Lynozyfic (linvoseltamab) / Regeneron, Sanofi - LARVOL DELTA

Linvoseltamab (LINVO) + bortezomib (BTZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): First results from the LINKER-MM2 trial. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05137054 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Linvoseltamab (LINVO) + carfilzomib (CFZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial results from the LINKER-MM2 trial. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05137054 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Indirect comparison of linvoseltamab versus elranatamab for triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM). (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Hematological Malignancies • Multiple Myeloma • Oncology

SYSTEMATIC REVIEW OF BISPECIFIC ANTIBODIES EFFICACY AND SAFETY IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2025) - "BCMA-targeting BsAbs include elranatamab (MagnetisMM-3, MagnetisMM-5, MagnetisMM-9), teclistamab (MajesTEC-1), and linvoseltamab (LINKER-MM1). BsAbs are a promising advancement in the treatment of R/RMM. Currently, three BsAbs - teclistamab (MajesTEC-1), talquetamab (MonumenTAL-1), and elranatamab (MagnetisMM-3)- have received accelerated FDA approval. However, BsAbs are associated with safety concerns, including cytokine release syndrome, hematologic toxicity, and an increased risk of infections."

Clinical • Review • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

LINVOSELTAMAB + BORTEZOMIB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: INITIAL RESULTS FROM THE LINKER-MM2 TRIAL (EHA 2025) - "This abstract is embargoed until May 22, 2025 (23:00 CEST), until publication by the American Society of Clinical Oncology, Inc. for their 2025 ASCO Annual Meeting.This abstract is embargoed until Thursday, June 12, 2025, 08:00 CEST.Presentation during EHA2025: All (e)Poster presentations will be made available as of Thursday, June 12, 2025 (08:00 CEST) will be accessible for on-demand viewing from June 18 to August 15, 2025 on the Congress platform."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

LINVOSELTAMAB + CARFILZOMIB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: INITIAL RESULTS FROM THE LINKER-MM2 TRIAL (EHA 2025) - "This abstract is embargoed until May 22, 2025 (23:00 CEST), until publication by the American Society of Clinical Oncology, Inc. for their 2025 ASCO Annual Meeting.This abstract is embargoed until Thursday, June 12, 2025, 08:00 CEST.Presentation during EHA2025: All Oral presentations will be presented between Thursday, June 12 and Sunday, June 15, 2025 and will be accessible for on-demand viewing from June 18 to August 15, 2025 on the Congress platform."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

EXPOSURE-RESPONSE ANALYSES OF VARIOUS EFFICACY AND SAFETY ENDPOINTS IN SUPPORT OF REGISTRATIONAL DOSE SELECTION OF LINVOSELTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2025) - P1/2 | "This E-R analysis identified a set of covariates that confirmed dose-related improvements in efficacy and safety, and demonstrated the influence of disease burden markers on these outcomes. This approach offers a data-driven, mechanistic insight into RRMM therapy and dose optimization. Overall, the E-R analyses support using the 200 over the 50 mg linvoseltamab dose after the step-up regimen."

Clinical • IO biomarker • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology

INDIRECT COMPARISON OF LINVOSELTAMAB VERSUS ELRANATAMAB FOR TRIPLE-CLASS EXPOSED RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2025) - "This abstract is embargoed until May 22, 2025 (23:00 CEST), until publication by the American Society of Clinical Oncology, Inc. for their 2025 ASCO Annual Meeting.This abstract is embargoed until Thursday, June 12, 2025, 08:00 CEST.Presentation during EHA2025: All (e)Poster presentations will be made available as of Thursday, June 12, 2025 (08:00 CEST) will be accessible for on-demand viewing from June 18 to August 15, 2025 on the Congress platform."

