The abnormal plasma cells are made from stem cells in the bone marrow. Click here for details. G protein-coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells. It isexcitingnot only because it isa bi-specific(important enough in itself) butalsobecause it involves a target not being used in any othermyelomadrugsso far. New blood cancer therapy successful in three-quarters of trial patients, The new treatment is currently under application for review by the FDA. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). June 29, 2022. Bookshelf Teclistamab, a B-cell maturation antigenCD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. And here were seeing responses of like 70 to 100%. Infections also occurred in more than . No, of course its nothing close to a cure. Initial treatment for multiple myeloma may involve chemotherapy, immunotherapy, and corticosteroid treatment. Other adverse events like bruising, headaches and blood in urine occurred at similar rates in both groups. Background: Intuitive Surgical collects new prostate procedure clearances for its single-port robot. In this instance, talquetamab binds to CD3, a receptor on immune T cells, and GPRC5D, a receptor found in high levels on cancerous plasma cells. 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. Both of those therapies bind to BCMA, a protein targeted by a wave of new drugs from Roche, Regeneron, AbbVie and Pfizer. Overall, with both oral and dermatologic therapies, Aronsons best advice is hydration. 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. 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. His interests focus on psychedelic science, new media, and science oddities. Learn more. Kerry Boyle D.Ac., M.S., L.Ac., Dipl. National Library of Medicine Another anti-CD38/CD3 BiTE . Can diet help improve depression symptoms? 5 months after I stopped, I recovered my sense of taste. Earlier in 2022, based on preliminary positive trial data, the FDA granted talquetamab Breakthrough Therapy designation. 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. Another important side effect was altered taste. This allowed the treatment priority and accelerated pathways through approval processes. Ongoing trials are assessing the optimal phase 2 dose, as well as assessing the agents efficacy in combination with approved and investigational therapy. Rich has written for a number of online and print publications over the last decade while also acting as film critic for several radio broadcasters and podcasts. Would you like email updates of new search results? 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. Taltz is a medicine used for treating moderate to severe plaque psoriasis, a disease causing red, scaly patches on the skin. Last Updated: 12/19/2022 12:57:45 PM. Other most common side effects are reported in table. 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 . Ive been on pretty much every approved drug regimen and theyve all worked really well for me. 2023 May;23(5):310-321. doi: 10.1016/j.clml.2023.01.017. 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. The new exclusion criteria could represent an incremental headwind for Bluebird should it get to market, wrote SVB Securities analyst Mani Foroohar. In its Physical Well-Being subscale, the FACT-G includes a question concerning side effect bother (item GP5: "I am bothered by side effects of treatment"), rated on a 5-point Likert scale from "not at all" to "very much." This single item will be included as an overall summary measure of the burden of treatment toxicities compared with each other. 2023 Apr;29(3):722-726. doi: 10.1177/10781552231154809. "It seems the total effect is a real drying effect. For example, skin and ear problems, which can sometimes affect patients a little bit differently, but can also be a quality-of-life issue. Clin Lymphoma Myeloma Leuk. Just under three-quarters of participants given a lower or higher dose of talquetamab in the Phase 2 portion of J&J's study responded to treatment, with around a third of each group achieving remission of their cancer. For full disclosures of the study authors, visit ash.confex.com. The Talquetamab / Daratumumab trial. 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. The response rate observed in this cohort, which Dr. Chari explained is higher than that of most currently accessible therapies, suggests talquetamab could offer a viable option for patients with hard-to-treat myeloma, offering a chance to extend patient . That was the TNB trial. 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. The median time to onset was 26.5, 6.7, and 41.5 days, respectively. And it is also important to note that different doses were tested, and the appropriate dose was selected. At the two recommended subcutaneous doses for a phase . 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 . Results At the data-cutoff date, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). 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. Oyster mushrooms contain antioxidants, which may lower cancer risk. 