talquetamab side effects

FOIA Bookshelf Both of those therapies bind to BCMA, a protein targeted by a wave of new drugs from Roche, Regeneron, AbbVie and Pfizer. 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. . Talquetamab is an IgG4 Fc-containing BsAb targeting G- protein-coupled receptor family C group 5 member D . Side Effects: Some Common, Some Unusual. Chari et al reported results of Talquetamab which targets GPRC5D which showed an ORR of 66% in 55 evaluable pts. "With a median follow-up of 14.9 months (range 0.5+ to 29.0), 74.1 percent of patients treated at the SC [subcutaneous] 0.4 mg/kg dose administered weekly achieved a response, 59.4 percent achieved a very good partial response or better, 33.6 percent achieved a complete response or better and 23.8 percent achieved a stringent complete response," reported pharmaceutical company Johnson & Johnson in a press release. 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 . In patients with multiple myeloma, GPRC5D is overexpressed and . I hadn't realized it, but was thinking I had just lost track of when I was getting it. Nearly 60% had a very good partial response, meaning that their cancer was substantially reduced. doi: 10.1016/j.bulcan.2021.10.003. Click here for details. Epub 2022 Dec 11. More than 30% of patients in both groups had a complete response or better, and nearly 60% had a very good partial response or better. 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. 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. Current treatment options for ITP, while [there] are many, can be associated with comorbidities, unsatisfactory efficacy and duration of effect, said Catherine Broome, a study author and associate professor of medicine at the Georgetown Lombardi Cancer Center in Washington, D.C., at an ASH press conference. It isexcitingnot only because it isa bi-specific(important enough in itself) butalsobecause it involves a target not being used in any othermyelomadrugsso far. Risperidone is well tolerated, with a lower side-effect profile than reported for most older neuroleptics. Talquetamab is a BiTE binding GPRC5D and CD3. "Hydrate, hydrate, hydrate," she said. Through patient education tactics, oncology nurses can help patients with multiple myeloma mitigate the oral and dermatologic toxicities associated with talquetamab. 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. They simultaneously plant a target flag on cancer cells and give immune cells a roadmap to that target. Taltz contains the active substance ixekizumab. They were very impressive results with deeper responses in heavily pretreated patients. All rights reserved. A standardized regimen of topical and oral supportive care appears to be beneficial in the management of . And responses tended to deepen over time. Talquetamab (JNJ-64407564) Several studies are exploring bispecific mAbs with antigen target different from BCMA. But there are six trials recruiting! 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 . with Nurses Exchange Best Strategies in Improving Delivery of Hepatic Artery Infusion Pump Education. They can have a limited impact on quality of life measures.. Nearly all multiple myeloma patients will relapse at some point in their treatment, becoming resistant to first one, then another frontline intervention. Many patients who reported burning, glossitis, we would treat for candida because our [ear nose and throat] ENT doctor felt that in the setting of such severe dryness, they may not present with oral plaques. Infections also occurred in more than half of patients on each drug dose, with 17% and 12% respectively graded as more severe. After initial priming, patients received either weekly or biweekly dosing throughout the study duration. Presented at: International Myeloma Society 6th Annual Nursing Symposium; August 25-27, 2022; Los Angeles, CA. Last year at ASH, I studied andlearned more about anew bi-specific antibody drug called talquetamab. Can diet help improve depression symptoms? In June 2022, the FDA granted talquetamab a breakthrough therapy designation.3. Cancerous plasma cells make abnormal antibodies called M-proteins that do not protect the body from infections. There's been amazing progress in the area of immunotherapy. Talquetamab is a new bi-specific drug that is currently gearing up for its Phase 2 studies. 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.. 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. Epub 2023 Feb 3. The researchers state that adverse side effects to talquetamab occurred "relatively frequently" but were most often mild. 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. The bottom line is that almost 70% of heavily pre-treated triple+ refractory patients responded! I tell patients to take a lukewarm or cool shower, [to use] heavy lubricants, body oil, those kinds of thingsbecause the dryness is really severe. Oncology nursing always has their finger on the pulse of the patients psychosocial [needs]. . Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. 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. pies without unacceptable side effects or had disease that had progressed with established therapies, and had an absolute neutrophil count Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody that targets GPRC5D. Some people may then receive a stem cell transplant, using their own or donor cells, to help them manufacture healthy blood cells. Ac., CYT, Enzalutamide, combined with standard treatment, shows promise in prostate cancer, What to know about endometrial stromal sarcoma. Many myeloma treatments (CAR-T, BLENREP, other bi-specifics, etc) target BCMA, an antigen found on 80-100% of myeloma cells. The results suggest that talquetamab could give hope to patients with refractory myeloma. Endometrial stromal sarcoma (ESS) is a rare form of uterine cancer that typically affects people during or after menopause. 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. All participants had received at least three prior treatments, including other types of drugs. Multiple myeloma is a cancer of plasma cells. Rich completed his Masters degree in the Arts back in 2013 before joining New Atlas in 2016. SOHO State-of-the-Art Updates and Next Questions | BCMA-Directed CAR T-Cells: Early Results and Future Directions. The CRS was low-grade without associated mortality. 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. Cancer Treatment Side Effects. Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. 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. Attendees of the American Society of Hematology's annual meeting walk across a conference hall in December 2022. So patients, hopefully, will have a new and very exciting different opportunity coming up for the treatment of relapsed or refractory multiple myeloma. 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. We have lot of patients start a nail hardener at the onset of therapy.. Bispecific Antibodies in Multiple Myeloma: Opportunities to Enhance Efficacy and Improve Safety. 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. Were hoping that this will soon become available so that patients can benefit.. 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. 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. 2023 Mar 18;15(6):1839. doi: 10.3390/cancers15061839. Between the Lines Podcast: Updates in Use of Proteasome Inhibitors for Relapsed/Refractory Multiple Myeloma. In the phase 2 trial, doctors administered all the treatments subcutaneously using doses that had been safe and successful in the phase 1 trial. News release. That is something which is again, unique, different. The Expanding Clinical Role of Bifunctional Antibodies. Careers. 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. Disclosure: This study was funded by Janssen Research & Development LLC. 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. Conclusions: 2021 Apr 27;5(8):2196-2215. doi: 10.1182/bloodadvances.2020003805. runny or stuffy nose. Side-Effects of Talquetamab At the time of the data cut-off, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). Patients enrolled in MomumenTAL-1 were assigned to a dose level and either the subcutaneous (n = 24; 31.6%) or intravenous (IV) dosing cohort (n = 52; 68.4%). Xerostomia . Topics covered: Drug commercialization, pharma salesforces, generic and biosimilar competition, drug advertising and much more. itching in the genital or other skin areas. Vyvgart, also known as efgartigimod, could help when other therapies dont work, study results presented Sunday suggest. Online ahead of print. Following our recent Biologics License Application submission to the US FDA, we look forward to working with the agency to make this available as a treatment option in the short term and continuing our longer-term investigations of talquetamab as we aim to develop additional options for patients with this complex blood cancer," said Sen Zhuang, vice president of clinical R&D at Janssen Research & Development. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. 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%. Bethesda, MD 20894, Web Policies A biologics license application has been submitted to the FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma. Saad Z. Usmani, MD. The number of patients it will impact is difficult to quantify and likely modest, Foroohar added, but still real.. Patients with measurable MM who were relapsed/refractory or . 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. 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. It also binds CD3, a protein on the surface of immune T-cells. . We tried several things. 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.
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