New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma
Model-based and post hoc MajesTEC-3 data suggest TECVAYLI plus DARZALEX FASPRO could substantially extend survival if used from early relapse.
Rhea-AI Summary
Johnson & Johnson (JNJ) reported new MajesTEC-3 analyses showing TECVAYLI plus DARZALEX FASPRO markedly improves outcomes in relapsed/refractory multiple myeloma.
Using a relative survival mixture cure model in patients with 1–3 prior lines of therapy, ~87% of those treated with the combination were estimated to have mortality risk and projected life expectancy similar to an age‑matched general population. Best‑fit modeling estimated an OS “cure fraction” of 86.6% versus 0% with pomalidomide- or bortezomib‑based standard of care and projected remaining life expectancy of 18.5 years versus 4.9 years.
A post hoc competing‑risk analysis showed a 90% reduction in disease‑progression risk at 36 months (8.7% vs 62.1% cumulative incidence) and 36‑month OS of 83.3% vs 65.0%, without a significant increase in non‑relapse mortality. MajesTEC-3 follow‑up is ongoing, and the company notes these long‑term projections remain model‑based.
Positive
- Estimated cure fraction 86.6% OS with TECVAYLI plus DARZALEX FASPRO vs 0% with DPd/DVd
- Projected remaining life expectancy 18.5 years with Tec-Dara vs 4.9 years with DPd/DVd
- Patients with estimated near–general population mortality risk ~87% on Tec-Dara in model
- Risk of disease progression 90% lower at 36 months vs DPd/DVd (8.7% vs 62.1%)
- 36‑month overall survival 83.3% with Tec-Dara vs 65.0% with DPd/DVd
- Post–10‑month OS 78% reduction in risk of death vs DPd/DVd (HR=0.22)
Negative
- Cytokine release syndrome (CRS) occurred in 64% of TECVAYLI‑treated patients in trials
- Recurrent CRS reported in 27% of treated patients
- Non‑relapse mortality similar at 36 months: 10.2% Tec-Dara vs 9.0% DPd/DVd
- No OS advantage vs DPd/DVd through first 10 months (HR=1.08)
- MajesTEC‑3 ongoing; long‑term survival benefits are based on statistical modeling, not mature OS alone
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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
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 ~
In the MajesTEC-3 study, TECVAYLI® plus DARZALEX FASPRO® significantly improved overall survival versus standard of care (SOC), with an estimated
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
"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
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
There was no difference in OS through 10 months (HR=1.08;
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
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 from just a few years to a decade or more. 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.
In August 2026, the EC approved an indication extension for TECVAYLI® in combination with daratumumab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The approval introduces a new treatment option as early as second line for patients living with RRMM.
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 TECVAYLI®
TECVAYLI® (teclistamab-cqyv) is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. TECVAYLI® received accelerated approval from the
In March 2026, the
To date, more than 30,000 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.
In August 2026, the EC approved an indication extension for TECVAYLI® in combination with daratumumab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The approval introduces a new treatment option as early as second line for patients living with RRMM.
For more information, visit www.TECVAYLI.com.
About DARZALEX FASPRO® and DARZALEX®
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for 11 indications in multiple myeloma, fiveof which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.13 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.
DARZALEX® (daratumumab) received
DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma. DARZALEX®-based regimens have been used in the treatment of more than 830,000 patients worldwide and more than 68,000 patients in the
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.
TECVAYLI® INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS 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:
- in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
- as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
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, life-threatening, or fatal 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 trials (monotherapy and combination therapy; N=448), CRS occurred in
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 the patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold until CRS resolves or permanently discontinue TECVAYLI based on severity.
TECVAYLI is available only through a restricted program under a REMS.
Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome - TECVAYLI can cause serious, life-threatening, or fatal neurologic toxicity, including immune effector cell associated neurotoxicity syndrome (ICANS).
In the clinical trials (monotherapy and combination therapy trials; N=448), neurologic toxicity occurred in
In MajesTEC-1, ICANS was reported in
In MajesTEC-3, ICANS was reported in
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, including ICANS during TECVAYLI treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold until neurologic toxicity resolves 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 receiving TECVAYLI 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. There was one fatal case of hepatic failure in MajesTEC-1. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448) elevated aspartate aminotransferase (AST) occurred in
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 MajesTEC-1 (N=165), in patients who received the recommended TECVAYLI dosage, serious infections, including opportunistic infections, occurred in
In MajesTEC-3 (N=283), in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj at the recommended dosage, serious infections, including opportunistic infections, occurred in
Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI and treat appropriately. Administer prophylactic antimicrobials according to current practice guidelines.
Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.
Monitor immunoglobulin levels prior to and during treatment with TECVAYLI and administer subcutaneous or intravenous immunoglobulin (IVIG) to maintain the serum levels >400 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
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),
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
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 (≥
The most common Grade 3 to 4 laboratory abnormalities (≥
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
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
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®.
DARZALEX FASPRO®: Hypersensitivity and Other Administration Reactions
Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®.
Systemic Reactions
In a pooled safety population of 1446 patients with multiple myeloma (N=1235) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO® as monotherapy or as part of a combination therapy,
In all patients (N=1639), systemic administration-related reactions occurred in
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
In this pooled safety population of 1446 patients with multiple myeloma (N=1253) or light chain amyloidosis (N=193), injection-site reactions occurred in
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
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 ≥
DARZALEX FASPRO®: ADVERSE REACTIONS
In multiple myeloma, the most common adverse reaction (≥
The most common hematologic laboratory abnormalities (≥
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 https://www.jnj.com/ or at www.innovativemedicine.jnj.com. 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 www.sec.gov, www.jnj.com, www.investor.jnj.com 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.
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*Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of |
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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; |
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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; |
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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 September 2026 |
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4 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-567. |
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5 National Cancer Institute. Plasma cell neoplasms. Accessed September 2026. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq |
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6 City of Hope. Multiple myeloma: Causes, symptoms & treatments. 2022. Accessed September 2026. https://www.cancercenter.com/cancer-types/multiple-myeloma |
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7 International Agency for Research on Cancer (World Health Organization). Multiple myeloma fact sheet. 2024. Accessed September 2026. https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf |
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8 SEER Explorer: An interactive website for SEER cancer statistics. Surveillance Research Program, National Cancer Institute. Accessed September 2026. https://seer.cancer.gov/explorer/ |
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9 American Cancer Society. What is multiple myeloma? Accessed September 2026. https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html |
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10 American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. Accessed September 2026. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html |
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11 Kazandjian D. Multiple myeloma epidemiology and survival: a unique malignancy. J Clin Oncol. 2018;36(15):1479-1487. https://pmc.ncbi.nlm.nih.gov/articles/PMC6119139/ |
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12 Johnson & Johnson. |
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13 DARZALEX FASPRO® U.S. Prescribing Information. 2025. |
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14 DARZALEX® U.S. Prescribing Information. 2022. |
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View original content to download multimedia:https://www.prnewswire.com/news-releases/new-model-based-analysis-further-supports-the-potential-of-tecvayli-teclistamab-cqyv-plus-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-to-redefine-long-term-survival-expectations-in-early-line-relapsedrefractory-multi-302887782.html
SOURCE Johnson & Johnson
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is the design and main objective of the Phase 3 MajesTEC-3 study?
MajesTEC-3 is an ongoing, randomized Phase 3 trial in patients with relapsed/refractory multiple myeloma who received 1–3 prior lines of therapy. It compares TECVAYLI plus subcutaneous daratumumab with investigator’s choice of daratumumab SC plus dexamethasone with either pomalidomide or bortezomib (DPd/DVd). The primary endpoint is progression‑free survival, and key secondary endpoints include complete response or better, overall response rate, MRD‑negativity, overall survival, symptom worsening, and safety.
What were the key 36‑month outcomes for TECVAYLI plus DARZALEX FASPRO in MajesTEC-3?
At 36 months, patients on TECVAYLI plus DARZALEX FASPRO had a cumulative incidence of disease progression of 8.7% versus 62.1% with DPd/DVd, corresponding to a 90% reduction in progression risk (subdistribution HR=0.10). Overall survival at 36 months was 83.3% with the combination and 65.0% with DPd/DVd. Non‑relapse mortality was 10.2% and 9.0%, respectively, without a significant difference between arms.
How did overall survival with Tec-Dara compare over different time periods in MajesTEC-3?
Across the entire follow‑up, TECVAYLI plus DARZALEX FASPRO significantly improved overall survival versus DPd/DVd. However, there was no OS difference through the first 10 months (HR=1.08). Beyond 10 months, OS favored the combination, with a 78% reduction in the risk of death compared with DPd/DVd (HR=0.22). A restricted mean survival time analysis also showed a statistically significant OS benefit.
What approvals currently support the earlier-line use of TECVAYLI in combination with DARZALEX FASPRO?
In March 2026, the U.S. FDA approved TECVAYLI in combination with DARZALEX FASPRO for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. In August 2026, the European Commission approved an indication extension for TECVAYLI in combination with daratumumab for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy, enabling use as early as the second line.
What are the main safety concerns highlighted for TECVAYLI?
The product information carries boxed warnings for cytokine release syndrome (CRS) and neurologic toxicity including ICANS, which can be life‑threatening or fatal. In clinical trials of monotherapy and combination therapy (N=448), CRS occurred in 64% of patients at the recommended dose, with 46% Grade 1, 18% Grade 2, and 0.2% Grade 3; recurrent CRS occurred in 27%. Patients require step‑up dosing, monitoring for CRS and neurologic events, and TECVAYLI is available only through the TECVAYLI and TALVEY REMS program.