Linvoseltamab-gcpt

Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC, Dec. 19, 2025 /PRNewswire/ -- USA News Group News Commentary – The recent FDA approval in November of the first bispecific antibody combination for second-line blood cancer treatment marks the departure from traditional chemotherapy that oncologists have been anticipating for decades[1]. Engineered cell therapies and bispecific antibodies are now achieving response rates exceeding 90% in patients with relapsed and refractory hematologic malignancies, demonstrating the transformative power of immunotherapy in blood cancers[2]. These breakthroughs position companies like GT Biopharma, Inc. (NASDAQ: GTBP), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), Genmab A/S (NASDAQ: GMAB), Autolus Therapeutics plc (NASDAQ: AUTL), and Lyell Immunopharma, Inc. (NASDAQ: LYEL). Market forecasters project the CAR-T cell therapy market will surge from $3.87 billion in 2024 to $13.25 billion by 2030, driven by unprecedented efficacy in relapsed and refractory patient populations[3]. GT Biopharma, Inc. (NASDAQ: GTBP), a clinical-stage immuno-oncology company, recently reported advancing its Phase 1 clinical trial of GTB-3650 to Cohort 4, where patients now receive 10μg/kg/day dosing. The company specializes in developing next-generation immunotherapy treatments targeting some of the world's most resistant cancer types through its proprietary natural killer cell engager TriKE platform. GT Biopharma's Phase 1 dose escalation trial evaluates GTB-3650 in patients facing relapsed or refractory blood cancers expressing CD33, particularly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These cancers represent exceptionally challenging cases where conventional treatments have either failed completely or provided only temporary benefit before disease returned. The therapy harnesses the patient's natural killer cells, an immune cell type that instinctively identifies and eliminates abnormal cells, directing them to attack cancer specifically. Treatment delivery follows a continuous infusion schedule structured as two-week treatment periods followed by two-week rest intervals, with cycles continuing up to four months depending on individual patient response. "We are highly encouraged by the continued progress of our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which has now advanced to Cohort 4 at a dose level of 10 µg/kg/day," said Michael Breen, Executive Chairman and CEO. "We look forward to assessing higher doses, as we are now approaching the efficacy range predicted by preclinical in vivo leukemia models, and we plan to share the next trial update in the first quarter of 2026." The six patients enrolled throughout Cohorts 1, 2, and 3 have completed GTB-3650 treatment successfully, establishing the therapy's safety profile across escalating dose concentrations. GT Biopharma indicates the current Cohort 4 dose of 10μg/kg/day represents a threshold where clinical efficacy becomes more likely, supported by encouraging immunological biomarker trends and zero dose-limiting toxicities across all completed cohorts. The first-in-human Phase 1 protocol plans for approximately 14 patients distributed across seven cohorts, with each cohort enrolling two patients at progressively increasing doses starting from 1.25μg/kg/day in Cohort 1 and potentially reaching 100μg/kg/day in Cohort 7 if warranted. Following Cohort 4, three additional escalation levels remain: Cohort 5 testing 25μg/kg/day, Cohort 6 evaluating 50μg/kg/day, and Cohort 7 examining the maximum protocol dose of 100μg/kg/day. The company anticipates providing its next comprehensive trial update during first quarter 2026. Beyond hematologic malignancies, GT Biopharma is advancing GTB-5550, targeting B7H3, a protein prevalent across multiple solid tumor categories including breast, lung, ovarian, pancreatic, bladder, and prostate cancers. Regulatory submission to initiate GTB-5550 human trials is expected in late December 2025 or January 2026. Designed as a subcutaneous injection, GTB-5550 offers the potential for eventual self-administration at home, significantly reducing patient burden. Both therapeutic candidates leverage GT Biopharma's proprietary TriKE platform utilizing specialized antibody fragments initially discovered in camels and llamas. These molecules provide distinct advantages compared to traditional antibodies through their compact size and enhanced stability. GT Biopharma maintains exclusive worldwide licensing rights from the University of Minnesota for this technology. CONTINUED… Read this and more news for GT Biopharma, Inc. at: Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) presented data from the Phase 1/2 LINKER-MM4 trial showing Lynozyfic monotherapy achieved very good partial response or better of ≥70% across all three dose groups in newly diagnosed multiple myeloma patients despite limited follow-up. The first-ever BCMAxCD3 bispecific monotherapy trial in this setting demonstrated that 95% of evaluable responders achieved minimal residual disease negative status at 10⁻⁵ sensitivity. "Lynozyfic monotherapy is already achieving MRD negativity rates comparable to quadruplet regimens but earlier in the treatment course, and these compelling results are expected to deepen with longer follow up," said Robert Orlowski, M.D., Ph.D., Deputy Chair, Professor of Medicine, and Director of Translational Myeloma Research in the Departments of Lymphoma/Myeloma and Experimental Therapeutics at The University of Texas MD Anderson Cancer Center and the lead investigator for the LINKER-MM4 trial. "These