Antibodies and bispecifics for multiple myeloma: effective effector 2021 Apr 27;5(8):2196-2215. doi: 10.1182/bloodadvances.2020003805. Results At the data-cutoff date, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). Experimental cancer therapy shows success in | EurekAlert! In the phase 2 trial, doctors administered all the treatments subcutaneously using doses that had been safe and successful in the phase 1 trial. A standardized regimen of topical and oral supportive care appears to be beneficial in the management of . 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. Saad Z. Usmani, MD. And at the various doses, deep, ongoing responses were noted. ABSTRACT 291: Phase I/II, first-in-human study of REGN5458 in 45 patients with relapsed and/or refractory multiple myeloma . The number of patients it will impact is difficult to quantify and likely modest, Foroohar added, but still real.. So those are side effects of both bispecific antibodies and CAR-T cells. Immunotherapy is a type of treatment that affects a person's immune system. 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%. 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. 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.. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Of these, more than 30% had a complete response, meaning that, following treatment, the researchers could detect no myeloma-specific markers. Posted: 12/11/2022 10:00:00 AM If myeloma stops responding to treatment, it is called refractory myeloma. Specialists highlight the best practices and latest treatment regimens for patients presenting with myelofibrosis, polycythemia vera, and essential thrombocythemia. Epcoritamab Shows a Manageable Safety and Robust Antitumour New blood cancer therapy successful in three-quarters of trial patients Talquetamab for relapsed/refractory multiple myeloma: Results from a [Bispecific antibodies in 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. Results: 2023 Apr 5;15(7):2160. doi: 10.3390/cancers15072160. 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. Biotin sprays, gels, candies, you name it, she said. At least he plans to, but we have zero CAR-T capacity and no idea when the situation . 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. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Recent updates on bispecific T-cell engager (BiTE) antibodies in Janssen announces US FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma. While Phase 1 trials are for the purpose of determining safety and dosage, they do yield results on side effects and efficacy as well. 1. Potentially Serious Side Effect Seen in Patient after Immunotherapy 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. Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. Bispecific Antibody Platform: Early Data in Relapsed and Refractory The results suggest that talquetamab could give hope to patients with refractory myeloma. Last year at ASH, I studied andlearned more about anew bi-specific antibody drug called talquetamab. 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. The most common side effects were neutropenia (40%), anemia (28%), and thrombocytopenia (20%). . Nurses Exchange Best Strategies in Improving Delivery of Hepatic Artery Infusion Pump Education. Patients would describe this as everything tasting like cardboard or sawdust, or that things that they used to enjoy now tasted completely different.. 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. Between the Lines Podcast: Updates in Use of Proteasome Inhibitors for Relapsed/Refractory Multiple Myeloma. doi: 10.1016/j.bulcan.2021.10.003. Talquetamab is a new bi-specific drug that is currently gearing up for its Phase 2 studies. Lindsay Diamond, MSN, AGNP-C, AOCNP, discusses findings from CheckMate 274 and other data presented during the 2023 ASCO Genitourinary Cancers Symposium. Talquetamab, a bispecific antibody against CD3 and GPRC5D, redirects T cells to mediate killing of GPRC5D-expressing myeloma cells. The median time to a measurable response was approximately 1.2 months in both dosing groups, and the median duration of response is 9.3 months to date with weekly dosing. Moreover, with proper education regarding treatment-emergent adverse event (TEAE) management, nurses can play a critical role in improving quality of life for patients receiving talquetamab.1, Nursing education, support, and management is absolutely vital, Aronson said in a presentation on the agents AE profile during the International Myeloma Societys 6th Annual Nursing Symposium. Its encouraging to see results from trials which indicate that talquetamab could be used to treat myeloma, but further studies are needed before it can be used in the clinic.. The CRS was low-grade without associated mortality. This is the new unmet need in multiple myeloma.. Talquetamab was designed to target the GPRC5Da receptor, which is highly present on cancerous plasma cells. The new exclusion criteria could represent an incremental headwind for Bluebird should it get to market, wrote SVB Securities analyst Mani Foroohar. Clipboard, Search History, and several other advanced features are temporarily unavailable. Side effects were relatively frequent, but typically mild. And here were seeing responses of like 70 to 100%. Recent advances in the treatment of multiple myeloma Oral antihistamines and topical corticosteroids are useful in addressing a body rash and injection-site reactions. 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 . Being a HealthTreeCoach is a newfound joy. The researchers said very few patients (5-6%) stopped talquetamab treatment because of side effects. 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. Onco-Nursing Experts Define Best Practices, Treatment Considerations for Managing Patients With MPNs. June 29, 2022. with Other adverse events like bruising, headaches and blood in urine occurred at similar rates in both groups. 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. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for 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. This one, talquetamab, came up with some different side effects. 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 are two problems: 1. side effects, and 2. the drugs stop working after a while. Lots of liquids, smoothies, small bites, [and teaching them to] sit upright when they eat [and] wash everything down with liquidbecause it seems that dryness was just extending all the way down the upper gastrointestinal [GI] tract., A take home is the early treatment of oral candida, she concluded. . 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. Anything less doesnt count.. Off-the-shelf Immune Drug for Aggressive Multiple Myeloma: Teclistamab About two-thirds had skin-related side effects like rash, and around . 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. Oyster mushrooms for cancer: Do they help? Teclistamab in Relapsed or Refractory Multiple Myeloma. Cytokine release syndrome, skin-related events, and dysgeusia were common with talquetamab treatment but were primarily low-grade. 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. Get the free daily newsletter read by industry experts. 