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Talquetamab gains EC approval for use in relapsed/refractory multiple myeloma

24th August 2023

Talquetamab has been granted a conditional marketing authorisation by the European Commission as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma.

Talquetamab (brand name Talvey) is approved as a weekly or biweekly subcutaneous injection after an initial step-up phase. It can be used as monotherapy for the treatment of patients relapsed and refractory multiple myeloma who have had an inadequate response to at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. They must also have demonstrated disease progression on the last treatment.

The treatment is a bispecific engaging antibody that binds to CD3, on the surface of T-cells, and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target highly expressed on the surface of multiple myeloma cells and hard keratinised tissues.

Multiple myeloma is a malignancy of terminally differentiated plasma cells that typically presents with bone marrow infiltration of clonal plasma cells and monoclonal protein in the serum and/or urine.

Commenting on the EC decision, Edmond Chan, senior director EMEA therapeutic area lead haematology, Janssen-Cilag Limited, said: ‘[This] brings a new off-the-shelf option, with a novel cellular target and the immediate option of biweekly dosing, to an area of high unmet clinical need.

‘The high overall response rates in patients with heavily pretreated multiple myeloma, including those with prior T-cell redirection therapy, are encouraging, and we believe talquetamab has the potential to offer physicians flexibility and versatility when determining the optimal treatment regimen for their patients.‘

The EC approval follows a similar FDA approval in the US in August 2023.

Talquetamab clinical efficacy

The talquetamab approval was based on efficacy data from the phase 1 and phase 2 MonumenTAL-1 study. In the trial, patients had received a median of five prior lines of therapy and talquetamab was given at a weekly dose of 0.4 mg/kg or biweekly 0.8 mg/kg.

For both dosage regimens, patients showed meaningful overall response rates. After a median follow-up of 12.7 months, 71.7% of response-evaluable patients treated at the 0.8 mg/kg biweekly dose achieved a response. Some 60.8% achieved a very good partial response (VGPR) or better and 38.7% achieved a complete response (CR) or better.

After a median follow-up of 18.8 months, 74.1% of response-evaluable patients treated with the 0.4 mg/kg weekly dose of talquetamab achieved a response; 59.5% a VGPR or better and 33.6% achieved a CR or better.

An estimated 76.3% and 51.5% of patients maintained a response for at least nine months at the 0.8 mg/kg biweekly and 0.4 mg/kg weekly talquetamab doses, respectively.

Maria-Victoria Mateos, consultant physician in haematology at the University Hospital of Salamanca in Spain, said: ‘As multiple myeloma progresses and patients cycle through treatments, the disease becomes
more difficult to treat and remission periods shorten. Targeting GPRC5D has been shown to deliver deep responses, and unlike many other targets for multiple myeloma, its expression is limited on immune cells providing an important new approach to targeting this heterogenous disease.‘

Talquetamab effective in relapsed/refractory multiple myeloma

16th January 2023

In a phase 1/2 trial talquetamab a bispecific antibody demonstrated robust efficacy in patients with relapsed/refractory multiple myeloma

Data presented by US researchers at the American Society of Haematology (ASH) conference in New Orleans, showed that talquetamab demonstrated robust efficacy and manageable safety in patients wit heavily pre-treated relapsed/refractory multiple myeloma.

Multiple myeloma is a malignancy of terminally differentiated plasma cells that typically presents with bone marrow infiltration of clonal plasma cells and monoclonal protein in the serum and/or urine. Multiple myeloma accounts for 10% of all haematological malignancies and the global incidence was found to be 160,000 in 2020 and with a mortality of 106,000. Although treatments have improved in recent years, a proportion of patients experience relapse as shown in a 2016 study of 511 patients, which found that 16.0% experienced early relapse, with median time to relapse of 8.0 months.

Talquetamab is a bispecific IgG4 antibody which binds to both the the G protein–coupled receptor, family C, group 5, member D (which is highly expressed on multiple myeloma (MM) cells plasma cells) as well as to CD38 receptors that are also highly and uniformly expressed on MM cells. In preclinical studies, talquetamab was found to be a promising novel anti-myeloma agent in relapsed/refractory MM. In MonumenTAL-1, a phase 1/2 trial, researchers collected safety, efficacy, pharmacokinetic and pharmacodynamic data and which was used to select two appropriate doses of talquetamab: 0.405 mg/kg subcutaneous (SC) weekly and 0.8 mg/kg SC every other week. In the data presented at ASH, researchers used both doses and recruited patients with relapsed/refractory disease with ≥3 prior lines of therapy. A step-up dosing schedule was used to mitigate the risk of severe cytokine release syndrome (CRS) and the primary endpoint was the overall response rate (ORR) based on independent committee review. Several secondary endpoints were used including the duration of response (DOR), the rate of complete response or better (≥CR) and progression-free survival (PFS) as well as the incidence of adverse events.

Talquetamab outcomes in relapsed/remitted disease

A total of 288 with median age was 67 years were included and of whom, 143, received the 0.405 mg/kg dose. Overall, patients had received a median of 5 prior therapies.

Among those receiving the 0.405 mg dose, the ORR was 73% and the median time to response was 1.2 months, the median time to complete response (CR) was 2.1 months and the median DOR was 9.3 months, with a median PFS of 7.5 months. The most common adverse events (AEs) were CRS (79%), dysgeusia (48%), anaemia (45%) and skin-related AEs (56%). Data for the 0.8 mg/kg patients was not given in the abstract.

The authors concluded that talquetamab demonstrated robust efficacy, adding that further phase 1 studies were in place to evaluate the drug in combination with other agents in patients with relapsed/refractory MM.

Chari A et al. Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D x CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Phase 1/2 Results from MonumenTAL-1. Abstract 157, ASH, 2022