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Positive data for patients with relapsed or refractory multiple myeloma

Long-term data from a Phase 1/2 study has shown that with 20 to 30 months of median follow-up, triple class exposed patients with relapsed or refractory multiple myeloma (RRMM), treated with TALVEY®▼ (talquetamab), maintained high overall response rates (ORR) and durable responses.
This was irrespective of whether they had received prior T-cell redirection therapy.1

The data, featured in a poster presentation at the 2024 European Hematology Association (EHA) Congress demonstrated the efficacy and durability of talquetamab when used before or after chimeric antigen receptor T-cell (CAR-T) therapy or bispecific antibody therapies in triple class exposed patients with RRMM.1

In MonumenTAL-1, 297 patients with no prior exposure to T-cell redirection therapy received talquetamab at the recommended Phase 2 dose (RP2D) of 0.8 mg/kg biweekly or 0.4 mg/kg weekly.1
At a median follow-up of 23.4 months, patients in the Q2W cohort demonstrated a median duration of response (DOR) of 17.5 months, with median DOR not reached in patients with complete response (CR) or better.1 For patients in the QW arm, a median follow-up of 29.8 months showed a median DOR of 9.5 months, with a median DOR of 28.6 months in patients with a CR or better.1
At 24 months, 67.1 percent and 60.6 percent of patients were alive from the two dosing cohorts, respectively.1
At a median follow-up of 20.5 months, talquetamab continued to show strong efficacy in patients with prior T-cell redirection therapy exposure, with 55.1 percent of patients achieving very good partial response (VGPR) or better and 57.3 percent alive at 24.2 months.1

Infection rates remained lower than in studies of B-cell maturation antigen (BCMA) targeted bispecific antibodies, consistent with previous reports.1
No increase in grade 3/4 infections was observed with longer follow-up.1
Weight loss, as assessed by vital signs, was evident early but stabilised and improved over time, including in patients with oral toxicities.1

Data from MonumenTAL-2 supports continued durable responses at one year, with investigational combination of talquetamab and pomalidomide, in patients with RRMM who had two or more prior lines of therapy.

Longer follow-up from the Phase 1b MonumenTAL-2 study of the investigational use of talquetamab and pomalidomide showed deep responses and a manageable safety profile in patients with RRMM and support the potential to combine talquetamab with an immunomodulatory agent (IMiD).2
These updated data, from the first study of a regimen combining a GPRC5D-targeted therapy and an immunomodulatory agent, were featured as a poster presentation at the 2024 EHA Congress.2

Dr. Leo Rasche, attending physician on the myeloma service, University Hospital of Würzburg said: “Results from the MonumenTAL-1 study continue to show deeper response levels and a longer duration of response in patients treated with either of the approved dose options of talquetamab, while the median overall survival has yet to be reached at two years. It is encouraging to see no notable increases in treatment-related discontinuations with this longer follow-up across cohorts.”

Edmond Chan, EMEA Therapeutic Area Lead Haematology at Johnson & Johnson Innovative Medicine said: “There remains a high unmet need for patients with heavily pretreated multiple myeloma as with each new line of therapy, patients tend to experience decreased responses, resulting in more frequent relapses. By targeting the novel receptor GPRC5D, and offering a biweekly dosing option, talquetamab plays an important role in the multiple myeloma treatment pathway. We remain focused on harnessing the potential of this pioneering therapy as we build on our ambition to transform outcomes for patients and eliminate cancer.”

References:

1 Rasche L, et al. Long-term efficacy and safety results from the Phase 1/2 MonumenTAL-1 study of talquetamab, a GPRC5DxCD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. Poster #P915. 2024 European Hematology Association Hybrid Congress. June 14, 2024.

2 Searle E, et al. Talquetamab, a GPRC5dxCD3 bispecific antibody, in combination with pomalidomide in patients with relapsed/refractory multiple myeloma: safety and efficacy results from the Phase 1b MonumenTAL-2 study. Poster #911. 2024 European Hematology Association Hybrid Congress. June 14, 2024.

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Joanna Harvey
Joanna Harvey
Marketing and Communication Executive | Uniphar Commercial

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