2023 Apr 5;15(7):2160. doi: 10.3390/cancers15072160. This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03158688) in the KdD - Carfilzomib, Dexamethasone and Daratumumab ARM group. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid. 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. But it is important to keep in mind that some of the side effects were a bit unique. Methods: 2022 Dec 15;387(24):2287-2290. doi: 10.1056/NEJMe2208708. All participants had received at least three prior treatments, including other types of drugs. A biologics license application has been submitted to the FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma. The recently announced Phase 1/2 talquetamab trial data covered several hundred multiple myeloma patients, spanning two different doses and either weekly or fortnightly dosing schedules. In a phase 1 study, we evaluated talquetamab administered intravenously weekly or every other week (in doses from 0.5 to 180 g per kilogram of body weight) or subcutaneously weekly, every other week, or monthly (5 to 1600 g per kilogram) in patients who had heavily pretreated relapsed or refractory multiple myeloma that had progressed with established therapies (a median of six previous lines of therapy) or who could not receive these therapies without unacceptable side effects. Duration of response is good too. Apr 28, 2023 11:39am. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. The most common AEs related to treatment with talquetamab include cytokine release syndrome (CRS), neurotoxicity, cytopenia, infections, skin and nail disorders, and oral toxicities. Cure Hub Side Effect Solutions My Journal University Coach Connect . The primary end points - the frequency and type of dose-limiting toxic effects (study part 1 only . Accessibility Bluebird believes lovo-cel may exacerbate the problems linked to alpha thalassemia trait. Nurses should encourage patients to incorporate thin liquids into their diet. This is the new unmet need in multiple myeloma.. Sikander Ailawadhi, MD, discussed the safety and efficacy of talquetamab in heavily pretreated patients with relapsed/refractory multiple myeloma following a readout of the phase 1/2 MonumenTAL-1 trial. If you . A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy Here are three storylines to emerge so far. . Earlier in 2022, based on preliminary positive trial data, the FDA granted talquetamab Breakthrough Therapy designation. In total, 55.3% of patients experienced dysgeusia, 21.1% experienced dry mouth, and 22.4% experienced dysphagia. But of course nothing works forever. Talquetamab for Multiple Myeloma Clinical Trial 2023 | Power Few side effects, though. sharing sensitive information, make sure youre on a federal I just get excited when I attend ASH and I see so many stellar people doing what seem to be super-human things by coming up with these life-lengthening miracles that just might possibly keep me alive until theres a cure. Other treatments target the symptoms to improve the patients quality of life. Argenx is developing a subcutaneous version of efgartigimod and expects to have results from a Phase 3 study testing that formulation in the second half of 2023. Intuitive Surgical collects new prostate procedure clearances for its single-port robot. Bispecific T cell engagers: an emerging therapy for management of Our dermatologist recommended against do a nail soaks, she noted. The authors concluded that the dose-escalation part of this first-in-human phase I/II study showed that subcutaneous epcoritamab had a manageable safety profile, with no grade 3 or higher CRS events, and induced robust single-agent antitumour activity in heavily pretreated patients. Presented at: European Hematology Association Congress 2022; June 9-12, 2022; Vienna, Austria. Onco-Nursing Experts Define Best Practices, Treatment Considerations for Managing Patients With MPNs. GPRC5D has limited expression on healthy human tissue but is highly expressed on malignant myeloma cells. loss of voice. Whats exciting is these are patients who are in their late 60s that have had so many prior therapies we wouldnt even think that their immune cells would work very well because theyve been so beaten up by all of these treatments. Subscribe to the weekly "HealthTree Community for Myeloma Newsletter" for Myeloma news, life 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. Usmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Lancet. No unexpected side effects were seen with this association. Recent advances in the treatment of multiple myeloma The same side effects that I mentioned are cytokine release syndrome. Some people may then receive a stem cell transplant, using their own or donor cells, to help them manufacture healthy blood cells. You? ASH 2022: Talquetamab generates high response rate in patients with As their number increases, the number of red blood cells, white blood cells and platelets, which are made from the same type of stem cell, decreases. Through patient education tactics, oncology nurses can help patients with multiple myeloma mitigate the oral and dermatologic toxicities associated with talquetamab. scaling of the skin. Oncology nursing always has their finger on the pulse of the patients psychosocial [needs]. SGO 2023 Annual Meeting on Womens Cancer, FDA Approves Polatuzumab Vedotin-piiq Plus R-CHP for Previously Untreated DLBCL Not Otherwise Specified and High-Grade B-Cell Lymphoma, Exercise and Wellness Programs May Enhance Well-Being and Reduce Health-Care Costs in Patients With Breast Cancer, Does Surveillance Mammography Benefit Geriatric Patients With Breast Cancer, Intraoperative vs Postoperative Lymph Node Pathology Evaluation in Patients With Breast Cancer Undergoing Mastectomy, Subcutaneous vs Intravenous Rituximab in First-Line Treatment of LowTumor Burden Follicular Lymphoma. Oral and Dermatologic Toxicities Associated With Talquetamab Can Be Results At the data-cutoff date, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). New blood cancer therapy successful in three-quarters of trial patients, The new treatment is currently under application for review by the FDA. This one, talquetamab, came up with some different side effects. You can use your HealthTree data to see if you qualify to join a talquetamab trial. doi: 10.1016/j.bulcan.2021.10.003. The Janssen Pharmaceutical Companies of Johnson & Johnson. There's been amazing progress in the area of immunotherapy. All rights reserved. In her role, Aronson cares for patients enrolled in the phase 1 MonumenTAL-1 trial (NCT03399799), a dose-escalation/dose-expansions study seeking to characterize the safety profile and recommended phase 2 dose for talquetamab in patients with multiple myeloma who either have relapsed/refractory disease or are ineligible for other available treatment options.2. Phase trial confirmed a 70% response rate in patients with advanced disease. Oral antihistamines and topical corticosteroids are useful in addressing a body rash and injection-site reactions. It also binds CD3, a protein on the surface of immune T-cells. 