Epub 2021 Aug 10. Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody that targets GPRC5D. Oyster mushrooms for cancer: Do they help? . Side effects with talquetamab were meanwhile relatively frequent, but typically mild. Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target . Another anti-CD38/CD3 BiTE . Victoria R. Crowder, BSN, RN, and co-investigators, highlight existing gaps in the understanding of malnutrition risks facing patients with acute myeloid leukemia and myelodysplastic syndromes. Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she concluded. HHS Vulnerability Disclosure, Help The median duration of response was 10.2 months and 7.8 months, respectively. Bethesda, MD 20894, Web Policies Copyright 2022 HealthTree Foundation. Researchers are continuing to collect data on the duration of response in the group receiving 0.8 mg/kg every other week and for patients in both dosing groups who had a complete response or better. Presented at: International Myeloma Society 6th Annual Nursing Symposium; August 25-27, 2022; Los Angeles, CA. A small study pairing Talquetamab with Daratumamab on heavily pre-treated patientseven patients whod already had BCMA targeted therapies (both CAR Tand BlenRep)even patients refractory to CD38 targeted therapy (daratumamab)showed efficacy similar to the single agent study! Get the free daily newsletter read by industry experts. Janssen is responsible for the development and commercialization of talquetamab. Were looking at all of that, to try to figure out how to optimize the combination of these drugs in a highly effective regimen, said Tendler. We've talked about this, but just to . Verkleij CPM, Broekmans MEC, van Duin M, Frerichs KA, Kuiper R, de Jonge AV, Kaiser M, Morgan G, Axel A, Boominathan R, Sendecki J, Wong A, Verona RI, Sonneveld P, Zweegman S, Adams HC, Mutis T, van de Donk NWCJ. These arent people with many options remaining, so in that setting 50% improvement is fantastic, he added. Expand Although T cells expressing CD38 might be attacked by AMG 424, this side effect is acceptable because the advantages outweigh the disadvantages . Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martnez-Lpez J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. Multiple myeloma is a cancer of plasma cells. Cancers (Basel). (December 10, 2021) Mount Sinai scientists have become the first to report a potentially serious side effect related to a new form of immunotherapy known as CAR-T cell therapy, which was recently approved for the treatment of multiple myeloma. The years biggest meeting on blood diseases kicked off this past weekend. Should it win an OK, talquetamab would join a cell therapy and another, recently cleared bispecific antibody in J&Js portfolio of multiple myeloma treatments. This activates an immune response to destroy myeloma cells by bringing T cells to the cancer, a strategy that researchers described as bringing your army to the enemy. It also uses a different target than other approved therapies; in this case, the target is a receptor expressed on the surface of cancer cells known as GPRC5D. And then there's another variety of CAR-T cell toxicity called neurologic toxicity, which has been really tough to handle in the rare cases where it's severe. NS-001. Background: Talquetamab is under investigation in clinical trial NCT04634552 (A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma). Immune checkpoints are a potential target for MM therapy since they are overexpressed in MM plasma cells . These cells, made in the bone marrow, are a vital part of the immune system. Ive been on pretty much every approved drug regimen and theyve all worked really well for me. and transmitted securely. Other treatments target the symptoms to improve the patients quality of life. And a new kind of drug from Argenx was included in the meetings highlights, with updated results detailing another potential use of the biotechnology companys medicine. It also featured important updates on Bluebird bios gene therapy for beta thalassemia and sickle cell disease, data for which have been a conference mainstay for nearly a decade. The primary objectives were to identify the recommended phase 2 doses (RP2Ds) (part 1) and assess talquetamab's safety and tolerability at the RP2Ds (part 2). Nurses should encourage patients to incorporate thin liquids into their diet. Can diet help improve depression symptoms? 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 . 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. Clin Lymphoma Myeloma Leuk. Few side effects, though. This allowed the treatment priority and accelerated pathways through approval processes. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional. Other most common side effects are reported in table. And responses tended to deepen over time. Looking forward to more breakthroughs. Hitting GPRC5D made its first splash as part of a preclinical Juno/Celgene Car-T therapy back at Ash 2018, and though it took a long time for this asset to enter the . The Talquetamab / Daratumumab trial. Copyright 2022 Massachusetts Medical Society. 5. A low blood cell count, called cytopenia, was among the most common adverse events . We would prescribe an ammonium lactate lotion to help with that turnover and also recommend a very heavy moisturizer [such as] Aquaphor or vanicream.. sneezing. They simultaneously plant a target flag on cancer cells and give immune cells a roadmap to that target. The number of patients it will impact is difficult to quantify and likely modest, Foroohar added, but still real.. . painful or difficult urination. Accessed August 25, 2022. MNT is the registered trade mark of Healthline Media. Between the Lines Podcast: Updates in Use of Proteasome Inhibitors for Relapsed/Refractory Multiple Myeloma. Talquetamab is one of several new drugs in the hopper that are giving us triple+ refractory myelomapatients a heart full of hope. 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. The primary end points - the frequency and type of dose-limiting toxic effects (study part 1 only), adverse events, and laboratory abnormalities - were assessed in order to select the recommended doses for a phase 2 study. Earlier in 2022, based on preliminary positive trial data, the FDA granted talquetamab Breakthrough Therapy designation. One dose-limiting toxic effect of grade 3 rash was reported in a patient who had received talquetamab at the 800-g dose level. In total, 165 patients were enrolled in the trial. The idea behind bispecific antibodies is they work to bridge immune cells with cancer cells. Data showed skin- and taste-related side effects were common, but typically rated mild. Tecvayli appeared well tolerated. MeSH The most common side effects were neutropenia (40%), anemia (28%), and thrombocytopenia (20%). Epub 2022 Jun 5. A standardized regimen of topical and oral supportive care appears to be beneficial in the management of . The side effects are troubling, some require hospitalization, especially because of infections. Lindsay Diamond, MSN, AGNP-C, AOCNP, discusses findings from CheckMate 274 and other data presented during the 2023 ASCO Genitourinary Cancers Symposium. Overall, with both oral and dermatologic therapies, Aronsons best advice is hydration. Rich completed his Masters degree in the Arts back in 2013 before joining New Atlas in 2016. You can use your HealthTree data to see if you qualify to join a talquetamab trial. The EQ-5D-5L is a generic measure of health status. This is a whole new era of cancer therapy, Dr. Chari said. The site is secure. They were very impressive results with deeper responses in heavily pretreated patients. (If you just need to know, that stands for G Protein-coupled Receptor class C Group 5 member D.). But there are six trials recruiting! The Expanding Clinical Role of Bifunctional Antibodies. Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. DB16678. The drug produced a substantial response, with only low-grade side effects, in 70% of the patients. (2016). We've been so busy adding drugs to the arsenal that [were] catching up to figure out the right sequences and unanswered questions.. Anti-PD1. Retrieved from, JMJ Launches Free Toolbox Talks App to Make Safety Accessible to All, Azzur Group Hosts Groundbreaking for Devens, MA Cleanrooms on Demand Facility, Vial VP of Business Development, Daniel Gallagher, to Present at Precision in Clinical Trials , Vivera Secures United Kingdom Patent for Innovative ZICOH Smart Inhaler Device, By signing up to receive our newsletter, you agree to our. Thanks for the information in this one in particular. Through patient education tactics, oncology nurses can help patients with multiple myeloma mitigate the oral and dermatologic toxicities associated with talquetamab. Some people may then receive a stem cell transplant, using their own or donor cells, to help them manufacture healthy blood cells. These are patients whove had typically five lines of therapy over several years. SOHO State-of-the-Art Updates and Next Questions | BCMA-Directed CAR T-Cells: Early Results and Future Directions. Dr. Chari explained: A complete response isnt actually a cure but its basically getting it down to a level where its undetectable. In the last week of the first cycle, I checked my plasmocytoma on Saturday and it seemed a little smaller. . Last year at ASH, I studied andlearned more about anew bi-specific antibody drug called talquetamab. Oral TEAEs were common in the trial with 57.9% of patients (n = 44) experiencing a grade 1 or 2 oral AE. Dermatologic TEAEs were reported by 