{"id":927484,"date":"2026-01-14T19:21:33","date_gmt":"2026-01-15T00:21:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/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-a\/"},"modified":"2026-01-14T19:21:33","modified_gmt":"2026-01-15T00:21:33","slug":"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-a","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/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-a\/","title":{"rendered":"TECVAYLI\u00ae 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"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n TECVAYLI\u00ae<\/sup> alone reduced risk of disease progression or death by 71% in a high unmet need population<\/p>\n

MajesTEC-9 is the second positive Phase 3 study to support TECVAYLI\u00ae<\/sup> regimens as a potential new standard of care as early as first relapse
<\/i>\n <\/p>\n

\n RARITAN, N.J.<\/span>, Jan. 14, 2026<\/span> \/PRNewswire\/ — Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma\u00a0therapies, today announced positive topline results from the investigational Phase 3 MajesTEC-9 study of TECVAYLI\u00ae<\/sup>\u00a0(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\u00ae<\/sup> compared to standard of care as early as second line.1<\/sup><\/p>\n

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\n \"(PRNewsfoto\/Johnson
\n <\/a>\n <\/p>\n<\/p><\/div>\n

Multiple myeloma is a blood cancer characterized by high rates of relapse. Despite recent advances in treatment, a significant unmet need remains <\/span>for additional, well\u2013tolerated therapies\u2014particularly in earlier lines of therapy for patients refractory to anti\u2013CD38 monoclonal antibodies and lenalidomide, commonly used medications in multiple myeloma.<\/p>\n

The MajesTEC-9 study evaluated\u00a0TECVAYLI\u00ae <\/sup>monotherapy in patients predominantly refractory to anti-CD38 and lenalidomide therapies.1<\/sup> These results build on the unprecedented MajesTEC-3 findings<\/a>\u00a0published in The New England Journal of Medicine, <\/i>which showed significant PFS and OS benefits with TECVAYLI\u00ae<\/sup> plus DARZALEX FASPRO<\/i>\u00ae <\/sup>(daratumumab and hyaluronidase-fihj) in patients who were na\u00efve or sensitive to an anti-CD38 therapy.2<\/sup> These two distinct Phase 3 studies address the continuum of unmet need.1,2,3<\/sup><\/p>\n

“The MajesTEC-9 results reinforce the potential of\u00a0TECVAYLI 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.”<\/p>\n

The MajesTEC-9 study evaluates the efficacy and safety of\u00a0TECVAYLI\u00ae<\/sup>, 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 <\/sup>All patients in MajesTEC-9 had to have received a prior anti-CD38 monoclonal antibody and lenalidomide.1 <\/sup>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<\/sup><\/p>\n

Those randomized to\u00a0TECVAYLI\u00ae<\/sup> 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<\/sup> The safety profile of TECVAYLI\u00ae <\/sup>monotherapy was clinically manageable using established protocols and consistent with its known profile, with no new safety concerns identified.1 <\/sup>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.<\/p>\n

“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.”<\/p>\n

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.<\/p>\n

\n About\u00a0TECVAYLI<\/b>
\n
\n \u00ae<\/sup>
\n <\/b>
\n
TECVAYLI\u00ae<\/sup> (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\u00ae<\/sup>\u00a0received accelerated approval<\/a> from the U.S. Food and Drug Administration (FDA) in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.4<\/sup><\/p>\n

In February 2024, the U.S. FDA approved<\/a><\/u>\u00a0the supplemental Biologics License Application (sBLA) for TECVAYLI\u00ae<\/sup>\u00a0for 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\u00ae<\/sup>.<\/p>\n

The European Commission (EC) granted TECVAYLI\u00ae<\/sup>\u00a0conditional marketing authorization<\/a><\/u>\u00a0in 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> a Type II variation application for TECVAYLI\u00ae<\/sup>, 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.<\/p>\n

