cevostamab (RG6160) / Roche - LARVOL DELTA

Cevostamab Plus Pomalidomide (Pom) and Dexamethasone (Dex) Induces Durable Remissions in BCMA-Naïve Patients With Relapsed/Refractory Multiple Myeloma (RRMM): CAMMA 1 Arm B Extended Follow-up Data (IMS 2026) - P1 | "Cevostamab plus pom-dex induces durable remissions in BCMA-naïve pts with RRMM. Updated data will be presented."

Clinical • IO biomarker • Cerebral Hemorrhage • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Septic Shock • Thrombocytopenia • GPRC5D

A Fixed-Duration, Modified Cevostamab Dosing Regimen Induces Durable Remissions That Continue After Completion in BCMA-Na�ve Pts With Relapsed/Refractory Multiple Myeloma (RRMM): CAMMA 1 Arm a Results (IMS 2026) - P1 | "CRS was managed with tocilizumab in 7 pts and steroids in 4 pts. A fixed-duration, modified cevostamab dosing regimen induces durable remissions that continue after treatment completion in BCMA-naïve pts with RRMM. Safety was manageable. Exposure-response analyses evaluating the relationship between the modified regimen, VGPR+ rates and DOR are ongoing and will be presented, as will data on B-cell recovery kinetics."

Clinical • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Leukemia • Multiple Myeloma • Neutropenia • Pneumonia • Rare Diseases • Respiratory Diseases • Septic Shock

…Extended follow-up from the Arm B dose-expansion portion of the phase 1b CAMMA 1 trial (NCT04910568) presented at the 23rd Annual International Myeloma Society (IMS) Meeting & Exposition (Cancer Network) - "At a median follow-up of approximately 20 months, the FcRH5/CD3 bispecific antibody plus pom-dex produced an overall response rate (ORR) of 86.2% (95% CI, 71.9%-100%) at the 70-mg cevostamab target dose and 88.0% (95% CI, 73.3%-100%) at the 105-mg target dose. Response rates were comparable across the 2 dose cohorts. In the 70-mg cohort (n = 29), the rate of complete response (CR) or better was 62.1% and the rate of very good partial response (VGPR) or better was 75.9%, including a stringent CR (sCR) in 44.8%. In the 105-mg cohort (n = 25), the rate of CR or better was 64.0%, and the rate of VGPR or better was 76.0%, including an sCR in 44.0%."

P1 data • Multiple Myeloma

Functional Implications of FCRL5 Mutations for Cevostamab Immune Escape in Multiple Myeloma (IMS 2026) - "Here, we describe two mechanistically different modes of resistance arising from acquired FCRL5 mutations upon prolonged cevostamab exposure. FCRL5 G455Efs 19 results in loss of FCRL5 surface expression making it inaccessible for cevostamab, whereas FCRL5 E115A preserves surface accessibility but rapidly internalizes antibody-receptor complexes, thereby hindering immune synapse formation with T cells. These findings further dissect recently recognized tumor intrinsic mechanisms of resistance to cevostamab."

Hematological Malignancies • Multiple Myeloma

Systematic Review and Meta-Analysis of Tocilizumab Prophylaxis for Cytokine Release Syndrome (CRS) in Bispecific Antibody Therapy for Multiple Myeloma (IMS 2026) - "Databases (PubMed, Cochrane, Embase, Google Scholar) and ClinicalTrials.gov were searched with MeSH terms and keywords for tocilizumab, prophylaxis, CRS, bispecific, teclistamab, talquetamab, elranatamab, linvoseltamab, cevostamab, and multiple myeloma. A single prophylactic dose of tocilizumab before the first step-up dose consistently and substantially reduces CRS — to a pooled 9% with almost absence of grade ≥3 events. This low rate of CRS with prophylactic tocilizumab could lend to safe adoption of bispecifics in academic and community practices."

Bispecific • Cytokine release syndrome • Retrospective data • Review • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia

An AI-Designed BCMA/FcRL5 Targeting TriTE Overcomes Antigen Escape and Outperforms BCMA-Directed Therapy in Multiple Myeloma (IMS 2026) - "Cytotoxicity was further enhanced in BCMA-knockout cells engineered to overexpress FcRL5; in this setting, CB-101 outperformed both Teclistamab and Cevostamab. CB-101, a BCMA/FcRL5 TriTE, demonstrated enhanced antitumor activity in vitro and in vivo, outperforming BCMA-directed therapy even at substantially lower doses and retaining efficacy in settings associated with antigen escape and drug resistance. Enabled by an AI-driven high-throughput discovery platform, this next-generation BCMA/FcRL5 TriTE with provocative preclinical data is now poised for clinical evaluation in MM and WM to improve outcomes."

IO biomarker • Hematological Disorders • Hematological Malignancies • Lymphoma • Lymphoplasmacytic Lymphoma • Multiple Myeloma • Waldenstrom Macroglobulinemia

CEVOLUTION: A Randomized Phase III Trial Comparing Cevostamab Plus Pomalidomide and Dexamethasone (Pom-Dex) Versus Standard of Care (SOC) in Relapsed/Refractory Multiple Myeloma (RRMM) (IMS 2026) - "Introduction: Efficacious new treatments are needed for RRMM patients (pts) with prior anti-CD38 antibody (Ab) and lenalidomide (len) exposure...In Arm B, pts will receive investigator’s choice of either daratumumab plus pom-dex, elotuzumab plus pom-dex or carfilzomib plus dex, with the choice informed by the pts prior treatment exposure and refractoriness to individual classes of agents... CEVOLUTION is a pivotal Phase III trial that is expected to inform the clinical efficacy and safety of cevostamab plus pom-dex in pts with RRMM."

Clinical • P3 data • Hematological Malignancies • Multiple Myeloma

Cevostamab Consolidation Following BCMA CAR T Cell Therapy: Primary Analysis of the Phase 2 "STEM" (Sequential T Cell-Engagement for Myeloma) Trial (IMS 2026) - P2 | " 27 pts (20M, 7F; median age 64; 21 White, 6 Black) enrolled, with median 4 (range 2-10) prior lines, 74% triple-class refractory, 11% prior BCMA therapy, and 11% prior talquetamab...93% received cilta-cel and 7% ide-cel... Cevo consolidation post-CAR T cells is feasible and well-tolerated in late-line RRMM, with 89% of pts showing sustained MRD-neg sCR at 1 year and promising 2-year PFS."

CAR T-Cell Therapy • Late-breaking abstract • P2 data • Cough • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Respiratory Diseases • Thrombocytopenia

Functional Implications of FCRL5 Mutations for Cevostamab Immune Escape in Multiple Myeloma (IMS 2026) - "Here, we describe two mechanistically different modes of resistance arising from acquired FCRL5 mutations upon prolonged cevostamab exposure. FCRL5 G455Efs 19 results in loss of FCRL5 surface expression making it inaccessible for cevostamab, whereas FCRL5 E115A preserves surface accessibility but rapidly internalizes antibody-receptor complexes, thereby hindering immune synapse formation with T cells. These findings further dissect recently recognized tumor intrinsic mechanisms of resistance to cevostamab."

Hematological Malignancies • Multiple Myeloma

Cevostamab, a FcRH5xCD3 bispecific T- cell engager for the treatment of Multiple Myeloma (IMS 2026) - No abstract available

Bispecific • Hematological Malignancies • Multiple Myeloma

Study of Belantamab Mafodotin, Cevostamab, Pomalidomide for RRMM Patients (MAPLE) (clinicaltrials.gov) - P1 | N=108 | Not yet recruiting | Sponsor: Canadian Myeloma Research Group

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Outcomes of Bispecific Antibody Rescue Therapy Following CAR-T Cell Therapy Failure in Relapsed/Refractory Multiple Myeloma: A Systematic Review and Meta-Analysis (SOHO 2026) - "Patients: Adults with RRMM progressing after commercial idecabtagene vicleucel or ciltacabtagene autoleucel; heavily pretreated (median, four to seven prior lines of therapy)...Interventions: BCMA-directed BsAbs (teclistamab, elranatamab; k = 4 studies) and GPRC5D/FcRH5-directed BsAbs (talquetamab, cevostamab; k = 2, descriptive only)... BsAbs demonstrate meaningful activity after BCMA-directed CAR-T failure in RRMM. GPRC5D-directed BsAbs showed numerically higher ORR (∼75%) than BCMA-directed BsAbs (∼49%), though this is based on descriptive data from two studies only and requires prospective validation. Substantial heterogeneity (I2 = 76.7%) highlights the influence of patient selection, BsAb target, and timing of initiation."

Bispecific • CAR T-Cell Therapy • Retrospective data • Review • Hematological Malignancies • Multiple Myeloma • Oncology

CEVOSTAMAB IN PATIENTS WITH RRMM WHO ARE TRIPLE-CLASS REFRACTORY AND HAVE RECEIVED A PRIOR BCMA-TARGETED ADC OR CAR T-CELL: INITIAL RESULTS FROM THE PHASE I/II CAMMA 2 STUDY (EHA 2024) - P1/2 | "CRS was managed with tocilizumab (7 pts) or steroids(8 pts); 1 patient received both. Initial data from Cohort A1 of CAMMA 2 demonstrate that cevostamab has promising activity and manageablesafety in pts with RRMM who are triple-class refractory and have received a prior BCMA-targeted ADC or CART-cell therapy."

CAR T-Cell Therapy • Clinical • IO biomarker • P1/2 data • Anemia • CNS Disorders • Epilepsy • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia • IL6

CEVOSTAMAB (FCRH5XCD3 BISPECIFIC ANTIBODY) INDUCES DURABLE RESPONSES IN PATIENTS WITH LATE-LINE RRMM WHO HAVE RECEIVED PRIOR BCMA-TARGETED CAR T-CELL THERAPY: EXPANSION RESULTS FROM THE CAMMA 2 STUDY (EHA 2026) - P1/2 | "CRS was frequently managed with tocilizumab (51.6%) or steroids (51.6%); all events resolved. Summary/Conclusion Cevostamab induces deep and durable responses in pts with late-line, triple-class refractory MM who have received prior BCMA- targeted CAR-T therapy. AEs are generally manageable, with a low rate of AEs leading to cevostamab discontinuation."

Bispecific • CAR T-Cell Therapy • Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Myelodysplastic Syndrome • Neutropenia • Pneumonia • Respiratory Diseases • Thrombocytopenia

Cevostamab in Patients with Heavily Pretreated Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from an Ongoing Phase I Study Demonstrate Clinically Meaningful Activity and Manageable Safety and Inform the Doses and Regimen for Combination Studies (ASH 2024) - P1 | "Pts with CRS were managed with tocilizumab (47.4%), steroids (21.1%), or both agents (10.5%). C1 TS dosing provides effective CRS mitigation. Cevostamab combination studies may use the 0.3/1.2/3.6mg TS regimen and the Q3W 160mg TD (or similar TD exposure)."

Clinical • P1 data • Anemia • Cough • Fatigue • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Rare Diseases • Respiratory Diseases • Septic Shock

Subcutaneous cevostamab demonstrates manageable safety and clinically meaningful activity in Relapsed/Refractory multiple myeloma (RRMM): First results from the Phase Ib CAMMA 3 study (ASH 2025) - "CRS primarily occurred in C1 and was mostly low Gr (Gr 1: 34.5%; Gr 2: 32.8%; Gr 3: 1.7%).Patients with CRS were frequently managed with tocilizumab (50.0%), steroids (67.5%), or both agents(32.5%); all events resolved. SC cevostamab monotherapy induces deep and durable responses and has manageablesafety in patients with late-line RRMM, many of whom had received prior BCMA-targeted therapies.Efficacy and safety (including CRS) appear generally comparable with that observed with IV cevostamabmonotherapy in patients with late-line RRMM, with the exception of the occurrence of low Gr ISRs."

Clinical • IO biomarker • P1 data • CNS Disorders • Dermatology • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Pruritus • Thrombocytopenia

Novel combination immunotherapy for relapsed/refractory multiple myeloma (RRMM): initial Phase 1 safety run-in results for cevostamab in combination with pomalidomide and dexamethasone (IMW 2023) - P1 | "Both daratumumab (dara), an anti-CD38 antibody, and pomalidomide (pom), an immunomodulatory drug (IMiD), exhibit T-cell co-stimulatory effects and are clinically active when administered alone or with dexamethasone (dex) in pts with RRMM (Lonial et al. Cevostamab plus pom and dex shows promising activity in pts with RRMM and warrants further evaluation to optimize the benefit/risk profile. Biomarker and updated clinical data will be presented."

Clinical • Combination therapy • IO biomarker • P1 data • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology

CEVOLUTION: A RANDOMIZED PHASE III TRIAL COMPARING THE EFFICACY AND SAFETY OF CEVOSTAMAB PLUS POMALIDOMIDE AND DEXAMETHASONE VERSUS STANDARD OF CARE IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2026) - "Background Anti-CD38 antibodies (Abs), such as daratumumab (dara) and isatuximab, and immunomodulatory drugs (IMiDs), such as lenalidomide (len), are frequently used in the early lines of multiple myeloma (MM) therapy...In Arm B, pts will receive investigator's choice of either dara plus pom-dex, elotuzumab plus pom-dex or carfilzomib plus dex, with the choice informed by the pts prior treatment exposure and refractoriness to individual classes of agents...First patient enrollment is expected in Q2 2026. Summary/Conclusion CEVOLUTION is a pivotal Phase III trial that is expected to inform the clinical efficacy and safety of cevostamab plus pom-dex in pts with RRMM."

Clinical • P3 data • Hematological Malignancies • Multiple Myeloma

Pretreatment with Tocilizumab Prior to the CD3 Bispecific Cevostamab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Showed a Marked Reduction in Cytokine Release Syndrome Incidence and Severity (ASH 2022) - P1 | "Pts in both arms received corticosteroid, antihistamine and acetaminophen premedication prior to cevostamab. Clinical data from the GO39775 study shows for the first time that TCZ pretreatment can significantly reduce the risk of developing TDB-induced CRS without an apparent impact on anti-myeloma activity. The data support additional investigation of the use of anti-cytokine pretreatment with the goal of substantially reducing the frequency and potentially the severity of CRS."

