Oncology On-The-Go Podcast: Multiple Myeloma Outcome Disparities, Trial Access. The immunotherapy being trialled is called talquetamab. At the data-cutoff date, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). At least he plans to, but we have zero CAR-T capacity and no idea when the situation . 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. These are patients whove had typically five lines of therapy over several years. Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. ASH: J&J makes case for just-filed GPRC5D drug talquetamab MonumenTAL-1 trial Shows Promise With Talquetamab in R/R Myeloma Topics covered: Gene replacement therapy, gene editing, engineered cell therapy, manufacturing, pricing, reimbursement and much more. Experimental cancer therapy shows success in | EurekAlert! At the time of data cut-off, 76 patients had been enrolled in the trial at Mount Sinai Hospital. 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. Results: Krina Patel, MD, MSc, discusses research and initiatives that may help to mitigate disparities in patients with multiple myeloma including factors such as gender, race, and ethnicity. Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. GPRC5D has limited expression on healthy human tissue but is highly expressed on malignant myeloma cells. Janssen is responsible for the development and commercialization of talquetamab. lower back or side pain. The same side effects that I mentioned are cytokine release syndrome. Topics covered: startup launches, funding, IPOs and much more. Intuitive Surgical collects new prostate procedure clearances for its single-port robot. New York, NY. We tried several things. So those are side effects of both bispecific antibodies and CAR-T cells. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Minnema MC, Krishnan A, Berdeja JG, et al. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for 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. She [noted] that that would increase the incidence of fungal issues. Whats really great is that some myeloma cells NOT having BCMA MIGHT have GPRC5D. This one, talquetamab, came up with some different side effects. Patients with measurable MM who were relapsed/refractory or . Data from patients who had received these same dosing regimens in the first phase were included in the analysis for the second phase. 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. Bispecific Antibody Platform: Early Data in Relapsed and Refractory After initial priming, patients received either weekly or biweekly dosing throughout the study duration. These cells, made in the bone marrow, are a vital part of the immune system. The primary endpoint of the study was met. itching in the genital or other skin areas. 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. 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. 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. Were hoping that this will soon become available so that patients can benefit.. Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects. Myeloma Bispecific Antibody Talquetamab Update - HealthTree for Myeloma Testing of that drug, known as lovo-cel, has already been stalled twice by the Food and Drug Administration due to safety concerns, causing Bluebird to fall behind a rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics thats now under rolling regulatory review in the U.S. Vertex and CRISPR aim to complete their filing by the end of the first quarter. Cancerous plasma cells make abnormal antibodies called M-proteins that do not protect the body from infections. 2023 May;23(5):310-321. doi: 10.1016/j.clml.2023.01.017. Clinical Updates: Emerging Therapies for Patients With Multiple Myeloma (2016). 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. Teclistamab (Tecvayli) for the Treatment of Multiple Myeloma It also binds CD3, a protein on the surface of immune T-cells. Conclusions: The most recent data on BiTE antibodies in RRMM has shown promising results with good . Bluebird believes lovo-cel may exacerbate the problems linked to alpha thalassemia trait. Epub 2023 Feb 12. 2023 Healthline Media UK Ltd, Brighton, UK. Known as a bispecific T-cell engager antibody, this treatment is a relatively new kind of immunotherapy approach. Thus, combination therapies may both enhance activity and offer a favorable side-effect profile. "Talquetamab induced a substantial response among patients with heavily pretreated, relapsed, or refractory multiple myeloma, the second-most-common blood cancer. A Surprisingly Happy Talquetamab Update : r/multiplemyeloma - Reddit 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. No modifications were caused by dry mouth. 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. 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. sore mouth or tongue. 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. One thing that will happen, though, is that my talquetamab dose will be increased to make up for the change in schedule. Shares climbed about 3% on Monday and, at about $400 apiece, trade near record highs. 2023 Apr 5;15(7):2160. doi: 10.3390/cancers15072160. 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 . 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. Janssen announces US FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma. Other treatments target the symptoms to improve the patients quality of life. . In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. (Janssen) to create and develop bispecific antibodies using Genmab's DuoBody technology platform. Taste changes were very common, Aronson said. Bluebird attributed both to underlying genetics specifically, a condition known as alpha thalassemia trait that is associated with anemia. Lindsay Diamond, MSN, AGNP-C, AOCNP, discusses findings from CheckMate 274 and other data presented during the 2023 ASCO Genitourinary Cancers Symposium. Cancer Treatment Side Effects. 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. Oral and dermatologic TEAEs, though generally mild, present an opportunity for oncology nurses to improve patient quality of life. Theyve exhausted many available therapies []. I hadn't realized it, but was thinking I had just lost track of when I was getting it. Epub 2022 Dec 11. Talquetamab, an off-the-shelf product, targets both CD3 and a G protein-coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells. . 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. Before These trials could give people with myeloma the chance to live longer by keeping their cancer at bay.. Cancers (Basel). 