A first-in-class bispecific GPRC5D-directed CD3 T-cell engager^1,2

Mechanism of Action¹

TALVEY^® is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T cells and GPRC5D expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as healthy tissues such as epithelial cells in keratinized tissues of the skin and tongue.

In vitro, TALVEY^® activated T cells caused the release of proinflammatory cytokines and resulted in the lysis of multiple myeloma cells. TALVEY^® had anti-tumor activity in mouse models of multiple myeloma.

Efficacy & Safety¹

MonumenTAL-1 study design: The efficacy of TALVEY^® was evaluated in 219 patients with relapsed or refractory multiple myeloma in the single-arm, open-label, multicenter, phase 1/2 trial. The trial included patients who had received ≥3 prior systemic therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Efficacy was based on ORR and DOR as assessed by an IRC using IMWG criteria.^*1,3

Most common adverse reactions

The most common adverse reactions (≥20%) were pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache. [see Clinical Trials Experience (6.1) in the full Prescribing Information).]

The most common Grade 3 or 4 laboratory abnormalities (≥30%) were lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, and hemoglobin decreased. [see Clinical Trials Experience (6.1) in the full Prescribing Information).]

REMS program

TALVEY^® is available only through a restricted program under a REMS called the TECVAYLI^® and TALVEY^® REMS because of the risks of CRS and neurologic toxicity, including ICANS.

^*Efficacy results reflect patients who received ≥4 prior lines of therapy. ^†T-cell redirection therapy refers to both CAR-T and bispecific antibody treatment. ^‡ORR: sCR+CR+VGPR+PR. ^§Due to rounding, calculation may not be exact.

Dosing & Administration¹

TALVEY^® is approved as a QW or Q2W subcutaneous injection after an initial step-up phase, offering physicians the flexibility to determine the optimal treatment regimen for patients

TALVEY^® is administered via subcutaneous injection by a healthcare provider according to the step-up dosing schedule

Administer pretreatment medications prior to each dose of TALVEY^® in the step-up dosing schedule as recommended [see Dosage and Administration (2.2, 2.3) in the full Prescribing Information].

Administer TALVEY^® subcutaneously according to the step-up dosing schedule to reduce the incidence and severity of CRS [see Dosage and Administration (2.2, 2.3) in the full Prescribing Information].

TALVEY^® should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS) [see Warnings and Precautions (5.1, 5.2) in full Prescribing Information].

Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TALVEY^® step-up dosing schedule [see Dosage and Administration (2.5) and Warnings and Precautions (5.1, 5.2) in the full Prescribing Information].

Weight-based dosing

Please refer to Tables 9-12 in the full Prescribing Information to determine total dose, injection volume, and number of vials required.

^*Based on actual body weight. ^†Dose may be administered between 2-7 days after step-up dose 3.