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 . Looking forward to more breakthroughs. Conclusions: pies without unacceptable side effects or had disease that had progressed with established therapies, and had an absolute neutrophil count Careers. These cells, made in the bone marrow, are a vital part of the immune system. Here are three storylines to emerge so far. 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). 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. Talquetamab side effects. Talquetamab: Uses, Interactions, Mechanism of Action - DrugBank 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. or who could not receive these therapies without unacceptable side effects. Methods: 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 . We need these off-the-shelf products because not everybody is going to go to large academic centre and go through the whole CAR-T and theres great future for this. Talquetamab for RRMM Granted FDA Breakthrough Therapy Designation In a Phase 3 trial of 131 patients with ITP who had received previous treatments, Argenxs drug led to sustained platelet responses in 22% of study participants, versus 5% of those on placebo. Teclistamab Appears Safe, Efficacious in Relapsed/Refractory Multiple Therapies already exist for ITP, which causes dangerously low platelet levels, but they have limitations. As with most new agents, assessing and responding to the AEs brought on by novel treatments is critical in ensuring that patients can continue with these therapies. 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. A total of 5 patients experienced dose interruptions because of a TEAE. This year, among the several bi-specifics on the ASH agenda, Talquetamab still peaks my interest. 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. 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. Oral and Dermatologic Toxicities Associated With Talquetamab Can Be This typically occurs on both the palms and the soles of the feet, she said. An official website of the United States government. Side Effects I've Experienced with Talquetamab - myelomablog 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. 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. His interests focus on psychedelic science, new media, and science oddities. In total 70% of patients experienced Cytokine Release Syndrome (CRS) but all events were minor. Like BCMA, Talquetamabs target, GPRC5D, is found on most myeloma cells. Unauthorized use of these marks is strictly prohibited. While that may not sound exciting, it means that much of the preliminary work necessary to prepare for FDA approval is well underway. Based on this promising data, an application to the US Food and Drug Administration (FDA) has been filed to bring the drug to market. "Human natural killer cell" [Micrograph]. Another anti-CD38/CD3 BiTE . The Talquetamab / Daratumumab trial. Myeloma affects around 6,000 people in the United Kingdom every year, causing more thaneight deaths each day. 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. Infections also occurred in more than half of patients on each drug dose, with 17% and 12% respectively graded as more severe. Expand 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 . 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. 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. Talquetamab/Daratumumab Shows Promise in Heavily Pretreated Myeloma 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. Copyright 2022 Massachusetts Medical Society. 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. Real-world clinical outcomes in patients with multiple myeloma treated with isatuximab after daratumumab treatment. One dose-limiting toxic effect of grade 3 rash was reported in a patient who had received talquetamab at the 800-g dose level. Each entry includes links to find associated clinical trials. Talquetamab for Multiple Myeloma Clinical Trial 2023 | Power Multiple myeloma is a cancer of plasma cells. It also binds CD3, a protein on the surface of immune T-cells. Kathleen Gander DNP, APRN, CNS; and Sarah Middlekauff, MSN, RN, OCN, relay their experiences in implementing a hepatic artery infusion pump educational intervention for oncology nurses. 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. Disclaimer. This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03158688) in the KdD - Carfilzomib, Dexamethasone and Daratumumab ARM group. "With a median follow-up of 14.9 months (range 0.5+ to 29.0), 74.1 percent of patients treated at the SC [subcutaneous] 0.4 mg/kg dose administered weekly achieved a response, 59.4 percent achieved a very good partial response or better, 33.6 percent achieved a complete response or better and 23.8 percent achieved a stringent complete response," reported pharmaceutical company Johnson & Johnson in a press release. The 73% response rate in this study is higher than that for most currently available therapies. 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. Paul G. Richardson, MD, and Christina Gasparetto, MD, offer insights into the use of proteasome inhibitors in relapsed or refractory multiple myeloma. Back pain can be a symptom of cancer or a side effect of cancer treatment. Newly approved and forthcoming T-cell-redirecting bispecific antibodies for the treatment of relapsed/refractory multiple myeloma. Cure Hub Side Effect Solutions My Journal University Coach Connect . Facebook And this particular study showed us a bit more mature, larger number, patient data of talquetamab in patients with relapsed/refractory myeloma. At the time of data cut-off, 76 patients had been enrolled in the trial at Mount Sinai Hospital. MonumenTAL-1 trial Shows Promise With Talquetamab in R/R Myeloma 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. Trimm 2 Study - Multiple Myeloma Clinical Trials There's been amazing progress in the area of immunotherapy. In patients with multiple myeloma, GPRC5D is overexpressed and . My colleague would tell patients your skin is going to peel like a lizard on your hands and feet, she said. Approximately 75% experienced cytokine release syndrome, which is known to be a common side effect of immunotherapy and includes symptoms such as fever development. 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. Bispecific T cell engagers: an emerging therapy for management of Clinical Updates: Emerging Therapies for Patients With Multiple Myeloma Almost all patients had grade 3 or 4 toxic effects, most commonly hematologic toxic effects and cytokine release syndrome. 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. Talquetamab had moderate side effects. J Oncol Pharm Pract. HealthTree Foundation / Myeloma Crowd is a qualified 501(c)(3) tax-exempt organization. J&J's next myeloma drug, Argenx's second act and a new question for Talquetamab (JNJ-64407564) is an investigational bispecific antibody. My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. So patients, hopefully, will have a new and very exciting different opportunity coming up for the treatment of relapsed or refractory multiple myeloma. Accessibility The blood tests which measured my myeloma (M spike, IGG, free light chains) all stayed pretty stable. It is the first bispecific agent targeting the protein GPRC5d in multiple myeloma patients," Chari said.