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 bispecific antibody against CD3 and GPRC5D, redirects T cells to mediate killing of GPRC5D-expressing myeloma cells. This allowed the treatment priority and accelerated pathways through approval processes. 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. You? If you . 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. The response rate observed in the study, which Dr. Chari explained is higher than . Get access to cutting edge treatment via Talquetamab, Daratumumab, Teclistamab. 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. PDF HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include N Engl J Med. sharing sensitive information, make sure youre on a federal Specific Cancers. 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 . To explore the feasibility of talquetamab in the RRMM setting, a first-in-human phase I study of talquetamab in patients with RRMM was conceived (NCT03399799).The results were presented by Ajai Chari during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition 1 and are summarized below.. Study design 1. (If you just need to know, that stands for G Protein-coupled Receptor class C Group 5 member D.). Oral antihistamines and topical corticosteroids are useful in addressing a body rash and injection-site reactions. And at the various doses, deep, ongoing responses were noted. Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg). . 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. Victoria R. Crowder, BSN, RN, and co-investigators, highlight existing gaps in the understanding of malnutrition risks facing patients with acute myeloid leukemia and myelodysplastic syndromes. Scientists use genetic rewiring to increase lifespan of cells. Talquetamab fo Multiple Myeloma - CancerConnect My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. We are getting into the realm of treatment in myeloma where the newer drugs are sometimes coming up with unique side effects. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. Few side effects, though. Only one patient to date at our center, has discontinued treatment due to an oral or dermatologic side effect. Unlike traditional monoclonal antibodies, bispecific antibodies are engineered to bind to two different antigens. While Phase 1 trials are for the purpose of determining safety and dosage, they do yield results on side effects and efficacy as well. For full disclosures of the study authors, visit ash.confex.com. New therapies are urgently needed to help people with treatment-resistant disease., Dr. Marianne Baker, research information manager at Cancer Research UK. Side Effects: Some Common, Some Unusual. 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. But of course nothing works forever. 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.. We've had, for example, a drug with ocular or eye toxicity. 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 technology has been in development for decades but it has only been in the last few years that bispecific antibodies have finally reached clinical uses. Data showed skin- and taste-related side effects were common, but typically rated mild. 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. Talquetamab, also known as GPRC5D T cell-redirecting antibody, recruits T cells to tumor cells and activate T cells. 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. These arent people with many options remaining, so in that setting 50% improvement is fantastic, he added. FDA Pauses Trial Evaluating MT-0169 in R/R Multiple Myeloma and Lymphoma. Cure Hub Side Effect Solutions My Journal University Coach Connect . Taltz is a medicine used for treating moderate to severe plaque psoriasis, a disease causing red, scaly patches on the skin. Infections also occurred in more than half of patients on each drug dose, with 17% and 12% respectively graded as more severe. Diagnosis and Management of Adult Malignancy-Associated Hemophagocytic Lymphohistiocytosis. For nail changes, Aronson recommends nail hardeners, Vitamin E lotion, and cuticle care products. Duration of response is good too. 8600 Rockville Pike Saad Z. Usmani, MD. 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. . Talquetamab fo Multiple Myeloma. [] [I]t really is a game-changing paradigm, said Dr. Chari. Talquetamab is one of several new drugs in the hopper that are giving us triple+ refractory myelomapatients a heart full of hope. Other adverse events like bruising, headaches and blood in urine occurred at similar rates in both groups. 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. Accessibility SOHO State-of-the-Art Updates and Next Questions | BCMA-Directed CAR T-Cells: Early Results and Future Directions. A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy scaling of the skin. Drugs targeting GPRC5D, for instance, could offer an alternative to BCMA-binding treatments. The Expanding Clinical Role of Bifunctional Antibodies. 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. Posted: 12/11/2022 10:00:00 AM Presented at: International Myeloma Society 6th Annual Nursing Symposium; August 25-27, 2022; Los Angeles, CA. Injection-site reactions were observed in 7.9% of patients. 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. . 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. The cases occurred in one adult and one younger study participant. Ash 2022 preview - a new multiple myeloma mechanism makes a splash 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. In June 2022, the FDA granted talquetamab a breakthrough therapy designation.3. Each entry includes links to find associated clinical trials. FDA Delays Quizartinib PDUFA Date for Newly Diagnosed FLT3-ITD+ AML. With bispecific antibodies, the way we give . But if you remember the picture, perhaps you also remember the comment from the patient. Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. Multiple myeloma is a cancer of plasma cells. MNT is the registered trade mark of Healthline Media. Grade ranged from grade 1 to grade 3 for the dermatologic events. In a separate cohort, 51 patients who had previously received therapies that redirect T cells showed a response to talquetamab. . (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. Vyvgart, also known as efgartigimod, could help when other therapies dont work, study results presented Sunday suggest.
talquetamab side effects