The European Commission (EC) has granted conditional marketing approval to talquetamab (Talvey®) for the treatment of relapsed and refractory myeloma. These patients must have undergone at least three prior treatments, including an immunomodulatory agent (such as lenalidomide or pomalidomide), a proteasome inhibitor (such as bortezomib or carfilzomib), and an anti-CD38 antibody (such as daratumumab). Additionally, they must have demonstrated disease progression on their most recent therapy.

Talquetamab is a bispecific antibody which targets the protein GPRC5D on myeloma cells and CD3 on the surface of T-cells. Talquetamab kills the myeloma by bringing both cell types into close contact.

Conditional approval means that talquetamab will be reassessed for safety and efficacy when the results of other, larger clinical trials become available.

Kate Morgan, Co-Chief Executive Officer at Myeloma Patients Europe (MPE), says:

¨The access to safe and effective treatments is very important for heavily pre-treated myeloma patients. Drugs like talquetamab can prolong survival and improve patients’ quality of life”.

In late July 2023, the Committee for Medicinal Products for Human Use (CHMP), which is the committee responsible for human medicines within the European Medicines Agency (EMA), issued a favourable opinion regarding talquetamab which was followed by the marketing authorisation. This decision was supported by the MonumenTAL-1 clinical trial, which included 187 patients who had previously received a median of four prior lines of therapies.

The trial looked at two doses of talquetamab – 0.4 mg/kg once a week or 0.8 mg/kg once every two weeks. According to the Janssen press release, as the time of analysis:

• 1% patients treated with the 0.4 mg/kg dose (every week) achieved a response, 59.5% achieved a VGPR or better and 33.6% achieved a CR or better. 51.5% of patients maintained a response for at least 9 months.
• 7% of patients treated at the 0.8 mg/kg dose (every two weeks) achieved a response. 60.8% achieved a very good partial response (VGPR) or better and 38.7% achieved a complete response (CR) or better. 76.3% of patients maintained a response for at least 9 months.

The study also included patients with prior exposure to bispecific antibody or CAR-T cell therapy (94% had B-cell maturation antigen (BCMA)-directed therapy), who received the 0.4 mg/kg dose (every week) of talquetamab. 64.7% of patients achieved a response, 54.9% achieved a VGPR or better and 35.3% achieved a CR or better.² Median duration of response was 11.9 months.

Watch this interview with Prof. Monique Minnema, internist and haematologist at Academic Medical Centre, Amsterdam, and the University Medical Centre, Utrecht, The Netherlands, summarising the results of the clinical trial MonumenTAL-1, presented at EHA 2023.

The European Commission’s (EC) approval comes after talquetamab received approval from the U.S. Food and Drug Administration (FDA) in August 2023. The FDA granted approval for the treatment of adult patients with relapsed or refractory myeloma, provided they had undergone at least four prior lines of therapy. These therapies must include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.