Talquetamab is a bispecific antibody, a type of monoclonal antibody that redirects T cells to act against myeloma cells. Can diet help improve depression symptoms? If myeloma stops responding to treatment, it is called refractory myeloma. Emerging Strategies to Manage Relapsed and/or Refractory Multiple Myeloma. There's been amazing progress in the area of immunotherapy. 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. 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. A low blood cell count, called cytopenia, was among the most common adverse events . Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for For patients experiencing palmar/plantar desquamation, ammonium lactate lotion, and emollients have shown efficacy. You? 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 . The site is secure. No, of course its nothing close to a cure. National Library of Medicine Background. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid. DB16678. Were hoping that this will soon become available so that patients can benefit.. Learn more, Enzalutamide improves survival rates for men with metastasized prostate cancer when added to standard treatment, the results from the clinical trial. ORR at RP2D (405 g/kg SC) was 69% in 19 pts treated at this dose. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. Epcoritamab Shows a Manageable Safety and Robust Antitumour Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target . GPRC5D has limited expression on healthy human tissue but is highly expressed on malignant myeloma cells. 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.. All participants had received at least three prior treatments, including other types of drugs. Janssen Submits Biologics License Application to U.S. FDA for Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she . 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. The Phase 1 data was published in The New England Journal of Medicine. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021. 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. Ac., CYT, Enzalutamide, combined with standard treatment, shows promise in prostate cancer, What to know about endometrial stromal sarcoma. Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody that targets GPRC5D. FDA Grants FTD to Off-the-Shelf CAR T in R/R Multiple Myeloma. The same side effects that I mentioned are cytokine release syndrome. 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. Topics covered: startup launches, funding, IPOs and much more. (Funded by bluebird bio and Celgene, a Bristol-Myers Squibb company . Grade ranged from grade 1 to grade 3 for the dermatologic events. Talquetamab, a bispecific antibody . Data showed skin- and taste-related side effects were common, but typically rated mild. 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. 2021 Oct;108(10S):S205-S212. ASH 2021: Update on Talquetamab - HealthTree for Myeloma Federal government websites often end in .gov or .mil. In total, 165 patients were enrolled in the trial. The primary endpoint of the study was met. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for 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 really great is that some myeloma cells NOT having BCMA MIGHT have GPRC5D. 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. The recently announced Phase 1/2 talquetamab trial data covered several hundred multiple myeloma patients, spanning two different doses and either weekly or fortnightly dosing schedules. Like BCMA, Talquetamabs target, GPRC5D, is found on most myeloma cells. 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. 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. Doctors can treat and control the disease, but it is currently regarded as not curable. Diagnosis and Management of Adult Malignancy-Associated Hemophagocytic Lymphohistiocytosis. 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. Although all oral symptoms were categorized as grade 1 or 2, they still had a significant effect on quality of life and treatment continuation; dysgeusia was responsible for 3 cases of dose interruptions, 1 case of dose reduction, and 1 treatment discontinuation; dysphagia was the catalyst for 3 cases of treatment interruptions. Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. 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. Sequencing is really important, and it's probably the thing that we do the least well in myeloma, he said at the press conference. The CRS was low-grade without associated mortality. Epub 2021 Aug 10. The adult patient, for instance, currently needs transfusions to handle her anemia and has intermittent bouts of chronic pain. Many [of these] patients reported rapid improvement once we treated them.. Talquetamab: Uses, Interactions, Mechanism of Action - DrugBank The new exclusion criteria could represent an incremental headwind for Bluebird should it get to market, wrote SVB Securities analyst Mani Foroohar. Talquetamab for Multiple Myeloma Talquetamab, a bifunctional antibody, directs activated T cells to tumor. We've had, for example, a drug with ocular or eye toxicity. In total 70% of patients experienced Cytokine Release Syndrome (CRS) but all events were minor. Therapies already exist for ITP, which causes dangerously low platelet levels, but they have limitations. Overall, with both oral and dermatologic therapies, Aronsons best advice is hydration. The blood tests which measured my myeloma (M spike, IGG, free light chains) all stayed pretty stable. N Engl J Med. painful or difficult urination. Talquetamab generates high response rate in patients with hard-to-treat CRS and cytopenia were primarily observed in early cycles and were reversable. Talquetamab fo Multiple Myeloma. 