Linvoseltamab-gcpt

ASH Annual Meeting and Exposition leaves the oncology community buzzing over a series of late-breaking presentations that experts are calling 'unprecedented.' Major pharmaceutical developers such as Johnson & Johnson, Arcellx, Gilead, Bristol Myers Squibb, Regeneron, AbbVie, CellCentric, Adaptive Biotechnologies, and others, presented pivotal data across the multiple myeloma treatment landscape, with results suggesting that long-term disease-free survival—and potentially a 'functional cure'—is becoming a reality for more patients. LAS VEGAS, Dec. 11, 2025 /PRNewswire/ -- The 67th American Society of Hematology (ASH) Annual Meeting, held December 6-9, 2025, in Orlando, Florida, showcased groundbreaking clinical advances in multiple myeloma treatment from leading biopharmaceutical companies. The conference featured unprecedented efficacy data demonstrating potential functional cures and innovative approaches across novel immunotherapies, bispecific antibodies, and next-generation targeted agents, signaling a major shift in how the disease is managed. Download the updated multiple myeloma market report featuring key results from ASH 2025 @ Multiple Myeloma Market Let's dive deep into the promising results presented at the ASH conference 2025 Johnson & Johnson's TECVAYLI Plus DARZALEX: Setting New Standard of Care Johnson & Johnson unveiled late-breaking results from the Phase III MajesTEC-3 study, presenting what has been characterized as the most impressive progression-free survival (PFS) benefit ever demonstrated in a Phase III multiple myeloma trial. The study evaluated the combination of TECVAYLI (teclistamab-cqyv), a first-in-class BCMAxCD3 bispecific antibody, combined with DARZALEX FASPRO (daratumumab plus hyaluronidase-fihj), a subcutaneous anti-CD38 monoclonal antibody. The combination demonstrated a hazard ratio of 0.17 for PFS—described as "the best hazard ratio we've seen in a phase III clinical trial in multiple myeloma" by lead investigator María-Victoria Mateos, MD, PhD, from the University of Salamanca. At three years of follow-up, 83.4% of patients treated with the teclistamab-dara combination remained alive and progression-free compared to just 29.7% in the control arm, with a median PFS not yet reached in the treatment group versus 18.1 months in controls. Beyond PFS, the data demonstrated sustained benefits across secondary endpoints. Complete response rates of 81.8% were achieved with the combination, compared to 31% in the control group, while minimal residual disease (MRD)-negative rates reached 57.6%, compared to 3.4% in controls. Overall survival was significantly prolonged, with a hazard ratio of 0.45; 91% of patients who were progression-free at six months remained progression-free at three years, suggesting a potential "functional cure" for relapsed/refractory multiple myeloma patients. Safety remained manageable despite the combination's potency. Cytokine release syndrome occurred in approximately 60% of patients. Still, it was limited to Grade 1 or 2 severity in all cases, while immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in only 1.1% of patients, all of which resolved. Deaths were approximately 50% lower with the combination compared to controls (15.9% versus 33.1%), with minimal treatment discontinuations due to adverse events (4.6% versus 5.5%). Gilead/Legend Biotech's CARVYKTI: Extended Follow-Up Affirms CAR-T Durability Gilead and Legend Biotech presented extended durability data for CARVYKTI (ciltacabtagene autoleucel), a BCMA-directed CAR T-cell therapy, demonstrating sustained disease control in patients with multiple myeloma. New Phase 3 data revealed that 80.5% of patients had not experienced disease progression at 30 months of follow-up, with 87.3% remaining alive after 2.5 years. The enduring response rates substantially exceed historical outcomes in heavily pretreated patient populations. In earlier trials evaluating cilta-cel after three or more prior lines of therapy, progression-free survival reached 59.9% with an overall survival of 70.6%, underscoring the durability advantage of this single-infusion therapy. The approval of CARVYKTI as a first relapse option represents a significant advancement, allowing earlier intervention in the disease course for appropriate patients. Bristol Myers Squibb's Iberdomide: Deepening Response Depth in