Prizloncabtagene autoleucel

iStock, Sundry Photography Analysts at Truist Securities called J&J’s CAR-T readout “compelling,” noting that the efficacy figures could position the cell therapy as a formidable competitor to the current standard of care, Gilead’s Yescarta. Johnson & Johnson ’s investigational CAR T therapy JNJ-4496 elicited a treatment response in up to 100% of dosed patients with large B cell lymphoma, posing a challenge to Gilead’s current standard of care Yescarta. Data from the Phase Ib trial , presented at the 2025 congress of the European Hematology Association on Friday, showed a 100% objective response rate (ORR) in patients with relapsed or refractory disease who had undergone one prior line of therapy. Complete response (CR) in this subgroup was 80%. In patients who had received two or more treatments, JNJ-4496’s ORR and CR rates dipped slightly to 92% and 75%, respectively. In an investor note on Saturday, Truist Securities called these data “compelling,” noting that they represent an “encouraging step up from the current standard of care, Yescarta.” For instance, in the second-line setting, Yescarta, a CAR T manufactured by Kite, showed a 65% CR, dropping to 36% in the third-line, according to the analysts. “High CR rates in a cross-trial [comparison] vs Yescarta were observed regardless of prior lines of therapy,” Truist added, however noting that JNJ-4496’s true edge was in safety. The Phase Ib study documented no cases of grade 3 or 4 cytokine release syndrome, a common adverse effect in immunotherapies. However, 84% of patients developed grade 3 or 4 treatment-emergent serious adverse events, the most of which was neutropenia, or low levels of a type of white blood cell. “The safety pro superior than Yescarta,” according to the Truist analysts, who added that JNJ-4496’s safety at the recommended Phase II dose “shows improvement over 1st gen CAR-Ts.” Friday’s readout comes as J&J works to maintain its leadership in the CAR T space, particularly as competitor Gilead builds up to a 2026 multiple myeloma launch of anitocabtagene autoleucel (anito-cel), its challenge to J&J and Legend Biotech’s Carvykti. Last month, Gilead’s partner Arcellx disclosed Phase II data showing a 97% ORR for anito-cel in patients with relapsed or refractory multiple myeloma at the fourth-line or later setting. CR was 68%. At the time, BMO Capital Markets wrote that anito-cel’s efficacy was “at a minimum comparable to Carvykti, with potentially better [overall survival] rates.” JNJ-4496 is an investigational CAR-T therapy that came under J&J’s fold in May 2023 when the pharma paid $245 million upfront —and promised an undisclosed amount in milestones, plus tiered royalties—to partner with the Shanghai-based AbelZeta Pharma (which at the time was still named Cellular Biomedicine Group). The molecule works by binding to both the CD19 and CD20 proteins, both of which are commonly found on malignant B cells, in turn leading to their destruction. According to J&J’s release on Friday, JNJ-4496 also carries a 4-1BB costimulatory domain, which is “intended to enhance binding strength and persistence” and surmount common pathways of treatment resistance.

Phase 1b study suggests a promising safety profile and highlights the potential of a novel dual-targeting CD19/CD20 CAR T in patients with relapsed or refractory disease 75-80% complete response rate among evaluable patients at the recommended Phase 2 dose MILAN, Italy I June 13, 2025 I Johnson & Johnson (NYSE: JNJ ) announced today the first clinical data from an ongoing Phase 1b study for JNJ-90014496 (JNJ-4496), an investigational dual-targeting anti-CD19/CD20 bispecific autologous chimeric antigen receptor (CAR) T-cell therapy, being studied in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) who have not been previously treated with CAR T-cell therapy. 1 Findings demonstrate the potential of JNJ-4496 in the treatment of patients with R/R LBCL, including R/R diffuse large B-cell lymphoma (DLBCL) – the most common type of aggressive lymphoma, a blood cancer that originates in the lymphatic system. 1,2 These data were presented as an oral presentation at the 2025 European Hematology Association (EHA) Congress ( Abstract #S239 ). 1 JNJ-4496, formerly known as C-CAR039, is a dual-targeting CAR T designed to bind to both CD19 and CD20 antigens — two cell surface proteins commonly expressed on malignant B-cells. This design, including a 4-1BB costimulatory domain, is intended to enhance binding strength and persistence, also potentially addressing common mechanisms of resistance in relapsed or refractory disease. In the Phase 1b dose confirmation study ( NCT05421663 ) in patients with R/R LBCL, data at the recommended Phase 2 dose (RP2D) were reported in patients with a median follow-up of 4 months. Results informed a RP2D of JNJ-4496 at 75 million CAR+ T-cells. Among the 22 patients in the RP2D group where efficacy was assessed, those who received one prior line of therapy (n=10) had an objective response rate (ORR) of 100 percent and a complete response rate (CRR) of 80 percent (95 percent confidence interval (CI), 69, 100). In the patients who had received two or more prior lines of therapy (n=12), the ORR was 92 percent and the CRR was 75 percent (95 percent CI, 62, 100). 