Other adverse events like bruising, headaches and blood in urine occurred at similar rates in both groups. Only one patient to date at our center, has discontinued treatment due to an oral or dermatologic side effect. Oral and dermatologic TEAEs, though generally mild, present an opportunity for oncology nurses to improve patient quality of life. 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. You? Therapies already exist for ITP, which causes dangerously low platelet levels, but they have limitations. Please enable it to take advantage of the complete set of features! The researchers said very few patients (5 to 6 percent) stopped talquetamab treatment because of side effects. An official website of the United States government. This is more convenient for patients and, Dr. Chari added, in the phase 2 trial there was a hint of more durable remissions in the 2-weekly., Future trials should see if talquetamabs specific targeting of myeloma could allow more patients to benefit from treatment, especially when combined with other drugs. Attendees of the American Society of Hematology's annual meeting walk across a conference hall in December 2022. Although T cells expressing CD38 might be attacked by AMG 424, this side effect is acceptable because the advantages outweigh the disadvantages . J Oncol Pharm Pract. (2016). Clipboard, Search History, and several other advanced features are temporarily unavailable. No modifications were caused by dry mouth. Paul G. Richardson, MD, and Christina Gasparetto, MD, offer insights into the use of proteasome inhibitors in relapsed or refractory multiple myeloma. [Bispecific antibodies in multiple myeloma]. (Funded by bluebird bio and Celgene, a Bristol-Myers Squibb company . 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. Our dermatologist recommended against do a nail soaks, she noted. For patients experiencing palmar/plantar desquamation, ammonium lactate lotion, and emollients have shown efficacy. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021. 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 . Epub 2022 Jun 5. painful or difficult urination. A low white blood count (neutropenia) occurred in 42% of the patients and Cytokine release syndrome (CRS) in 64%. Talquetamab binds to both T cells and multiple myeloma cells. The idea behind bispecific antibodies is they work to bridge immune cells with cancer cells. Janssen is responsible for the development and commercialization of talquetamab. 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. 2022 Dec 15;387(24):2287-2290. doi: 10.1056/NEJMe2208708. Another anti-CD38/CD3 BiTE . Reducing Medical and Other Debt Through Negotiation, Getting Fit and Keeping Bones Safe (Live Exercise Demo), SouthEast Myeloma Community- Understanding Immunotherapy. Background. My doc said he will put me on CAR-T when the Talquetamab fails. In the last week of the first cycle, I checked my plasmocytoma on Saturday and it seemed a little smaller. Talquetamab was designed to target the GPRC5Da receptor, which is highly present on cancerous plasma cells. Living With Cancer. 2023 Apr 28. doi: 10.1007/s00277-023-05218-1. 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). Characterization and Management of Oral and Dermatological Toxicities "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. But neither are expected to give the cash-strapped company significant revenue, making a third program for sickle cell disease crucial to its future. 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. One dose-limiting toxic effect of grade 3 rash was reported in a patient who had received talquetamab at the 800-g dose level. It lasted about a year. Most of the reported adverse events (side effects) were mild or moderate in severity. This typically occurs on both the palms and the soles of the feet, she said. This site needs JavaScript to work properly. About two-thirds had skin-related side effects like rash, and around . So patients, hopefully, will have a new and very exciting different opportunity coming up for the treatment of relapsed or refractory multiple myeloma. Intuitive Surgical collects new prostate procedure clearances for its single-port robot. 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. doi: 10.1016/j.bulcan.2021.10.003. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Chari et al reported results of Talquetamab which targets GPRC5D which showed an ORR of 66% in 55 evaluable pts. And here were seeing responses of like 70 to 100%. Talquetamab: Uses, Interactions, Mechanism of Action - DrugBank 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. The years biggest meeting on blood diseases kicked off this past weekend. 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. Novel Experimental Drugs for Treatment of Multiple Myeloma Taltz is a medicine used for treating moderate to severe plaque psoriasis, a disease causing red, scaly patches on the skin. with I am looking forward to seeing how the reduction in frequency of administration will improve the side effects I've been experiencing. More than 7 days . DrugBank Accession Number. Through patient education tactics, oncology nurses can help patients with multiple myeloma mitigate the oral and dermatologic toxicities associated with talquetamab. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. Bookshelf G protein-coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells. Lots of liquids, smoothies, small bites, [and teaching them to] sit upright when they eat [and] wash everything down with liquidbecause it seems that dryness was just extending all the way down the upper gastrointestinal [GI] tract., A take home is the early treatment of oral candida, she concluded. Generic Name. Like BCMA, Talquetamabs target, GPRC5D, is found on most myeloma cells. J&J's next myeloma drug, Argenx's second act and a new question for Topics covered: Drug commercialization, pharma salesforces, generic and biosimilar competition, drug advertising and much more. 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 . Some people may then receive a stem cell transplant, using their own or donor cells, to help them manufacture healthy blood cells. . Phase trial confirmed a 70% response rate in patients with advanced disease. sharing sensitive information, make sure youre on a federal Beth Faiman Discusses Recent Changes in Multiple Myeloma Treatment Landscape. Tecvayli appeared well tolerated. But it is important to keep in mind that some of the side effects were a bit unique. 5 months after I stopped, I recovered my sense of taste. ABSTRACT 291: Phase I/II, first-in-human study of REGN5458 in 45 patients with relapsed and/or refractory multiple myeloma . 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 . Ive been on pretty much every approved drug regimen and theyve all worked really well for me. Unlike traditional monoclonal antibodies, bispecific antibodies are engineered to bind to two different antigens. There's been amazing progress in the area of immunotherapy. Management of Relapsed-Refractory Multiple Myeloma in the Era of Advanced Therapies: Evidence-Based Recommendations for Routine Clinical Practice. Ive been fighting Multiple Myeloma for more than 15 years. Taltz contains the active substance ixekizumab. FDA Delays Quizartinib PDUFA Date for Newly Diagnosed FLT3-ITD+ AML. Injection-site reactions were observed in 7.9% of patients. ASH 2021: Update on Talquetamab - HealthTree for Myeloma Type. Conclusions: The most recent data on BiTE antibodies in RRMM has shown promising results with good . You can use your HealthTree data to see if you qualify to join a talquetamab trial. 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. June 29, 2022. 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. Blood Adv. HHS Vulnerability Disclosure, Help Of these, more than 30% had a complete response, meaning that, following treatment, the researchers could detect no myeloma-specific markers. . If myeloma stops responding to treatment, it is called refractory myeloma. Updated Data for Janssen's Bispecific Teclistamab Suggest Continued In patients with multiple myeloma, GPRC5D is overexpressed and . runny or stuffy nose. I lost a lot of sleep over this, Aronson shared, noting that her patients were distressed by these AEs. Topics covered: Gene replacement therapy, gene editing, engineered cell therapy, manufacturing, pricing, reimbursement and much more. The Expanding Clinical Role of Bifunctional Antibodies. In total, 55.3% of patients experienced dysgeusia, 21.1% experienced dry mouth, and 22.4% experienced dysphagia. 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. 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 events in 75% of patients" All of the noted side effects, however, were considered manageable and reversible. An off-the-shelf immunotherapy for myeloma called talquetamab is This was for talquetamab, which again targets this specific anchor. Patients with measurable MM who were relapsed/refractory or . The side effects are troubling, some require hospitalization, especially because of infections. Side effects with talquetamab were meanwhile relatively frequent, but typically mild. But it is important to keep in mind that some of the side effects were a bit unique. 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. Data showed skin- and taste-related side effects were common, but typically rated mild. 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. 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. Teclistamab (Tecvayli) for the Treatment of Multiple Myeloma Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target . 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. 2021 Oct;108(10S):S205-S212. We've talked about this, but just to . 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. As with the oral reactions, Aronson acknowledged that no therapeutic interventions have been identified as best practice in addressing dermatologic reactions. The Talquetamab / Daratumumab trial. Oral TEAEs were common in the trial with 57.9% of patients (n = 44) experiencing a grade 1 or 2 oral AE. Just under three-quarters of participants given a lower or higher dose of talquetamab in the Phase 2 portion of J&Js study responded to treatment, with around a third of each group achieving remission of their cancer. Global Pipeline | Genmab Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. Kerry Boyle D.Ac., M.S., L.Ac., Dipl. Known as a bispecific T-cell engager antibody, this treatment is a relatively new kind of immunotherapy approach. Recent advances in the treatment of multiple myeloma In the phase 1 trial, 232 patients with relapsed or refractory myeloma were given talquetamab. We would prescribe an ammonium lactate lotion to help with that turnover and also recommend a very heavy moisturizer [such as] Aquaphor or vanicream.. And responses tended to deepen over time. 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 . Ash 2022 preview - a new multiple myeloma mechanism makes a splash Talquetamab Generates High Response Rate in Relapsed or Refractory The latest R&D info about Janssen-Cilag Ltd.: pipelines, patents Talquetamab fo Multiple Myeloma - CancerConnect Duration of response is good too. 8600 Rockville Pike Topics covered: startup launches, funding, IPOs and much more. With bispecific antibodies, the way we give . Oyster mushrooms for cancer: Do they help? And this will us the idea that, for example, if you've had a BCMA-directed CAR T cell, you still could be treated with a bispecific such as talquetamab. The same side effects that I mentioned are cytokine release syndrome. She [noted] that that would increase the incidence of fungal issues. Talquetamab side effects. Their findings were published as a case study in Nature Medicine in December. It isexcitingnot only because it isa bi-specific(important enough in itself) butalsobecause it involves a target not being used in any othermyelomadrugsso far. Accessed August 25, 2022. These arent people with many options remaining, so in that setting 50% improvement is fantastic, he added. . CRS and cytopenia were primarily observed in early cycles and were reversable. There are two problems: 1. side effects, and 2. the drugs stop working after a while. (Its also found on hairfollicle cells but dont worry youre not going to lose your hair again.) Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she . Learn more. Were hoping that this will soon become available so that patients can benefit.. This is a list of most of the side effects I've had since I started talquetamab. We've been so busy adding drugs to the arsenal that [were] catching up to figure out the right sequences and unanswered questions.. Get the free daily newsletter read by industry experts. Oral antihistamines and topical corticosteroids are useful in addressing a body rash and injection-site reactions. 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. With talquetamab, only about half the patients make it to only a little more than a year before they relapse. 2023 Apr;29(3):722-726. doi: 10.1177/10781552231154809. or who could not receive these therapies without unacceptable side effects. 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 . That was the TNB trial. Between the Lines Podcast: Updates in Use of Proteasome Inhibitors for Relapsed/Refractory Multiple Myeloma. The median duration of response was 10.2 months and 7.8 months, respectively. 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. 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. 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. Talquetamab fo Multiple Myeloma. Presented at: European Hematology Association Congress 2022; June 9-12, 2022; Vienna, Austria. Conclusions: 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. Back pain can be a symptom of cancer or a side effect of cancer treatment. Janssen Submits Biologics License Application to U.S. FDA for
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