Latest news with #CAR_T_cell_therapy
Medscape
04-07-2025
- Health
- Medscape
Radiation Bridging in CAR T: Where Are We Now?
While the use of radiation bridging therapy (BT) in chimeric antigen receptor (CAR) T-cell therapy for blood cancer is expanding, plenty of unanswered questions remain on topics such as ideal timing and doses, a radiologist cautioned hematologist colleagues . The lack of guidelines has immediate clinical implications, said John P. Plastaras, MD, PhD, professor of radiation oncology at the Hospital of the University of Pennsylvania, Philadelphia, in a presentation at 18th International Conference on Malignant Lymphoma (ICML) 2025 in Lugano, Switzerland . ' This actually just came up the other day when one of our medical colleagues said, 'I'm really worried about this patient. They're ready for CAR T cell, but I think you need to radiate this area. Can you do it a week after [therapy]?' The answer is, 'We don't know.'' On the other hand, clinicians now have clarity about safety and interaction with CAR T-cell therapy, he noted, and data is coming in rapidly. Here are some questions and answers about radiation BT: What is BT in CAR T-cell therapy? BT refers to treatment that provides a 'bridge' for patients between the components of CAR T-cell therapy. As a 2024 report about BT in hematologic cancer explained, the treatment 'is delivered after leukapheresis for CAR T-cells' — the process in which white cells are removed from a patient's blood, which is then returned to the body — 'has been completed and before lymphodepleting chemotherapy and CAR T-cell infusion.' The report said 'patients who receive BT are predominantly those with a higher disease burden and rapidly progressive disease. These patients tend to have worse overall outcomes, likely related to their aggressive underlying disease.' Where does radiation fit into BT? According to the 2024 report, 'combination chemoimmunotherapy has typically been the form of BT that is used most often.' Targeted therapy is another option, the report said, although data is from 'very small sample sizes.' And then there's radiation, which the report said is useful 'particularly in patients with limited sites of disease or patients who are at risk for structural complications such as airway compromise or renal dysfunction.' What do we know about radiation's efficacy? The first oral report on bridging radiation in CAR T-cell therapy only appeared in 2018, Plastaras said, followed by the first published report in 2019. Despite this fairly short time period, 'we are certainly seeing a lot of new data,' Plastaras said. He highlighted the newly released International Lymphoma Radiation Oncology Group (ILROG) study of radiation BT in conjunction with CAR T-cell therapy for relapsed/refractory B-cell lymphomas. The retrospective study of 172 patients at 10 institutions treated from 2018 to 2020 showed that 1- and 2-year progression-free survival (PFS) rate was 43% (95% CI, 36-51) and overall survival rate was 38% (95% CI, 30-45). In a multivariable model, comprehensive radiation BT was linked to superior PFS than focal therapy (hazard ratio, 0.38; 95% CI, 0.22-0.63; P < .001). 'Comprehensive radiation was a very strong predictor for improved PFS, but we did not see was a huge dose effect,' said Plastaras, who coauthored the study. What about toxicity? Questions about other clinical matters were resolved prior to 2022, he said, when CAR T-cell therapy was used primarily in third line and later settings . 'Does radiation cause excess toxicities?' he asked. 'A lot of the single-institution studies answered that, and I think most medical oncologists and hematologists are okay with this idea that radiation isn't causing a lot of excess toxicities.' As for whether radiation interferes with the effectiveness of CAR T-cell therapy, 'the data to this point have demonstrated that probably not,' he said. 'We've probably put that one to bed.' What do we know about treatment timing? 'The timing question is still quite open,' Plastaras said. 'How much time should there be between radiation and lympho-depleting chemotherapy? Is it better to put the radiation very close to the CAR T-cell [therapy] so this priming effect might happen, or can that happen weeks in advance? We don't know the answers to those.' According to Plastaras, researchers are still trying to understand the role radiation the consolidation period after CAR T-cell therapy. 'If we wait for day-30 PET [scan], is that OK? Do we need to wait longer? Are we going to mess up the lymph nodes that have CAR T-cells floating around in them?' What about doses and imaging? There's also a lack of insight into technical questions about radiation dose and fractionation. 'The [radiation] volume question is one of key importance. Do we just do gross disease? Do we treat all the other small spots out there, and importantly, do we treat regional nodes or not? We get these questions all the time.' The role of imaging is also unclear, he said, in terms of timing during and after bridging radiation therapy and after CAR T-cell therapy. What do we need to learn about now? Looking forward, Plastaras outlined what he called 'version 2.0' questions for the evolving field: Can radiation rebulking decrease CAR-T cell toxicities? Will very low dose 'priming' radiation affect outcomes? He highlighted other questions: Can radiation be part of a combined modality approach in limited stage relapsed/refractory disease? Should central nervous system lymphoma be treated differently? When will we get new guidelines? According to Plastaras, Memorial Sloan Kettering Cancer Center Radiology Oncologist Brandon Imber,MD, MA, in New York City, is leading a new ILROG guideline project with the intention of publishing details in the journal Blood . 'This is a work in progress,' Plastaras said. 'Our target is 2025 to at least get something submitted.'