Newly Diagnosed Myeloma Bristol Myers Squibb revealed compelling data on iberdomide, an oral cereblon E3 ligase modulator (CELMoD) agent, demonstrating that the drug delivers deep and sustained responses in newly diagnosed multiple myeloma. A Phase 2 clinical trial examining different doses of iberdomide as maintenance therapy following autologous stem-cell transplantation enrolled 120 patients and showed that approximately half achieved MRD negativity (no detectable cancer), with over 80% remaining cancer-free after two years. Additional Phase 1b/2a data supported the efficacy and safety of iberdomide in combination with daratumumab and dexamethasone for transplant-deferred or ineligible newly diagnosed patients, demonstrating robust responses with sustained minimal residual disease (MRD) negativity. A cooperative group analysis of iberdomide maintenance after autologous stem-cell transplantation continued to show benefit, positioning this agent as a valuable maintenance option across multiple treatment settings. Furthermore, BMS presented Phase 1b data on elranatamab combined with iberdomide ( MagnetisMM-30 trial) in relapsed/refractory multiple myeloma patients, achieving a 95.5% objective response rate with a safety profile consistent with known toxicities of each agent. Regeneron's LYNOZYFIC: First BCMA×CD3 Bispecific in Frontline Setting Regeneron showcased data on LYNOZYFIC (linvoseltamab-gcpt), a bispecific antibody targeting BCMA and CD3, highlighting promising early clinical results as a monotherapy for newly diagnosed multiple myeloma patients. The Phase 1/2 LINKER MM4 trial represents the first evaluation of a BCMA×CD3 bispecific antibody as monotherapy in the frontline myeloma setting, potentially redefining initial treatment strategies. Updated results from the LINKER MM2 study, in which LYNOZYFIC was combined with different anti-CD38 monoclonal antibodies in relapsed or refractory patients, further demonstrated the drug's potential to redefine treatment approaches at early disease stages and improve patient outcomes. Regeneron's hematology program demonstrated significant momentum with regulatory approvals for blood cancer treatments throughout 2025. AbbVie's Etentamig: Next-Generation T-Cell Engager Shows Promise AbbVie presented Phase 1b data evaluating etentamig, a BCMAxCD3 bispecific T-cell engager, in combination with pomalidomide and dexamethasone in 85 heavily pretreated relapsed/refractory multiple myeloma patients who had received at least three prior lines of therapy. The combination demonstrated the therapeutic potential of AbbVie's T-cell engager approach in this difficult-to-treat patient population. CellCentric's Inobrodib: Novel Oral Mechanism for Treatment-Resistant Patients CellCentric unveiled Phase 2 dose optimization results for inobrodib in combination with pomalidomide plus dexamethasone, demonstrating strong clinical efficacy in heavily pretreated relapsed/refractory multiple myeloma patients. Among heavily pretreated patients (median five prior lines of therapy) who were pomalidomide-refractory and had previously failed on BCMA and/or T-cell engager therapy, inobrodib achieved objective response rates of 60% at 20 mg and 75% at 30 mg—representing at least a two-fold increase compared to real-world response rates of 25-30% in similar patient populations after BCMA/bispecific agents. As an oral small-molecule drug targeting p300/CBP bromodomains, inobrodib offers a differentiated mechanism of action for patients ineligible for, or after, bispecific and BCMA-targeting agents. The favorable tolerability profile, with the most common adverse events being cytopenias and fatigue, positions this agent as a compelling option for community-based treatment, where more than 70% of myeloma patients are managed. Arcellx's Anitocabtagene Autoleucel: Novel CAR-T Architecture Arcellx presented new clinical data from the iMMagine-1 study evaluating anitocabtagene autoleucel (anito-cel), the first BCMA CAR T-cell therapy utilizing the company's novel compact D-Domain technology, in patients with relapsed or refractory multiple myeloma. This differentiated CAR-T architecture represents an innovative approach to autologous T-cell immunotherapy in multiple myeloma. Adaptive Biotechnologies' clonoSEQ: MRD Testing Drives Treatment Decisions Adaptive Biotechnologies showcased the expanding clinical