TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide
TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide |
| [14-January-2026] |
TECVAYLI® alone reduced risk of disease progression or death by 71% in a high unmet need population RARITAN, N.J., Jan. 14, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced positive topline results from the investigational Phase 3 MajesTEC-9 study of TECVAYLI® (teclistamab-cqyv) monotherapy, showing a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death in a patient population that was predominantly refractory to anti-CD38 therapy and lenalidomide. Data confirm superior progression-free survival (PFS) and overall survival (OS) with TECVAYLI® compared to standard of care as early as second line.1
Multiple myeloma is a blood cancer characterized by high rates of relapse. Despite recent advances in treatment, a significant unmet need remains for additional, well–tolerated therapies—particularly in earlier lines of therapy for patients refractory to anti–CD38 monoclonal antibodies and lenalidomide, commonly used medications in multiple myeloma. The MajesTEC-9 study evaluated TECVAYLI® monotherapy in patients predominantly refractory to anti-CD38 and lenalidomide therapies.1 These results build on the unprecedented MajesTEC-3 findings published in The New England Journal of Medicine, which showed significant PFS and OS benefits with TECVAYLI® plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in patients who were naïve or sensitive to an anti-CD38 therapy.2 These two distinct Phase 3 studies address the continuum of unmet need.1,2,3 "The MajesTEC-9 results reinforce the potential of TECVAYLI to transform treatment earlier in the multiple myeloma journey, with an immunotherapy regimen widely available for all appropriate patients, including those commonly treated in the community setting," said Roberto Mina, M.D., Associate Professor, Winship Cancer Institute of Emory University, formerly Assistant Professor, University of Turin, Turin, Italy.* "The impressive results show a significant improvement in progression-free and overall survival as a monotherapy in patients with refractory multiple myeloma, and together with the MajesTEC-3 results, help establish TECVAYLI as an essential therapy for patients as early as first relapse." The MajesTEC-9 study evaluates the efficacy and safety of TECVAYLI®, a bispecific T-cell engager antibody therapy, versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy.1 All patients in MajesTEC-9 had to have received a prior anti-CD38 monoclonal antibody and lenalidomide.1 Overall, the majority of patients enrolled were refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%), and more than 90% were refractory to their last line of therapy.1 Those randomized to TECVAYLI® had a clinically meaningful and statistically significant 71% reduction in the risk of progression or death [hazard ratio (HR)=0.29 (95% confidence interval (CI): 0.23, 0.38)] and a 40% reduction in the risk of death [HR=0.60 (95% CI: 0.43, 0.83)].1 The safety profile of TECVAYLI® monotherapy was clinically manageable using established protocols and consistent with its known profile, with no new safety concerns identified.1 Topline data were confirmed following this first pre-specified interim analysis. Based on the strength of the data, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study. "TECVAYLI continues to break new ground as a first-in-class bispecific T-cell engager antibody and the MajesTEC-9 results are the latest example of Johnson & Johnson's commitment to provide critical treatment options for patients at every stage of their disease," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Innovative Medicine. "In addition to the other transformational therapies in our multiple myeloma portfolio, we continue to redefine the future for patients, bringing us another step closer to cure." The full results of the Phase 3 MajesTEC-9 study will be presented at a future major medical meeting and shared with global health authorities. About TECVAYLI® In February 2024, the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI® for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with RRMM who achieved and maintained a complete response (CR) or better for a minimum of six months. Since FDA approval, more than 20,800 patients have been treated worldwide with TECVAYLI®. The European Commission (EC) granted TECVAYLI® conditional marketing authorization in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023, the EC approved a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response or better for a minimum of six months. For more information, visit www.TECVAYLI.com. About DARZALEX FASPRO® and DARZALEX® DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant-eligible and ineligible.6 In 2025, DARZALEX FASPRO® was approved by the U.S. FDA and EMA as the first and only treatment for patients with high-risk smoldering multiple myeloma. DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma.5 DARZALEX®-based regimens have been used in the treatment of more than 618,000 patients worldwide and more than 68,000 patients in the U.S. alone. In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. For more information, visit www.DARZALEX.com. About Multiple Myeloma TECVAYLI® IMPORTANT SAFETY INFORMATION INDICATION AND USAGE TECVAYLI® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI®. Initiate treatment with TECVAYLI® step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving TECVAYLI®. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI® until neurologic toxicity resolves or permanently discontinue based on severity. TECVAYLI® is available only through a restricted program called the TECVAYLI® and TALVEY® Risk Evaluation and Mitigation Strategy (REMS). WARNINGS AND PRECAUTIONS Cytokine Release Syndrome - TECVAYLI® can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI® at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%. Recurrent CRS occurred in 33% of patients. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). Less than 3% of patients developed first occurrence of CRS following subsequent doses of TECVAYLI®. The median time to onset of CRS was 2 (range: 1 to 6) days after the most recent dose with a median duration of 2 (range: 1 to 9) days. Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation). Initiate therapy according to TECVAYLI® step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI® accordingly. At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold or permanently discontinue TECVAYLI® based on severity. TECVAYLI® is available only through a restricted program under a REMS. Neurologic Toxicity including ICANS - TECVAYLI® can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI® at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of patients. The most frequent neurologic toxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%). With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI®. In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI® at the recommended dose. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent doses of TECVAYLI®. The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or permanently discontinue TECVAYLI® based on severity per recommendations and consider further management per current practice guidelines. Due to the potential for neurologic toxicity, patients are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI® step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves. TECVAYLI® is available only through a restricted program under a REMS. TECVAYLI® and TALVEY® REMS - TECVAYLI® is available only through a restricted program under a REMS called the TECVAYLI® and TALVEY® REMS because of the risks of CRS and neurologic toxicity, including ICANS. Hepatotoxicity - TECVAYLI® can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI® at the recommended dose in the clinical trial, there was one fatal case of hepatic failure. Elevated aspartate aminotransferase (AST) occurred in 34% of patients, with Grade 3 or 4 elevations in 1.2%. Elevated alanine aminotransferase (ALT) occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%. Elevated total bilirubin occurred in 6% of patients with Grade 3 or 4 elevations in 0.6%. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity. Infections - TECVAYLI® can cause severe, life-threatening, or fatal infections. In patients who received TECVAYLI® at the recommended dose in the clinical trial, serious infections, including opportunistic infections, occurred in 30% of patients, with Grade 3 or 4 infections in 35%, and fatal infections in 4.2%. Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity. Monitor immunoglobulin levels during treatment with TECVAYLI® and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Neutropenia - TECVAYLI® can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI® at the recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade 3 or 4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3% 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 TECVAYLI® at the recommended dose in the clinical trial, 1.2% of patients experienced systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue. Local Reactions - In patients who received TECVAYLI® at the recommended dose in the clinical trial, injection-site reactions occurred in 35% of patients, with Grade 1 injection-site reactions in 30% and Grade 2 in 4.8%. 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 woman. Advise pregnant women 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 Please read full Prescribing Information, including Boxed WARNING, for TECVAYLI®. DARZALEX FASPRO® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS
DARZALEX FASPRO® as monotherapy is indicated for the treatment of adult patients with high-risk smoldering multiple myeloma. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Hypersensitivity and Other Administration Reactions Systemic Reactions In all patients (N=1639), systemic administration-related reactions occurred in 7% of patients with the first injection, 0.5% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 283 systemic administration-related reactions that occurred in 135 patients, 240 (85%) occurred on the day of DARZALEX FASPRO® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients. Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision. Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions. Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®. Local Reactions Infections Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX FASPRO® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Neutropenia Thrombocytopenia Embryo-Fetal Toxicity The combination of DARZALEX FASPRO® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy. Interference With Serological Testing Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO®. Type and screen patients prior to starting DARZALEX FASPRO®. Interference With Determination of Complete Response ADVERSE REACTIONS The most common adverse reactions (≥20%) in patients with high-risk smoldering multiple myeloma who received DARZALEX FASPRO® monotherapy are upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions. The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin. Please click here to read the full Prescribing Information for DARZALEX FASPRO®. DARZALEX® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS
CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Infusion-Related Reactions When DARZALEX® dosing was interrupted in the setting of 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%) with those reported in previous studies at Week 2 or subsequent infusions. In EQUULEUS, patients receiving combination treatment (n=97) were administered the first 16 mg/kg dose at Week 1 split over two days, ie, 8 mg/kg on Day 1 and Day 2, respectively. The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions. Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt DARZALEX® infusion for reactions of any severity and institute medical management as needed. Permanently discontinue DARZALEX® therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion. To reduce the risk of delayed infusion-related reactions, administer oral corticosteroids to all patients following DARZALEX® infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease. Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®. Interference With Serological Testing Neutropenia and Thrombocytopenia Interference With Determination of Complete Response Embryo-Fetal Toxicity The combination of DARZALEX® 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. ADVERSE REACTIONS Please click here to read the full Prescribing Information for DARZALEX®. About Johnson & Johnson Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientific Affairs, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements Footnotes 1 MajesTEC-9, NCT05572515. A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Investigator's Choice of PVd (Pomalidomide, Bortezomib, Dexamethasone) or Kd (Carfilzomib, Dexamethasone) in Participants With Relapsed or Refractory Multiple Myeloma. https://clinicaltrials.gov/study/NCT05572515. Accessed January 2026. 2 Mateos, M.V., Moreau, P., Garfall, A. L., van de Donk, N. W. C. J., et al. (2025) Teclistamab plus daratumumab versus standard regimens in relapsed or refractory multiple myeloma: MajesTEC-3 Trial Results. The New England Journal of Medicine, 393(23), https://doi.org/10.1056/NEJMoa2514663. 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). https://clinicaltrials.gov/study/NCT05083169. Accessed January 2026. 4 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. https://www.jnj.com/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 January 2026. 5 DARZALEX FASPRO® U.S. Prescribing Information. 6 DARZALEX® U.S. Prescribing Information. 7 Rajkumar SV. Multiple Myeloma: 2020 Update on Diagnosis, Risk-Stratification and Management. Am J Hematol. 2020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178. 8 National Cancer Institute. Plasma cell neoplasms. National Institutes of Health. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq. Accessed January 2026. 9 City of Hope. Multiple myeloma: Causes, symptoms & treatments. https://www.cancercenter.com/cancer-types/multiple-myeloma. Accessed January 2026. 10 American Cancer Society. Myeloma cancer statistics. https://cancerstatisticscenter.cancer.org/types/myeloma. Accessed January 2026. 11 SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/explorer/. Accessed January 2026. 12 American Cancer Society. What is multiple myeloma? https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed January 2026. 13 American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html. Accessed January 2026.
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