For more information, visit www.TECVAYLI.com<\/a>.<\/p>\n

\n About\u00a0DARZALEX\u00a0FASPRO\u00ae<\/sup>\u00a0<\/i>and DARZALEX\u00ae<\/sup>
<\/b>DARZALEX\u00a0FASPRO<\/i>\u00ae<\/sup>\u00a0(daratumumab and hyaluronidase-fihj)\u00a0received<\/a>\u00a0U.S. FDA approval in May 2020 and is approved for 11 indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.5<\/sup>\u00a0It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX\u00a0FASPRO<\/i>\u00ae<\/sup>\u00a0is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE\u00ae<\/sup>\u00a0drug delivery technology.<\/p>\n

DARZALEX\u00ae<\/sup>\u00a0(daratumumab) received\u00a0U.S. FDA approval<\/a>\u00a0in 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<\/sup>\u00a0In 2025, DARZALEX\u00a0FASPRO\u00ae <\/sup><\/i>was approved by the U.S. FDA and EMA as the first and only treatment for patients with high-risk smoldering multiple myeloma.<\/p>\n

DARZALEX\u00ae<\/sup>\u00a0is the first CD38-directed antibody approved to treat multiple myeloma.5<\/sup>\u00a0DARZALEX\u00ae<\/sup>-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.<\/p>\n

In\u00a0August 2012<\/a>, Janssen Biotech, Inc. and Genmab A\/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.<\/p>\n

For more information, visit\u00a0www.DARZALEX.com<\/a>.<\/p>\n

\n About Multiple Myeloma<\/b>
\n
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.5\u00a0<\/sup>In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.6 <\/sup>Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease.7 <\/sup>In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease.8<\/sup>\u00a0People living with multiple myeloma have a 5-year survival rate of 59.8 percent.9<\/sup>\u00a0While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.10,11<\/sup><\/p>\n

\n TECVAYLI\u00ae<\/sup>\u00a0IMPORTANT SAFETY INFORMATION<\/b>\n <\/p>\n

\n INDICATION AND USAGE<\/b>\n <\/p>\n

TECVAYLI\u00ae<\/sup>\u00a0(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.<\/p>\n

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).<\/p>\n

\n IMPORTANT SAFETY INFORMATION<\/b>\n <\/p>\n

\n WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME<\/b>\n <\/p>\n

\n Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI\u00ae<\/sup>. Initiate treatment with TECVAYLI\u00ae<\/sup>\u00a0step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI\u00ae<\/sup>\u00a0until CRS resolves or permanently discontinue based on severity.<\/b>\n <\/p>\n

\n Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving TECVAYLI\u00ae<\/sup>. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI\u00ae<\/sup>\u00a0until neurologic toxicity resolves or permanently discontinue based on severity.<\/b>\n <\/p>\n

\n TECVAYLI\u00ae<\/sup>\u00a0is available only through a restricted program called the TECVAYLI\u00ae<\/sup>\u00a0and TALVEY<\/b>
\n
\n \u00ae<\/sup>
\n <\/i>
\n \u00a0Risk Evaluation and Mitigation Strategy (REMS).<\/b>\n <\/p>\n

\n WARNINGS AND PRECAUTIONS<\/b>\n <\/p>\n

\n Cytokine Release Syndrome<\/b>\u00a0–<\/b>\u00a0TECVAYLI\u00ae<\/sup>\u00a0can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI\u00ae<\/sup>\u00a0at 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\u00ae<\/sup>. 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).<\/p>\n

Initiate therapy according to TECVAYLI\u00ae<\/sup>\u00a0step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI\u00ae<\/sup>\u00a0accordingly. 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\u00ae<\/sup>\u00a0based on severity.<\/p>\n

TECVAYLI\u00ae<\/sup>\u00a0is available only through a restricted program under a REMS.<\/p>\n

\n Neurologic Toxicity including ICANS<\/b>\u00a0–<\/b>\u00a0TECVAYLI\u00ae<\/sup>\u00a0can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).<\/p>\n

