Elizabeth Aronson, MSN, FNP-BCN, OCN, shares what stood out to her about the phase 2 MonumenTAL-1 study assessing talquetamab in multiple myeloma.
Talquetamab-tgsv (Talvey), a GPRC5D bispecific antibody that is delivered subcutaneously, received accelerated approval on August 10, 2023, to treat patients with relapsed or refractory multiple myeloma (RRMM) who have already undergone 4 prior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Data from the phase 2 MonumenTAL-1 study (NCT04634552) supported the regulatory decision, which enrolled 187 patients with heavily pretreated multiple myeloma.
In an interview with Oncology Nursing News®, Elizabeth Aronson, MSN, FNP-BCN, OCN, who is a clinical nurse practitioner specializing in bone marrow transplant and immune effector cell therapies at Mount Sinai Hospital, walked through the clinical trial data supporting the approval and shared what stood out to her about the current evidence.
Aronson’s institution hosted a large portion of the MonumenTAL-1 study, so she already has had lots of experiencing caring for patients receiving talquetamab. She shared that her and her team are excited about this new agent, especially because it is the first approved therapy that targets GPRC5D.
As Aronson explained, talquetamab is a bispecific that is given subcutaneously. It should be administered through a step-up dosing schedule to mitigate cytokine release syndrome and other immune effector cell-associated neurotoxicity syndrome (ICANS).
The MonumenTAL-1 trial enrolled patients who were heavily pretreated, so they had already received the standard-of-care therapies and their disease had progressed. As Aronson pointed out, approximately three quarters of patients were triple-class refractory. Of note, the trial also included a cohort of patients who had undergone prior treatment with a bispecific antibody or CAR T-cell therapy, as well as a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
In the trial, patients were able to receive the therapy on either a weekly or biweekly dosing schedule. Among patients who received a biweekly subcutaneous dose of 0.8 mg/kg, the overall response rate (ORR) was 73.6% (95% CI, 63.0-82.4). At a median follow-up of nearly 6 months (range, 0-9.5), the very good partial response rate was 58% and the complete response rate was 33%.
Among patients who received therapy on a weekly schedule, the ORR was 73.0% (95% CI, 63.2-81.4). At a median follow-up of nearly 14 months (range, 0.8-15.4), the very good partial response rate was 57% and the complete response rate was 35%.
Because of the unique mechanism of action exhibited by the drug, patients may experience oral and dermatologic toxicities. Nurses should be aware that besides CRS and neurotoxicity, skin and nail disorders, and oral toxicities are common. However, oral and dermatologic adverse events can be mitigated with nurse intervention.
U.S. FDA approves Talvey (talquetamab-tgvs), a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma. News release. Janssen. August 10, 2023. Accessed August 10, 2023. https://www.janssen.com/us-fda-approves-talveytm-talquetamab-tgvs-first-class-bispecific-therapy-treatment-patients-heavily