utility of clonoSEQ, a minimal residual disease (MRD) detection test, with 32 abstracts focused on multiple myeloma at ASH 2025. Presentations highlighted the growing use of clonoSEQ to evaluate treatment response, real-world evidence linking MRD status to clinical outcomes, and guidance on treatment strategies. Notably, Phase 2 AURA trial data involving 200 newly diagnosed multiple myeloma patients demonstrated that profound MRD responses and sustained MRD negativity were associated with significantly enhanced progression-free survival. The test's critical role in identifying optimal candidates for intensified maintenance therapy in MRD-positive patients post-transplant was particularly emphasized, with data showing substantially higher MRD-negativity rates when guided by clonoSEQ. Live MMR Vaccine Safety in Daratumumab-Treated Myeloma Patients New research presented at ASH 2025 addressed an important question regarding vaccine safety in multiple myeloma patients receiving immunosuppressive therapy. A clinical trial of 41 patients with multiple myeloma who had undergone autologous stem-cell transplantation and were receiving daratumumab demonstrated that the live MMR vaccine was safe and well-tolerated in this population. None of the vaccinated patients developed active measles, mumps, or rubella disease following vaccination, with no hospitalizations or deaths reported. Multiple Myeloma Market Implications and Expansion The convergence of unprecedented efficacy data across multiple modalities has profound implications for the multiple myeloma market. The multiple myeloma therapeutic market, estimated at $22 billion in 2024, is projected to grow at a significant CAGR, reaching $33 billion by 2034, growth substantially accelerated by these clinical advances. The rapid advancement of bispecific antibodies, CAR-T therapies, and next-generation proteasome inhibitors has expanded treatment options but intensified competitive pressures. For Johnson & Johnson, overlap between TECVAYLI-based combination regimens and its approved CAR-T product, CARVYKTI, raises a risk of internal market cannibalization, potentially driving the company to accelerate the rollout of combination strategies to protect its commercial footing. Meanwhile, Bristol Myers Squibb, the Genmab/Pfizer alliance, and newer entrants are shaping a market trajectory in which bispecific and CAR-T platforms increasingly dominate the relapsed/refractory landscape. Still, proteasome inhibitors continue to command a significant share in frontline and maintenance settings. In summary, the 2025 ASH Annual Meeting marks a pivotal moment for multiple myeloma treatment. Data showing that bispecific combinations, CAR-T therapies, and other emerging modalities can deliver deep, durable responses, with the possibility of functional cures for some patients, redefines expectations for a disease long viewed as incurable. The combination of unprecedented efficacy, better safety, and improved accessibility driven by manufacturing advances positions the multiple myeloma market for significant growth. Source: Multiple Myeloma Market Report Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Sanofi, Karyopharm Therapeutics, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. 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London: A recently approved antibody drug from Regeneron Pharmaceuticals eradicates residual traces of multiple myeloma after initial treatments, potentially allowing patients to avoid grueling bone marrow transplants, preliminary data from a small mid-stage trial suggest. Patients in the trial had received initial treatments that eliminated nearly all of their cancer cells. Usually, individuals with residual cancer cells , accounting for roughly half of patients treated with modern first-line drugs, would go on to receive high-dose toxic chemotherapy to destroy the remaining cancer cells and a bone marrow transplant to regrow healthy replacements. Study leader Dr. C. Ola Landgren of University of Miami Miller School of Medicine called the regimen "a brutal treatment." Instead, patients in the study received Regeneron's Lynozyfic, which was approved by the U.S. Food and Drug Administration in July for treatment of recurrent multiple myeloma. While most therapeutic antibodies attach to a single target, Lynozyfic attaches to two, CD3, a protein on T cells that destroys cancerous cells, and BCMA, a protein on multiple myeloma cells. None of the 18 trial participants who have so far completed up to six cycles of treatment with Lynozyfic have had detectable residual disease afterward on highly sensitive tests, the researchers reported at the American Society of Hematology annual meeting in Orlando. Ultimately they plan to enroll a total of 50 patients. Those who test negative for residual multiple myeloma cells can expect to live years longer without their cancer returning than those positive for it, Landgren said in a statement. "Based on my experience, I would predict that after having such a good response after such a short time, the disease most likely could stay away for many years," he said. "Could it never come back in some patients? I would say it's possible." GLP-1 DRUGS DO NOT APPEAR TO CUT CANCER RISKS Widely used weight-loss medications from the class known as GLP-1s likely have little or no effect on risk for obesity-related cancers, a large study suggests, although longer follow-up is needed to be certain. Researchers analyzed data from 48 trials involving 94,245 participants with type 2 diabetes or overweight or obesity who were randomly assigned to receive GLP-1 drugs or a placebo. Results showed the drugs probably have little or no effect on risk for cancers of the thyroid, pancreas, colon and rectum, stomach, esophagus, liver, gallbladder, breast, ovaries, endometrium, kidneys, or the blood cancer multiple myeloma or the brain cancer meningioma, researchers reported in Annals of Internal Medicine. Twenty of the trials tested semaglutide, the main ingredient in Novo Nordisk's Ozempic, Wegovy, and Rybelsus. Ten tested Novo's liraglutide, sold as Victoza and Saxenda. Eli Lilly's tirzepatide, sold as Mounjaro and Zepbound, was tested in eight trials. The remaining 11 trials tested Sanofi's Adlyxin (sold as Lyxumia outside the U.S.), Lilly's Trulicity, or AstraZeneca's Byetta. Most of the studies were not designed to assess cancer risks or benefits, and for some outcomes the findings were of low certainty, the researchers acknowledged. Longer-term studies with cancer-specific end points are needed to clarify potential risks or protective effects of the medicines, the researchers said. PRE-TEEN SMARTPHONE OWNERSHIP LINKED WITH HEALTH RISKS Smartphone ownership in early adolescence is linked with higher risks for depression, obesity, and insufficient sleep, according to a large U.S. study. More than 10,500 youngsters from 21 states were surveyed annually between 2018 and 2021 and also screened for depression, obesity, and whether or not they were getting a full nine hours of sleep per night. By age 12, roughly two-thirds of the children owned a smartphone, researchers reported in Pediatrics. These young smartphone owners had a 31% higher risk of depression, a 40% higher risk of obesity, and a 62% higher risk of insufficient sleep compared to their peers who did not own smartphones, the researchers found. By age 13, those who hadn't owned a smartphone at age 12 but who had acquired one in the past year were 57% more likely to report symptoms of clinical depression and 50% more likely to be getting insufficient sleep, compared to children who still didn't own smartphones. The younger the age at which children acquired a smartphone, the greater their risk of obesity and insufficient sleep at age 13, the researchers also found. "Our findings suggest that we should view smartphones as a significant factor in teen health, approaching the decision to give a child a phone with care and considering potential impacts on their life and health," study leader Dr. Ran Barzilay of the Hospital of the University of Pennsylvania said in a statement. The study cannot prove the smartphones caused these problems, and the authors say the devices will not be associated with detrimental outcomes in every adolescent. "Rather, we advocate for thoughtful consideration of the health implications, balancing both positive and negative consequences," Barzilay said. "For many teens, smartphones can play a constructive role by strengthening social connections, supporting learning, and providing access to information and resources that promote personal growth," he added. (To receive the full newsletter in your inbox for free sign up here) (Reporting by Nancy Lapid; Editing by Bill Berkrot)