results underscore Lynozyfic's potential as a foundational component of frontline treatment regimens for multiple myeloma – or even a monotherapy regimen – for both transplant-eligible and transplant-ineligible patients." The broad clinical development program includes ongoing Phase 2 expansion at the recommended 200mg dose and the LINKER-MM6 trial evaluating combination therapy in transplant-ineligible newly diagnosed patients. Regeneron will host a virtual Regeneron Roundtable investor event on December 10 to discuss its multiple myeloma development program. Genmab A/S (NASDAQ: GMAB) announced new data from its Phase 1b/2 EPCORE CLL-1 trial demonstrating epcoritamab's effectiveness as both monotherapy and in combination regimens for patients with Richter transformation, a rare and aggressive evolution of chronic lymphocytic leukemia. In first-line monotherapy, patients achieved a 57% overall response rate with 52% complete response, while 95% of evaluable responders achieved minimal residual disease negative status across all dose groups. "The results from these trials demonstrate the potential of epcoritamab as a monotherapy, and in combination, in patients with Richter transformation, a rare, often fatal, transformation of chronic lymphocytic leukemia into an aggressive lymphoma, mostly diffuse large B-cell lymphoma," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We are deeply committed to exploring epcoritamab as a potential core therapy across a range of B-cell malignancies, both as an initial treatment and as a later line of therapy." Genmab continues expanding epcoritamab's development across hematologic malignancies through multiple ongoing Phase 3 trials in collaboration with AbbVie. Autolus Therapeutics plc (NASDAQ: AUTL) presented initial clinical data from its CATULUS Phase 1 trial demonstrating obe-cel achieved a 95.5% overall response rate with 90.9% complete response in pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia. The safety profile was consistent with the adult experience, showing low rates of high-grade cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (both 8.7%), with 20 of 21 responding patients remaining in ongoing remission at data cutoff. "Pediatric patients with r/r B-ALL have a poor prognosis, particularly those who relapse early," said Dr. Matthias Will, Chief Development Officer of Autolus. "We were pleased to share the first data from the Phase 1 CATULUS trial showing obe-cel can produce high remission rates in this pediatric patient population, including in patients with high-risk relapse and patients with primary CNS relapse. Consistent with our experience in the adult population, data show low rates of severe CRS and ICANS." Autolus also presented post-hoc analyses from the FELIX pivotal trial demonstrating that CAR T-cell persistence at three months post-infusion may serve as a marker for predicting long-term outcomes in adult r/r B-ALL patients. Planning for the Phase 2 expansion of the CATULUS trial is underway to further explore obe-cel in pediatric relapsed/refractory B-ALL patients. Lyell Immunopharma, Inc. (NASDAQ: LYEL) presented new clinical data from its ongoing trial of rondecabtagene autoleucel showing 93% overall response and 76% complete response rates with median progression-free survival of 18 months in patients with relapsed/refractory large B-cell lymphoma in the third-or-later-line setting at the 67th American Society of Hematology Annual Meeting. Patients evaluated in the second-line setting, comprised predominantly of those with primary refractory disease, achieved an 83% overall response rate and 61% complete response rate, with 70% of complete responders remaining in complete response at six months or longer. "These data from the ongoing clinical trial showing high rates of durable complete responses along with a manageable safety profile in patients with high-risk large B-cell lymphoma represent the potential of ronde-cel to improve patient outcomes," said Sarah M. Larson, MD, Associate Professor at the David Geffen School of Medicine, University of California, Los Angeles. "The two pivotal trials underway, including the first-of-its kind head-to-head CAR T-cell trial, are expected to provide a comprehensive and robust evaluation of the potential for ronde-cel to demonstrate differentiated benefit over approved CD19 CAR T-cell therapies." Ronde-cel demonstrated a manageable safety profile appropriate for outpatient administration with no high-grade cytokine release syndrome and five percent or less of patients experiencing Grade 3 or greater immune effector cell-associated neurotoxicity syndrome following dexamethasone prophylaxis. Lyell has initiated two pivotal clinical trials, PiNACLE-H2H, a Phase 3 head-to-head randomized controlled trial versus lisocabtagene maraleucel or axicabtagene ciloleucel in the second-line setting, and PiNACLE, a single-arm registration trial enrolling up to 120 patients in the third-or-later-line setting. Article Sources: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of GT Biopharma, Inc. but reserve the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of GT Biopharma, Inc. by CDMG; this is a paid advertisement, we currently own shares of GT Biopharma, Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. 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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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It supports pharmaceutical companies by providing comprehensive, end-to-end solutions to enhance their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo