Cytokine release syndrome, skin-related events, and dysgeusia were common with talquetamab treatment but were primarily low-grade. In her role, Aronson cares for patients enrolled in the phase 1 MonumenTAL-1 trial (NCT03399799), a dose-escalation/dose-expansions study seeking to characterize the safety profile and recommended phase 2 dose for talquetamab in patients with multiple myeloma who either have relapsed/refractory disease or are ineligible for other available treatment options.2. The myeloma cancer cells also build up in the bone marrow and form tumors. . 5 months after I stopped, I recovered my sense of taste. So patients, hopefully, will have a new and very exciting different opportunity coming up for the treatment of relapsed or refractory multiple myeloma. June 29, 2022. 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 . Topics covered: Drug commercialization, pharma salesforces, generic and biosimilar competition, drug advertising and much more. Xerostomia . No modifications were caused by dry mouth. 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 Another important side effect was altered taste. Bispecific Antibody Platform: Early Data in Relapsed and Refractory 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. Talquetamab: Uses, Interactions, Mechanism of Action - DrugBank 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. 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. Drilling down into the data, there were 59% very good partial responses (VGPR) with the lower dose, along with . Multiple myeloma is a cancer of plasma cells. Intuitive Surgical collects new prostate procedure clearances for its single-port robot. 2021 Apr 27;5(8):2196-2215. doi: 10.1182/bloodadvances.2020003805. Infections also occurred in more than half of patients on each drug dose, with 17% and 12% respectively graded as more severe. 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.. Teclistamab (Tecvayli) for the Treatment of Multiple Myeloma Dima D, Ullah F, Mazzoni S, Williams L, Faiman B, Kurkowski A, Chaulagain C, Raza S, Samaras C, Valent J, Khouri J, Anwer F. Cancers (Basel). We've had, for example, a drug with ocular or eye toxicity. Nearly all multiple myeloma patients will relapse at some point in their treatment, becoming resistant to first one, then another frontline intervention. Copyright 2022 HealthTree Foundation. "Hydrate, hydrate, hydrate," she said. Recent advances in the treatment of multiple myeloma Bispecific Antibody Cancer Treatment Shows 73% Response Rate 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. All rights reserved. Cancer Treatment Side Effects. Talquetamab, also known as GPRC5D T cell-redirecting antibody, recruits T cells to tumor cells and activate T cells. GPRC5D has limited expression on healthy human tissue but is highly expressed on malignant myeloma cells. Nurse Practitioners/Physician's Assistants, 2022 ASCO Genitourinary Cancers Symposium Urothelial Cancer Updates, Contemporary Concepts in Hematologic Oncology, Insights from Experts at Mayo Clinic on Translating Evidence to Clinical Practice, Optimizing Outcomes in Patients with HER2+ Metastatic Breast Cancer, | 2022 ASCO Genitourinary Cancers Symposium Urothelial Cancer Updates, | Contemporary Concepts in Hematologic Oncology, | Insights from Experts at Mayo Clinic on Translating Evidence to Clinical Practice, | Optimizing Outcomes in Patients with HER2+ Metastatic Breast Cancer. All participants had received at least three prior treatments, including other types of drugs. FDA Pauses Trial Evaluating MT-0169 in R/R Multiple Myeloma and Lymphoma. 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. 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: J&J makes case for just-filed GPRC5D drug talquetamab Learn more, Enzalutamide improves survival rates for men with metastasized prostate cancer when added to standard treatment, the results from the clinical trial. Clinical Updates: Emerging Therapies for Patients With Multiple Myeloma Get the free daily newsletter read by industry experts. 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, 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 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. Ive been fighting Multiple Myeloma for more than 15 years. 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. Paul G. Richardson, MD, and Christina Gasparetto, MD, offer insights into the use of proteasome inhibitors in relapsed or refractory multiple myeloma. Talquetamab (JNJ-64407564) Several studies are exploring bispecific mAbs with antigen target different from BCMA. After sifting through two papers, two presentations, an article and a poster; heres what I thought youd like to know. Back pain can be a symptom of cancer or a side effect of cancer treatment. FDA/EMA Accept Ide-Cel Applications for Earlier R/R Multiple Myeloma Use. Were hoping that this will soon become available so that patients can benefit.. Then I was in TRIMM-2. The side effects are troubling, some require hospitalization, especially because of infections. The drug produced a substantial response, with only low-grade side effects, in 70% of the patients. 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 . Talquetamab is a first-in-class, off-the-shelf (ready to use), investigational bispecific T-cell engager antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3, a primary . [] [I]t really is a game-changing paradigm, said Dr. Chari. Grade ranged from grade 1 to grade 3 for the dermatologic events. More than 7 days . Data showed skin- and taste-related side effects were common, but typically rated mild. At the data-cutoff date, 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 . Taltz | European Medicines Agency 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. Kikuchi T, Tsukada N, Nomura M, Kasuya Y, Oda Y, Sato K, Takei T, Ogura M, Abe Y, Suzuki K, Ishida T. Ann Hematol. Can this be used for MM treatment? : r/multiplemyeloma These trials could give people with myeloma the chance to live longer by keeping their cancer at bay.. Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she concluded. Step-up dose 1 . Online ahead of print. Ive been on pretty much every approved drug regimen and theyve all worked really well for me. Between the Lines Podcast: Updates in Use of Proteasome Inhibitors for Relapsed/Refractory Multiple Myeloma. Nurses Call for More Research on Nutrition Challenges for Patients With AML/MDS. A tolerable side-effect profile was observed in patients previously treated with anti-BCMA treatment, . 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 bottom line is that almost 70% of heavily pre-treated triple+ refractory patients responded! The idea behind bispecific antibodies is they work to bridge immune cells with cancer cells. The response rate observed in the study, which Dr. Chari explained is higher than . One thing that will happen, though, is that my talquetamab dose will be increased to make up for the change in schedule. For patients experiencing palmar/plantar desquamation, ammonium lactate lotion, and emollients have shown efficacy. Unable to load your collection due to an error, Unable to load your delegates due to an error. Risperidone is well tolerated, with a lower side-effect profile than reported for most older neuroleptics. The disease, which affects around one in 132 people in the United States, is rarely diagnosed in people under the age of 65. Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. G protein-coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells. Reducing Medical and Other Debt Through Negotiation, Getting Fit and Keeping Bones Safe (Live Exercise Demo), SouthEast Myeloma Community- Understanding Immunotherapy. 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. This is a whole new era of cancer therapy, Dr. Chari said. Rich completed his Masters degree in the Arts back in 2013 before joining New Atlas in 2016. But if you remember the picture, perhaps you also remember the comment from the patient. I hadn't realized it, but was thinking I had just lost track of when I was getting it. official website and that any information you provide is encrypted 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. Type. Our dermatologist recommended against do a nail soaks, she noted. Talquetamab for Multiple Myeloma Talquetamab, a bifunctional antibody, directs activated T cells to tumor. Duration of delay from the last dose administered Action . A total of 5 patients experienced dose interruptions because of a TEAE. After becoming refractory to available therapies, median overall survival is 6-11 months. 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. . Hydrate, hydrate, hydrate, she said. My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. Last year at ASH, I studied andlearned more about anew bi-specific antibody drug called talquetamab. Cancerous plasma cells make abnormal antibodies called M-proteins that do not protect the body from infections. The blood tests which measured my myeloma (M spike, IGG, free light chains) all stayed pretty stable. 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. So after a month, I was pretty low about talquetamab. Talquetamab was designed to target the GPRC5Da receptor, which is highly present on cancerous plasma cells. MonumenTAL-1 trial Shows Promise With Talquetamab in R/R Myeloma 2023 Healthline Media UK Ltd, Brighton, UK. This typically occurs on both the palms and the soles of the feet, she said. 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. We've talked about this, but just to . The immunotherapy being trialled is called talquetamab. Diagnosis and Management of Adult Malignancy-Associated Hemophagocytic Lymphohistiocytosis. Taste changes were very common, Aronson said. Talquetamab is a bispecific antibody, a type of monoclonal antibody that redirects T cells to act against myeloma cells. CRS and cytopenia were primarily observed in early cycles and were reversable. Oncology nursing always has their finger on the pulse of the patients psychosocial [needs]. 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. 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. Side-Effects of Talquetamab At the time of the data cut-off, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). Talquetamab is under investigation in clinical trial NCT04634552 (A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma). Myeloma affects around 6,000 people in the United Kingdom every year, causing more thaneight deaths each day. 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. Whats exciting is these are patients who are in their late 60s that have had so many prior therapies we wouldnt even think that their immune cells would work very well because theyve been so beaten up by all of these treatments. The most surprising and disappointing problem I've encountered is the loss of my sense of taste. Get access to cutting edge treatment via Talquetamab, Daratumumab, Teclistamab. Data from patients who had received these same dosing regimens in the first phase were included in the analysis for the second phase. There are two problems: 1. side effects, and 2. the drugs stop working after a while. 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%). 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. The https:// ensures that you are connecting to the 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. We've had, for example, a drug with ocular or eye toxicity. 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 gist was that the temporary side effect was nothing if the drug works! (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. 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! Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects. ASCO: J&J's subcutaneous bispecifics tackle multiple myeloma in phase 1 Also, you can look at the national clinical trial registry athttps://clinicaltrials.govThe Phase 2 trial is number: NCT04634552. And at the various doses, deep, ongoing responses were noted. 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. Posted: 12/11/2022 10:00:00 AM How Viagra became a new 'tool' for young men, Ankylosing Spondylitis Pain: Fact or Fiction, A safer blood thinner? All rights reserved. At the two recommended subcutaneous doses for a phase . National Library of Medicine These arent people with many options remaining, so in that setting 50% improvement is fantastic, he added. Talquetamab, a bispecific antibody . 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. HealthTree Foundation / Myeloma Crowd is a qualified 501(c)(3) tax-exempt organization. Clin Lymphoma Myeloma Leuk. Janssen is responsible for the development and commercialization of talquetamab. 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. Janssen announces US FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma. 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. So that would indicate the possibility that GPRC5D could potentially kill myeloma cells left behind after BCMA-based regimens are used! Oral TEAEs were common in the trial with 57.9% of patients (n = 44) experiencing a grade 1 or 2 oral AE. Phase trial confirmed a 70% response rate in patients with advanced disease. Vyvgart, also known as efgartigimod, could help when other therapies dont work, study results presented Sunday suggest. Other than some minor fatigue and some of the normal side effects of being 66, Im feeling great! Few side effects, though. runny or stuffy nose. A new therapy that makes the immune system kill bone marrow cancer cells was successful in as many as 73 percent of patients in two clinical trials, according to researchers from The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. . NS-001. They were very impressive results with deeper responses in heavily pretreated patients. In the phase 1 trial, 232 patients with relapsed or refractory myeloma were given talquetamab. Talquetamab is a BiTE binding GPRC5D and CD3. Data from the phase 3 KarMMA-3 trial support several applications for idecabtagene vicleucel in earlier use for triple-class exposed multiple myeloma in the United States, Europe, and Japan. Federal government websites often end in .gov or .mil. Last December, Argenx, a Dutch biotechnology company, won FDA approval for its first drug, securing clearance for Vyvgart in a rare condition known as generalized myasthenia gravis. 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. ORR at RP2D (405 g/kg SC) was 69% in 19 pts treated at this dose. This allowed the treatment priority and accelerated pathways through approval processes.
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