In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI\u00ae<\/sup>\u00a0at 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-Barr\u00e9 syndrome (one patient each) occurred in patients who received TECVAYLI\u00ae<\/sup>.<\/p>\n

In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI\u00ae<\/sup>\u00a0at 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\u00ae<\/sup>. 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.<\/p>\n

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\u00ae<\/sup>\u00a0based on severity per recommendations and consider further management per current practice guidelines.<\/p>\n

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\u00ae<\/sup>\u00a0step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves.<\/p>\n

TECVAYLI\u00ae<\/sup>\u00a0is available only through a restricted program under a REMS.<\/p>\n

\n TECVAYLI\u00ae<\/sup>\u00a0and TALVEY<\/b>
\n
\n \u00ae<\/sup>
\n <\/i>
\n \u00a0REMS –\u00a0<\/b>TECVAYLI\u00ae<\/sup>\u00a0is available only through a restricted program under a REMS called the TECVAYLI\u00ae<\/sup>\u00a0and TALVEY\u00ae\u00a0<\/sup><\/i>REMS because of the risks of CRS and neurologic toxicity, including ICANS.<\/p>\n

\n Hepatotoxicity –\u00a0<\/b>TECVAYLI\u00ae<\/sup>\u00a0can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI\u00ae<\/sup>\u00a0at 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.<\/p>\n

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI\u00ae<\/sup>\u00a0or consider permanent discontinuation of TECVAYLI\u00ae<\/sup>\u00a0based on severity.<\/p>\n

\n Infections –\u00a0<\/b>TECVAYLI\u00ae<\/sup>\u00a0can cause severe, life-threatening, or fatal infections. In patients who received TECVAYLI\u00ae<\/sup>\u00a0at 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%.<\/p>\n

Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI\u00ae<\/sup>\u00a0and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI\u00ae<\/sup>\u00a0or consider permanent discontinuation of TECVAYLI\u00ae<\/sup>\u00a0based on severity.<\/p>\n

Monitor immunoglobulin levels during treatment with TECVAYLI\u00ae<\/sup>\u00a0and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis.<\/p>\n

\n Neutropenia –<\/b>\u00a0TECVAYLI\u00ae<\/sup>\u00a0can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI\u00ae<\/sup>\u00a0at 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.<\/p>\n

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\u00ae<\/sup>\u00a0based on severity.<\/p>\n

\n Hypersensitivity and Other Administration Reactions –\u00a0<\/b>TECVAYLI\u00ae<\/sup>\u00a0can cause both systemic administration-related and local injection-site reactions.\u00a0Systemic Reactions<\/u>\u00a0– In patients who received TECVAYLI\u00ae<\/sup>\u00a0at 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.\u00a0Local Reactions<\/u>\u00a0– In patients who received TECVAYLI\u00ae<\/sup>\u00a0at 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\u00ae<\/sup>\u00a0or consider permanent discontinuation of TECVAYLI\u00ae<\/sup>\u00a0based on severity.<\/p>\n

\n Embryo-Fetal Toxicity –<\/b>\u00a0Based on its mechanism of action, TECVAYLI\u00ae<\/sup>\u00a0may 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\u00ae<\/sup>\u00a0and for 5 months after the last dose.<\/p>\n

\n ADVERSE REACTIONS
<\/b>The most common adverse reactions (\u226520%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (\u226520%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.<\/p>\n

\n Please read full\u00a0Prescribing Information<\/a><\/u>, including Boxed WARNING, for TECVAYLI\u00ae<\/sup>.<\/b>\n <\/p>\n

\n DARZALEX FASPRO<\/i>\u00ae<\/sup> INDICATIONS AND IMPORTANT SAFETY INFORMATION<\/b>\u00a0<\/p>\n

\n INDICATIONS
<\/b>DARZALEX FASPRO<\/i>\u00ae<\/sup> (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:<\/p>\n