The immunotherapy being trialled is called talquetamab. 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. painful or difficult urination. Scientists use genetic rewiring to increase lifespan of cells. Also, you can look at the national clinical trial registry athttps://clinicaltrials.govThe Phase 2 trial is number: NCT04634552. Lindsay Diamond Discusses Ongoing Role of Immunotherapy in Bladder Cancer. Bull Cancer. 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 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 . This drug entry is a stub and has not been fully annotated. HealthTree Foundation / Myeloma Crowd is a qualified 501(c)(3) tax-exempt organization. Disclosure: This study was funded by Janssen Research & Development LLC. New therapies are urgently needed to help people with treatment-resistant disease., Dr. Marianne Baker, research information manager at Cancer Research UK. We are getting into the realm of treatment in myeloma where the newer drugs are sometimes coming up with unique side effects. This was for talquetamab, which again targets this specific anchor. 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. 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. Living With Cancer. Were looking at all of that, to try to figure out how to optimize the combination of these drugs in a highly effective regimen, said Tendler. Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. I lost a lot of sleep over this, Aronson shared, noting that her patients were distressed by these AEs. This year, among the several bi-specifics on the ASH agenda, Talquetamab still peaks my interest. 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. Talquetamab, a bispecific antibody against CD3 and GPRC5D, redirects T cells to mediate killing of GPRC5D-expressing myeloma cells. GPRC5D has limited expression on healthy human tissue but is highly expressed on malignant myeloma cells. The 73% response rate in this study is higher than that for most currently available therapies. 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. Talquetamab is an IgG4 Fc-containing BsAb targeting G- protein-coupled receptor family C group 5 member D . 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. 8600 Rockville Pike Courtesy of Matt Herp / American Society of Hematology, Bluebird bios gene therapy for beta thalassemia, published in The New England Journal of Medicine, Drugmakers take sides in Amgen, Regeneron fight over antibody patents, Sanofi strikes a $150M deal for Mazes Pompe disease drug, Astellas to acquire eye drug developer Iveric Bio for $5.9B, Initial launches with $75M and a new idea for targeting problematic proteins, FDA approves new ALS medicine in precedent-setting decision, The latest developments on the gene therapy frontier, US cancer deaths are falling but not fast enough, GSK struggles to make investors believe its growth story, US FDA declines to approve Ascendis hormone disorder therapy, Alnylams early Alzheimers results encourage, but company discloses new hurdle, Lilly drug Mounjaro succeeds in second weight loss study, Novartis trims 10% of drug pipeline in research cutback, Morphic shares swing on study data for drug viewed as oral Entyvio. 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. Now, talquetamab, or talq for short, is a bi-specific antibody against a target called GPRC5D. In a separate cohort, 51 patients who had previously received therapies that redirect T cells showed a response to talquetamab. 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. The site is secure. Healthy plasma cells produce antibodies to help people fight disease. Theyve exhausted many available therapies []. The primary end points - the frequency and type of dose-limiting toxic effects (study part 1 only . Side-Effects of Talquetamab At the time of the data cut-off, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). That is something which is again, unique, different. 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 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 . Using a different target opens up all kinds of new possibilities. 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. FDA/EMA Accept Ide-Cel Applications for Earlier R/R Multiple Myeloma Use. At the two recommended subcutaneous doses for a phase . Conclusions: Anti-PD1. Apr 28, 2023 11:39am. Taltz is a medicine used for treating moderate to severe plaque psoriasis, a disease causing red, scaly patches on the skin. Bluebird attributed both to underlying genetics specifically, a condition known as alpha thalassemia trait that is associated with anemia. Duration of response is good too. 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. 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. 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. Talquetamab (JNJ-64407564) binds to GPRC5D and CD3 to induce T-cell . Cytokine release syndrome, skin-related events, and dysgeusia were common with talquetamab treatment but were primarily low-grade. Another anti-CD38/CD3 BiTE . Topics covered: Gene replacement therapy, gene editing, engineered cell therapy, manufacturing, pricing, reimbursement and much more. Find out how likely it is to occur and why it happens. 1. The study enrolled a total of 288 patients who were unable to tolerate existing therapies or who experienced disease progression after at least three multiple myeloma therapies. The results suggest that talquetamab could give hope to patients with refractory myeloma. Kikuchi T, Tsukada N, Nomura M, Kasuya Y, Oda Y, Sato K, Takei T, Ogura M, Abe Y, Suzuki K, Ishida T. Ann Hematol. N Engl J Med. Keep up with the story. Minnema MC, Krishnan A, Berdeja JG, et al. In total 70% of patients experienced Cytokine Release Syndrome (CRS) but all events were minor. We tried several things. Please enable it to take advantage of the complete set of features! Oral TEAEs were common in the trial with 57.9% of patients (n = 44) experiencing a grade 1 or 2 oral AE. Is the ketogenic diet right for autoimmune conditions? Unable to load your collection due to an error, Unable to load your delegates due to an error. Posted: 12/11/2022 10:00:00 AM 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. The researchers said very few patients (5-6%) stopped talquetamab treatment because of side effects. I am looking forward to seeing how the reduction in frequency of administration will improve the side effects I've been experiencing. But there are six trials recruiting! 