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. 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. Each entry includes links to find associated clinical trials. These findings were presented by Ajai Chari, MD, and colleagues at the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 157). Data showed skin- and taste-related side effects were common, but typically rated mild. Nurses Exchange Best Strategies in Improving Delivery of Hepatic Artery Infusion Pump Education. 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. CB-011, which received fast track designation from the FDA, is currently under investigation as a treatment for those with relapsed or refractory multiple myeloma in the phase 1 CaMMouflage trial. Talquetamab fo Multiple Myeloma. 2023 Apr 28. doi: 10.1007/s00277-023-05218-1. Shares climbed about 3% on Monday and, at about $400 apiece, trade near record highs. So that would indicate the possibility that GPRC5D could potentially kill myeloma cells left behind after BCMA-based regimens are used! They can have a limited impact on quality of life measures.. Let BioPharma Dive's free newsletter keep you informed, straight from your inbox. This is a list of most of the side effects I've had since I started talquetamab. Step-up dose 1 . Of these, dysgeusia, dry mouth, and dysphagia were the most experienced symptoms. The years biggest meeting on blood diseases kicked off this past weekend. Talquetamab, a novel CD3 X GPRC5D bispecific antibody, represents a promising therapy for patients with relapsed or refractory multiple myeloma, according to Elizabeth Aronson, MSN, FNP-BCN, OCN. FOIA Few side effects, though. Epub 2022 Dec 11. 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. Side effects with talquetamab were meanwhile relatively frequent, but typically mild. Subscribe to the weekly "HealthTree Community for Myeloma Newsletter" for Myeloma news, life 2021 Oct;108(10S):S205-S212. Based on this promising data, an application to the US Food and Drug Administration (FDA) has been filed to bring the drug to market. But there are six trials recruiting! Apr 28, 2023 11:39am. While that may not sound exciting, it means that much of the preliminary work necessary to prepare for FDA approval is well underway. The same side effects that I mentioned are cytokine release syndrome. Anemia, in this context, can be worrisome as a potential sign of emerging blood cancer. I am looking forward to seeing how the reduction in frequency of administration will improve the side effects I've been experiencing. It was pretty gross. Unauthorized use of these marks is strictly prohibited. Bispecific Antibodies in Multiple Myeloma: Opportunities to Enhance Efficacy and Improve Safety. Tecvayli appeared well tolerated. The cases occurred in one adult and one younger study participant. 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. News release. Bethesda, MD 20894, Web Policies Data from patients who had received these same dosing regimens in the first phase were included in the analysis for the second phase. Lindsay Diamond, MSN, AGNP-C, AOCNP, discusses findings from CheckMate 274 and other data presented during the 2023 ASCO Genitourinary Cancers Symposium. 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. Disclaimer. . Nearly 60% had a very good partial response, meaning that their cancer was substantially reduced. Over the course of the trial, 73% of patients responded positively to the drug. A low white blood count (neutropenia) occurred in 42% of the patients and Cytokine release syndrome (CRS) in 64%. HHS Vulnerability Disclosure, Help The EQ-5D-5L is a generic measure of health status. 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. Bull Cancer. Some people may then receive a stem cell transplant, using their own or donor cells, to help them manufacture healthy blood cells. So those are side effects of both bispecific antibodies and CAR-T cells. At the two subcutaneous doses recommended for a phase 2 study (405 g per kilogram weekly [30 patients] and 800 g per kilogram every other week [44 patients]), common adverse events were cytokine release syndrome (in 77% and 80% of the patients, respectively), skin-related events (in 67% and 70%), and dysgeusia (in 63% and 57%); all but one cytokine release syndrome event were of grade 1 or 2. Side-Effects of Talquetamab At the time of the data cut-off, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). Thus, combination therapies may both enhance activity and offer a favorable side-effect profile. After initial priming, patients received either weekly or biweekly dosing throughout the study duration. The Expanding Clinical Role of Bifunctional Antibodies. These arent people with many options remaining, so in that setting 50% improvement is fantastic, he added. 