Medscape
30-06-2025
- Health
- Medscape
FDA Drops REMS Programs for Some CAR-Ts
Using chimeric antigen receptor (CAR) T-cell therapies for blood cancer should be less burdensome following labeling updates from the FDA. Specifically, the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) program requirements from two BCMA-directed CAR T-cell therapies for multiple myeloma — ciltacabtagene autoleucel (Carvykti; Janssen) and idecabtagene vicleucel (Abecma; BMS) — and one CD19-directed therapy for lymphoma, lisocabtagene maraleucel (Breyanzi; BMS). In a June 26 letter to Janssen explaining the move, the agency said that 'the established management guidelines and extensive experience of the medical hematology/oncology community in diagnosing and managing the risks of cytokine release syndrome (CRS) and neurologic toxicities across products in the class of BCMA- and CD19-directed autologous CAR T cell immunotherapies' means that REMS programs are no long necessary to ensure safe use. The agency further streamlined the labels of the two BMS therapies by reducing requirements to stay near a health facility after treatment from 4 to 2 weeks and by dropping driving restrictions after treatment from 8 to 2 weeks. In a press statement, BMS applauded the 'class-wide label updates that will help ease known barriers to treatment and administration while maintaining patient safety.' The company also noted that recent studies have made it clear that the 'vast majority of serious adverse events' with CAR T-cell therapy occur within the first 2 weeks of infusion. 'Today's announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy,' said Sally Werner, RN, BSN, CEO of Cancer Support Community, in the press release. M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@
Reuters
27-06-2025
- Business
- Reuters
US FDA eliminates risk evaluation and mitigation strategies for CAR-T cancer therapies
June 27 (Reuters) - The U.S. Food and Drug Administration said on Friday that it had eliminated the risk evaluation and mitigation strategies (REMS) for currently approved Bristol-Myers Squibb's (BMY.N), opens new tab CAR T cell immunotherapies.
Medical News Today
24-06-2025
- Health
- Medical News Today
What happens if CAR T-cell therapy fails to treat multiple myeloma?
Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy. Immunotherapy helps the body's immune system locate and attack the cancer Food and Drug Administration (FDA) has approved two CAR T-cell therapies to treat multiple myeloma (MM): Idecabtagene vicleucel (ide-cel, Abecma) and Ciltacabtagene autoleucel (cilta-cel, Carvykti). These target a protein called BCMA, which is found on myeloma cells. CAR T-cell therapy has shown great success in treating MM that has not responded to other treatments or has come back. However, this treatment may not work for everybody. Most CAR T-cell therapy failures occur within 6 months of to a 2022 article, there is no agreed-upon standard of care if CAR T-cell therapy fails. Instead, a person will work with their healthcare team to come up with a different treatment plan. In some cases, they may suggest a second round of CAR T-cell the most commonly used therapies after CAR T-cell failure include:chemotherapy with the drug lenalidomidetargeted therapychemoimmunotherapybispecific antibodieslocalized radiation therapyFinding out that a treatment option has not worked can be challenging to manage. A person may benefit from seeking support from loved ones, support groups, mental health professionals, and a member of their healthcare team. A mental health professional can help a person manage the psychological aspects of living with a medical condition, and a healthcare professional will be able to answer any questions a person may undergoing treatment for MM can find support and resources at the following organizations:American Cancer SocietyLeukemia & Lymphoma SocietyCancerCareMultiple Myeloma Research FoundationInternational Myeloma FoundationLearn moreWhat to do next when multiple myeloma treatment stops workingCan multiple myeloma be cured?Multiple myeloma: Treatment and moreTypes of maintenance therapy for multiple myelomaWhat are some risks of stopping treatment for multiple myeloma?
Medscape
23-06-2025
- Health
- Medscape
Clinical Advances in Multiple Myeloma From ASCO 2025
The coming of age of chimeric antigen receptor (CAR) T-cell therapy, the selection of postinduction therapy on the basis of residual disease activity, and a novel drug delivery system are among the developments in multiple myeloma (MM) presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Dr Joseph Mikhael, from City of Hope Cancer Center in Phoenix, Arizona, opens with long-term follow-up data from the CARTITUDE-1 trial of ciltacabtagene autoleucel CAR T-cell therapy in heavily pretreated relapsed/refractory MM. One third of patients remained progression free for 5 or more years following a single infusion, offering hope of a cure. Next, he discusses the MIDAS trial of newly diagnosed MM, in which the treatment choice was driven by residual disease activity after induction therapy. The results indicated that autologous stem cell transplant may not be beneficial in patients with no residual disease activity and could potentially be avoided. Dr Mikhael then turns to follow-up from PERSEUS, again in newly diagnosed disease. The data showed daratumumab to be a key component of both induction therapy when combined with bortezomib, lenalidomide, dexamethasone, and maintenance therapy in combination with lenalidomide. In closing, he discusses a German trial that underlined the importance of aggressive treatment in high-risk newly diagnosed MM as well as an analysis of an on-body delivery system for subcutaneous isatuximab that met with patient satisfaction.
