In total, 165 patients were enrolled in the trial. Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target . . Paul G. Richardson, MD, and Christina Gasparetto, MD, offer insights into the use of proteasome inhibitors in relapsed or refractory multiple myeloma. ABSTRACT 291: Phase I/II, first-in-human study of REGN5458 in 45 patients with relapsed and/or refractory multiple myeloma . Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. Oyster mushrooms contain antioxidants, which may lower cancer risk. 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. 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. Specific Cancers. 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. Rich completed his Masters degree in the Arts back in 2013 before joining New Atlas in 2016. Ive recently retired from a career as a CPA. Retrieved from, JMJ Launches Free Toolbox Talks App to Make Safety Accessible to All, Azzur Group Hosts Groundbreaking for Devens, MA Cleanrooms on Demand Facility, Vial VP of Business Development, Daniel Gallagher, to Present at Precision in Clinical Trials , Vivera Secures United Kingdom Patent for Innovative ZICOH Smart Inhaler Device, By signing up to receive our newsletter, you agree to our. The primary endpoint of the study was met. 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. I am looking forward to seeing how the reduction in frequency of administration will improve the side effects I've been experiencing. Learn more here. Then I was in TRIMM-2. 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. 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. Presented at: European Hematology Association Congress 2022; June 9-12, 2022; Vienna, Austria. Therapies already exist for ITP, which causes dangerously low platelet levels, but they have limitations. For full disclosures of the study authors, visit ash.confex.com. 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%. A tolerable side-effect profile was observed in patients previously treated with anti-BCMA treatment, . Talquetamab, a bispecific antibody . Epub 2021 Aug 10. I lost a lot of sleep over this, Aronson shared, noting that her patients were distressed by these AEs. A Promising New Treatment Emerges For Multiple Myeloma Following treatment with the immunotherapy drug in the Mount Sinai Health System trial, almost three-quarters of the participants showed improvement, with 30% having a complete response to the drug. Healthy plasma cells produce antibodies to help people fight disease. We've talked about this, but just to . June 29, 2022. This is a whole new era of cancer therapy, Dr. Chari said. We tried several things. Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martnez-Lpez J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. 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. As with the oral reactions, Aronson acknowledged that no therapeutic interventions have been identified as best practice in addressing dermatologic reactions. Like BCMA, Talquetamabs target, GPRC5D, is found on most myeloma cells. 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. Attendees of the American Society of Hematology's annual meeting walk across a conference hall in December 2022. 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. New Cancer Drug Achieves 73% Response Rate in Patients The range for dosing was biweekly or weekly treatment at a dosage of 1.5 to 180 g/kg with IV administration and 5 to 800 g/kg with subcutaneous treatment. "Hydrate, hydrate, hydrate," she said. Taltz contains the active substance ixekizumab. Children and Cancer . Duration of delay from the last dose administered Action . Abstract - American Society of Hematology The most common AEs related to treatment with talquetamab include cytokine release syndrome (CRS), neurotoxicity, cytopenia, infections, skin and nail disorders, and oral toxicities. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Here are three storylines to emerge so far. All participants had received at least three prior treatments, including other types of drugs. Nurses Call for More Research on Nutrition Challenges for Patients With AML/MDS. 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! 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. Ongoing trials are assessing the optimal phase 2 dose, as well as assessing the agents efficacy in combination with approved and investigational therapy. If you . 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. No unexpected side effects were seen with this association. Myeloma Bispecific Antibody Talquetamab Update - HealthTree for Myeloma Step-up dose 1 . The Talquetamab / Daratumumab trial. So the researchers believe that talquetamab could offer a viable option for patients whose myeloma has stopped responding to other therapies. We are getting into the realm of treatment in myeloma where the newer drugs are sometimes coming up with unique side effects. 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. . It lasted about a year. Talquetamab for Multiple Myeloma Talquetamab, a bifunctional antibody, directs activated T cells to tumor. Tecvayli appeared well tolerated. The . 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. Real-world clinical outcomes in patients with multiple myeloma treated with isatuximab after daratumumab treatment. But it is important to keep in mind that some of the side effects were a bit unique. FDA Considering Talquetamab for Hard-to-treat Multiple The younger patient doesnt, but Bluebird still plans to screen for patients with the alpha thalassemia trait in the future and exclude them from its ongoing studies. "Talquetamab induced a substantial response among patients with heavily pretreated, relapsed, or refractory multiple myeloma, the second-most-common blood cancer. DrugBank Accession Number. Bispecific Antibody Cancer Treatment Shows 73% Response Rate loss of voice. Effects of teclistamab and talquetamab on soluble BCMA levels in patients with relapsed/refractory multiple myeloma Blood Adv . Talquetamab for relapsed/refractory multiple myeloma: Results from a (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. Cancer Treatment Side Effects. Oral TEAEs were common in the trial with 57.9% of patients (n = 44) experiencing a grade 1 or 2 oral AE. Side-Effects of Talquetamab At the time of the data cut-off, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). A standardized regimen of topical and oral supportive care appears to be beneficial in the management of . 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. . with Copyright 2022 HealthTree Foundation. SOHO State-of-the-Art Updates and Next Questions | BCMA-Directed CAR T-Cells: Early Results and Future Directions. 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. Talquetamab: New drug may offer hope for those with hard-to-treat blood Patients would describe this as everything tasting like cardboard or sawdust, or that things that they used to enjoy now tasted completely different.. These cells, made in the bone marrow, are a vital part of the immune system. It was pretty gross. Taltz | European Medicines Agency For now, the best preventative and therapeutic approaches to dermatologic and oral AEs have yet to be identified. These are patients whove had typically five lines of therapy over several years. Also at ASH, Roche and Bristol Myers Squibb presented data for a GPRC5D-targeting bispecific antibody and cell therapy, respectively.