ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021. Talquetamab, a bispecific antibody against CD3 and GPRC5D, redirects T cells to mediate killing of GPRC5D-expressing myeloma cells. Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. Generic Name. itching in the genital or other skin areas. Talquetamab is a BiTE binding GPRC5D and CD3. Ive recently retired from a career as a CPA. Cytokine release syndrome, skin-related events, and dysgeusia were common with talquetamab treatment but were primarily low-grade. The primary endpoint of the study was met. Paul G. Richardson, MD, and Christina Gasparetto, MD, offer insights into the use of proteasome inhibitors in relapsed or refractory multiple myeloma. Let BioPharma Dive's free newsletter keep you informed, straight from your inbox. 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. If myeloma stops responding to treatment, it is called refractory myeloma. And at the various doses, deep, ongoing responses were noted. Ongoing trials are assessing the optimal phase 2 dose, as well as assessing the agents efficacy in combination with approved and investigational therapy. technology has been in development for decades, Rewired genetic 'clock' slows aging and increases cellular lifespan, Surfcycle: A highway-speed, lane-splitting stand-up scooter on steroids, Astronomers spot nearest star-destroying black hole. They simultaneously plant a target flag on cancer cells and give immune cells a roadmap to that target. Background: You? "It seems the total effect is a real drying effect. New York, NY. 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. Oncology On-The-Go Podcast: Multiple Myeloma Outcome Disparities, Trial Access. HHS Vulnerability Disclosure, Help All rights reserved. The median duration of response was 10.2 months and 7.8 months, respectively. Of these, dysgeusia, dry mouth, and dysphagia were the most experienced symptoms. Multiple myeloma is a cancer of plasma cells. The Phase 1 data was published in The New England Journal of Medicine. We've had, for example, a drug with ocular or eye toxicity. It is graphic, but it prepared patients for what to expect.. Federal government websites often end in .gov or .mil. So that would indicate the possibility that GPRC5D could potentially kill myeloma cells left behind after BCMA-based regimens are used! Talquetamab is an IgG4 Fc-containing BsAb targeting G- protein-coupled receptor family C group 5 member D . Oral and dermatologic TEAEs, though generally mild, present an opportunity for oncology nurses to improve patient quality of life. When patients are having taste changes, and their wife is in tears saying I want him to eat, he wont eat, what do I do? Thats where we really can come in and help., Aronson is a clinical nurse practitioner specializing in bone marrow transplant and immune effector cell therapies at Mount Sinai Hospital. 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. They were divided into two groups, one of which received the drug intravenously, and the other subcutaneously. 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. So after a month, I was pretty low about talquetamab. Results: pies without unacceptable side effects or had disease that had progressed with established therapies, and had an absolute neutrophil count So patients, hopefully, will have a new and very exciting different opportunity coming up for the treatment of relapsed or refractory multiple myeloma. Other treatments target the symptoms to improve the patients quality of life. Learn more, Enzalutamide improves survival rates for men with metastasized prostate cancer when added to standard treatment, the results from the clinical trial. The safety data imply that no laboratory or cardiac monitoring is necessary with this drug. "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. This allowed the treatment priority and accelerated pathways through approval processes. Online ahead of print. Living With Cancer. 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. Now, talquetamab, or talq for short, is a bi-specific antibody against a target called GPRC5D. 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. Looking forward to more breakthroughs. Side effects were relatively frequent, but typically mild. Expand Side Effects: Some Common, Some Unusual. We've been so busy adding drugs to the arsenal that [were] catching up to figure out the right sequences and unanswered questions.. We have lot of patients start a nail hardener at the onset of therapy.. Patients with measurable MM who were relapsed/refractory or . 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. And it also gave us a glimpse into the side effect profile for this drug, which I don't think the side effects were that severe. (Abstract #S188) and talquetamab (Abstract #S183) cohorts of the TRIMM-2 study will be featured as oral presentations at the European Hematology Association (EHA) 2022 Congress taking place in Vienna, . The number of patients it will impact is difficult to quantify and likely modest, Foroohar added, but still real.. 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. 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. Duration of delay from the last dose administered Action . Ive been on pretty much every approved drug regimen and theyve all worked really well for me. New data from an ongoing Phase 1/2 clinical trial has revealed an experimental immunotherapy led to successful response rates in 73% of patients suffering from multiple myeloma, a deadly form of blood cancer. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. 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. Drilling down into the data, there were 59% very good partial responses (VGPR) with the lower dose, along with . You can use your HealthTree data to see if you qualify to join a talquetamab trial. She [noted] that that would increase the incidence of fungal issues. Another important side effect was altered taste. The appearance of Johnson & Johnson's talquetamab in this year's Ash press programme will highlight GPRC5D blockade as an important new mechanism in treating multiple myeloma. The myeloma cancer cells also build up in the bone marrow and form tumors. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. For example, skin and ear problems, which can sometimes affect patients a little bit differently, but can also be a quality-of-life issue. Can diet help improve depression symptoms? (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. Talquetamab is a bispecific antibody, a type of monoclonal antibody that redirects T cells to act against myeloma cells. 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. Between the Lines Podcast: Updates in Use of Proteasome Inhibitors for Relapsed/Refractory Multiple Myeloma. Last year at ASH, I studied andlearned more about anew bi-specific antibody drug called talquetamab. 1. FDA Pauses Trial Evaluating MT-0169 in R/R Multiple Myeloma and Lymphoma. 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. Onco-Nursing Experts Define Best Practices, Treatment Considerations for Managing Patients With MPNs. This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03158688) in the KdD - Carfilzomib, Dexamethasone and Daratumumab ARM group. 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. Talquetamab fo Multiple Myeloma. The disease, which affects around one in 132 people in the United States, is rarely diagnosed in people under the age of 65. 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. Initial treatment for multiple myeloma may involve chemotherapy, immunotherapy, and corticosteroid treatment. Data from patients who had received these same dosing regimens in the first phase were included in the analysis for the second phase. Taltz is a medicine used for treating moderate to severe plaque psoriasis, a disease causing red, scaly patches on the skin. This drug entry is a stub and has not been fully annotated. 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.. Investigators used a step-up dosing schema and premedications to mitigate AEs. A tolerable side-effect profile was observed in patients previously treated with anti-BCMA treatment, . It is produced on the base of DuoBody technology. Phase trial confirmed a 70% response rate in patients with advanced disease. Earlier in 2022, based on preliminary positive trial data, the FDA granted talquetamab Breakthrough Therapy designation. Using a different target opens up all kinds of new possibilities. . A low white blood count (neutropenia) occurred in 42% of the patients and Cytokine release syndrome (CRS) in 64%. It also binds CD3, a protein on the surface of immune T-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. Vyvgart, also known as efgartigimod, could help when other therapies dont work, study results presented Sunday suggest. Nearly all multiple myeloma patients will relapse at some point in their treatment, becoming resistant to first one, then another frontline intervention. The side effects are troubling, some require hospitalization, especially because of infections. ATLANTA, Ga., December 11, 2021- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of talquetamab (NCT03399799).Talquetamab is the only investigational off-the-shelf T cell redirecting bispecific antibody in clinical development targeting both GPRC5D, a novel multiple myeloma target . 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 . runny or stuffy nose. These trials could give people with myeloma the chance to live longer by keeping their cancer at bay.. FDA Delays Quizartinib PDUFA Date for Newly Diagnosed FLT3-ITD+ AML. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. The fast-advancing pipeline could expand options for multiple myeloma patients, but also raise questions about how treatments should be sequenced and how future drug trials might best be designed. government site. GPRC5D has limited expression on healthy human tissue but is highly expressed on malignant myeloma cells. The . Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. Subscribe to the weekly "HealthTree Community for Myeloma Newsletter" for Myeloma news, life This year, among the several bi-specifics on the ASH agenda, Talquetamab still peaks my interest. Rich completed his Masters degree in the Arts back in 2013 before joining New Atlas in 2016. But I'm curious then, maybe we can talk a little bit about the side effects. All rights reserved. Both of those therapies bind to BCMA, a protein targeted by a wave of new drugs from Roche, Regeneron, AbbVie and Pfizer. Cancer Treatment Side Effects. Anti-PD1. or who could not receive these therapies without unacceptable side effects. 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. 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. Bluebird attributed both to underlying genetics specifically, a condition known as alpha thalassemia trait that is associated with anemia. Dr. Chari explained: A complete response isnt actually a cure but its basically getting it down to a level where its undetectable. Last Updated: 12/19/2022 12:57:45 PM. 2023 Apr 5;15(7):2160. doi: 10.3390/cancers15072160. 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. The researchers said very few patients (5 to 6 percent) stopped talquetamab treatment because of side effects. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. A total of 5 patients experienced dose interruptions because of a TEAE. (2016). Kerry Boyle D.Ac., M.S., L.Ac., Dipl. The years biggest meeting on blood diseases kicked off this past weekend. In total, 165 patients were enrolled in the trial. After becoming refractory to available therapies, median overall survival is 6-11 months. lower back or side pain. All side effects, not much to show for it. Nearly 60% had a very good partial response, meaning that their cancer was substantially reduced. Reducing Medical and Other Debt Through Negotiation, Getting Fit and Keeping Bones Safe (Live Exercise Demo), SouthEast Myeloma Community- Understanding Immunotherapy. 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. I hadn't realized it, but was thinking I had just lost track of when I was getting it. June 29, 2022. (If you just need to know, that stands for G Protein-coupled Receptor class C Group 5 member D.). 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. The primary objectives were to identify the recommended phase 2 doses (RP2Ds) (part 1) and assess talquetamab's safety and tolerability at the RP2Ds (part 2). 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. Another anti-CD38/CD3 BiTE . A medrol dose (Pak) may be used for more severe cases. National Library of Medicine Side effects with talquetamab were meanwhile relatively frequent, but typically mild. Xerostomia . As with the oral reactions, Aronson acknowledged that no therapeutic interventions have been identified as best practice in addressing dermatologic reactions. On Friday, J&J submitted an application for U.S. approval, meaning the drug could reach market in the near future. In patients with multiple myeloma, GPRC5D is overexpressed and . Unlike traditional monoclonal antibodies, bispecific antibodies are engineered to bind to two different antigens. There are two problems: 1. side effects, and 2. the drugs stop working after a while. Immunotherapy is a type of treatment that affects a person's immune system. Talquetamab is one of several new drugs in the hopper that are giving us triple+ refractory myelomapatients a heart full of hope. Get access to cutting edge treatment via Talquetamab, Daratumumab, Teclistamab. The researchers said very few patients (5-6%) stopped talquetamab treatment because of side effects. Read on for details and takeaways from the meeting over the weekend: Like many new drug targets, its name is complicated and better off abbreviated. DB16678. This is the new unmet need in multiple myeloma.. J&Js therapy, called talquetamab, is a bispecific antibody aimed at both GPRC5D and a protein expressed by immune cells. 2021 Oct;108(10S):S205-S212. Patients would describe this as everything tasting like cardboard or sawdust, or that things that they used to enjoy now tasted completely different.. Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches. One thing that will happen, though, is that my talquetamab dose will be increased to make up for the change in schedule. 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. This is a list of most of the side effects I've had since I started talquetamab. 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.. 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. Overall, with both oral and dermatologic therapies, Aronsons best advice is hydration. No modifications were caused by dry mouth. My colleague would tell patients your skin is going to peel like a lizard on your hands and feet, she said. The immunotherapy being trialled is called talquetamab. Argenx is developing a subcutaneous version of efgartigimod and expects to have results from a Phase 3 study testing that formulation in the second half of 2023. The 73% response rate in this study is higher than that for most currently available therapies. Careers. Kikuchi T, Tsukada N, Nomura M, Kasuya Y, Oda Y, Sato K, Takei T, Ogura M, Abe Y, Suzuki K, Ishida T. Ann Hematol. Overall, across all treatment groups the trial found 73% of subjects responded positively to the treatment. 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. So the researchers believe that talquetamab could offer a viable option for patients whose myeloma has stopped responding to other therapies. Known as a bispecific T-cell engager antibody, this treatment is a relatively new kind of immunotherapy approach. . This one, talquetamab, came up with some different side effects. Epub 2021 Aug 10. 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. About two-thirds had skin-related side effects like rash, and around . Blood Adv. 2023 Apr 28. doi: 10.1007/s00277-023-05218-1. SOHO State-of-the-Art Updates and Next Questions | BCMA-Directed CAR T-Cells: Early Results and Future Directions. After sifting through two papers, two presentations, an article and a poster; heres what I thought youd like to know. 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 . 5 months after I stopped, I recovered my sense of taste. That is something which is again, unique, different. Nurses should encourage patients to incorporate thin liquids into their diet. It is scheduled to be annotated soon. 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. Shares climbed about 3% on Monday and, at about $400 apiece, trade near record highs. Our dermatologist recommended against do a nail soaks, she noted. No other study participants in the trial had the same genotype. 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. Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she concluded. In the phase 2 trial, doctors administered all the treatments subcutaneously using doses that had been safe and successful in the phase 1 trial. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. 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. Many [of these] patients reported rapid improvement once we treated them.. 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. The cases occurred in one adult and one younger study participant. 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. A biologics license application has been submitted to the FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma. 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. We're not used to seeing that, but something important to keep in mind. Epub 2022 Dec 11. Data showed skin- and taste-related side effects were common, but typically rated mild. Oncology nursing always has their finger on the pulse of the patients psychosocial [needs]. Janssen is responsible for the development and commercialization of talquetamab. 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. With talquetamab, only about half the patients make it to only a little more than a year before they relapse. It is used in adults who require systemic treatment (treatment with medicines affecting the whole body). For now, the best preventative and therapeutic approaches to dermatologic and oral AEs have yet to be identified. New blood cancer therapy successful in three-quarters of trial patients, The new treatment is currently under application for review by the FDA.