1 “There is a pressing need to continue advancing therapies for patients with relapsed or refractory diffuse large B-cell lymphoma. Only about 40 percent of patients have long-term remissions with currently available single-antigen-targeting CD19 CAR T therapies,” said Krish Patel*, M.D., Director of Lymphoma Research, Sarah Cannon Research Institute (SCRI), and principal study investigator. “The data presented today show encouraging clinical activity and promising safety, and represent a step forward in delivering a potential new treatment option to patients living with the most common type of aggressive lymphoma.” Within the RP2D safety group (n=25), 52 percent of patients (n=13) received two or more prior lines of therapy, and 56 percent (n=14) received bridging therapy. In the RP2D cohort studied, no cases of Grade 3 or 4 cytokine release syndrome were observed. Two patients had immune effector cell-associated neurotoxicity syndrome (ICANS), one Grade 1 and one Grade 3. The Grade 3 event occurred in a patient with central nervous system (CNS) lymphoma. Overall, 84 percent of patients (n=21) had Grade 3/4 treatment-emergent adverse events (TEAEs), and 28 percent (n=7) reported serious TEAEs. The most common Grade 3/4 TEAE was neutropenia, a reduction in white blood cells (72 percent). One patient experienced a Grade 3 infection. 1 “We’re really excited to share the first results for our dual-targeting anti-CD19/CD20 CAR T-cell therapy in relapsed or refractory large B-cell lymphoma, underscoring our more than decade-long commitment to addressing unmet needs for patients with B-cell malignancies,” said Jeffrey Infante, M.D., Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine. “As we continue to unlock the full potential of CAR T-cell therapies through novel next-generation approaches, these promising data reinforce earlier long-term findings and highlight the potential of JNJ-4496 to improve outcomes for patients.” These data are advancing our pipeline of CAR T therapies for the treatment of B-cell malignancies and are an extension of our worldwide collaboration and licensing agreement initiated with AbelZeta Inc. (formerly Cellular Biomedicine Group, Inc.) in 2023 to develop and commercialize next-generation CAR T-cell therapies (excluding Greater China). A Phase 1 study for C-CAR039 was conducted in China for the treatment of patients with B-cell non-Hodgkin lymphoma (predominantly LBCL). 3 Johnson & Johnson is also evaluating the safety and efficacy of this asset (known as JNJ-4496 outside of Greater China) through a separate study involving a global patient population. 4 In addition to the oral presentation of JNJ-4496 at EHA, the global clinical study data will be presented at the 2025 International Conference on Malignant Lymphoma from June 17—21. About large B-cell lymphoma Large B-cell lymphoma is a type of non-Hodgkin lymphoma (NHL), a blood cancer that originates in the lymphatic system, arising from abnormal B cells, a type of white blood cell responsible for producing antibodies to fight infections. 2 The malignant cells grow rapidly in lymph nodes or other organs and can spread quickly throughout the body. 2 These abnormal cells are larger than normal, healthy B-cells. 2 Diffuse (D) LBCL is the most common and aggressive type where cells are spread out (diffuse) rather than grouped together when they are examined under a microscope. 2 DLBCL accounts for approximately 40 percent of all NHL cases globally and is estimated to have 150,000 new cases diagnosed each year. 5 While some patients respond to initial treatment, up to 40 percent can relapse or become refractory to therapy. 6 LBCL and DLBCL patients often face limited treatment options and a poor prognosis, highlighting the urgent need for innovative therapies. Common symptoms include rapidly growing lymph nodes, fever, night sweats, weight loss, and fatigue. 2 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 https://www.innovativemedicine.jnj.com . Follow us at @JanssenUS and @JNJInnovMed . Janssen Research & Development, LLC, Janssen Biotech, Inc., and Janssen Global Services, LLC are Johnson & Johnson companies. * Dr. Krish Patel, Director of Lymphoma Research, Sarah Cannon Research Institute (SCRI), U.S., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Patel K et al. A Global Phase 1b Study Of JNJ-90014496, A CD19/CD20 Bi-Specific Chimeric Antigen Receptor (CAR) T-Cell Therapy, In Patients (Pts) With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL). 2025 European Hematology Association. https://library.ehaweb.org/eha/2025/eha2025-congress/4159316/matthew.ku.a.global.phase.1b.study.of.jnj-90014496.a.cd19.cd20.bi-specific.html . Last accessed June 2025. 2 Lymphoma Action. Diffuse Large B-Cell Lymphoma. https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/diffuse-large-b-cell-lymphoma . Last accessed June 2025. 3 ClinicalTrials.gov. Study of C-CAR039 in relapsed/refractory B-cell non-Hodgkin lymphoma. Identifier NCT05149391. https://clinicaltrials.gov/study/NCT05149391?term=C-CAR039&rank=1 . Accessed June 2025. 4 Clinicaltrials.gov. A Phase 1b Multicenter, Open-Label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CART-Cell Therapy in Adult Participants With B-Cell Non-Hodgkin Lymphoma. Identifier NCT05421663. https://clinicaltrials.gov/study/NCT05421663 . Last accessed June 2025. 5 Berhan A et al. Diffuse large B cell lymphoma (DLBCL): epidemiology, pathophysiology, risk stratification, advancement in diagnostic approaches and prospects: narrative review. Discov Oncol . 2025 Feb 15;16:184. https://link-springer-com.libproxy1.nus.edu.sg/content/pdf/10.1007/s12672-025-01958-w.pdf. Last accessed June 2025. 6 García-Sancho AM et al. Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma: New Approved Options. J Clin Med . 2023 Dec 22;13(1):70. https://www.mdpi.com/2077-0383/13/1/70. Last accessed June 2025. SOURCE: Johnson & Johnson