And this particular study showed us a bit more mature, larger number, patient data of talquetamab in patients with relapsed/refractory myeloma. 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%. Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she concluded. Talquetamab is a CPRC5DxCD3 . A biologics license application has been submitted to the FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma. Bispecific Antibody Cancer Treatment Shows 73% Response Rate Antibody Treatment Makes Inroads Against Multiple Myeloma Subscribe to the weekly "HealthTree Community for Myeloma Newsletter" for Myeloma news, life 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.. Step-up dose 1 . Talquetamab is a new bi-specific drug that is currently gearing up for its Phase 2 studies. Almost all patients had grade 3 or 4 toxic effects, most commonly hematologic toxic effects and cytokine release syndrome. Side Effects I've Experienced with Talquetamab - myelomablog Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects. Topics covered: Gene replacement therapy, gene editing, engineered cell therapy, manufacturing, pricing, reimbursement and much more. Bookshelf Earlier in 2022, based on preliminary positive trial data, the FDA granted talquetamab Breakthrough Therapy designation. Other adverse events like bruising, headaches and blood in urine occurred at similar rates in both groups. . My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. Whats really great is that some myeloma cells NOT having BCMA MIGHT have GPRC5D. The immunotherapy being trialled is called talquetamab. This was for talquetamab, which again targets this specific anchor. FDA Considering Talquetamab for Hard-to-treat Multiple Only one patient to date at our center, has discontinued treatment due to an oral or dermatologic side effect. 2023 Healthline Media UK Ltd, Brighton, UK. Reducing Medical and Other Debt Through Negotiation, Getting Fit and Keeping Bones Safe (Live Exercise Demo), SouthEast Myeloma Community- Understanding Immunotherapy. pies without unacceptable side effects or had disease that had progressed with established therapies, and had an absolute neutrophil count Is the ketogenic diet right for autoimmune conditions? They were very impressive results with deeper responses in heavily pretreated patients. "Talquetamab induced a substantial response among patients with heavily pretreated, relapsed, or refractory multiple myeloma, the second-most-common blood cancer. 5. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for A Study of Comparing Talquetamab to Belantamab Mafodotin in ASH 2022: Talquetamab generates high response rate in patients with Grade ranged from grade 1 to grade 3 for the dermatologic events. 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. Educated Patient Multiple Myeloma Summit BiTE and Future Myeloma The response rate observed in the study, which Dr. Chari explained is higher than that for most currently accessible therapies, suggests talquetamab could offer a viable option for patients whose myeloma has stopped responding to most . No, of course its nothing close to a cure. Talquetamab fo Multiple Myeloma. Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects. sneezing. Get the free daily newsletter read by industry experts. Epcoritamab Shows a Manageable Safety and Robust Antitumour While Phase 1 trials are for the purpose of determining safety and dosage, they do yield results on side effects and efficacy as well. Talquetamab binds to both T cells and multiple myeloma cells. 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. Patients with measurable MM who were relapsed/refractory or . 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. 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. Trimm 2 Study - Multiple Myeloma Clinical Trials Rich completed his Masters degree in the Arts back in 2013 before joining New Atlas in 2016. 2023 Apr 28. doi: 10.1007/s00277-023-05218-1. Many [of these] patients reported rapid improvement once we treated them.. The most common AEs related to treatment with talquetamab include cytokine release syndrome (CRS), neurotoxicity, cytopenia, infections, skin and nail disorders, and oral toxicities. 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(December 10, 2021) Mount Sinai scientists have become the first to report a potentially serious side effect related to a new form of immunotherapy known as CAR-T cell therapy, which was recently approved for the treatment of multiple myeloma. Oncology nursing always has their finger on the pulse of the patients psychosocial [needs]. Looking forward to more breakthroughs. 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. 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. News release. The new exclusion criteria could represent an incremental headwind for Bluebird should it get to market, wrote SVB Securities analyst Mani Foroohar. Talquetamab: New drug may offer hope for those with hard-to-treat blood Also, you can look at the national clinical trial registry athttps://clinicaltrials.govThe Phase 2 trial is number: NCT04634552. As their number increases, the number of red blood cells, white blood cells and platelets, which are made from the same type of stem cell, decreases. Side-Effects of Talquetamab At the time of the data cut-off, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). Good oral care is really key, she said, adding that the standard recommendations to prevent mucositis for patients about to undergo transplant are relevant with this patient population as well to reduce the bioburden in the mouth. 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. There's been amazing progress in the area of immunotherapy. Talquetamab is a bispecific antibody, a type of monoclonal antibody that redirects T cells to act against myeloma cells. 