48.7% (n = 37) of patients in this trial. "Talquetamab induced a substantial response among patients with heavily pretreated, relapsed, or refractory multiple myeloma, the second-most-common blood cancer. The most common side effects reported in the clinical trial for Tecvayli were hypogammaglobulinaemia (a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high), cytokine release syndrome (CRS) (i.e. New blood cancer therapy successful in three-quarters of trial patients, The new treatment is currently under application for review by the FDA. By The ASCO Post Staff PMC There are currently three FDA-approved bispecfiic antibody therapies on the market (primarily targeting cancers), and more than 100 prospective antibodies in clinical trials (aimed at everything from Alzheimer's to diabetes). FDA Pauses Trial Evaluating MT-0169 in R/R Multiple Myeloma and Lymphoma. 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. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid. Editors note: This story has been updated to clarify the status of Vertex and CRISPRs regulatory application. Initial treatment for multiple myeloma may involve chemotherapy, immunotherapy, and corticosteroid treatment. Many [of these] patients reported rapid improvement once we treated them.. itching in the genital or other skin areas. 1. . This one, talquetamab, came up with some different side effects. . 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. Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects. Multiple myeloma is a cancer of plasma cells. Topics covered: Drug commercialization, pharma salesforces, generic and biosimilar competition, drug advertising and much more. Biotin sprays, gels, candies, you name it, she said. Hydrate, hydrate, hydrate, she said. Let BioPharma Dive's free newsletter keep you informed, straight from your inbox. No, of course its nothing close to a cure. Talquetamab (JNJ-64407564) binds to GPRC5D and CD3 to induce T-cell . In addition, several other studies are underway to assess the use of talquetamab in combination with other existing and investigational multiple myeloma therapies, which could allow patients to have similar or improved benefits, potentially in earlier stages of treatment. The appearance of Johnson & Johnson's talquetamab in this year's Ash press programme will highlight GPRC5D blockade as an important new mechanism in treating multiple myeloma. Side effects include: Thrombocytopenia with . My doc said he will put me on CAR-T when the Talquetamab fails. The most common AEs related to treatment with talquetamab include cytokine release syndrome (CRS), neurotoxicity, cytopenia, infections, skin and nail disorders, and oral toxicities. 2023 Apr 28. doi: 10.1007/s00277-023-05218-1. Oncology On-The-Go Podcast: Multiple Myeloma Outcome Disparities, Trial Access. According to Aronson, this is an agent with an exciting efficacy profile for a population of patients facing a poor prognosis; at the European Hematological Association Congress 2022, the updated phase 1 findings from the trial showed an overall response rate of 64% to 70%. Talquetamab (JNJ-64407564) Several studies are exploring bispecific mAbs with antigen target different from BCMA. 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. Apr 28, 2023 11:39am. FDA Grants FTD to Off-the-Shelf CAR T in R/R Multiple Myeloma. After initial priming, patients received either weekly or biweekly dosing throughout the study duration. There are two problems: 1. side effects, and 2. the drugs stop working after a while. Endometrial stromal sarcoma (ESS) is a rare form of uterine cancer that typically affects people during or after menopause. And it is also important to note that different doses were tested, and the appropriate dose was selected. doi: 10.1016/j.bulcan.2021.10.003. The results suggest that talquetamab could give hope to patients with refractory myeloma. ATLANTA, Ga., December 11, 2021- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of talquetamab (NCT03399799).Talquetamab is the only investigational off-the-shelf T cell redirecting bispecific antibody in clinical development targeting both GPRC5D, a novel multiple myeloma target . Ive recently retired from a career as a CPA. 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. A standardized regimen of topical and oral supportive care appears to be beneficial in the management of . When patients are having taste changes, and their wife is in tears saying I want him to eat, he wont eat, what do I do? Thats where we really can come in and help., Aronson is a clinical nurse practitioner specializing in bone marrow transplant and immune effector cell therapies at Mount Sinai Hospital. Study results presented on Saturday and published in The New England Journal of Medicine suggest it could be the next promising drug to emerge in multiple myeloma an area already of intense drugmaker interest. Talquetamab is a CPRC5DxCD3 . 2023 Mar 17;15(6):1819. doi: 10.3390/cancers15061819. At the time of data cut-off, 76 patients had been enrolled in the trial at Mount Sinai Hospital. or who could not receive these therapies without unacceptable side effects. 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. However, research has not proven these mushrooms can prevent cancer. The researchers said very few patients (5-6%) stopped talquetamab treatment because of side effects. The safety data imply that no laboratory or cardiac monitoring is necessary with this drug. They can have a limited impact on quality of life measures.. My mother has been in a talquetamab trial about 2 months now and has also experienced loss of taste and also loss of smell, dry mouth, swallowing . Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. Infections also occurred in more than half of patients on each drug dose, with 17% and 12% respectively graded as more severe. Cure Hub Side Effect Solutions My Journal University Coach Connect . Topics covered: Gene replacement therapy, gene editing, engineered cell therapy, manufacturing, pricing, reimbursement and much more. Talquetamab. 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. 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. Anemia, in this context, can be worrisome as a potential sign of emerging blood cancer. Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. Dima D, Ullah F, Mazzoni S, Williams L, Faiman B, Kurkowski A, Chaulagain C, Raza S, Samaras C, Valent J, Khouri J, Anwer F. Cancers (Basel). (Its also found on hairfollicle cells but dont worry youre not going to lose your hair again.) (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, . 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. "Hydrate, hydrate, hydrate," she said. with Side-Effects of Talquetamab At the time of the data cut-off, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). In this video: Dr. Jesus Berdeja (Sarah Cannon Center for Blood Cancers, Nashville, TN, USA) presents updated results of patients treated at the recommended phase II dose in the first . The gist was that the temporary side effect was nothing if the drug works! Effects of teclistamab and talquetamab on soluble BCMA levels in patients with relapsed/refractory multiple myeloma Blood Adv . The Janssen Pharmaceutical Companies of Johnson & Johnson. (a median of six previous lines of therapy) or who could not receive these therapies without unacceptable side effects. lower back or side pain. Many patients who reported burning, glossitis, we would treat for candida because our [ear nose and throat] ENT doctor felt that in the setting of such severe dryness, they may not present with oral plaques. Talquetamab fo Multiple Myeloma. FDA/EMA Accept Ide-Cel Applications for Earlier R/R Multiple Myeloma Use. Like BCMA, Talquetamabs target, GPRC5D, is found on most myeloma cells. 2023 Apr;29(3):722-726. doi: 10.1177/10781552231154809. The response rate observed in the study, which Chari explained is higher than that for most . In a separate cohort, 51 patients who had previously received therapies that redirect T cells showed a response to talquetamab. The disease, which affects around one in 132 people in the United States, is rarely diagnosed in people under the age of 65. Of these, dysgeusia, dry mouth, and dysphagia were the most experienced symptoms. Intuitive Surgical collects new prostate procedure clearances for its single-port robot. It is graphic, but it prepared patients for what to expect.. While Phase 1 trials are for the purpose of determining safety and dosage, they do yield results on side effects and efficacy as well. Read on for details and takeaways from the meeting over the weekend: Like many new drug targets, its name is complicated and better off abbreviated. Their findings were published as a case study in Nature Medicine in December. Children and Cancer . Generic Name. The Phase 2 trial data has yet to be formally published in a peer-reviewed journal, however, the Phase 1 data has just been published in The New England Journal of Medicine. Specific Cancers. Lindsay Diamond Discusses Ongoing Role of Immunotherapy in Bladder Cancer. . Taste changes were very common, Aronson said. 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. "It seems the total effect is a real drying effect. This site needs JavaScript to work properly. New York, NY. National Library of Medicine Only one patient to date at our center, has discontinued treatment due to an oral or dermatologic side effect. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Kerry Boyle D.Ac., M.S., L.Ac., Dipl.
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