Talquetamab is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[1][9][6][5]
The US Food and Drug Administration (FDA) label prescribing information has a boxed warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity.[1][9]
Efficacy was evaluated in MMY1001 (MonumenTAL-1) (NCT03399799, NCT04634552), a single-arm, open-label, multicenter study that included 187 participants who had previously received at least four prior systemic therapies.[9] Participants received talquetamab-tgvs 0.4 mg/kg subcutaneously weekly, following two step-up doses in the first week of therapy, or talquetamab-tgvs 0.8 mg/kg subcutaneously biweekly (every two weeks), following three step-up doses, until disease progression or unacceptable toxicity.[9]
The main efficacy outcome measures were overall response rate and duration of response as assessed by an independent review committee using IMWG criteria.[9] The primary efficacy population consisted of participants who had previously received at least four prior lines of therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[9] Overall response rate in the 100 participants receiving 0.4 mg/kg weekly was 73% (95% confidence interval (CI): 63.2%, 81.4%) and median duration of response was 9.5 months (95% CI: 6.5, not estimable).[9] Overall response rate in the 87 participants receiving 0.8 mg/kg biweekly was 73.6% (95% CI: 63%, 82.4%) and median duration of response was not estimable.[9] An estimated 85% of responders maintained response for at least nine months.[9]
In the United States, Janssen received breakthrough therapy designation for talquetamab in June 2022, for the treatment of adults with relapsed or refractory multiple myeloma, who have previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.[12] Janssen filed for approval from the FDA in December 2022,[13] and from the European Medicines Agency in January 2023.[14]
On 20 July 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Talvey, intended for the treatment of multiple myeloma.[15] Talvey was reviewed under EMA's accelerated assessment program.[15] The applicant for this medicinal product is Janssen-Cilag International N.V.[15] Talquetamab was approved for medical use in the European Union in August 2023.[6][5]
^ abcd"Talvey EPAR". European Medicines Agency. 21 September 2023. Retrieved 6 October 2023.
^ abcd"Talvey Product information". Union Register of medicinal products. 22 August 2023. Archived from the original on 25 August 2023. Retrieved 25 August 2023.
^ ab"Talquetamab". NCI Drug Dictionary. National Cancer Institute. Archived from the original on 11 August 2023. Retrieved 30 January 2023.
^ abc"Talvey: Pending EC decision". European Medicines Agency (EMA). 21 July 2023. Archived from the original on 25 August 2023. Retrieved 25 August 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Clinical trial number NCT03399799 for "Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (MonumenTAL-1)" at ClinicalTrials.gov
Clinical trial number NCT04634552 for "A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma" at ClinicalTrials.gov