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. FDA Grants FTD to Off-the-Shelf CAR T in R/R Multiple Myeloma. And here were seeing responses of like 70 to 100%. Ive been on pretty much every approved drug regimen and theyve all worked really well for me. However, research has not proven these mushrooms can prevent cancer. . And at the various doses, deep, ongoing responses were noted. 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. Talquetamab is a bispecific antibody, a type of monoclonal antibody that redirects T cells to act against myeloma cells. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021. We are getting into the realm of treatment in myeloma where the newer drugs are sometimes coming up with unique side effects. However, in her practice, certain interventions have proven useful in mitigating some of the toxicities experienced by patients. After initial priming, patients received either weekly or biweekly dosing throughout the study duration. 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 . Talquetamab for Multiple Myeloma Talquetamab, a bifunctional antibody, directs activated T cells to tumor. 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. Last Updated: 12/19/2022 12:57:45 PM. Talquetamab, a G protein-coupled receptor family C group 5 member D X CD3 bispecific antibody, in relapsed/refractory multiple myeloma: updated efficacy and safety results from MonumenTAL-1. 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. The blood tests which measured my myeloma (M spike, IGG, free light chains) all stayed pretty stable. At least he plans to, but we have zero CAR-T capacity and no idea when the situation . Between the Lines Podcast: Updates in Use of Proteasome Inhibitors for Relapsed/Refractory Multiple Myeloma. Beth Faiman, PhD, CNP, discusses reclassifying patients with multiple myeloma, the accelerated approval of teclistamab, and the removal of belantamab mafodotin from the US market. Side effects include: Thrombocytopenia with . Each entry includes links to find associated clinical trials. 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. 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. 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 . The drug produced a substantial response, with only low-grade side effects, in 70% of the patients. In June 2022, the FDA granted talquetamab a breakthrough therapy designation.3. Get the free daily newsletter read by industry experts. No unexpected side effects were seen with this association. (Its also found on hairfollicle cells but dont worry youre not going to lose your hair again.) With bispecific antibodies, the way we give . Teclistamab in Relapsed or Refractory Multiple Myeloma. 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! Hitting GPRC5D made its first splash as part of a preclinical Juno/Celgene Car-T therapy back at Ash 2018, and though it took a long time for this asset to enter the . This means slippery stuff [that] goes down, she explained. Cancerous plasma cells make abnormal antibodies called M-proteins that do not protect the body from infections. Oral and dermatologic TEAEs, though generally mild, present an opportunity for oncology nurses to improve patient quality of life. Clipboard, Search History, and several other advanced features are temporarily unavailable. There are two problems: 1. side effects, and 2. the drugs stop working after a while. 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. CRS and cytopenia were primarily observed in early cycles and were reversable. "Hydrate, hydrate, hydrate," she said. 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 uses a different target called GPRC5D. For now, the best preventative and therapeutic approaches to dermatologic and oral AEs have yet to be identified. The Expanding Clinical Role of Bifunctional Antibodies. Real-world clinical outcomes in patients with multiple myeloma treated with isatuximab after daratumumab treatment. Another important side effect was altered taste. Overall, across all treatment groups the trial found 73% of subjects responded positively to the treatment. 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. With talquetamab, only about half the patients make it to only a little more than a year before they relapse. So after a month, I was pretty low about talquetamab. Learn more. 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. Cancers (Basel). runny or stuffy nose. 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. 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 . Nearly 60% had a very good partial response, meaning that their cancer was substantially reduced. Immune checkpoints are a potential target for MM therapy since they are overexpressed in MM plasma cells . Xerostomia . Chari et al reported results of Talquetamab which targets GPRC5D which showed an ORR of 66% in 55 evaluable pts. Topics covered: startup launches, funding, IPOs and much more. Talquetamab fo Multiple Myeloma. It is the first bispecific agent targeting the protein GPRC5d in multiple myeloma patients," Chari said. DrugBank Accession Number. Data showed skin- and taste-related side effects were common, but typically rated mild. Of these, dysgeusia, dry mouth, and dysphagia were the most experienced symptoms. 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. 2023 Apr 28. doi: 10.1007/s00277-023-05218-1. The same side effects that I mentioned are cytokine release syndrome. lower back or side pain. scaling of the skin. Unlike traditional monoclonal antibodies, bispecific antibodies are engineered to bind to two different antigens. After sifting through two papers, two presentations, an article and a poster; heres what I thought youd like to know. 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. 2021 Apr 27;5(8):2196-2215. doi: 10.1182/bloodadvances.2020003805. Whats really great is that some myeloma cells NOT having BCMA MIGHT have GPRC5D. Anemia, in this context, can be worrisome as a potential sign of emerging blood cancer. Other most common side effects are reported in table. The CRS was low-grade without associated mortality. (If you just need to know, that stands for G Protein-coupled Receptor class C Group 5 member D.). 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. Federal government websites often end in .gov or .mil. Conclusions: The most recent data on BiTE antibodies in RRMM has shown promising results with good . 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. ASH 2021: Update on Talquetamab (Plain English Version), Soporte Para Pacientes de Mieloma Mltiple, University of Miami's Minimal Residual Disease (MRD) Meeting, Sequencing BCMA Therapies with Dr. Joshua Richter, Treating Multiple Myeloma by Exploding Cancerous Cells, Defining Your Risk of Progression With Smoldering Myeloma, Cevostamab, a New Bispecific Antibody for Refractory/Relapsed Multiple Myeloma, Blood-Based Single Cell Sequencing Holds the Key to Better Treatment Outcomes, Clinical Trial: Patient and Care Partner Experiences Living with Multiple Myeloma, HealthTree Coach has a New & Improved Website. Online ahead of print. One of the things that I think is very telling with efgartigimod is, no matter what subgroup we looked at, it showed a benefit over placebo, said Broome. Janssen announces US FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma. This typically occurs on both the palms and the soles of the feet, she said. 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.. Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. Taste changes were very common, Aronson said. sneezing. Rich completed his Masters degree in the Arts back in 2013 before joining New Atlas in 2016. No other study participants in the trial had the same genotype. Data showed skin- and taste-related side effects were common, but typically rated mild. Grade ranged from grade 1 to grade 3 for the dermatologic events. The median time to onset was 26.5, 6.7, and 41.5 days, respectively. 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 . Emerging Strategies to Manage Relapsed and/or Refractory Multiple Myeloma. Over the course of the trial, 73% of patients responded positively to the drug. ORR at RP2D (405 g/kg SC) was 69% in 19 pts treated at this dose. Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. "Human natural killer cell" [Micrograph]. . 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 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. My doc said he will put me on CAR-T when the Talquetamab fails. The https:// ensures that you are connecting to the But it is important to keep in mind that some of the side effects were a bit unique. ABSTRACT 291: Phase I/II, first-in-human study of REGN5458 in 45 patients with relapsed and/or refractory multiple myeloma . 2023 Apr;29(3):722-726. doi: 10.1177/10781552231154809. There are two problems: 1. side effects, and 2. the drugs stop working after a while. Blood Adv. Therapies already exist for ITP, which causes dangerously low platelet levels, but they have limitations. Infections also occurred in more than . 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. Clin Lymphoma Myeloma Leuk. Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. Talquetamab is under investigation in clinical trial NCT04634552 (A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma). doi: 10.1016/j.bulcan.2021.10.003. 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. We've had, for example, a drug with ocular or eye toxicity. In total, 55.3% of patients experienced dysgeusia, 21.1% experienced dry mouth, and 22.4% experienced dysphagia. Duration of delay from the last dose administered Action . 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. Oncology nursing always has their finger on the pulse of the patients psychosocial [needs]. FDA Pauses Trial Evaluating MT-0169 in R/R Multiple Myeloma and Lymphoma. At the time of data cut-off, 76 patients had been enrolled in the trial at Mount Sinai Hospital. N Engl J Med. We have lot of patients start a nail hardener at the onset of therapy.. It was pretty gross. Accessed August 25, 2022. Last year at ASH, I studied andlearned more about anew bi-specific antibody drug called talquetamab. Phase trial confirmed a 70% response rate in patients with advanced disease. Like BCMA, Talquetamabs target, GPRC5D, is found on most myeloma cells. These are patients whove had typically five lines of therapy over several years. Initial treatment for multiple myeloma may involve chemotherapy, immunotherapy, and corticosteroid treatment. . Talquetamab is a new bi-specific drug that is currently gearing up for its Phase 2 studies. Looking forward to more breakthroughs. Copyright 2022 Massachusetts Medical Society. A low white blood count (neutropenia) occurred in 42% of the patients and Cytokine release syndrome (CRS) in 64%. Hydrate, hydrate, hydrate, she said. We've had, for example, a drug with ocular or eye toxicity. Accessed August 25, 2022. Effects of teclistamab and talquetamab on soluble BCMA levels in patients with relapsed/refractory multiple myeloma Blood Adv . 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. 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. Would you like email updates of new search results? The primary objectives were to identify the recommended phase 2 doses (RP2Ds) (part 1) and assess talquetamab's safety and tolerability at the RP2Ds (part 2).
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