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. The results suggest that talquetamab could give hope to patients with refractory myeloma. 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. 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. I lost a lot of sleep over this, Aronson shared, noting that her patients were distressed by these AEs. Taltz Side Effects: Common, Severe, Long Term - Drugs.com So those are side effects of both bispecific antibodies and CAR-T cells. This allowed the treatment priority and accelerated pathways through approval processes. That data has revealed most patients treated with talquetamab experienced mild side effects, but only around five percent had to cease treatment due to those adverse effects. 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! In total 70% of patients experienced Cytokine Release Syndrome (CRS) but all events were minor. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for 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. Disclosure: This study was funded by Janssen Research & Development LLC. Talquetamab for relapsed/refractory multiple myeloma: Results from a His interests focus on psychedelic science, new media, and science oddities. FDA Grants FTD to Off-the-Shelf CAR T in R/R Multiple Myeloma. 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. Approximately 75% experienced cytokine release syndrome, which is known to be a common side effect of immunotherapy and includes symptoms such as fever development. Teclistamab (Tecvayli) for the Treatment of Multiple Myeloma . Additionally, updated results show that 31 of 32 patients in the pivotal portion of lovo-cels trial havent had a painful episode known as a vaso-occlusive crisis through at least two years of follow-up. Get access to cutting edge treatment via Talquetamab, Daratumumab, Teclistamab. Talquetamab: An Antibody for Multiple Myeloma official website and that any information you provide is encrypted The most common side effects were neutropenia (40%), anemia (28%), and thrombocytopenia (20%). Oral antihistamines and topical corticosteroids are useful in addressing a body rash and injection-site reactions. Another anti-CD38/CD3 BiTE . Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. Epub 2022 Jun 5. Children and Cancer . 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. 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 . Online ahead of print. 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 drug produced a substantial response, with only low-grade side effects, in 70% of the patients. Dr. Chari explained: A complete response isnt actually a cure but its basically getting it down to a level where its undetectable. But a new kind of therapy, a bispecific antibody called Talquetamab, has been showing pro . PMC I am looking forward to seeing how the reduction in frequency of administration will improve the side effects I've been experiencing. J&Js therapy, called talquetamab, is a bispecific antibody aimed at both GPRC5D and a protein expressed by immune cells. You? They can have a limited impact on quality of life measures.. 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. 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. Apr 28, 2023 11:39am. Immune checkpoints are a potential target for MM therapy since they are overexpressed in MM plasma cells . Talquetamab (JNJ-64407564) Several studies are exploring bispecific mAbs with antigen target different from BCMA. Drugs targeting GPRC5D, for instance, could offer an alternative to BCMA-binding treatments. If myeloma stops responding to treatment, it is called refractory myeloma. lower back or side pain. loss of voice. 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. After becoming refractory to available therapies, median overall survival is 6-11 months. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. 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. 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. Talquetamab Study in RRMM | Int'l Myeloma Foundation This is a whole new era of cancer therapy, Dr. Chari said. Of the 288 patients in this trial, 143 received a single dose of the drug weekly, and 145 received a double dose every 2 weeks. 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. New therapies are urgently needed to help people with treatment-resistant disease., Dr. Marianne Baker, research information manager at Cancer Research UK. And here were seeing responses of like 70 to 100%. Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. Janssen Presents Updated Results Evaluating First-in-Class Talquetamab PDF HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include The updated Phase 1 results from the MonumenTAL study found that Talquetamab is well tolerated and highly effective at both recommended Phase 2 doses. Heres the joy part. Let BioPharma Dive's free newsletter keep you informed, straight from your inbox. These trials could give people with myeloma the chance to live longer by keeping their cancer at bay.. 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. 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. Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody that targets GPRC5D. Of these, dysgeusia, dry mouth, and dysphagia were the most experienced symptoms. Updates on Efficacy/Safety Results from MonumenTAL-1 (Talquetamab Can this be used for MM treatment? : r/multiplemyeloma With bispecific antibodies, the way we give . It lasted about a year. 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. Multiple myeloma is a cancer of plasma cells. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. Xerostomia . Kikuchi T, Tsukada N, Nomura M, Kasuya Y, Oda Y, Sato K, Takei T, Ogura M, Abe Y, Suzuki K, Ishida T. Ann Hematol. Sequencing is really important, and it's probably the thing that we do the least well in myeloma, he said at the press conference. For now, the best preventative and therapeutic approaches to dermatologic and oral AEs have yet to be identified. Effects of teclistamab and talquetamab on soluble BCMA levels in The primary endpoint of the study was met. New blood cancer therapy successful in three-quarters of trial patients MonumenTAL-1 trial Shows Promise With Talquetamab in R/R Myeloma Unauthorized use of these marks is strictly prohibited. Initial treatment for multiple myeloma may involve chemotherapy, immunotherapy, and corticosteroid treatment. Back pain can be a symptom of cancer or a side effect of cancer treatment. One thing that will happen, though, is that my talquetamab dose will be increased to make up for the change in schedule. Taltz contains the active substance ixekizumab. Learn more here. 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. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021. 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. This year, among the several bi-specifics on the ASH agenda, Talquetamab still peaks my interest. For example, skin and ear problems, which can sometimes affect patients a little bit differently, but can also be a quality-of-life issue. While that may not sound exciting, it means that much of the preliminary work necessary to prepare for FDA approval is well underway. 2022 Dec 15;387(24):2287-2290. doi: 10.1056/NEJMe2208708. We've had, for example, a drug with ocular or eye toxicity. Onco-Nursing Experts Define Best Practices, Treatment Considerations for Managing Patients With MPNs. Ongoing trials are assessing the optimal phase 2 dose, as well as assessing the agents efficacy in combination with approved and investigational therapy. Almost through cycle 8 of talquetamab / daratumumab / pomalidomide Presented at: European Hematology Association Congress 2022; June 9-12, 2022; Vienna, Austria. Infections also occurred in more than half of patients on each drug dose, with 17% and 12% respectively graded as more severe. Talquetamab Generates High Response Rate in Relapsed or Refractory runny or stuffy nose. Clipboard, Search History, and several other advanced features are temporarily unavailable. Accessibility 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. Type. And at the various doses, deep, ongoing responses were noted. Dr. Chari explained: Myeloma response means [] theres a 50% reduction in the myeloma level, so if its less than 50% it is not considered a response and when you submit to the [Food and Drug Administration], and when they look at regulatory approval, its 50% or higher. FOIA Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target . 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. So patients, hopefully, will have a new and very exciting different opportunity coming up for the treatment of relapsed or refractory multiple myeloma. FDA Delays Quizartinib PDUFA Date for Newly Diagnosed FLT3-ITD+ AML. 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. Palmar/plantar desquamation was the most prevalent dermatologic TEAE and occurred in 33.9% (n = 25) of patients, followed in close succession by nail disorders (17%) and systemic rash (7.9%). All side effects, not much to show for it. The . ABSTRACT 291: Phase I/II, first-in-human study of REGN5458 in 45 patients with relapsed and/or refractory multiple myeloma . ATLANTA, Ga., December 11, 2021- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of talquetamab (NCT03399799).Talquetamab is the only investigational off-the-shelf T cell redirecting bispecific antibody in clinical development targeting both GPRC5D, a novel multiple myeloma target . Click here for details. 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. 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. 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. 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 . The side effects are troubling, some require hospitalization, especially because of infections. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Epub 2023 Feb 12. DrugBank Accession Number. Paul G. Richardson, MD, and Christina Gasparetto, MD, offer insights into the use of proteasome inhibitors in relapsed or refractory multiple myeloma. Posted: 12/11/2022 10:00:00 AM J Oncol Pharm Pract. Now, trials of talquetamab have shown very promising results in people with refractory myeloma. Teclistamab in Relapsed or Refractory Multiple Myeloma. Other most common side effects are reported in table. Using a different target opens up all kinds of new possibilities. Oral TEAEs were common in the trial with 57.9% of patients (n = 44) experiencing a grade 1 or 2 oral AE. Please enable it to take advantage of the complete set of features! This drug entry is a stub and has not been fully annotated. 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. Through patient education tactics, oncology nurses can help patients with multiple myeloma mitigate the oral and dermatologic toxicities associated with talquetamab. Ive been fighting Multiple Myeloma for more than 15 years. 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. 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. The Talquetamab / Daratumumab trial. Lindsay Diamond Discusses Ongoing Role of Immunotherapy in Bladder Cancer. Talquetamab, Cevostamab and Elranatamab in RRMM For patients experiencing palmar/plantar desquamation, ammonium lactate lotion, and emollients have shown efficacy. My colleague would tell patients your skin is going to peel like a lizard on your hands and feet, she said.