Epub 2023 Feb 12. Federal government websites often end in .gov or .mil. 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. The response rate observed in the study, which Chari explained is higher than that for most . Talquetamab, a novel CD3 X GPRC5D bispecific antibody, represents a promising therapy for patients with relapsed or refractory multiple myeloma, according to Elizabeth Aronson, MSN, FNP-BCN, OCN. We have lot of patients start a nail hardener at the onset of therapy.. That data has revealed most patients treated with talquetamab experienced mild side effects, but only around five percent had to cease treatment due to those adverse effects. 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. (a median of six previous lines of therapy) or who could not receive these therapies without unacceptable side effects. We are getting into the realm of treatment in myeloma where the newer drugs are sometimes coming up with unique side effects. Newly approved and forthcoming T-cell-redirecting bispecific antibodies for the treatment of relapsed/refractory multiple myeloma. 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. Doctors can treat and control the disease, but it is currently regarded as not curable. Talquetamab, a bispecific antibody . Tecvayli appeared well tolerated. loss of voice. The study enrolled a total of 288 patients who were unable to tolerate existing therapies or who experienced disease progression after at least three multiple myeloma therapies. making it an attractive therapeutic target. 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. Accessed August 25, 2022. 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 . Cancerous plasma cells make abnormal antibodies called M-proteins that do not protect the body from infections. 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. sneezing. Ajai Chari, MD, discusses the safety and efficacy of talquetamab plus daratumumab in heavily pretreated patients with multiple myeloma, initial data from phase 1b TRIMM-2 trial, and the potential . But of course nothing works forever. 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. Intuitive Surgical collects new prostate procedure clearances for its single-port robot. The drug produced a substantial response, with only low-grade side effects, in 70% of the patients. Presented at: International Myeloma Society 6th Annual Nursing Symposium; August 25-27, 2022; Los Angeles, CA. New therapies are urgently needed to help people with treatment-resistant disease., Dr. Marianne Baker, research information manager at Cancer Research UK. Were hoping that this will soon become available so that patients can benefit.. Known as a bispecific T-cell engager antibody, this treatment is a relatively new kind of immunotherapy approach. 2023 Apr 5;15(7):2160. doi: 10.3390/cancers15072160. Lindsay Diamond Discusses Ongoing Role of Immunotherapy in Bladder Cancer. Janssen is responsible for the development and commercialization of talquetamab. 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. Here are three storylines to emerge so far. This is the new unmet need in multiple myeloma.. Ac., CYT, Enzalutamide, combined with standard treatment, shows promise in prostate cancer, What to know about endometrial stromal sarcoma. CB-011, which received fast track designation from the FDA, is currently under investigation as a treatment for those with relapsed or refractory multiple myeloma in the phase 1 CaMMouflage trial. Minnema MC, Krishnan A, Berdeja JG, et al. 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. Nurses should encourage patients to incorporate thin liquids into their diet. Talquetamab appears to have a have favorable risk/benefit profile in RRMM with durable responses and manageable toxicities. Another important side effect was altered taste. 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. Apr 28, 2023 11:39am. Infections also occurred in more than . With talquetamab, only about half the patients make it to only a little more than a year before they relapse. 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. By The ASCO Post Staff Talquetamab had moderate side effects. Learn more, Enzalutamide improves survival rates for men with metastasized prostate cancer when added to standard treatment, the results from the clinical trial. 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. Talquetamab (JNJ-64407564) binds to GPRC5D and CD3 to induce T-cell . 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. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. 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. Victoria R. Crowder, BSN, RN, and co-investigators, highlight existing gaps in the understanding of malnutrition risks facing patients with acute myeloid leukemia and myelodysplastic syndromes. Epub 2022 Dec 11. Management of Relapsed-Refractory Multiple Myeloma in the Era of Advanced Therapies: Evidence-Based Recommendations for Routine Clinical Practice. 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. We've been so busy adding drugs to the arsenal that [were] catching up to figure out the right sequences and unanswered questions.. And it is also important to note that different doses were tested, and the appropriate dose was selected. Bull Cancer. HHS Vulnerability Disclosure, Help Saad Z. Usmani, MD. Conclusions: 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. James J. Driscoll, MD, PhD, and James Ignatz-Hoover, MD, PhD, share a perspective on a study published recently in ONCOLOGY. J Oncol Pharm Pract. Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody that targets GPRC5D. 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. Anti-PD1. and transmitted securely. Step-up dose 1 . We've talked about this, but just to . The results of the phase 1 trial appeared in the New England Journal of Medicine, and the phase 2 trial results were presented at the annual meeting of the American Society of Hematology. Immune checkpoints are a potential target for MM therapy since they are overexpressed in MM plasma cells . Online ahead of print. Of these, dysgeusia, dry mouth, and dysphagia were the most experienced symptoms. It is the first bispecific agent targeting the protein GPRC5d in multiple myeloma patients," Chari said. 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 . Bispecific Antibodies in Multiple Myeloma: Opportunities to Enhance Efficacy and Improve Safety. Thus, combination therapies may both enhance activity and offer a favorable side-effect profile. There are two problems: 1. side effects, and 2. the drugs stop working after a while. Few side effects, though. Xerostomia . 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. We would prescribe an ammonium lactate lotion to help with that turnover and also recommend a very heavy moisturizer [such as] Aquaphor or vanicream.. Before 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. The median time to onset was 26.5, 6.7, and 41.5 days, respectively. Unable to load your collection due to an error, Unable to load your delegates due to an error. Epub 2021 Aug 10. lower back or side pain. News release. New blood cancer therapy successful in three-quarters of trial patients, The new treatment is currently under application for review by the FDA. . 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 . It lasted about a year. 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. The EQ-5D-5L is a generic measure of health status. No, of course its nothing close to a cure. Just under three-quarters of participants given a lower or higher dose of talquetamab in the Phase 2 portion of J&J's study responded to treatment, with around a third of each group achieving remission of their cancer. Ive been on pretty much every approved drug regimen and theyve all worked really well for me. Injection-site reactions were observed in 7.9% of patients. A tolerable side-effect profile was observed in patients previously treated with anti-BCMA treatment, . Drugs targeting GPRC5D, for instance, could offer an alternative to BCMA-binding treatments. Teclistamab, a B-cell maturation antigenCD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Patients would describe this as everything tasting like cardboard or sawdust, or that things that they used to enjoy now tasted completely different.. Careers. For full disclosures of the study authors, visit ash.confex.com. 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. 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. Taltz contains the active substance ixekizumab. For patients experiencing palmar/plantar desquamation, ammonium lactate lotion, and emollients have shown efficacy. 2023 Feb 28;7(4):644-648. doi: 10.1182/bloodadvances.2022007625. Conclusions: The most recent data on BiTE antibodies in RRMM has shown promising results with good . So after a month, I was pretty low about talquetamab. The abnormal plasma cells are made from stem cells in the bone marrow. Multiple myeloma is a cancer of plasma cells. There are two problems: 1. side effects, and 2. the drugs stop working after a while. Real-world clinical outcomes in patients with multiple myeloma treated with isatuximab after daratumumab treatment. While that may not sound exciting, it means that much of the preliminary work necessary to prepare for FDA approval is well underway. No other study participants in the trial had the same genotype. . [] [I]t really is a game-changing paradigm, said Dr. Chari. Clin Lymphoma Myeloma Leuk. Accessed August 25, 2022. After becoming refractory to available therapies, median overall survival is 6-11 months. Dermatologic TEAEs were reported by 48.7% (n = 37) of patients in this trial. The primary endpoint of the study was met. Kikuchi T, Tsukada N, Nomura M, Kasuya Y, Oda Y, Sato K, Takei T, Ogura M, Abe Y, Suzuki K, Ishida T. Ann Hematol. In total, 165 patients were enrolled in the trial. Diagnosis and Management of Adult Malignancy-Associated Hemophagocytic Lymphohistiocytosis. Back pain can be a symptom of cancer or a side effect of cancer treatment. Copyright 2022 Massachusetts Medical Society. Kathleen Gander DNP, APRN, CNS; and Sarah Middlekauff, MSN, RN, OCN, relay their experiences in implementing a hepatic artery infusion pump educational intervention for oncology nurses. Disclosure: This study was funded by Janssen Research & Development LLC. Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects. sharing sensitive information, make sure youre on a federal Get the free daily newsletter read by industry experts. 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 is a bispecific antibody, a type of monoclonal antibody that redirects T cells to act against myeloma cells. At median follow-ups of 11.7 months (in patients who had received talquetamab at the 405-g dose level) and 4.2 months (in those who had received it at the 800-g dose level), the percentages of patients with a response were 70% (95% confidence interval [CI], 51 to 85) and 64% (95% CI, 48 to 78), respectively. No one is going to be cured with one treatment, said Craig Tendler, J&Js global head of oncology late clinical development, in an interview. Initial treatment for multiple myeloma may involve chemotherapy, immunotherapy, and corticosteroid treatment. I hadn't realized it, but was thinking I had just lost track of when I was getting it. With talquetamab, only about half the patients make it to only a little more than a year before they relapse. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. Background. . HealthTree Foundation / Myeloma Crowd is a qualified 501(c)(3) tax-exempt organization. It is used in adults who require systemic treatment (treatment with medicines affecting the whole body). PMC "Hydrate, hydrate, hydrate," she said. Clipboard, Search History, and several other advanced features are temporarily unavailable. Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she . . You? It also binds CD3, a protein on the surface of immune T-cells. Researchers said 5% to 6% of patients stopped talquetamab treatment early due to side effects. 2021 Apr 27;5(8):2196-2215. doi: 10.1182/bloodadvances.2020003805. Please enable it to take advantage of the complete set of features! The immunotherapy being trialled is called talquetamab. (Funded by bluebird bio and Celgene, a Bristol-Myers Squibb company . 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. 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. However, research has not proven these mushrooms can prevent cancer. On Friday, J&J submitted an application for U.S. approval, meaning the drug could reach market in the near future. Overall, across all treatment groups the trial found 73% of subjects responded positively to the treatment. Hydrate, hydrate, hydrate, she said. (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, . 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. Sequencing is really important, and it's probably the thing that we do the least well in myeloma, he said at the press conference. Each entry includes links to find associated clinical trials. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. 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 Specific Cancers. Talquetamab, also known as GPRC5D T cell-redirecting antibody, recruits T cells to tumor cells and activate T cells. My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. The most common side effects were neutropenia (40%), anemia (28%), and thrombocytopenia (20%). 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. 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. Learn more here. Cytokine release syndrome, skin-related events, and dysgeusia were common with talquetamab treatment but were primarily low-grade. They were very impressive results with deeper responses in heavily pretreated patients. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Only one patient to date at our center, has discontinued treatment due to an oral or dermatologic side effect. 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. Other than some minor fatigue and some of the normal side effects of being 66, Im feeling great! Of the 288 patients in this trial, 143 received a single dose of the drug weekly, and 145 received a double dose every 2 weeks. 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). The FDA has pushed back the PDUFA date for quizartinib for select patients with acute myeloid leukemia. Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. Researchers said 5-6% of patients stopped talquetamab treatment early due to side effects. Although T cells expressing CD38 might be attacked by AMG 424, this side effect is acceptable because the advantages outweigh the disadvantages . Known in full as G protein-coupled receptor, family C, group 5, member D, the protein found on cancerous plasma cells drew attention over the weekend as Johnson & Johnson unveiled new data for an experimental multiple myeloma treatment. Accessibility Ongoing trials are assessing the optimal phase 2 dose, as well as assessing the agents efficacy in combination with approved and investigational therapy. There's been amazing progress in the area of immunotherapy. 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. Duration of delay from the last dose administered Action . Only one patient to date at our center, has discontinued treatment due to an oral or dermatologic side effect. Beth Faiman Discusses Recent Changes in Multiple Myeloma Treatment Landscape. National Library of Medicine Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target . As with the oral reactions, Aronson acknowledged that no therapeutic interventions have been identified as best practice in addressing dermatologic reactions. In an early-phase trial, nearly three-quarters of patients who received talquetamaba first-in-class, off-the-shelf, T-cellredirecting bispecific antibody targeting both the GPRC5D and CD3 receptorsfor relapsed or refractory multiple myeloma saw a significant reduction in cancer burden within a few months. 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 . Emerging Strategies to Manage Relapsed and/or Refractory Multiple Myeloma. We see these [new drugs] as being part of regimens that will be used as complementary mechanisms of action, based upon sequencing, trying to address specific patient subgroups and disease characteristics., Chari, from Mount Sinai, agreed. 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. 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. Theyve exhausted many available therapies []. 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. G protein-coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells.
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