Hematological Malignancies • Multiple Myeloma • Oncology

REAL-WORLD EFFECTIVENESS OF BELANTAMAB MAFODOTIN, BCMA-CD3 BISPECIFIC ANTIBODIES AND TALQUETAMAB IN PATIENTS WITH TRIPLE-CLASS-EXPOSED MULTIPLE MYELOMA. FIRST RESULTS FROM THE DANISH ABCD-STUDY. (EHA 2025) - "34 patients received BCMA-ADC belantamab mafodotin (belamaf), 59 patients received a BCMA-BsAb (49 teclistamab, 4 elranatamab, 6 linvoseltamab) and 19 patients received GPRC5D-BsAb talquetamab. Our study confirms the clinical activity of ABC-therapies in TCE patients in a real-world setting. We found that class-specific AEs for each respective drug were a frequent cause for reductions of dose and dose intensity. The retrospective nature, heterogeneous population and sample-size can explain the differences in effectiveness in our cohort compared to prospective clinical studies."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Keratitis • Multiple Myeloma • Neutropenia • Ocular Inflammation • Oncology • Ophthalmology • Respiratory Diseases

MASS SPECTROMETRY ENABLES PRECISE MONITORING OF BISPECIFIC ANTIBODY THERAPY IN MULTIPLE MYELOMA (EHA 2025) - "Therapeutic antibodies, including Elranatamab, Teclistamab, Talquetamab, and Linvoseltamab, were assessed in serum samples...Bispecific antibodies were detected in 11 serum samples (8 cases of Linvoseltamab and 3 cases of Teclistamab), while Daratumumab was also detected in 5 additional samples.Measurable residual disease (MRD) was assessed using next-generation flow (NGF) in bone marrow samples from 19 patients... Bispecific antibodies represent a good alternative for relapsed MM patients, achieving CR in at least 66% of patients. In addition, only one patient relapsed during the follow-up. MS enables accurate identification of bispecific antibodies in serum samples, ensuring no interference with MP quantification."

Hematological Malignancies • Multiple Myeloma • Oncology

Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Oct 2025 ➔ Mar 2028 | Trial primary completion date: Oct 2025 ➔ Mar 2028

Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

Regeneron to Highlight Advances at ASCO with Phase 3 Adjuvant Libtayo (cemiplimab) CSCC Updates and Promising Early Blood Cancer Data with Linvoseltamab Combination (GlobeNewswire) - "Eighteen presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma...Notable presentations at ASCO on Regeneron’s oncology pipeline include detailed efficacy and safety findings from the Phase 3 C-POST trial evaluating the adjuvant use of the PD-1 inhibitor Libtayo in post-surgical high-risk cutaneous squamous cell carcinoma (CSCC). The results will be presented in an oral session on Saturday, May 31...Regeneron will debut results from two cohorts of the LINKER-MM2 trial...which will be featured in two rapid oral presentations on Monday, June 2...In addition, the results of a cooperative group study reporting on the primary analysis of a randomized Phase 2 trial of vidutolimod..."

Clinical data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Lymphoma • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Use of an Independent Data Review Committee to Promote Best Practices for External Control Arms: A Case Study in Relapsed/Refractory Multiple Myeloma (ISPOR 2025) - P, P1/2 | "We describe experience in leveraging an Independent Data Review Committee (IDRC) to assess data quality, relevance, and comparability of cohorts for a RWD-derived ECA study in multiple myeloma (MM). R5458-ONC-21101 (NCT05673967) is a global, non-interventional study examining RWD from patients with triple-class exposed or refractory MM initiating standard-of-care (SOC) treatment to contextualize results from the linvoseltamab (anti-BCMA×CD3 antibody) 200 mg cohort of the LINKER-MM1 phase 1/2 clinical trial (NCT03761108)... An IDRC provides impartial evaluation of data suitability for comparing clinical trial and RW SOC cohorts, minimizing biases and strengthening regulatory/health technology submissions. Selection of unbiased experts, and a predefined assessment process and charter, are essential to the IDRC's successful implementation in RW studies."

Case study • Clinical • Review • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

Lynozyfic (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma (GlobeNewswire) - "Regeneron Pharmaceuticals, Inc...announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The indication is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy....The EC approval is based on results from the pivotal LINKER-MM1 trial..."

EMA approval • Multiple Myeloma

A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant (clinicaltrials.gov) - P3 | N=1000 | Not yet recruiting | Sponsor: European Myeloma Network B.V.

New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Dickran Kazandjian, MD

Minimal residual disease • New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma (GlobeNewswire) - "Regeneron Pharmaceuticals, Inc...announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. The European Commission is expected to announce a final decision in the coming months. The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial..."

CHMP • EMA approval • Multiple Myeloma

LINKER-MM3: A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=380 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Dec 2032 ➔ Apr 2033 | Trial primary completion date: Dec 2032 ➔ Apr 2033

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma (GlobeNewswire) - "Regeneron Pharmaceuticals, Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last line of therapy. The target action date for the FDA decision is July 10, 2025....The BLA is supported by data from the pivotal LINKER-MM1 trial investigating linvoseltamab in R/R MM..."

FDA filing • PDUFA • Multiple Myeloma

An evaluation of linvoseltamab for treatment of relapsed/refractory multiple myeloma. (PubMed, Expert Opin Biol Ther) - "Linvoseltamab has a similar efficacy profile with favorable CRS incidence and time-to-onset compared to other approved bispecific antibodies. Pending final regulatory approval and labeling, further real-world analyses are needed to evaluate its final role in the evolving landscape of T cell redirection therapy for MM."

Journal • Review • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

Regeneron Provides Business Updates and Highlights from Broad Clinical Pipeline at the 43rd Annual J.P. Morgan Healthcare Conference (GlobeNewswire) - "Libtayo (cemiplimab) exceeded $1 billion in sales for 2024 and remains foundational to Regeneron’s oncology portfolio....Fianlimab (LAG3) for melanoma: Combining fianlimab and Libtayo, two potentially best-in-class checkpoint inhibitors, has the potential for differentiated efficacy and safety versus the current standard-of-care. Results from the first Phase 3 study in first-line metastatic melanoma are expected in the second half of 2025, with a potential BLA submission to follow....Linvoseltamab (BCMAxCD3) for multiple myeloma: Linvoseltamab has potential to be the best-in-class BCMAxCD3 bispecific with its differentiated clinical profile, dosing regimen and administration method. The linvoseltamab BLA has been resubmitted following resolution of third-party manufacturing issues, with launch anticipated in mid-2025."

FDA filing • Launch US • P3 data • Sales • Melanoma

A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=186 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Reducing Time Toxicity for Anti-B-Cell Maturation Antigen (BCMA) Bispecific Treatment: Evidence from Pivotal Single-Arm Trial Data on Teclistamab, Elranatamab, and Linvoseltamab for Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM) (ASH 2024) - "Conclusions : Extended dosing intervals with BCMA bsAbs can substantially reduce time toxicity for patients with RRMM. Linvoseltamab had the lowest number of TRC days among BCMA bsAbs."

Hematological Malignancies • Multiple Myeloma • Oncology

Comprehensive Review of Bispecific Antibody Constructs In Multiple Myeloma: Affinities, Dosing Strategies and Future Perspectives. (PubMed, Clin Lymphoma Myeloma Leuk) - "Teclistamab, elranatamab (both BCMA × CD3), and talquetamab (GPRC5D × CD3) are approved for treating MM patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody...As linvoseltamab, alnuctamab, and ABBV-383 (all BCMA × CD3), as well as forimtamig (GPRC5D × CD3) and cevostamab (FcRH5 × CD3) progress through late-stage clinical development, emerging trispecific antibodies are now available that target either 2 different MM-associated antigens or provide additional co-stimulatory signals to prevent T-cell exhaustion. Despite this plethora of therapeutic options, resistance to bsAbs is an inevitability, and the optimal positioning of these drugs within the current MM treatment landscape remains to be determined. In this review, we examine the available data on all clinically accessible bsAbs, evaluating their potential, current limitations, and..."

Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Characterization of Linvoseltamab's BCMA Binding Epitope and Efficacy Against BCMA Mutations in Relapsed/Refractory Multiple Myeloma (ASH 2024) - "Linvoseltamab contacts a total of 16 BCMA residues which largely overlap with the reported epitopes of teclistamab and elranatamab (Lee, H., et al, Nat Med. This study identified a unique binding orientation for linvoseltamab and demonstrated that linvoseltamab retains its binding and functional activity even in the presence of an identified BCMA mutation (R27P) that negatively impacts other BCMAxCD3 bispecific antibodies. This suggests that linvoseltamab may be less susceptible to resistance mechanisms that involve these mutations, resulting in improved patient outcomes."

Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology