Release Date: 22-Apr-2023
Advancements in technology used in the pharmaceutical domain have enabled the development of several novel medicines and therapies having mechanisms unanticipated before. An example of this is Talquetamab, an antibody targeting GPRC5D, a novel drug target expressed on myeloma cells, identified recently. Cancer keeps evolving its survival methods, making it important to develop new therapies to counter its resistance mechanisms. Moreover, doctors and the patient populations have always welcomed therapeutic products having novel mechanisms of treatment, boosting the development of more novel therapies. Though GPRC5D does not have a clearly defined role in the human body, its overexpression in multiple myeloma is enough for it to be considered as a target. Talquetamab is under review by the major drug regulatory bodies FDA and EMA, and their responses are awaited.
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Talquetamab was developed by Janssen, a division of global pharmaceutical giant Johnson and Johnson, for the treatment of multiple myeloma, a form of cancer that damages plasma cells in the bone marrow. It is a bispecific antibody that binds both CD3, which is present on the surface of T cells, and GPRC5D, or the G protein-coupled receptor class C group 5 member D, which is present on the surface of myeloma cells. By engaging with both GPRC5D and CD3, Talquetamab recruits T cells to myeloma cells, which leads to the activation of T cells and subsequent killing of myeloma cells. Talquetamab has thus demonstrated strong anti-myeloma effectiveness in preclinical trials, even in cells which are refractory to conventional treatments.
Both Janssen and Johnson and Johnson are currently investigating Talquetamab in clinical studies for the treatment of multiple myeloma that has come back or become resistant to current treatment. In March 2021, Talquetamab was the subject of a phase 1b study involving patients who have relapsed or resistant multiple myeloma, and the companies reported encouraging findings. According to the trial, patients endured Talquetamab well and exhibited promising anti-tumor effectiveness, with a 69% overall rate of response in patients who were eligible for the clinical trials. Therefore, it is anticipated that Talquetamab may offer patients with multiple myeloma a new therapy option if it is approved, especially those who have tried and failed prior medications or have few other options.
Talquetamab has demonstrated promise in a number of ongoing clinical trials, including a Phase 3 study comparing it to the gold standard therapy for those with relapsed or refractory multiple myeloma, and is getting closer to receiving marketing approval. Janssen is also conducting a late phase clinical trial to assess the effectiveness of the candidate when combined with other modern and conventional treatments such as Darzalex (daratumumab), pomalidomide and dexamethasone.
In mid-2022, Johnson and Johnson announced that the US FDA granted the Breakthrough Therapy Designation to Talquetamab for use in the treatment of adult patients with recurrent or refractory multiple myeloma that have undergone a minimum of four previous lines of medical treatment, which includes an immune-modulating agent, a proteasome inhibitor, as well as an anti-CD38 antibody. This designation was supported by results obtained from the MonumenTAL-1 study of Talquetamab. In addition to this, Talquetamab was also given the Orphan Drug Designation by the agency in May 2021 as well as the PRIME status by the EU EMA in January 2021.
In January 2023, Johnson and Johnson announced that it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). In November 2022, the EMA also granted Johnson and Johnson accelerated evaluation for Talquetamab. In the same year, the company also submitted the Biologics License Application (BLA) to the US FDA in December 2022. All of these designations serve to highlight Talquetamab's potential as a multiple myeloma treatment. Talquetamab is attractive as a highly effective oral medication because it provides accessibility for the larger myeloma population of patients as well as healthcare providers. It is useful when other treatment alternatives have failed and has a controllable safety profile. It is also appealing and very useful for real-world practice to be capable to combine it with different general tactics to reach a larger patient base.