However, in her practice, certain interventions have proven useful in mitigating some of the toxicities experienced by patients. By The ASCO Post Staff New blood cancer therapy successful in three-quarters of trial patients, The new treatment is currently under application for review by the FDA. . runny or stuffy nose. 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. Biotin sprays, gels, candies, you name it, she said. Last Updated: 12/19/2022 12:57:45 PM. That is something which is again, unique, different. Apr 28, 2023 11:39am. 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 was designed to target the GPRC5Da receptor, which is highly present on cancerous plasma cells. This typically occurs on both the palms and the soles of the feet, she said. government site. Study results presented on Saturday and published in The New England Journal of Medicine suggest it could be the next promising drug to emerge in multiple myeloma an area already of intense drugmaker interest. Were hoping that this will soon become available so that patients can benefit.. Ongoing trials are assessing the optimal phase 2 dose, as well as assessing the agents efficacy in combination with approved and investigational therapy. The Janssen Pharmaceutical Companies of Johnson & Johnson. 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). Many myeloma treatments (CAR-T, BLENREP, other bi-specifics, etc) target BCMA, an antigen found on 80-100% of myeloma cells. If you follow a few myelomagroups on Facebook you might have seen a really gnarly picture of the hands of a patient in a Talquetamab trial. 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. Bispecific Antibodies in Multiple Myeloma: Opportunities to Enhance Efficacy and Improve Safety. The primary end points - the frequency and type of dose-limiting toxic effects (study part 1 only . 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. or who could not receive these therapies without unacceptable side effects. Before Chari et al reported results of Talquetamab which targets GPRC5D which showed an ORR of 66% in 55 evaluable pts. Topics covered: Drug commercialization, pharma salesforces, generic and biosimilar competition, drug advertising and much more. We've been so busy adding drugs to the arsenal that [were] catching up to figure out the right sequences and unanswered questions.. Subscribe to the weekly "HealthTree Community for Myeloma Newsletter" for Myeloma news, life 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. In total, 165 patients were enrolled in the trial. The .gov means its official. The . Epub 2023 Feb 3. Data from patients who had received these same dosing regimens in the first phase were included in the analysis for the second phase. 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. The immunotherapy being trialled is called talquetamab. With talquetamab, only about half the patients make it to only a little more than a year before they relapse. Drugs targeting GPRC5D, for instance, could offer an alternative to BCMA-binding treatments. Get access to cutting edge treatment via Talquetamab, Daratumumab, Teclistamab. 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. The abnormal plasma cells are made from stem cells in the bone marrow. 5. Specific Cancers. Cancer Treatment Side Effects. 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. N Engl J Med. You can use your HealthTree data to see if you qualify to join a talquetamab trial. . Duration of response is good too. Talquetamab is a BiTE binding GPRC5D and CD3. 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. 5 months after I stopped, I recovered my sense of taste. Step-up dose 1 . 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. (If you just need to know, that stands for G Protein-coupled Receptor class C Group 5 member D.). Myeloma affects around 6,000 people in the United Kingdom every year, causing more thaneight deaths each day. Living With Cancer. Intuitive Surgical collects new prostate procedure clearances for its single-port robot. How Viagra became a new 'tool' for young men, Ankylosing Spondylitis Pain: Fact or Fiction, A safer blood thinner? Known as a bispecific T-cell engager antibody, this treatment is a relatively new kind of immunotherapy approach. Nurses Call for More Research on Nutrition Challenges for Patients With AML/MDS. Newly approved and forthcoming T-cell-redirecting bispecific antibodies for the treatment of relapsed/refractory multiple myeloma. Whats really great is that some myeloma cells NOT having BCMA MIGHT have GPRC5D. 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. 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 new exclusion criteria could represent an incremental headwind for Bluebird should it get to market, wrote SVB Securities analyst Mani Foroohar. 2023 Apr;29(3):722-726. doi: 10.1177/10781552231154809. In a separate cohort, 51 patients who had previously received therapies that redirect T cells showed a response to talquetamab. While that may not sound exciting, it means that much of the preliminary work necessary to prepare for FDA approval is well underway. 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 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. The number of patients it will impact is difficult to quantify and likely modest, Foroohar added, but still real.. FDA/EMA Accept Ide-Cel Applications for Earlier R/R Multiple Myeloma Use. FOIA Talquetamab is an IgG4 Fc-containing BsAb targeting G- protein-coupled receptor family C group 5 member D . "It seems the total effect is a real drying effect. Scientists use genetic rewiring to increase lifespan of cells. I just get excited when I attend ASH and I see so many stellar people doing what seem to be super-human things by coming up with these life-lengthening miracles that just might possibly keep me alive until theres a cure. Get the free daily newsletter read by industry experts. 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%). A biologics license application has been submitted to the FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma. Can diet help improve depression symptoms? 