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. The myeloma cancer cells also build up in the bone marrow and form tumors. sore mouth or tongue. They were divided into two groups, one of which received the drug intravenously, and the other subcutaneously. 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 extend patient life spans. 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. Careers. Bookshelf Abstract - American Society of Hematology Notably, among a group of patients who had either previously had cell therapy or another bispecific antibody, 63% responded to treatment with talquetamab. The researchers said very few patients (5-6%) stopped talquetamab treatment because of side effects. Taltz Side Effects: Common, Severe, Long Term - Drugs.com Nurses Exchange Best Strategies in Improving Delivery of Hepatic Artery Infusion Pump Education. Now, trials of talquetamab have shown very promising results in people with refractory myeloma. Generic Name. This means slippery stuff [that] goes down, she explained. Learn more here. 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. Janssen Presents Updated Results Evaluating First-in-Class Talquetamab The Expanding Clinical Role of Bifunctional Antibodies. with Ive been on pretty much every approved drug regimen and theyve all worked really well for me. We've had, for example, a drug with ocular or eye toxicity. Apr 28, 2023 11:39am. We've talked about this, but just to . But it is important to keep in mind that some of the side effects were a bit unique. 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. 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. Updates on Efficacy/Safety Results from MonumenTAL-1 (Talquetamab Ash 2022 preview - a new multiple myeloma mechanism makes a splash Bispecific Antibody Platform: Early Data in Relapsed and Refractory PMC Being a HealthTreeCoach is a newfound joy. (Funded by Janssen Research and Development; MonumenTAL-1 ClinicalTrials.gov number, NCT03399799.). Drugs targeting GPRC5D, for instance, could offer an alternative to BCMA-binding treatments. The primary end points - the frequency and type of dose-limiting toxic effects (study part 1 only . "Talquetamab induced a substantial response among patients with heavily pretreated, relapsed, or refractory multiple myeloma, the second-most-common blood cancer. But of course nothing works forever. Anemia, in this context, can be worrisome as a potential sign of emerging blood cancer. You can use your HealthTree data to see if you qualify to join a talquetamab trial. Minnema MC, Krishnan A, Berdeja JG, et al. ABSTRACT 291: Phase I/II, first-in-human study of REGN5458 in 45 patients with relapsed and/or refractory multiple myeloma . 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. With talquetamab, only about half the patients make it to only a little more than a year before they relapse. 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. It was pretty gross. Taltz contains the active substance ixekizumab. 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. 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). Results from the TRiMM-2 study of talquetamab (Abstract #161) and teclistamab (Abstract #1647) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)will also be presented. A Study of Talquetamab in Participants With Relapsed or Refractory Disclaimer. The median time to onset was 26.5, 6.7, and 41.5 days, respectively. 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. Living With Cancer. A standardized regimen of topical and oral supportive care appears to be beneficial in the management of . 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. Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects. J Oncol Pharm Pract. Rich completed his Masters degree in the Arts back in 2013 before joining New Atlas in 2016. 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 . On Friday, J&J submitted an application for U.S. approval, meaning the drug could reach market in the near future. While Phase 1 trials are for the purpose of determining safety and dosage, they do yield results on side effects and efficacy as well. These arent people with many options remaining, so in that setting 50% improvement is fantastic, he added. However, research has not proven these mushrooms can prevent cancer. Recent updates on bispecific T-cell engager (BiTE) antibodies in 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. Other adverse events like bruising, headaches and blood in urine occurred at similar rates in both groups. 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. Using a different target opens up all kinds of new possibilities. Taltz is a medicine used for treating moderate to severe plaque psoriasis, a disease causing red, scaly patches on the skin. Earlier in 2022, based on preliminary positive trial data, the FDA granted talquetamab Breakthrough Therapy designation. . The abnormal plasma cells are made from stem cells in the bone marrow. Ailawadhi: So, [the Face-Off discussion from] the [2022 ASH Annual Meeting and Exposition] was a very interesting discussion about some of the important, interesting highlighted clinical trials. 