 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. 29,30 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 3 1 ,3 2 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died. 3 3 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 3 4,35,36 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 3 7 About Johnson & Johnson’s Multiple Myeloma Portfolio Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies. Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses. Through ongoing research and a robust clinical program, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Key Search Terms MajesTEC-3 Phase 3 clinical trial TECVAYLI Teclistamab DARZALEX Daratumumab Teclistamab and daratumumab combination TECVAYLI and DARZALEX combination Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy CD38-targeted therapy BCMA-targeted bispecific therapy Combination immunotherapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment *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, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. CP-604037 September 2026 END References: 1 van den Donk Niels., et al. Projecting Functional Cure in Patients with Relapsed/Refractory Multiple Myeloma(RRMM) in the MajesTEC-3 Study ofTeclistamab-Daratumumab (Tec-Dara) Usinga Mixture Cure Model . Presented at: 2026 International Myeloma Society Meeting; 23 September; Glasgow. 2 Costa L., et al. Overall Survival, Progression and Non-Relapse Mortality With Teclistamab Plus Daratumumab ​(Tec-Dara) vs Dara-Based Triplets in Relapsed/Refractory Multiple Myeloma (RRMM): MajesTEC-3 Post Hoc Analysis . Presented at: 2026 International Myeloma Society Meeting; 23 September; Glasgow. 3 Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. The New England Journal of Medicine. 2025; Full article and supplementary material. Available at: . Last accessed: September 2026. 4 ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: . Last accessed: September 2026. 5 Johnson & Johnson.com. Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Available at: . Last accessed: September 2026. 6 Johnson & Johnson.com. European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care. Available at: . Last accessed: September 2026. 7 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: September 2026. 8 Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine. 2022;287(6):494-505. 9 ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: September 2026. 1 0 ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: September 2026. 1 1 ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: . Last accessed: September 2026. 1 2 ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: . Last accessed: September 2026. 1 3 J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of June 2026. 1 4 J&J Data on File. Number of Patients Treated with DARZALEX ® Worldwide as of August 2026. 1 5 European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: . Last accessed: September 2026. 1 6 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: September 2026. 1 7 J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026. 18 Fedele G, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNy cytokines and proliferation. Mediators Inflamm. 2013;564687. 19 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38. 2 0 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115. 2 1 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141. 2 2 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812. 2 3 Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80. 2 4 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. 2 5 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884. 2 6 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518. 2 7 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. 28 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313. 29 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 3 0 Myeloma UK. What is myeloma? Available at: . Last accessed: September 2026. 3 1 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 3 2 Mayo Clinic. Multiple Myeloma. Available at: 20353378 . Last accessed: September 2026. 3 3 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2024, by Country. Multiple Myeloma. Available at: . Last accessed: September 2026. 3 4 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 3 5 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. 3 6 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430. 3 7 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: . Last accessed: September 2026. CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investorcontact: JessMargevich investor-relations@its.jnj.com