EHA 2025: J&J's dual-targeting bispecifics could redefine SOC for r/r MM
EMD is defined as soft tissue/organ-associated plasmacytomas that have no contact with bony structures. It represents an aggressive form of MM and occurs when myeloma cells spread and form tumours (plasmacytomas) in areas such as soft tissues and organs. EMD is commonly observed in haematologic malignancies such as MM, with a prevalence of roughly 6%–20% in r/r MM. The current standard of care (SOC) for patients with r/r MM with EMD includes combination regimens with PI, IMiD, or anti-CD38 monoclonal antibodies and may also involve chimeric antigen receptor (CAR)-T cell therapy or radiotherapy. Despite the promising efficacy of these advanced therapies, patients with MM and EMD consistently show lower response rates and shorter durations of remission across clinical trials compared to those with r/r MM without EMD. This highlights a significant unmet need for more effective therapeutic options in this high-risk population. According to GlobalData's Multiple Myeloma: Epidemiology Forecast to 2032 report, the number of diagnosed prevalent cases of MM in the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China) is projected to increase from 328,151 in 2025 to 352,348 by 2032 at an annual growth rate of 1.12%.
The RedirecTT-1 trial is the largest EMD study to date, with 90 patients enrolled who were TCE. The investigational combination of Tecvayli and Talvey demonstrated a robust overall response rate (ORR) of 78.9% (95% CI: 69.0–86.8), with 54.4% achieving a complete response or better. Notably, high response rates were maintained even among patients previously treated with BCMA CAR-T (ORR: 83.3%, 95% CI: 58.6–96.4) and anti-FcRH5 bispecifics (ORR: 75.0%, 95% CI: 34.9–96.8). At a median follow-up of 13.4 months, 66.2% of responders remained in remission, indicating the potential for deep and sustained responses. Progression-free survival at one year was 61.0%, while 64.1% of patients maintained their responses, with a median duration of response of 13.8 months. Overall survival data had not yet matured, but the one-year survival rate was reported at 74.5%. Discontinuations due to adverse events (AEs) were infrequent; only four patients discontinued Talvey. Most cases of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome were Grade 1 and 2. 10 patients (11.1%) experienced Grade 5 AEs, five of which were infection-related, consistent with infection rates observed in monotherapy studies involving BCMA-targeting bispecifics.
The impressive results from the first oncology study to combine two bispecific antibodies are likely to reshape the SOC for patients with r/r MM and EMD. This dual-antigen targeting strategy enhances tumour cell recognition in a biologically and genetically heterogeneous patient population, helps overcome treatment resistance, and reduces the risk of relapse caused by antigen escape, particularly in those with EMD. Despite the strong efficacy and durability of response, the high incidence of Grade 3 and 4 infections and infection-related deaths highlights the need for careful consideration of dosing strategies and prophylactic interventions, including intravenous immunoglobulin, antibacterial, and antiviral therapies. In parallel, J&J is also advancing its BiTE portfolio through the Phase III MonumenTAL-6 clinical trial, which combines Tecvayli and Talvey, with results expected in 2026. J&J already dominates the MM market with Tecvayli, Talvey and its CAR-T cell therapy Carvykti (ciltacabtagene autoleucel), and is continuing to expand its pipeline. One of these assets, a trispecific T-cell engager, JNJ-79635322, is currently being evaluated in a Phase I clinical trial. It targets CD3, BCMA, and GPRC5D, and, if it progresses to later-stage trials and success, could become the first-in-class trispecific antibody in R/R MM. Its single-agent design offers a potential advantage in the overcrowded BiTE market, although it remains in early development. According to GlobalData's analyst consensus forecast, Tecvayli and Talvey are projected to generate global sales of $4.4bn and $1.8bn. respectively by 2031.
"EHA 2025: J&J's dual-targeting bispecifics could redefine SOC for r/r MM" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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More information about Gilead's recently announced strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as updates on Gilead's access strategies in countries and regions around the world: See Gilead press release More information about the WHO's recently announced guidelines for the use of lenacapavir for PrEP: See Gilead company statement Lenacapavir for PrEP is not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. About the PURPOSE Program Gilead's landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity. 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U.S. Indication for Yeztugo® Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Contraindications Warnings and precautions Adverse reactions Drug interactions Dosage and administration About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available Truvada, Truvada for PrEP, Yeztugo, Yeytuo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on CONTACT: Ashleigh Koss, Media [email protected] Ross, Investors [email protected] KEYWORD: EUROPE UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: AIDS HEALTH INFECTIOUS DISEASES HOSPITALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Gilead Sciences, Inc. Copyright Business Wire 2025. PUB: 07/25/2025 03:00 AM/DISC: 07/25/2025 03:01 AM
