Dr Schinke on the Safety Profile of Talquetamab in Relapsed/Refractory Myeloma

Carolina D. Schinke, MD, associate professor, medicine, Myeloma Center, University of Arkansas for Medical Sciences, discusses the safety profile of talquetamab-tgvs (Talvey) in the phase 1/2 MonumenTAL-1 trial (NCT04634552) of patients with relapsed/refractory multiple myeloma.

The MonumenTAL-1 trial evaluated the safety and efficacy of the first-in-class, GPRC5D-targeted bispecific antibody talquetamab in patients with treatment-naïve or relapsed/refractory multiple myeloma. In patients that have been previously exposed to T-cell redirection therapy (TCR).

Updates findings from the phase 2 portion of the trial were presented at the 2023 ASCO Annual Meeting, revealing that high, durable responses were produced with talquetamab across all cohorts and that the agent was well tolerated. Based on these data, talquetamab was granted accelerated approval by the FDA on August 10, 2023, for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 4 prior therapies, not including a prior bispecific antibody.

This safety analysis revealed that cytokine release syndrome (CRS) was reported in 79.0% of patients without prior exposure to T-cell redirecting therapy who were treated with talquetamab, Schinke begins. However, most events were low-grade, occurring early in the disease course during step-up dosing or with the first full dose, and were successfully treated with supportive measures, she states. However, some patients did require tocilizumab (Actemra) to manage their CRS, Schinke notes. The incidence of immune effector cell–associated neurotoxicity syndrome (ICANS) was also low, occurring in up to 11.0% of patients across cohorts, Schinke reports.

Several adverse effects (AEs) unique to talquetamab were also observed, Schinke continues. These included skin changes, nail changes and dysgeusia. Over half of patients reported skin changes, such as a rash or dry skin, but these instances were primarily cosmetic and grade 1/2, Schinke details. Although cases of dysgeusia were reported as grade 1/2, no grade 3 and 4 classifications exist, Schinke says. Therefore, a more accurate assessment of the severity of dysgeusia in some patients could not be ascertained, she explains.

Despite their frequency, these AEs did not negatively affect overall quality of life or lead to treatment discontinuation in most patients, Schinke concludes.