Clinical • Cytokine release syndrome • Hematological Disorders • Hematological Malignancies • Hepatology • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia • Transplantation • CRP • IL6 • TNFA

Redefining the Horizon: A Deep Survival Mixture Meta-Analysis Quantifying the Statistical Cure Fraction of Cellular Therapies in Relapsed Multiple Myeloma (SOHO 2026) - "Trials included ciltacabtagene autoleucel (cilta-cel; CARTITUDE-4, N = 208), idecabtagene vicleucel (ide-cel; KarMMa-3, N = 254), teclistamab (MajesTEC-1, N = 165), elranatamab (MagnetisMM-3, N = 123), talquetamab (MonumenTAL-1, N = 143), and cevostamab (phase 1/2, N = 160). Deep survival mixture modeling provides mathematically verifiable cure fraction estimates. CAR-T therapies possess a statistically significant cure fraction, whereas bispecific antibodies demonstrate almost nil cure probability despite similar initial response rates. This quantitative distinction resolves clinical sequencing debates: prioritize curative-intent CAR-T therapy first in eligible RRMM patients."

Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Hoffmann-La Roche

IO biomarker • New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participnats With With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=240 | Active, not recruiting | Sponsor: Genentech, Inc. | Trial primary completion date: Dec 2026 ➔ Jun 2030 | Recruiting ➔ Active, not recruiting | N=40 ➔ 240 | Trial completion date: Dec 2026 ➔ Jun 2030

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Phase 2 study of cevostamab consolidation following BCMA CAR T cell therapy: preliminary safety, efficacy, and correlative data from the "STEM" (Sequential T Cell-Engagement for Myeloma) trial (ASH 2025) - P2 | "Median number of prior lines was 4 (2-10), with 74% triple-class refractory, 11% prior BCMA therapy, and 11% prior talquetamab. Twenty-five (93%) received cilta-cel and 2 (7%) ide-cel... To date, cevostamab consolidation starting 10-12 weeks post-CAR T cell infusion at 3.6mgsingle step-up and 132mg q3wk target dose appears feasible and well-tolerated in heavily-pretreatedRRMM, with low rates of non-hematologic G3/4 TEAE's, including infections. Preliminary efficacy appearspromising, with over 90% showing sustained MRD-negative CR at 1 year. Analyses and follow-up areongoing."

CAR T-Cell Therapy • Clinical • IO biomarker • P2 data • Ataxia • Autoimmune Hepatitis • Cough • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Movement Disorders • Multiple Myeloma • Musculoskeletal Pain • Neutropenia • Respiratory Diseases • Thrombocytopenia

Phase 2 Study of Cevostamab Consolidation Following BCMA CAR T Cell Therapy: Preliminary Safety and Efficacy Data from the "STEM" (Sequential T Cell-Engagement for Myeloma) Trial (IMS 2025) - P2 | "RRMM pts who received standard of care CAR T cells (ide-cel or cilta-cel), with stable disease or better, receive cevo starting 10-12 weeks (wks) post-CART at step-up dose of 3.6mg IV on Cycle 1 Day 1 (C1D1), followed by 132mg starting C1D8, then q3wks for total of 8 cycles...Median number of prior lines was 4 (2-10), with 74% triple-class refractory, 11% prior BCMA therapy, and 11% prior talquetamab... To date, cevostamab consolidation post-CAR T cell infusion appears feasible and well-tolerated in late-line RRMM, with low rates of non-hematologic G3/4 TEAEs, including infections. Preliminary efficacy appears promising, with over 90% showing sustained MRD-negative sCR at 1 year."

CAR T-Cell Therapy • Clinical • IO biomarker • Late-breaking abstract • P2 data • Ataxia • Autoimmune Hepatitis • Cough • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Inflammation • Movement Disorders • Multiple Myeloma • Neutropenia • Respiratory Diseases • Thrombocytopenia

Enduring Responses after 1-Year, Fixed-Duration Cevostamab Therapy in Patients with Relapsed/Refractory Multiple Myeloma: Early Experience from a Phase I Study (ASH 2022) - P1 | "Early data from this Phase I study suggest that patients can maintain durable responses (≥6 months) after completion of 17 cycles of cevostamab treatment, highlighting the potential for an extended treatment-free period following fixed-duration therapy. Further data are needed to confirm the duration of response and associated correlates following completion of treatment. Additional data on responding patients with premature discontinuation of treatment (i.e."

Clinical • P1 data • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology • Pneumonia • Respiratory Diseases