Ajai Chari, MD, director, discusses the safety profile of talquetamab following the drug’s FDA approval for patients with relapsed/refractory multiple myeloma.
Ajai Chari, MD, director, clinical research, Multiple Myeloma Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses the safety profile of talquetamab-tgvs (Talvey) following the drug’s FDA approval for patients with relapsed/refractory multiple myeloma.
Talquetamab was granted accelerated approval by the regulatory agency on August 10, 2023, for patients with relapsed/refractory multiple myeloma who have received at least 4 prior therapies, including an immunomodulatory agent, an anti-CD38 antibody, and a proteasome inhibitor. Notably, this approval was supported by data from the phase 2 MonumenTAL-1 trial (NCT04634552). Regarding the agent’s safety profile, Chari says that cytokine release syndrome (CRS) is relatively common, and any-grade CRS occurred in 77% and 80% of patients who received the agent subcutaneously at 405 µg weekly and 800 µg every 2 weeks, respectively. However, CRS associated with talquetamab tends to be of a low grade.
However, talquetamab is associated with adverse effects (AEs) specific to GPRC5D. This gene is overexpressed in heavily keratinized tissues, leading to the occurrence of manageable rashes, Chari notes. These rashes are usually mild and can be effectively treated with topical creams such as emollients and topical steroids. In rare instances of high-grade rash with extensive distribution, an oral steroid course may be considered, he emphasizes. Additionally, nail changes, including brittle nails and changes in texture, have been observed. Another AE is taste and oral toxicity, which may be alleviated with hydration solutions, Chari explains.
In MonumenTAL-1, few patients discontinued talquetamab treatment because of AEs, as evidenced by investigators’ experience at the Icahn School of Medicine at Mount Sinai in New York, New York, where only 1 out of approximately 100 patients discontinued treatment for this reason, Chari emphasizes.
High-grade infections were relatively infrequent, and in both the 405 µg weekly and 800 µg every 2 weeks arms, 7% of patients experienced infections of grade 3 or higher, Chari continues. In contrast, some bispecific antibodies targeting BCMA can have infection rates as high as 45%, with associated infectious deaths, he says. Talquetamab, however, has been associated with 0 deaths attributed to AEs. This highlights its safety profile and feasibility of administration even during the COVID-19 pandemic, Chari says. Although areas of the multiple myeloma treatment paradigm need improvement, talquetamab is an exciting addition to the armamentarium, he concludes.