No other study participants in the trial had the same genotype. Ajai Chari, MD, discusses the safety and efficacy of talquetamab plus daratumumab in heavily pretreated patients with multiple myeloma, initial data from phase 1b TRIMM-2 trial, and the potential . Real-world clinical outcomes in patients with multiple myeloma treated with isatuximab after daratumumab treatment. Cancerous plasma cells make abnormal antibodies called M-proteins that do not protect the body from infections. Biotin sprays, gels, candies, you name it, she said. N Engl J Med. Also, I discourage patients from putting fans next to their bed, because a lot of patients would say they really noticed it was worse at night.. In total, 55.3% of patients experienced dysgeusia, 21.1% experienced dry mouth, and 22.4% experienced dysphagia. 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. Myeloma affects around 6,000 people in the United Kingdom every year, causing more thaneight deaths each day. Can diet help improve depression symptoms? (a median of six previous lines of therapy) or who could not receive these therapies without unacceptable side effects. James J. Driscoll, MD, PhD, and James Ignatz-Hoover, MD, PhD, share a perspective on a study published recently in ONCOLOGY. itching in the genital or other skin areas. Looking forward to more breakthroughs. 2023 Apr;29(3):722-726. doi: 10.1177/10781552231154809. 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. Background: 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. She [noted] that that would increase the incidence of fungal issues. Also, you can look at the national clinical trial registry athttps://clinicaltrials.govThe Phase 2 trial is number: NCT04634552. One thing that will happen, though, is that my talquetamab dose will be increased to make up for the change in schedule. Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody that targets GPRC5D. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. Now, talquetamab, or talq for short, is a bi-specific antibody against a target called GPRC5D. Would you like email updates of new search results? It is graphic, but it prepared patients for what to expect.. For now, the best preventative and therapeutic approaches to dermatologic and oral AEs have yet to be identified. Only one patient to date at our center, has discontinued treatment due to an oral or dermatologic side effect. Ive recently retired from a career as a CPA. 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 . Learn more here. Before 1. and transmitted securely. 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. Copyright 2022 HealthTree Foundation. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. Onco-Nursing Experts Define Best Practices, Treatment Considerations for Managing Patients With MPNs. Cancers (Basel). As with the oral reactions, Aronson acknowledged that no therapeutic interventions have been identified as best practice in addressing dermatologic reactions. Just under three-quarters of participants given a lower or higher dose of talquetamab in the Phase 2 portion of J&Js study responded to treatment, with around a third of each group achieving remission of their cancer. loss of voice. The primary end points - the frequency and type of dose-limiting toxic effects (study part 1 only . Doctors can treat and control the disease, but it is currently regarded as not curable. Find out how likely it is to occur and why it happens. My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. A standardized regimen of topical and oral supportive care appears to be beneficial in the management of . 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. 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 events in 75% of patients" All of the noted side effects, however, were considered manageable and reversible. And at the various doses, deep, ongoing responses were noted. runny or stuffy nose. Talquetamab (JNJ-64407564) is an investigational bispecific antibody. The years biggest meeting on blood diseases kicked off this past weekend. Of these, more than 30% had a complete response, meaning that, following treatment, the researchers could detect no myeloma-specific markers. Talquetamab is a CPRC5DxCD3 . This means that three-quarters of these patients are looking at a new lease on life, said Dr. Chari, of the Tisch Cancer Institute at Mount Sinai in New York. No modifications were caused by dry mouth. Serious side effects were reported in 8% of efgartigimod-treated patients and nearly 16% of those who received placebo, but none were deemed to be drug-related. 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. Over the course of the trial, 73% of patients responded positively to the drug. Lindsay Diamond, MSN, AGNP-C, AOCNP, discusses findings from CheckMate 274 and other data presented during the 2023 ASCO Genitourinary Cancers Symposium. Although T cells expressing CD38 might be attacked by AMG 424, this side effect is acceptable because the advantages outweigh the disadvantages . Our dermatologist recommended against do a nail soaks, she noted. Infections also occurred in more than . Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. Epub 2021 Aug 10. 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. Aronson E. Characterization and management of oral and dermatological toxicities in patients receiving the CD3 X GPRC5D bispecific antibody talquetamab for the treatment of relapsed/refractory multiple myeloma. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021. Copyright 2022 Massachusetts Medical Society. The safety data imply that no laboratory or cardiac monitoring is necessary with this drug. ORR at RP2D (405 g/kg SC) was 69% in 19 pts treated at this dose. Other than some minor fatigue and some of the normal side effects of being 66, Im feeling great! New data from an ongoing Phase 1/2 clinical trial has revealed an experimental immunotherapy led to successful response rates in 73% of patients suffering from multiple myeloma, a deadly form of blood cancer. Management of Relapsed-Refractory Multiple Myeloma in the Era of Advanced Therapies: Evidence-Based Recommendations for Routine Clinical Practice. Oncology nursing always has their finger on the pulse of the patients psychosocial [needs]. No, of course its nothing close to a cure. Overall, across all treatment groups the trial found 73% of subjects responded positively to the treatment. With talquetamab, only about half the patients make it to only a little more than a year before they relapse. Current treatment options for ITP, while [there] are many, can be associated with comorbidities, unsatisfactory efficacy and duration of effect, said Catherine Broome, a study author and associate professor of medicine at the Georgetown Lombardi Cancer Center in Washington, D.C., at an ASH press conference. There's been amazing progress in the area of immunotherapy. Generic Name. 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. . Talquetamab is a bispecific antibody, a type of monoclonal antibody that redirects T cells to act against myeloma cells. About two-thirds had skin-related side effects like rash, and around . The blood tests which measured my myeloma (M spike, IGG, free light chains) all stayed pretty stable. National Library of Medicine G protein-coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells. The most common AEs related to treatment with talquetamab include cytokine release syndrome (CRS), neurotoxicity, cytopenia, infections, skin and nail disorders, and oral toxicities. To explore the feasibility of talquetamab in the RRMM setting, a first-in-human phase I study of talquetamab in patients with RRMM was conceived (NCT03399799).The results were presented by Ajai Chari during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition 1 and are summarized below.. Study design 1. 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. Scientists use genetic rewiring to increase lifespan of cells. The median time to onset was 26.5, 6.7, and 41.5 days, respectively. Paul G. Richardson, MD, and Christina Gasparetto, MD, offer insights into the use of proteasome inhibitors in relapsed or refractory multiple myeloma. The same side effects that I mentioned are cytokine release syndrome. We tried several things. Data showed skin- and taste-related side effects were common, but typically rated mild. Both of those therapies bind to BCMA, a protein targeted by a wave of new drugs from Roche, Regeneron, AbbVie and Pfizer. So those are side effects of both bispecific antibodies and CAR-T cells. The researchers state that adverse side effects to talquetamab occurred "relatively frequently" but were most often mild. 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. Another important side effect was altered taste. Talquetamab is an IgG4 Fc-containing BsAb targeting G- protein-coupled receptor family C group 5 member D . Talquetamab (JNJ-64407564) is a bispecific IgG4 antibody that redirects T-cell killing to multiple myeloma cells by binding to the novel target, GPRC5D, and CD3. Lindsay Diamond Discusses Ongoing Role of Immunotherapy in Bladder Cancer. Beth Faiman Discusses Recent Changes in Multiple Myeloma Treatment Landscape. 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. For patients experiencing palmar/plantar desquamation, ammonium lactate lotion, and emollients have shown efficacy. FDA Grants FTD to Off-the-Shelf CAR T in R/R Multiple Myeloma. Through patient education tactics, oncology nurses can help patients with multiple myeloma mitigate the oral and dermatologic toxicities associated with talquetamab. The fast-advancing pipeline could expand options for multiple myeloma patients, but also raise questions about how treatments should be sequenced and how future drug trials might best be designed. Results At the data-cutoff date, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). This one, talquetamab, came up with some different side effects. 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. 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! (If you just need to know, that stands for G Protein-coupled Receptor class C Group 5 member D.). Duration of response is good too. A medrol dose (Pak) may be used for more severe cases. Kikuchi T, Tsukada N, Nomura M, Kasuya Y, Oda Y, Sato K, Takei T, Ogura M, Abe Y, Suzuki K, Ishida T. Ann Hematol. There are two problems: 1. side effects, and 2. the drugs stop working after a while. Patients would describe this as everything tasting like cardboard or sawdust, or that things that they used to enjoy now tasted completely different.. 2021 Oct;108(10S):S205-S212. Other clinical pearls, according to Aronson, include certain dietary modifications and early treatment of oral candida. lower back or side pain. Oral antihistamines and topical corticosteroids are useful in addressing a body rash and injection-site reactions. His interests focus on psychedelic science, new media, and science oddities. "It seems the total effect is a real drying effect. For full disclosures of the study authors, visit ash.confex.com. All rights reserved. In an early-phase trial, nearly three-quarters of patients who received talquetamaba first-in-class, off-the-shelf, T-cellredirecting bispecific antibody targeting both the GPRC5D and CD3 receptorsfor relapsed or refractory multiple myeloma saw a significant reduction in cancer burden within a few months. The researchers said very few patients (5 to 6 percent) stopped talquetamab treatment because of side effects. government site. Subscribe to the weekly "HealthTree Community for Myeloma Newsletter" for Myeloma news, life Were hoping that this will soon become available so that patients can benefit.. With bispecific antibodies, the way we give . The Expanding Clinical Role of Bifunctional Antibodies. If you follow a few myelomagroups on Facebook you might have seen a really gnarly picture of the hands of a patient in a Talquetamab trial. New York, NY. 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. One year later, data presented at ASH could help the company make the case for approval in another uncommon autoimmune disease: primary immune thrombocytopenia, or ITP. Last December, Argenx, a Dutch biotechnology company, won FDA approval for its first drug, securing clearance for Vyvgart in a rare condition known as generalized myasthenia gravis. I tell patients to take a lukewarm or cool shower, [to use] heavy lubricants, body oil, those kinds of thingsbecause the dryness is really severe. Nearly 60% had a very good partial response, meaning that their cancer was substantially reduced. Duration of delay from the last dose administered Action . Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target . Nurse Practitioners/Physician's Assistants, 2022 ASCO Genitourinary Cancers Symposium Urothelial Cancer Updates, Contemporary Concepts in Hematologic Oncology, Insights from Experts at Mayo Clinic on Translating Evidence to Clinical Practice, Optimizing Outcomes in Patients with HER2+ Metastatic Breast Cancer, | 2022 ASCO Genitourinary Cancers Symposium Urothelial Cancer Updates, | Contemporary Concepts in Hematologic Oncology, | Insights from Experts at Mayo Clinic on Translating Evidence to Clinical Practice, | Optimizing Outcomes in Patients with HER2+ Metastatic Breast Cancer. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). If you . Let BioPharma Dive's free newsletter keep you informed, straight from your inbox. . 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. Editors note: This story has been updated to clarify the status of Vertex and CRISPRs regulatory application. Each entry includes links to find associated clinical trials. Apalutamide Elicits PSA Response, Lowers Progression to Castration Resistant Disease in mCSPC, Nurse Investigators on Using Weighted Blankets to Alleviate Anxiety During Cancer Treatment Infusions, Best Practices on Managing AEs With Darolutamide Plus ADT/Docetaxel in mHPSC, Jessica MacIntyre on Improving LLS Referrals For Patients With Hematologic Malignancies. ABSTRACT 291: Phase I/II, first-in-human study of REGN5458 in 45 patients with relapsed and/or refractory multiple myeloma . One of these was the MonumenTAL-1 trial, which is a clinical trial for a newer bi-specific antibody called talquetamab, in patients with relapsed/refractory multiple myeloma. Disclaimer. The median duration of response was 10.2 months and 7.8 months, respectively. New therapies are urgently needed to help people with treatment-resistant disease., Dr. Marianne Baker, research information manager at Cancer Research UK. Please enable it to take advantage of the complete set of features! Clipboard, Search History, and several other advanced features are temporarily unavailable. The abnormal plasma cells are made from stem cells in the bone marrow. Some people may then receive a stem cell transplant, using their own or donor cells, to help them manufacture healthy blood cells. Other adverse events like bruising, headaches and blood in urine occurred at similar rates in both groups. Oyster mushrooms for cancer: Do they help?
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