Talvey

Multiple myeloma — relapsed or refractory, after at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

0.4 mg/kg every 2 weeks schedule: Step-up Day 1: 0.01 mg/kg SC, Day 4: 0.06 mg/kg SC, Day 7: 0.4 mg/kg SC, then 0.4 mg/kg every 2 weeks
0.8 mg/kg every 2 weeks schedule: Step-up Day 1: 0.01 mg/kg SC, Day 4: 0.06 mg/kg SC, Day 7: 0.4 mg/kg SC, Day 10: 0.8 mg/kg SC, then 0.8 mg/kg every 2 weeks
Pre-medication similar to Tecvayli
Hospitalize 48 hours after each step-up dose

Injection: 2 mg/mL in 1.5 mL (3 mg) and 40 mg/mL in 10 mL (400 mg) single-dose vials

None listed.

• CRS: 77% (1% Grade ≥3). Primarily during step-up dosing.
• Neurologic Toxicity: 30% (4% Grade ≥3). Including ICANS, headache, motor/sensory neuropathy.
• Infections: 57% (25% Grade ≥3). Fatal infections reported.
• Oral Toxicity: Dysgeusia (63%), oral disorders (38%). Related to GPRC5D expression in oral tissue. Usually self-resolving.
• Skin Toxicity: 56% including rash, skin exfoliation, nail disorders (40%). Related to GPRC5D expression in skin/hair.
• Cytopenias: Lymphopenia 80% (73% Grade 3-4), neutropenia 57% (39% Grade 3-4), anemia 40% (29% Grade 3-4).
• Weight Loss: 23%. Monitor nutritional status.
• Hypogammaglobulinemia: 16%.

CRS (77%), dysgeusia (63%), skin toxicity (56%), infections (57%), musculoskeletal pain (40%), nail disorders (40%), oral disorders (38%), fatigue (31%), nausea (27%), weight loss (23%), pyrexia (22%), neutropenia (57%), lymphopenia (80%), anemia (40%)

CRS in 79% (Grade 3+ in 1%). ICANS in 6%. Dysgeusia in 62%. Skin and nail disorders in 67%. Serious infections in 24% (including fatal). Grade 3+ weight decrease in 6%.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

CRS in 79% (Grade 3+ in 1%). ICANS in 6%. Dysgeusia in 62%. Skin and nail disorders in 67%. Serious infections in 24% (including fatal). Grade 3+ weight decrease in 6%.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Talquetamab is a bispecific humanized IgG4 monoclonal antibody that binds to GPRC5D (G Protein-Coupled Receptor Class C Group 5 Member D) on myeloma cells and CD3 on T cells. GPRC5D is a novel target broadly expressed on myeloma cells with limited normal tissue expression (keratinocytes, hair follicles, oral mucosa). By bridging T cells to GPRC5D-expressing myeloma cells, talquetamab redirects T-cell mediated killing independently of BCMA.

Half-life: approximately 10 days at target dose. Step-up dosing minimizes CRS severity. Non-linear PK at lower doses due to target-mediated drug disposition. Steady-state by approximately Cycle 5.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• MonumenTAL-1 — Talquetamab in relapsed/refractory multiple myeloma. Phase I/II.
  🔬 NCT03399799 ↗ 📄 Primary Publication ↗

Talvey has FDA-approved indications across the following cancer types covered on PipelineEvidence: