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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. In June 2022, the FDA granted talquetamab a breakthrough therapy designation.3. 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. 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). And it also gave us a glimpse into the side effect profile for this drug, which I don't think the side effects were that severe. Would you like email updates of new search results? If myeloma stops responding to treatment, it is called refractory myeloma. For example, skin and ear problems, which can sometimes affect patients a little bit differently, but can also be a quality-of-life issue. runny or stuffy nose. 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. The updated Phase 1 results from the MonumenTAL study found that Talquetamab is well tolerated and highly effective at both recommended Phase 2 doses. lower back or side pain. View duration, location, compensation, and staffing details. Myeloma stories, Myeloma clinical trials, Myeloma 101 articles and events with Myeloma Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021. 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 the phase 1 trial, 232 patients with relapsed or refractory myeloma were given talquetamab. 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. An official website of the United States government. 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. 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. 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. 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. Diagnosis and Management of Adult Malignancy-Associated Hemophagocytic Lymphohistiocytosis. All rights reserved. New therapies are urgently needed to help people with treatment-resistant disease., Dr. Marianne Baker, research information manager at Cancer Research UK. However, in her practice, certain interventions have proven useful in mitigating some of the toxicities experienced by patients. Following our recent Biologics License Application submission to the US FDA, we look forward to working with the agency to make this available as a treatment option in the short term and continuing our longer-term investigations of talquetamab as we aim to develop additional options for patients with this complex blood cancer," said Sen Zhuang, vice president of clinical R&D at Janssen Research & Development. Talquetamab, a bispecific antibody . Learn more, Enzalutamide improves survival rates for men with metastasized prostate cancer when added to standard treatment, the results from the clinical trial. and transmitted securely. Talquetamab is under investigation in clinical trial NCT04634552 (A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma). But it is important to keep in mind that some of the side effects were a bit unique. SOHO State-of-the-Art Updates and Next Questions | BCMA-Directed CAR T-Cells: Early Results and Future Directions. 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. These trials could give people with myeloma the chance to live longer by keeping their cancer at bay.. Cytokine release syndrome, skin-related events, and dysgeusia were common with talquetamab treatment but were primarily low-grade. The .gov means its official. "Human natural killer cell" [Micrograph]. Copyright 2022 HealthTree Foundation. 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. They simultaneously plant a target flag on cancer cells and give immune cells a roadmap to that target. Xerostomia . June 29, 2022. 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. 2022 Dec 15;387(24):2287-2290. doi: 10.1056/NEJMe2208708. Bispecific Antibodies in Multiple Myeloma: Opportunities to Enhance Efficacy and Improve Safety. 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 . Multiple myeloma is a cancer of plasma cells. And at the various doses, deep, ongoing responses were noted. A decision by the Supreme Court could have far-reaching effects on the lucrative market for antibody drugs, spurring responses from many of the industrys top companies. FDA Delays Quizartinib PDUFA Date for Newly Diagnosed FLT3-ITD+ AML. Teclistamab in Relapsed or Refractory Multiple Myeloma. Talquetamab. Side-Effects of Talquetamab At the time of the data cut-off, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). There's been amazing progress in the area of immunotherapy. 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 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 . Janssen announces US FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma. . 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). 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. ABSTRACT 291: Phase I/II, first-in-human study of REGN5458 in 45 patients with relapsed and/or refractory multiple myeloma . official website and that any information you provide is encrypted In total 70% of patients experienced Cytokine Release Syndrome (CRS) but all events were minor. Newly approved and forthcoming T-cell-redirecting bispecific antibodies for the treatment of relapsed/refractory multiple myeloma. Bethesda, MD 20894, Web Policies 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. Janssen is responsible for the development and commercialization of talquetamab. Few side effects, though. All side effects, not much to show for it. 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. Ive recently retired from a career as a CPA. Nurses should encourage patients to incorporate thin liquids into their diet. 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. After an initial phase generated encouraging results in terms of safety and efficacy, researchers began enrolling additional patients to assess the agents efficacy with two different dosing regimens0.4 mg/kg weekly and 0.8 mg/kg every other week. The adult patient, for instance, currently needs transfusions to handle her anemia and has intermittent bouts of chronic pain. Minnema MC, Krishnan A, Berdeja JG, et al. Talquetamab (JNJ-64407564) binds to GPRC5D and CD3 to induce T-cell . 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. Presented at: International Myeloma Society 6th Annual Nursing Symposium; August 25-27, 2022; Los Angeles, CA. making it an attractive therapeutic target. Kerry Boyle D.Ac., M.S., L.Ac., Dipl. Results: Talquetamab is a CPRC5DxCD3 . With bispecific antibodies, the way we give . . But of course nothing works forever. Talquetamab, also known as GPRC5D T cell-redirecting antibody, recruits T cells to tumor cells and activate T cells. The median duration of response was 10.2 months and 7.8 months, respectively. Accessed August 25, 2022. But a new kind of therapy, a bispecific antibody called Talquetamab, has been showing pro . 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. 5 months after I stopped, I recovered my sense of taste. 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 . Oyster mushrooms for cancer: Do they help? 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. Between the Lines Podcast: Updates in Use of Proteasome Inhibitors for Relapsed/Refractory Multiple Myeloma. Can diet help improve depression symptoms? Anemia, in this context, can be worrisome as a potential sign of emerging blood cancer. 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. Bluebird attributed both to underlying genetics specifically, a condition known as alpha thalassemia trait that is associated with anemia. This one, talquetamab, came up with some different side effects. Clin Lymphoma Myeloma Leuk. Bookshelf Were hoping that this will soon become available so that patients can benefit.. 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. The idea behind bispecific antibodies is they work to bridge immune cells with cancer cells. Editors note: This story has been updated to clarify the status of Vertex and CRISPRs regulatory application. Only one patient to date at our center, has discontinued treatment due to an oral or dermatologic side effect. Many [of these] patients reported rapid improvement once we treated them.. Our dermatologist recommended against do a nail soaks, she noted. Cure Hub Side Effect Solutions My Journal University Coach Connect . 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. This year, among the several bi-specifics on the ASH agenda, Talquetamab still peaks my interest. The side effects are troubling, some require hospitalization, especially because of infections. Expand My colleague would tell patients your skin is going to peel like a lizard on your hands and feet, she said. 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. Ac., CYT, Enzalutamide, combined with standard treatment, shows promise in prostate cancer, What to know about endometrial stromal sarcoma. 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. Kikuchi T, Tsukada N, Nomura M, Kasuya Y, Oda Y, Sato K, Takei T, Ogura M, Abe Y, Suzuki K, Ishida T. Ann Hematol. Clipboard, Search History, and several other advanced features are temporarily unavailable. You? National Library of Medicine Initial treatment for multiple myeloma may involve chemotherapy, immunotherapy, and corticosteroid treatment. No, of course its nothing close to a cure. Following treatment with the immunotherapy drug in the Mount Sinai Health System trial, almost three-quarters of the participants showed improvement, with 30% having a complete response to the drug. 2023 Apr 5;15(7):2160. doi: 10.3390/cancers15072160. But there are six trials recruiting! Earlier in 2022, based on preliminary positive trial data, the FDA granted talquetamab Breakthrough Therapy designation. Talquetamab binds to both T cells and multiple myeloma cells. pies without unacceptable side effects or had disease that had progressed with established therapies, and had an absolute neutrophil count Most of the reported adverse events (side effects) were mild or moderate in severity. 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 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. It also binds CD3, a protein on the surface of immune T-cells. 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. Unauthorized use of these marks is strictly prohibited. It was pretty gross. Data from the phase 3 KarMMA-3 trial support several applications for idecabtagene vicleucel in earlier use for triple-class exposed multiple myeloma in the United States, Europe, and Japan. 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.

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