These data, featured in a poster presentation at the 2024
'Results from the MonumenTAL-1 study continue to show deeper response levels and a longer duration of response in patients treated with either of the approved dose options of talquetamab, while the median overall survival has yet to be reached at two years,' said Dr.
In MonumenTAL-1, 297 patients with no prior exposure to T-cell redirection therapy received TALVEY at the recommended Phase 2 dose (RP2D) of 0.8 mg/kg biweekly (Q2W) [n=154] or 0.4 mg/kg weekly (QW) [n=143].1 At a median follow-up of 23.4 months, patients in the Q2W cohort demonstrated a median duration of response (DOR) of 17.5 months, with median DOR not reached in patients with complete response (CR) or better. For patients in the QW arm, a median follow-up of 29.8 months showed a median DOR of 9.5 months with a median DOR of 28.6 months in patients with a CR or better. At 24 months, 67.1 percent and 60.6 percent of patients were alive from the two dosing cohorts, respectively.1
At a median follow-up of 20.5 months, TALVEY continued to show strong efficacy in patients with prior T-cell redirection therapy exposure (n=78), with 55.1 percent of patients achieving very good partial response (VGPR) or better and 57.3 percent alive at 24.2 months.1
Infection rates remained lower than in studies of B-cell maturation antigen-targeted bispecific antibodies (BsAbs), consistent with previous reports. No increase in grade 3/4 infections was observed, with longer follow-up GPRC5D-associated adverse events (AEs) led to few dose reductions and discontinuations. One additional patient discontinued treatment due to AEs since the previous report. Weight loss, as assessed by vital signs, was evident early but stabilized and improved over time, including in patients with oral toxicities.
Data from MonumenTAL-2 support continued durable responses at one year with investigational combination of TALVEY and pomalidomide in patients with RRMM who had two prior lines of therapy
Longer follow-up from the Phase 1b MonumenTAL-2 study of the investigational use of TALVEY and pomalidomide show deep responses and a manageable safety profile in patients with RRMM and support the potential to combine TALVEY with an immunomodulatory agent (IMiD). These updated data, from the first-ever study of a regimen combining a GPRC5D-targeted therapy and an immunomodulatory agent, were featured as a poster presentation at the 2024
Patients in the Phase 1b MonumenTAL-2 study (n=35) were treated with subcutaneous (SC) TALVEY at the RP2D of 0.8 mg/kg (Q2W) (n=19) or 0.4 mg/kg (QW) (n=16) with step-up doses, plus 2.0 mg of oral pomalidomide daily. At a median follow-up of 16.8 months (range, 1.2-25.1), response-evaluable patients demonstrated an ORR of 88.6 percent (VGPR, 80 percent).2
'With multiple dosing options and the ability to be used both before or after CAR-T therapy and BCMA bispecifics, TALVEY is an important and versatile treatment option for the treatment of relapsed or refractory multiple myeloma,' said
At 12 months, 80.4 percent of patients who achieved a CR or better maintained their response.2 The progression-free survival (PFS) rate at 12 months was 72.6 percent.2
The most common grade 3/4 hematologic AEs were neutropenia (57.1 percent), anemia (25.7 percent), and thrombocytopenia (20 percent).2 Taste, nail, skin, and rash toxicities occurred in 85.7 percent, 68.6 percent, 74.3 percent, and 20 percent of patients, respectively; the majority were grade 1/2 with few discontinuations.2 Cytokine release syndrome (CRS) occurred in 74.3 percent and infections occurred in 80 percent (22.9 percent grade 3/4) of patients.2
Dr.
About TALVEY
TALVEY (talquetamab-tgvs) received approval from the
TALVEY is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as some healthy tissues such as epithelial cells of the skin and tongue.
About MonumenTAL-1
MonumenTAL-1 (Phase 1: NCT03399799, Phase 2: NCT04634552) is a Phase 1/2 single-arm, open-label, multicohort, multicenter dose-escalation study involving more than 300 patients.5,6 Phase 1 evaluated the safety and efficacy of TALVEY in adults with relapsed or refractory multiple myeloma who received three or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The study excluded patients who experienced T-cell redirection therapy within 3 months, prior Grade 3 or higher CRS related to any T-cell redirection therapy, an autologous stem cell transplant within 12 weeks, an allogenic stem cell transplant within 6 months,
Phase 2 of the study evaluated the efficacy of TALVEY in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2D), established as SC 0.4 mg/kg weekly and 0.8 mg/kg every two weeks, respectively. Efficacy was based on overall response rate (ORR) and duration of response (DOR) as assessed by an Independent Review Committee using the
About MonumenTAL-2
The MonumenTAL-2 (NCT05050097) study is an ongoing Phase 1 study of subcutaneous talquetamab in combination with carfilzomib, daratumumab SC, lenalidomide or pomalidomide for the treatment of patients with multiple myeloma. The primary objective of the MonumenTAL-2 study is to identify and characterize the safety of the treatment combinations. Secondary objectives of the MonumenTAL-2 study include overall response rates, duration of response and time to response.7
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.8 In multiple myeloma, these plasma cells change, spread rapidly and replace normal cells in the bone marrow with tumors.9 Multiple myeloma is the third most common blood cancer and remains an incurable disease.10 In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the
About
At
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TALVEY (talquetamab-tgvs). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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