. Here are three storylines to emerge so far. Oral and dermatologic TEAEs, though generally mild, present an opportunity for oncology nurses to improve patient quality of life. For patients experiencing palmar/plantar desquamation, ammonium lactate lotion, and emollients have shown efficacy. Patients enrolled in MomumenTAL-1 were assigned to a dose level and either the subcutaneous (n = 24; 31.6%) or intravenous (IV) dosing cohort (n = 52; 68.4%). The results of the phase 1 trial appeared in the New England Journal of Medicine, and the phase 2 trial results were presented at the annual meeting of the American Society of Hematology. And this will us the idea that, for example, if you've had a BCMA-directed CAR T cell, you still could be treated with a bispecific such as talquetamab. Tecvayli appeared well tolerated. Dr. Ajai Chari, director of clinical research in the Multiple Myeloma Program at The Tisch Cancer Institute and lead author of both studies, explained for Medical News Today how it works: Basically one side is binding to the immune cells known as T cells, and the other side is binding to the myeloma cancer cell, and when those T cells are brought into proximity of the cancer [] they release chemicals that poke holes in the cancer cell membrane and the cancer cells die., Dr. Baker was cautiously optimistic about the therapy: Talquetamab sticks to both cancer-killing immune cells and myeloma cells, helping the immune system to recognize and destroy the cancer. Phase trial confirmed a 70% response rate in patients with advanced disease. Talquetamab, an off-the-shelf product, targets both CD3 and a G protein-coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells. More than 30% of patients in both groups had a complete response or better, and nearly 60% had a very good partial response or better. The .gov means its official. Unauthorized use of these marks is strictly prohibited. Online ahead of print. (If you just need to know, that stands for G Protein-coupled Receptor class C Group 5 member D.). Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she . MeSH So those are side effects of both bispecific antibodies and CAR-T cells. However, research has not proven these mushrooms can prevent cancer. Topics covered: Gene replacement therapy, gene editing, engineered cell therapy, manufacturing, pricing, reimbursement and much more. Talquetamab is a CPRC5DxCD3 . As part of CancerNetworks Face-Off video series, Sikander Ailawadhi, MD, professor of medicine in the Division of Hematology/Oncology at the Mayo Clinic, Jacksonville, Florida, discussed results from the phase 1/2 MonumenTAL-1 trial (NCT04634552), designed to investigate talquetamab in heavily pretreated patients with relapsed/refractory multiple myeloma. Epub 2022 Dec 11. (Abstract #S188) and talquetamab (Abstract #S183) cohorts of the TRIMM-2 study will be featured as oral presentations at the European Hematology Association (EHA) 2022 Congress taking place in Vienna, . Immune checkpoints are a potential target for MM therapy since they are overexpressed in MM plasma cells . It seems the total effect is a real drying effect. Additionally, updated results show that 31 of 32 patients in the pivotal portion of lovo-cels trial havent had a painful episode known as a vaso-occlusive crisis through at least two years of follow-up. Looking forward to more breakthroughs. . . The response rate observed in the study, which Dr. Chari explained is higher than that for most currently accessible therapies, suggests talquetamab could offer a viable option for patients whose myeloma has stopped responding to most . But it is important to keep in mind that some of the side effects were a bit unique. sharing sensitive information, make sure youre on a federal So the researchers believe that talquetamab could offer a viable option for patients whose myeloma has stopped responding to other therapies. Talquetamab was designed to target the GPRC5Da receptor, which is highly present on cancerous plasma cells. Patients would describe this as everything tasting like cardboard or sawdust, or that things that they used to enjoy now tasted completely different.. No one is going to be cured with one treatment, said Craig Tendler, J&Js global head of oncology late clinical development, in an interview. Expand A new therapy that makes the immune system kill bone marrow cancer cells was successful in as many as 73 percent of patients in two clinical trials, according to researchers from The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. The Janssen Pharmaceutical Companies of Johnson & Johnson. About three-quarters of patients experienced cytokine-release syndrome, 60% experienced skin-related side effects such as rash, about half reported taste changes, and about half reported nail disorders. Krina Patel, MD, MSc, discusses research and initiatives that may help to mitigate disparities in patients with multiple myeloma including factors such as gender, race, and ethnicity. Both of those therapies bind to BCMA, a protein targeted by a wave of new drugs from Roche, Regeneron, AbbVie and Pfizer. For now, the best preventative and therapeutic approaches to dermatologic and oral AEs have yet to be identified. Known as a bispecific T-cell engager antibody, this treatment is a relatively new kind of immunotherapy approach. The study participants had all been previously treated with at least three different therapies without achieving lasting remission, suggesting talquetamab could offer new hope for patients with hard-to-treat multiple myeloma. But neither are expected to give the cash-strapped company significant revenue, making a third program for sickle cell disease crucial to its future. Talquetamab is a BiTE binding GPRC5D and CD3. We tried several things. with The bottom line is that almost 70% of heavily pre-treated triple+ refractory patients responded! View duration, location, compensation, and staffing details. a condition causing fever, vomiting, shortness of breath, headache and low blood . The results suggest that talquetamab could give hope to patients with refractory myeloma. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. We need options for those patients, said Ajai Chari, a study author and hematologist from the Tisch Cancer Institute at Mount Sinai in New York, in a press conference held by ASH. Conclusions: The most recent data on BiTE antibodies in RRMM has shown promising results with good . The American Society of Hematologys annual conference is the years biggest stage for the most consequential research in treating blood diseases, attracting doctors, drugmakers and investors eager to vet the latest clinical trial results. Many [of these] patients reported rapid improvement once we treated them.. FOIA Editors note: This story has been updated to clarify the status of Vertex and CRISPRs regulatory application. The side effects are troubling, some require hospitalization, especially because of infections. So after a month, I was pretty low about talquetamab. Clin Lymphoma Myeloma Leuk. Few side effects, though. Oncology On-The-Go Podcast: Multiple Myeloma Outcome Disparities, Trial Access. Many of those with a very good partial response had a 90% improvement., He told MNT that phase 3 trials are now underway using a the 2-weekly dosing pattern. More than 7 days . ASH 2021: Update on Talquetamab (Plain English Version), Soporte Para Pacientes de Mieloma Mltiple, University of Miami's Minimal Residual Disease (MRD) Meeting, Sequencing BCMA Therapies with Dr. Joshua Richter, Treating Multiple Myeloma by Exploding Cancerous Cells, Defining Your Risk of Progression With Smoldering Myeloma, Cevostamab, a New Bispecific Antibody for Refractory/Relapsed Multiple Myeloma, Blood-Based Single Cell Sequencing Holds the Key to Better Treatment Outcomes, Clinical Trial: Patient and Care Partner Experiences Living with Multiple Myeloma, HealthTree Coach has a New & Improved Website. Talquetamab had moderate side effects. Talquetamab is a bispecific antibody, a type of monoclonal antibody that redirects T cells to act against myeloma cells. Would you like email updates of new search results? Heres the joy part. We are getting into the realm of treatment in myeloma where the newer drugs are sometimes coming up with unique side effects. Last Updated: 12/19/2022 12:57:45 PM. The https:// ensures that you are connecting to the Teclistamab in Relapsed or Refractory Multiple Myeloma. Additionally, Shain said that patients on other BiTE therapies may experience an increased risk of infection, as well as rashes, nail issues, loss of taste and other side effects all of which should be brought up to the health care team to ensure that patients can remain on therapy. Earlier in 2022, based on preliminary positive trial data, the FDA granted talquetamab Breakthrough Therapy designation. We've talked about this, but just to . Track your myeloma and find treatment options, Journal your myeloma story in video, audio and writing, Learn from 150+ myeloma experts in video lessons, Find a free personal coach to help navigate your myeloma, Join our new social media app for myeloma patients, Tackle challenges and crush your fitness goals together, Stay up-to-date with thousands of myeloma news articles, Listen to one-on-one interviews with experts on clinical trials, Attend in-person meetings with myeloma experts, Join community groups with other patients and caregivers, Answer survey questions to advance myeloma research, Find answers to commonly asked questions when navigating HealthTree services. The phase 1 MonumentTAL-1 trial (NCT03399799) found that the recommended phase II dose (RP2D) of talquetamab was durable and continuous compared with a subcutaneous dose, producing an overall response rate of 70%, especially in triple-refractory (65.2%) and penta-refractory (83.3%) patients with relapsed/refractory (R/R) multiple myeloma, in a presentation during the 2021 virtual American . Side effects, CRS, but also I wanted to point out, unique to this target, we also saw nail toxicity, because GRC5D is expressed on keratinized tissue, also dysgeusia, which, which is a little . News release. Approximately 74% of patients receiving 0.4 mg/kg of talquetamab weekly and 73% of those receiving 0.8 mg/kg every other week saw a measurable improvement of their cancer following treatment, the primary endpoint for the trials second phase. Also, you can look at the national clinical trial registry athttps://clinicaltrials.govThe Phase 2 trial is number: NCT04634552. The researchers state that adverse side effects to talquetamab occurred "relatively frequently" but were most often mild. The researchers said very few patients (5 to 6 percent) stopped talquetamab treatment because of side effects. While Phase 1 trials are for the purpose of determining safety and dosage, they do yield results on side effects and efficacy as well. This is the new unmet need in multiple myeloma.. In addition to various side effects including Cytokine Release Syndrome (SRS) which are seen in many targeted therapies, Talquetamab causes some skin related and nail disorder adverse eventsin 75% of patientsAll of the noted side effects, however, were considered manageable and reversible. Data showed skin- and taste-related side effects were common, but typically rated mild. Many myeloma treatments (CAR-T, BLENREP, other bi-specifics, etc) target BCMA, an antigen found on 80-100% of myeloma cells. Federal government websites often end in .gov or .mil. Beth Faiman, PhD, CNP, discusses reclassifying patients with multiple myeloma, the accelerated approval of teclistamab, and the removal of belantamab mafodotin from the US market. Notably, among a group of patients who had either previously had cell therapy or another bispecific antibody, 63% responded to treatment with talquetamab. Subscribe to the BioPharma Dive free daily newsletter, Subscribe to BioPharma Dive for top news, trends & analysis, The free newsletter covering the top industry headlines, National Institutes of Allergy and Infectious Diseases. One of the things that I think is very telling with efgartigimod is, no matter what subgroup we looked at, it showed a benefit over placebo, said Broome. Dermatologic TEAEs were reported by 48.7% (n = 37) of patients in this trial. CRS and cytopenia were primarily observed in early cycles and were reversable. Epub 2022 Jun 5. Other treatments target the symptoms to improve the patients quality of life. Approximately 75% experienced cytokine release syndrome, which is known to be a common side effect of immunotherapy and includes symptoms such as fever development. The primary endpoint of the study was met.
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