"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. Myeloma stories, Myeloma clinical trials, Myeloma 101 articles and events with Myeloma The CRS was low-grade without associated mortality. 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. 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. Their findings were published as a case study in Nature Medicine in December. Only one patient to date at our center, has discontinued treatment due to an oral or dermatologic side effect. 5 months after I stopped, I recovered my sense of taste. Posted: 12/11/2022 10:00:00 AM This site needs JavaScript to work properly. Talquetamab side effects. Rich completed his Masters degree in the Arts back in 2013 before joining New Atlas in 2016. Known as a bispecific T-cell engager antibody, this treatment is a relatively new kind of immunotherapy approach. Over the course of the trial, 73% of patients responded positively to the drug. Drugs targeting GPRC5D, for instance, could offer an alternative to BCMA-binding treatments. 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 researchers said very few patients (5 to 6 percent) stopped talquetamab treatment because of side effects. We've had, for example, a drug with ocular or eye toxicity. One of these was the MonumenTAL-1 trial, which is a clinical trial for a newer bi-specific antibody called talquetamab, in patients with relapsed/refractory multiple myeloma. Newly approved and forthcoming T-cell-redirecting bispecific antibodies for the treatment of relapsed/refractory multiple myeloma. SOHO State-of-the-Art Updates and Next Questions | BCMA-Directed CAR T-Cells: Early Results and Future Directions. Diagnosis and Management of Adult Malignancy-Associated Hemophagocytic Lymphohistiocytosis. Hitting GPRC5D made its first splash as part of a preclinical Juno/Celgene Car-T therapy back at Ash 2018, and though it took a long time for this asset to enter the . Bluebird got a much-needed lift this year when U.S. regulators approved two of its gene therapies. MNT is the registered trade mark of Healthline Media. These cells, made in the bone marrow, are a vital part of the immune system. It seems the total effect is a real drying effect. The study participants had all been previously treated with at least three different therapies without achieving lasting remission, suggesting talquetamab could offer new hope for patients with hard-to-treat multiple myeloma. Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects. DB16678. We have lot of patients start a nail hardener at the onset of therapy.. All rights reserved. Talquetamab for Multiple Myeloma Talquetamab, a bifunctional antibody, directs activated T cells to tumor. It also binds CD3, a protein on the surface of immune T-cells. An official website of the United States government. Endometrial stromal sarcoma (ESS) is a rare form of uterine cancer that typically affects people during or after menopause. This novel blood clot treatment doesn't increase bleeding risk, Why young women have more adverse outcomes after a heart attack than young men, Gut microbiome appears to fluctuate throughout the day and across seasons, One-hour endoscopic procedure could eliminate the need for insulin for type 2 diabetes, New clues to slow aging? Other adverse events like bruising, headaches and blood in urine occurred at similar rates in both groups. And this particular study showed us a bit more mature, larger number, patient data of talquetamab in patients with relapsed/refractory myeloma. 2023 Mar 17;15(6):1819. doi: 10.3390/cancers15061819. 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 . If you . 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. That is something which is again, unique, different. But I'm curious then, maybe we can talk a little bit about the side effects. There's been amazing progress in the area of immunotherapy. For nail changes, Aronson recommends nail hardeners, Vitamin E lotion, and cuticle care products. (Funded by Janssen Research and Development; MonumenTAL-1 ClinicalTrials.gov number, NCT03399799.). 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. 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. Accessed August 25, 2022. 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. Although T cells expressing CD38 might be attacked by AMG 424, this side effect is acceptable because the advantages outweigh the disadvantages . So patients, hopefully, will have a new and very exciting different opportunity coming up for the treatment of relapsed or refractory multiple myeloma. Talquetamab (JNJ-64407564) binds to GPRC5D and CD3 to induce T-cell . The Phase 2 trial data has yet to be formally published in a peer-reviewed journal, however, the Phase 1 data has just been published in The New England Journal of Medicine. Approximately 75% experienced cytokine release syndrome, which is known to be a common side effect of immunotherapy and includes symptoms such as fever development. Verkleij CPM, Broekmans MEC, van Duin M, Frerichs KA, Kuiper R, de Jonge AV, Kaiser M, Morgan G, Axel A, Boominathan R, Sendecki J, Wong A, Verona RI, Sonneveld P, Zweegman S, Adams HC, Mutis T, van de Donk NWCJ. Presented at: European Hematology Association Congress 2022; June 9-12, 2022; Vienna, Austria. Anything less doesnt count.. 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. Side effects with talquetamab were meanwhile relatively frequent, but typically mild. Generic Name. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. . On Friday, J&J submitted an application for U.S. approval, meaning the drug could reach market in the near future. Using a different target opens up all kinds of new possibilities. government site. We've been so busy adding drugs to the arsenal that [were] catching up to figure out the right sequences and unanswered questions.. The primary endpoint of the study was met. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid. One of the things that I think is very telling with efgartigimod is, no matter what subgroup we looked at, it showed a benefit over placebo, said Broome. Unlike traditional monoclonal antibodies, bispecific antibodies are engineered to bind to two different antigens. Step-up dose 1 . Through patient education tactics, oncology nurses can help patients with multiple myeloma mitigate the oral and dermatologic toxicities associated with talquetamab. We've talked about this, but just to . Researchers are continuing to collect data on the duration of response in the group receiving 0.8 mg/kg every other week and for patients in both dosing groups who had a complete response or better. "Talquetamab induced a substantial response among patients with heavily pretreated, relapsed, or refractory multiple myeloma, the second-most-common blood cancer. 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. Data from patients who had received these same dosing regimens in the first phase were included in the analysis for the second phase. . 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 . Effects of teclistamab and talquetamab on soluble BCMA levels in patients with relapsed/refractory multiple myeloma Blood Adv . Overall, with both oral and dermatologic therapies, Aronsons best advice is hydration. (Its also found on hairfollicle cells but dont worry youre not going to lose your hair again.) 2022 Dec 15;387(24):2287-2290. doi: 10.1056/NEJMe2208708. National Library of Medicine [] [I]t really is a game-changing paradigm, said Dr. Chari. Before 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.. Of these, more than 30% had a complete response, meaning that, following treatment, the researchers could detect no myeloma-specific markers. Learn more here. 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. Xerostomia . Scientists use genetic rewiring to increase lifespan of cells. Multiple myeloma is an incurable blood cancer that affects cells inside a patient's bone marrow. ORR at RP2D (405 g/kg SC) was 69% in 19 pts treated at this dose. 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. News release. Kerry Boyle D.Ac., M.S., L.Ac., Dipl. experts. Children and Cancer . The results suggest that talquetamab could give hope to patients with refractory myeloma. 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. Duration of delay from the last dose administered Action . For now, the best preventative and therapeutic approaches to dermatologic and oral AEs have yet to be identified. 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). Conclusions: The most recent data on BiTE antibodies in RRMM has shown promising results with good . But it is important to keep in mind that some of the side effects were a bit unique. 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. For example, skin and ear problems, which can sometimes affect patients a little bit differently, but can also be a quality-of-life issue. While Phase 1 trials are for the purpose of determining safety and dosage, they do yield results on side effects and efficacy as well. Here are three storylines to emerge so far. 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. 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. Like BCMA, Talquetamabs target, GPRC5D, is found on most myeloma cells. The abnormal plasma cells are made from stem cells in the bone marrow. Intuitive Surgical collects new prostate procedure clearances for its single-port robot. (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. But if you remember the picture, perhaps you also remember the comment from the patient. In total, 55.3% of patients experienced dysgeusia, 21.1% experienced dry mouth, and 22.4% experienced dysphagia. The safety data imply that no laboratory or cardiac monitoring is necessary with this drug. Side-Effects of Talquetamab At the time of the data cut-off, 232 patients had received talquetamab (102 intravenously and 130 subcutaneously). Therapies already exist for ITP, which causes dangerously low platelet levels, but they have limitations. itching in the genital or other skin areas. 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. This was for talquetamab, which again targets this specific anchor. Patients would describe this as everything tasting like cardboard or sawdust, or that things that they used to enjoy now tasted completely different.. Unauthorized use of these marks is strictly prohibited. Side effects were relatively frequent, but typically mild. Many myeloma treatments (CAR-T, BLENREP, other bi-specifics, etc) target BCMA, an antigen found on 80-100% of myeloma cells. 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. 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. Sikander Ailawadhi, MD, discussed the safety and efficacy of talquetamab in heavily pretreated patients with relapsed/refractory multiple myeloma following a readout of the phase 1/2 MonumenTAL-1 trial. Talquetamab fo Multiple Myeloma. 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. The median time to onset was 26.5, 6.7, and 41.5 days, respectively.
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