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. However, research has not proven these mushrooms can prevent cancer. The side effects are troubling, some require hospitalization, especially because of infections. Cancerous plasma cells make abnormal antibodies called M-proteins that do not protect the body from infections. Another important side effect was altered taste. 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. So those are side effects of both bispecific antibodies and CAR-T cells. Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. For full disclosures of the study authors, visit ash.confex.com. My colleague would tell patients your skin is going to peel like a lizard on your hands and feet, she said. Accessibility All rights reserved. The Expanding Clinical Role of Bifunctional Antibodies. Now, trials of talquetamab have shown very promising results in people with refractory myeloma. No unexpected side effects were seen with this association. Oncology On-The-Go Podcast: Multiple Myeloma Outcome Disparities, Trial Access. 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. Talquetamab is under investigation in clinical trial NCT04634552 (A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma). 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. Data showed skin- and taste-related side effects were common, but typically rated mild. 2023 May;23(5):310-321. doi: 10.1016/j.clml.2023.01.017. . Dose delays may also be an effective method of mitigating oral and dermatologic therapies, she concluded. All side effects, not much to show for it. 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. Nearly 60% had a very good partial response, meaning that their cancer was substantially reduced. 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.. 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 Infections also occurred in more than half of patients on each drug dose, with 17% and 12% respectively graded as more severe. Topics covered: startup launches, funding, IPOs and much more. 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. But if you remember the picture, perhaps you also remember the comment from the patient. Talquetamab is one of several new drugs in the hopper that are giving us triple+ refractory myelomapatients a heart full of hope. There are two problems: 1. side effects, and 2. the drugs stop working after a while. G protein-coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells. The Talquetamab / Daratumumab trial. 2023 Feb 28;7(4):644-648. doi: 10.1182/bloodadvances.2022007625. Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg). 2023 Apr 5;15(7):2160. doi: 10.3390/cancers15072160. Bookshelf Bluebird got a much-needed lift this year when U.S. regulators approved two of its gene therapies. And then there's another variety of CAR-T cell toxicity called neurologic toxicity, which has been really tough to handle in the rare cases where it's severe. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Side effects include: Thrombocytopenia with . But of course nothing works forever. Talquetamab induced a substantial response among patients with heavily pretreated relapsed or refractory multiple myeloma. Please enable it to take advantage of the complete set of features! If you . 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. Diagnosis and Management of Adult Malignancy-Associated Hemophagocytic Lymphohistiocytosis. Ac., CYT, Enzalutamide, combined with standard treatment, shows promise in prostate cancer, What to know about endometrial stromal sarcoma. The disease, which affects around one in 132 people in the United States, is rarely diagnosed in people under the age of 65. Learn more here. My husband and I live in Spokane Washington but spend our winters in Lake Havasu City Arizona. 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%. For example, skin and ear problems, which can sometimes affect patients a little bit differently, but can also be a quality-of-life issue. 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. 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. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid. Epub 2021 Aug 10. In patients with multiple myeloma, GPRC5D is overexpressed and . Phase trial confirmed a 70% response rate in patients with advanced disease. 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. 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. . Background: A standardized regimen of topical and oral supportive care appears to be beneficial in the management of . Cytokine release syndrome, skin-related events, and dysgeusia were common with talquetamab treatment but were primarily low-grade. 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 . Each entry includes links to find associated clinical trials. 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. Ive been fighting Multiple Myeloma for more than 15 years. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. The same side effects that I mentioned are cytokine release syndrome. sneezing. For nail changes, Aronson recommends nail hardeners, Vitamin E lotion, and cuticle care products. Therapies already exist for ITP, which causes dangerously low platelet levels, but they have limitations. Copyright 2022 Massachusetts Medical Society. Talquetamab is a bispecific antibody, a type of monoclonal antibody that redirects T cells to act against myeloma cells. Hydrate, hydrate, hydrate, she said. PMC Would you like email updates of new search results? They were very impressive results with deeper responses in heavily pretreated patients. Dermatologic TEAEs were reported by 48.7% (n = 37) of patients in this trial. We've talked about this, but just to . One thing that will happen, though, is that my talquetamab dose will be increased to make up for the change in schedule. 2022 Dec 15;387(24):2287-2290. doi: 10.1056/NEJMe2208708. 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