2023 Healthline Media UK Ltd, Brighton, UK. Generic Name. Other treatments target the symptoms to improve the patients quality of life. This is a whole new era of cancer therapy, Dr. Chari said. All participants had received at least three prior treatments, including other types of drugs. These cells, made in the bone marrow, are a vital part of the immune system. Before This one, talquetamab, came up with some different side effects. technology has been in development for decades, Rewired genetic 'clock' slows aging and increases cellular lifespan, Surfcycle: A highway-speed, lane-splitting stand-up scooter on steroids, Astronomers spot nearest star-destroying black hole. Ive recently retired from a career as a CPA. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. Multiple myeloma is a cancer of plasma cells. pies without unacceptable side effects or had disease that had progressed with established therapies, and had an absolute neutrophil count It lasted about a year. The site is secure. Immune checkpoints are a potential target for MM therapy since they are overexpressed in MM plasma cells . There are two problems: 1. side effects, and 2. the drugs stop working after a while. Talquetamab is under investigation in clinical trial NCT04634552 (A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma). sore mouth or tongue. 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. 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. . Xerostomia . Saad Z. Usmani, MD. We've talked about this, but just to . itching in the genital or other skin areas. All rights reserved. Management of Relapsed-Refractory Multiple Myeloma in the Era of Advanced Therapies: Evidence-Based Recommendations for Routine Clinical Practice. This drug entry is a stub and has not been fully annotated. 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. The https:// ensures that you are connecting to the We see these [new drugs] as being part of regimens that will be used as complementary mechanisms of action, based upon sequencing, trying to address specific patient subgroups and disease characteristics., Chari, from Mount Sinai, agreed. If myeloma stops responding to treatment, it is called refractory myeloma. Cancerous plasma cells make abnormal antibodies called M-proteins that do not protect the body from infections. Cure Hub Side Effect Solutions My Journal University Coach Connect . Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. Anti-PD1. Conclusions: 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. My doc said he will put me on CAR-T when the Talquetamab fails. I hadn't realized it, but was thinking I had just lost track of when I was getting it. Investigators behind a phase 1 trial investigating MT-0169 in relapsed or refractory multiple myeloma and non-Hodgkin lymphoma will pause enrollment of new patients following prior reports of cardiac adverse effects in 2 patients. Methods: We have lot of patients start a nail hardener at the onset of therapy.. Oral and dermatologic TEAEs, though generally mild, present an opportunity for oncology nurses to improve patient quality of life. 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. In the last week of the first cycle, I checked my plasmocytoma on Saturday and it seemed a little smaller. This is more convenient for patients and, Dr. Chari added, in the phase 2 trial there was a hint of more durable remissions in the 2-weekly., Future trials should see if talquetamabs specific targeting of myeloma could allow more patients to benefit from treatment, especially when combined with other drugs. Testing of that drug, known as lovo-cel, has already been stalled twice by the Food and Drug Administration due to safety concerns, causing Bluebird to fall behind a rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics thats now under rolling regulatory review in the U.S. Vertex and CRISPR aim to complete their filing by the end of the first quarter. Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she concluded. But I'm curious then, maybe we can talk a little bit about the side effects. 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. Other clinical pearls, according to Aronson, include certain dietary modifications and early treatment of oral candida. Talquetamab side effects. Clipboard, Search History, and several other advanced features are temporarily unavailable. Diagnosis and Management of Adult Malignancy-Associated Hemophagocytic Lymphohistiocytosis. After sifting through two papers, two presentations, an article and a poster; heres what I thought youd like to know. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Effects of teclistamab and talquetamab on soluble BCMA levels in patients with relapsed/refractory multiple myeloma Blood Adv . The company hasnt seen evidence of an emerging cancer, a top safety concern of treatments like lovo-cel, or other findings that would suggest the treatment is causing a problem. Onco-Nursing Experts Define Best Practices, Treatment Considerations for Managing Patients With MPNs. At median follow-ups of 11.7 months (in patients who had received talquetamab at the 405-g dose level) and 4.2 months (in those who had received it at the 800-g dose level), the percentages of patients with a response were 70% (95% confidence interval [CI], 51 to 85) and 64% (95% CI, 48 to 78), respectively. 