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. Based on this promising data, an application to the US Food and Drug Administration (FDA) has been filed to bring the drug to market. 2023 Feb 28;7(4):644-648. doi: 10.1182/bloodadvances.2022007625. 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. 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. Other most common side effects are reported in table. This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03158688) in the KdD - Carfilzomib, Dexamethasone and Daratumumab ARM group. Our dermatologist recommended against do a nail soaks, she noted. The . So patients, hopefully, will have a new and very exciting different opportunity coming up for the treatment of relapsed 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. A Surprisingly Happy Talquetamab Update : r/multiplemyeloma - Reddit Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. Oyster mushrooms for cancer: Do they help? Trimm 2 Study - Multiple Myeloma Clinical Trials 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. G protein-coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells. Also, you can look at the national clinical trial registry athttps://clinicaltrials.govThe Phase 2 trial is number: NCT04634552. The results suggest that talquetamab could give hope to patients with refractory myeloma. Subscribe to the BioPharma Dive free daily newsletter, Subscribe to BioPharma Dive for top news, trends & analysis, The free newsletter covering the top industry headlines, National Institutes of Allergy and Infectious Diseases. And this particular study showed us a bit more mature, larger number, patient data of talquetamab in patients with relapsed/refractory myeloma. My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. Reducing Medical and Other Debt Through Negotiation, Getting Fit and Keeping Bones Safe (Live Exercise Demo), SouthEast Myeloma Community- Understanding Immunotherapy. So after a month, I was pretty low about talquetamab. New therapies are urgently needed to help people with treatment-resistant disease., Dr. Marianne Baker, research information manager at Cancer Research UK. Get the free daily newsletter read by industry experts. The side effects are troubling, some require hospitalization, especially because of infections. 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. Ive been fighting Multiple Myeloma for more than 15 years. Biotin sprays, gels, candies, you name it, she said. Unlike traditional monoclonal antibodies, bispecific antibodies are engineered to bind to two different antigens. MonumenTAL-1 trial Shows Promise With Talquetamab in R/R Myeloma 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. Teclistamab (JNJ-64007957) may be a safe and efficacious treatment option for patients with relapsed/refractory multiple myeloma, according to findings from a phase I study presented at the 2020 American Society of Clinical Oncology . With bispecific antibodies, the way we give . The median duration of response was 10.2 months and 7.8 months, respectively. Side effects with talquetamab were meanwhile relatively frequent, but typically mild. Teclistamab in Relapsed or Refractory Multiple Myeloma. The researchers state that adverse side effects to talquetamab occurred "relatively frequently" but were most often mild. 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 . Heres the joy part. A low white blood count (neutropenia) occurred in 42% of the patients and Cytokine release syndrome (CRS) in 64%. It is graphic, but it prepared patients for what to expect.. Nurses Call for More Research on Nutrition Challenges for Patients With AML/MDS. This was for talquetamab, which again targets this specific anchor. Effects of teclistamab and talquetamab on soluble BCMA levels in Initial treatment for multiple myeloma may involve chemotherapy, immunotherapy, and corticosteroid treatment. Oncology On-The-Go Podcast: Multiple Myeloma Outcome Disparities, Trial Access. Data from patients who had received these same dosing regimens in the first phase were included in the analysis for the second phase. Some people may then receive a stem cell transplant, using their own or donor cells, to help them manufacture healthy blood cells. Conclusions: Children and Cancer . In the last week of the first cycle, I checked my plasmocytoma on Saturday and it seemed a little smaller. Off-the-shelf immunotherapy could offer new hope for patients with hard The most common side effects were neutropenia (40%), anemia (28%), and thrombocytopenia (20%). 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. lower back or side pain. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. FDA Pauses Trial Evaluating MT-0169 in R/R Multiple Myeloma and Lymphoma. A Study Comparing Talquetamab in Combination With Daratumumab or in [Bispecific antibodies in multiple myeloma]. Ongoing trials are assessing the optimal phase 2 dose, as well as assessing the agents efficacy in combination with approved and investigational therapy. 5. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. At least he plans to, but we have zero CAR-T capacity and no idea when the situation . The updated Phase 1 results from the MonumenTAL study found that Talquetamab is well tolerated and highly effective at both recommended Phase 2 doses.
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