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. Get access to cutting edge treatment via Talquetamab, Daratumumab, Teclistamab. For patients experiencing palmar/plantar desquamation, ammonium lactate lotion, and emollients have shown efficacy. official website and that any information you provide is encrypted Get the free daily newsletter read by industry experts. Side effects include: Thrombocytopenia with . Reducing Medical and Other Debt Through Negotiation, Getting Fit and Keeping Bones Safe (Live Exercise Demo), SouthEast Myeloma Community- Understanding Immunotherapy. Of these, more than 30% had a complete response, meaning that, following treatment, the researchers could detect no myeloma-specific markers. The drug produced a substantial response, with only low-grade side effects, in 70% of the patients. MonumenTAL-1 trial Shows Promise With Talquetamab in R/R Myeloma 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Ive been on pretty much every approved drug regimen and theyve all worked really well for me. There are two problems: 1. side effects, and 2. the drugs stop working after a while. Recent updates on bispecific T-cell engager (BiTE) antibodies in Overall, with both oral and dermatologic therapies, Aronsons best advice is hydration. Initial treatment for multiple myeloma may involve chemotherapy, immunotherapy, and corticosteroid treatment. a condition causing fever, vomiting, shortness of breath, headache and low blood . We tried several things. Accessed August 25, 2022. Sequencing is really important, and it's probably the thing that we do the least well in myeloma, he said at the press conference. So patients, hopefully, will have a new and very exciting different opportunity coming up for the treatment of relapsed or refractory multiple myeloma. Talquetamab is a CPRC5DxCD3 . This is a list of most of the side effects I've had since I started talquetamab. A medrol dose (Pak) may be used for more severe cases. Specific Cancers. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. After becoming refractory to available therapies, median overall survival is 6-11 months. ASH 2021: Update on Talquetamab - HealthTree for Myeloma This is a target that is present on plasma cells and has come up as a newer target that can be exploited for disease control. Copyright 2022 Massachusetts Medical Society. The study enrolled a total of 288 patients who were unable to tolerate existing therapies or who experienced disease progression after at least three multiple myeloma therapies. ABSTRACT 291: Phase I/II, first-in-human study of REGN5458 in 45 patients with relapsed and/or refractory multiple myeloma . But if you remember the picture, perhaps you also remember the comment from the patient. Other than some minor fatigue and some of the normal side effects of being 66, Im feeling great! Online ahead of print. itching in the genital or other skin areas. We're not used to seeing that, but something important to keep in mind. It was pretty gross. Anemia, in this context, can be worrisome as a potential sign of emerging blood cancer. The bottom line is that almost 70% of heavily pre-treated triple+ refractory patients responded! Topics covered: Drug commercialization, pharma salesforces, generic and biosimilar competition, drug advertising and much more. We've had, for example, a drug with ocular or eye toxicity. 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 . Dr. Chari explained: Myeloma response means [] theres a 50% reduction in the myeloma level, so if its less than 50% it is not considered a response and when you submit to the [Food and Drug Administration], and when they look at regulatory approval, its 50% or higher. (Funded by Janssen Research and Development; MonumenTAL-1 ClinicalTrials.gov number, NCT03399799.). MNT is the registered trade mark of Healthline Media. Teclistamab (Tecvayli) for the Treatment of Multiple Myeloma Bluebird also expects to file for approval early next year, and bolstered its case at ASH with a presentation intended to distance its gene therapy from two cases of persistent anemia among patients in its clinical trial. Talquetamab is one of several new drugs in the hopper that are giving us triple+ refractory myelomapatients a heart full of hope. 2023 May;23(5):310-321. doi: 10.1016/j.clml.2023.01.017. The https:// ensures that you are connecting to the Infections also occurred in more than half of patients on each drug dose, with 17% and 12% respectively graded as more severe. Disclaimer. My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. A tolerable side-effect profile was observed in patients previously treated with anti-BCMA treatment, . Presented at: International Myeloma Society 6th Annual Nursing Symposium; August 25-27, 2022; Los Angeles, CA. Talquetamab: Uses, Interactions, Mechanism of Action - DrugBank Talquetamab, a bispecific antibody against CD3 and GPRC5D, redirects T cells to mediate killing of GPRC5D-expressing myeloma cells. And at the various doses, deep, ongoing responses were noted. Facebook Known in full as G protein-coupled receptor, family C, group 5, member D, the protein found on cancerous plasma cells drew attention over the weekend as Johnson & Johnson unveiled new data for an experimental multiple myeloma treatment. FDA Grants FTD to Off-the-Shelf CAR T in R/R Multiple Myeloma. In patients with multiple myeloma, GPRC5D is overexpressed and . A Promising New Treatment Emerges For Multiple Myeloma Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. Janssen is responsible for the development and commercialization of talquetamab. [Bispecific antibodies in multiple myeloma]. 2023 Apr 28. doi: 10.1007/s00277-023-05218-1. Talquetamab Study in RRMM | Int'l Myeloma Foundation "Human natural killer cell" [Micrograph]. Bethesda, MD 20894, Web Policies The safety data imply that no laboratory or cardiac monitoring is necessary with this drug. Bispecific Antibody Platform: Early Data in Relapsed and Refractory Cancerous plasma cells make abnormal antibodies called M-proteins that do not protect the body from infections. At the two recommended subcutaneous doses for a phase .
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