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. 2023 Mar 18;15(6):1839. doi: 10.3390/cancers15061839. The most common side effects were neutropenia (40%), anemia (28%), and thrombocytopenia (20%). She [noted] that that would increase the incidence of fungal issues. 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.. Scientists use genetic rewiring to increase lifespan of cells. Living With Cancer. Learn more here. government site. Here we report updated results with additional patients (pts) and longer follow-up from MonumenTAL-1, a phase 1 trial of talquetamab in relapsed/refractory multiple myeloma (RRMM). This is the new unmet need in multiple myeloma.. Emerging Strategies to Manage Relapsed and/or Refractory Multiple Myeloma. Their findings were published as a case study in Nature Medicine in December. . FDA/EMA Accept Ide-Cel Applications for Earlier R/R Multiple Myeloma Use. Specific Cancers. That is something which is again, unique, different. New York, NY. This means slippery stuff [that] goes down, she explained. This typically occurs on both the palms and the soles of the feet, she said. 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. DB16678. We tried several things. Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma that had progressed with established therapies or who could not receive these therapies without unacceptable side effects. Get access to cutting edge treatment via Talquetamab, Daratumumab, Teclistamab. For now, the best preventative and therapeutic approaches to dermatologic and oral AEs have yet to be identified. Cancer Treatment Side Effects. Learn more, Enzalutamide improves survival rates for men with metastasized prostate cancer when added to standard treatment, the results from the clinical trial. Careers. FDA Grants FTD to Off-the-Shelf CAR T in R/R Multiple Myeloma. 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. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. . These cells, made in the bone marrow, are a vital part of . Ive been fighting Multiple Myeloma for more than 15 years. Oral TEAEs were common in the trial with 57.9% of patients (n = 44) experiencing a grade 1 or 2 oral AE. Cancers (Basel). However, in her practice, certain interventions have proven useful in mitigating some of the toxicities experienced by patients. Patients with measurable MM who were relapsed/refractory or . This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03158688) in the KdD - Carfilzomib, Dexamethasone and Daratumumab ARM group. runny or stuffy nose. Topics covered: startup launches, funding, IPOs and much more. We've been so busy adding drugs to the arsenal that [were] catching up to figure out the right sequences and unanswered questions.. 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). It is graphic, but it prepared patients for what to expect.. (Its also found on hairfollicle cells but dont worry youre not going to lose your hair again.) Editors note: This story has been updated to clarify the status of Vertex and CRISPRs regulatory application. Most of the reported adverse events (side effects) were mild or moderate in severity. Janssen is responsible for the development and commercialization of talquetamab. The response rate observed in this cohort, which Dr. Chari explained is higher than that of most currently accessible therapies, suggests talquetamab could offer a viable option for patients with relapsed or refractory myeloma, offering a chance to . Talquetamab is one of several new drugs in the hopper that are giving us triple+ refractory myelomapatients a heart full of hope. 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. The myeloma cancer cells also build up in the bone marrow and form tumors. The response rate observed in this cohort, which Dr Chari explained is higher than that of most currently accessible therapies, suggests talquetamab could offer a viable option for patients with hard-to-treat myeloma, offering a chance to extend patient . "Human natural killer cell" [Micrograph]. 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 . 1. DrugBank Accession Number. We've had, for example, a drug with ocular or eye toxicity. MNT is the registered trade mark of Healthline Media. Our dermatologist recommended against do a nail soaks, she noted. An official website of the United States government. 5. This years meeting, hosted in New Orleans, put a spotlight on new kinds of antibody drugs for cancer, including some that home in on a novel target in multiple myeloma. Theyve exhausted many available therapies []. Blood Adv. Unable to load your collection due to an error, Unable to load your delegates due to an error. In the phase 1 trial, 232 patients with relapsed or refractory myeloma were given talquetamab. 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. Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects.
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