TALVEY®
(talquetamab-tgvs)
Medical inquiries
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
TALVEY® (talquetamab-tgvs)
Medical Information
TALVEY - Occurrence and Management of Administration-Related Reactions
Last Updated: 05/14/2025
Summary
- Janssen does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
- Administration-related reactions (ARRs) have been reported as adverse events (AEs) in the MonumenTAL-1 study.1
- MonumenTAL-1 is an ongoing, open-label, phase 1/2 study evaluating the efficacy and safety of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy (LOTs), including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).1-
4 - Chari et al (2025)3
, 5 published the safety and efficacy results from the post hoc analysis of phases 1 and 2 of the MonumenTAL-1 study, including administration-related reactions. - Chari et al (2022)1 published the safety and efficacy results of TALVEY in the phase 1 portion of the MonumenTAL-1 study, including injection-site reactions.
- As per the MonumenTAL-1 study (Part 3) protocol, patients were required to be managed for occurrence of systemic ARRs during therapy with TALVEY.4
- Purcell et al (2023)6
presented the nursing experience on the management of injection site reactions from a single center in the phase 1/2 MonumenTAL-1 study.
- Chari et al (2025)3
Clinical Data - monumental-1 study
- Part 1 (phase 1; dose escalation): to characterize the safety of TALVEY and determine the RP2Ds and schedule.
- Part 2 (phase 1; dose expansion): to further characterize the safety of TALVEY at the RP2Ds.
- Part 3 (phase 2): to evaluate the efficacy of TALVEY at the RP2Ds.
Study Design/Methods (Phase 2)
Patients were enrolled into 1 of the following 3 cohorts2
- T-cell redirection (TCR) therapy naive: 0.4 mg/kg subcutaneous (SC) QW, not previously exposed to TCR such as CAR-T or BsAbs (prior B-cell maturation antigen [BCMA] antibody-drug conjugate [ADC] allowed).
- TCR naive: 0.8 mg/kg SC every other week (Q2W), not previously exposed to TCRs (prior BCMA ADC allowed).
- Prior TCR exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.
- Among the prior TCR-exposed cohort, patients were divided based on type of TCR (CAR-T, BsAb, or CAR-T and BsAb).
- Key eligibility criteria3:
- ≥18 years of age, measurable multiple myeloma (MM) per International Myeloma Working Group (IMWG) criteria.
- ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.
Safety Results
- Injection site erythema (grade 1 or 2) was reported in 13% of patients (n/N=10/78) in the prior TCR cohort. No ARRs were reported in the 0.4 mg/kg SC QW and the 0.8 mg/kg SC Q2W cohorts.
Safety Results
- Injection site reactions (grade 1 or 2) were reported in 20% of patients in the 0.405 mg/kg SC QW cohort and 7% of patients in the 0.8 mg/kg SC Q2W cohort.
- Per study protocol, patients are required to be managed for occurrence of ARRs during therapy with TALVEY for both intravenous (IV) and SC administration; however, for the purpose of this summary, management guidelines only for SC administration have been described below.
- ARR events may include wheezing, flushing, hypoxemia, fever, chills, rigors, bronchospasm, headache, rash, pruritus, arthralgia, hypo- or hypertension, etc. Institutional guidelines must be followed for managing anaphylactic reactions.
- Trained clinical personnel should be prepared to intervene in the event of ARRs. Resources necessary for resuscitation (ie, agents such as epinephrine and aerosolized bronchodilator; medical equipment such as oxygen, tracheostomy equipment, and a defibrillator) should be readily available. Vital signs and laboratory parameters should be monitored at regular intervals until normalized.
- Guidelines for managing ARRs are summarized in the Table: Guidelines for the Management of ARRs in MonumenTAL-1.
| Symptoms | Treatment/Intervention for SC Injection |
|---|---|
| Mild or moderate reaction: requires therapy | Start IV fluids; give diphenhydramine 50 mg (or equivalent) IV or paracetamol 650-1,000 mg (acetaminophen) or both; consider corticosteroids and bronchodilator therapy; monitor the patient closely until recovery from symptoms. If symptoms recur, administer diphenhydramine 50 mg IV and monitor the patient until resolution of symptoms. Treatment rechallenge at next scheduled dose at the discretion of investigator if the patient has no further symptoms in the interval. |
| Severe or prolonged (ie, not rapidly responsive to symptomatic medication) reaction: recurrence of symptoms following initial improvement Hospitalization indicated for other clinical sequelae (eg, renal impairment, pulmonary infiltrates) Life-threatening: pressor or ventilator support indicated | Start IV saline infusion. Recommend the following treatment and any other therapies deemed necessary to manage the event: bronchodilators, epinephrine 0.2-1 mg of a 1:1000 solution for subcutaneous administration or 0.1-0.25 mg of a 1:10,000 solution injected slowly for IV administration, and/or diphenhydramine 50 mg IV with methylprednisolone 100 mg IV (or equivalent). Investigators should follow institutional guidelines for the treatment of anaphylaxis. Monitor until medically stable, per the investigator’s medical judgment. After a grade ≥3 ARR, hospitalization required for subsequent dose: Part 3: ≥36 hours Discontinuation of treatment: If the ARR is of grade 4 |
| Abbreviations: ARR, administration-related reaction; IV, intravenous; NCI-CTCAE, National Cancer Institute-Common Terminology Criteria for Adverse Events; SC, subcutaneous. a | |
Safety Results
- Among the 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W cohorts, 24 patients received TALVEY. Of these, 8 patients received 0.4 mg/kg SC QW, and 16 patients received 0.8 mg/kg SC Q2W doses.
- Management of injection site reactions: loratadine 10 mg orally daily for 3-5 days post-TALVEY dose and triamcinolone 0.1% cream twice a day.
Literature Search
A literature search of MEDLINE®
References
| 1 | Chari A, Minnema MC, Berdeja JG, et al. Talquetamab, a T-cell-redirecting GPRC5D bispecific antibody for multiple myeloma. N Engl J Med. 2022;387(24):2232-2244. |
| 2 | |
| 3 | |
| 4 | |
| 5 | |
| 6 | |
| 7 | |
| 8 | |
| 9 |
Endchat
Chat live