Dr Chari on the FDA Approval of Talquetamab in Relapsed/Refractory Multiple Myeloma

Ajai Chari, MD, director, clinical research, Multiple Myeloma Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses the significance of the FDA approval of talquetamab-tgvs (Talvey) in patients with relapsed/refractory multiple myeloma.

On August 10, 2023, the FDA granted accelerated approval to talquetamab for adult 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. This approval was supported by findings from the phase 2 MonumenTAL-1 trial (NCT04634552), in which patients who had received 4 or more prior lines of therapy and had no prior T-cell redirection therapy (n = 187) who were treated with subcutaneous talquetamab at 0.8 mg/kg every 2 weeks achieved an overall response rate (ORR) of 73.6% (95% CI, 63.0%-82.4%). Furthermore, patients with no prior exposure to T-cell redirection therapy who received the agent at 0.4 mg/kg weekly achieved an ORR of 73.0% (95% CI, 63.2%-81.4%). Moreover, MonumenTAL-1 included 32 patients with at least 4 prior lines of therapy including prior bispecific antibody or CAR T-cell exposure who received talquetamab at 0.4 mg/kg weekly. In these patients, the ORR was 72% (95% CI, 53%-86%).

In the current arena of advances with T-cell redirection therapy in patients with multiple myeloma, CAR T-cell therapy and bispecific antibodies are eliciting deep and durable responses, Chari says. Prior to the approval of talquetamab, all approved treatments for patients with multiple myeloma targeted BCMA, Chari explains. The bispecific antibody talquetamab is the first agent to target GPRC5D, Chari notes.

In addition, talquetamab is an off-the-shelf bispecific antibody, which increases its accessibility to patients, according to Chari. Furthermore, its adverse effect profile is unique compared with those of other bispecific antibodies and opens the door to potential combinations with other agents, Chari concludes.