Ciltacabtagene autoleucel

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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ORLANDO, Fla. — Clinical trials in multiple myeloma continue to rapidly progress, and nowhere was this more apparent than at the American Society of Hematology’s annual meeting. Companies like Johnson & Johnson, Gilead and Arcellx were in Florida to present their data. Leading the pack were data for J&J’s Tecvayli, a bispecific antibody targeting BCMA and CD3. Results from last month’s abstract showed that Tecvayli, when combined with Darzalex, another J&J antibody, cut the risk of disease progression or death by 83% compared to standard Darzalex regimens. On overall survival, the Tecvayli combination cut the risk of death by 54%. Patients included in the study, called MajesTEC-3, previously tried one to three prior treatment regimens. The data raise questions about whether clinicians should give multiple myeloma patients antibody treatment before CAR-T therapy or after. Several factors are at play: continuous treatment versus a one-time infusion; how patients’ resistance might develop after each regimen; different side effects; and the concentration of CAR-T centers around urban areas. Imran Khan, vice president of US medical affairs in hematology at J&J, said that more options for patients are better. (J&J sells Tecvayli, Darzalex and the CAR-T treatment Carvykti.) Khan said which therapies patients receive first shouldn’t matter much because there are “washout periods” in between treatments where they don’t get anything, giving their immune systems time to recover. “Does getting one therapy preclude the patient getting the subsequent therapy with one versus the other? The answer is no, you can get one first and the other,” Khan said. Physicians aren’t so sure the treatment orders are interchangeable. Michael Rosenzweig, chief of multiple myeloma research at the City of Hope, said he would likely opt for CAR-Ts first — at least in the short-term. He noted that current data show bispecifics tend to work better after CAR-Ts compared to the reverse, should patients’ disease progress. Rosenzweig also said that with CAR-Ts, being off-treatment for long periods appeals more to patients. Krina Patel of MD Anderson Cancer Center, principal investigator on a trial of a competing cell therapy called anito-cel, echoed that CAR-T therapies should come ahead of bispecifics. Patel said J&J’s second-line-plus study does not necessarily reflect how most patients are treated in the US, where they receive Darzalex early on. Concerns also remain about the infection risk for those who take bispecifics. The Tecvayli-Darzalex combination resulted in 54.1% of patients facing severe or life-threatening infections, compared to 43.4% of those who received standard treatments. María-Victoria Mateos, an investigator on the study, said at a press briefing Monday that keeping doctors informed of the infection risk will be important. She noted most patients likely to receive the bispecifics are in rural and community settings where physicians are extremely busy. The Tecvayli data spelled more competition for Gilead and Arcellx’s CAR-T anito-cel. On Tuesday, Arcellx saw its shares $ACLX fall 3% after it jumped Monday following Arcellx’s own data report. J&J’s partner on Carvykti, Legend Biotech, saw its shares $LEGN fall 6% Tuesday. Over the past month, Arcellx’s have fallen 16% and Legend’s by 23%. That’s even as Arcellx reported on Saturday strong data on its own experimental CAR-T therapy. The company said that at a median follow-up of 15.9 months, its therapy elicited a 96% overall response rate and 74% complete response rate. Ninety-one of 96 patients had no detectable myeloma cells present in their bone marrow. As with previous cuts of data, Arcellx said it has not seen cases of certain neurotoxicities like Parkinsonism, cranial nerve palsies or Guillain-Barré syndrome, as well as no enterocolitis — which are side effects reported with Carvykti treatment. Gilead’s cell therapy unit Kite and Arcellx said they expect to launch anito-cel next year. Kite leader Cindy Perettie declined to comment on the timing of the FDA filing. It’s unclear how new FDA standards for CAR-T approvals described Monday by Vinay Prasad and other FDA officials will impact Arcellx and Gilead’s bid for approval. Others are in earlier stages of study for new multiple myeloma regimens. Regeneron reported findings from 45 patients in the Phase 1/2 LINKER-MM4 study, suggesting that its multiple myeloma bispecific Lynozyfic can be used as a solo treatment in newly diagnosed patients. In three dose groups, 70% or more patients achieved a “very good partial response” or better. The Phase 2 part of the study is continuing at the high dose of 200 mg. CellCentric CEO Will West said his company is planning registrational trials of its small molecule multiple myeloma drug, particularly for patients who have failed a bispecific antibody or can’t tolerate one. The company said it can fund an accelerated approval-enabling study. “But if we are to do a full Phase 3 ourselves, we will be looking to raise around another $200 million early next year,” West said. Bristol Myers Squibb is running a suite of Phase 3 trials in multiple myeloma for its protein degrader programs iberdomide and mezigdomide. The drugs are a new type of protein degrader called cereblon E3 ligase modulators, or CELMoDs. They work as molecular glue by sticking cereblon to a disease-causing protein, leading it to be destroyed by the body. At ASH, the company also touted results from early-stage trials that combined the CELMoDs with Pfizer’s bispecific T cell engager Elrexfio. The trials, which were not sponsored by BMS, enrolled certain relapsed or refractory patients. “We are incredibly encouraged by combination data with T cell engagers,” said Anne Kerber, BMS’ head of development in hematology, oncology and cell therapy . “That’s a very plausible, logical next step biologically.” In an abstract, investigators said early data from the first part of the Phase 1/2 mezigdomide study showed the combination was “clinically feasible” and showed “therapeutic potential.” In the Pfizer-sponsored iberdomide study, investigators said in an abstract that early Phase 1b results showed “encouraging efficacy.”