Lisocabtagene maraleucel

Bristol Myers Squibb recently presented for the first time data from its clinical trial of a cell therapy for autoimmune diseases, which has quickly become one of the most crowded fields in biopharma. Bristol Myers is developing an experimental cell therapy that uses the same construct as its approved blood cancer CAR-T treatment, Breyanzi, but with a shortened 5-day manufacturing process. The clinical study is still in its early days and includes people with several autoimmune conditions. So far, the company has reported clinical responses in all seven lupus patients with at least one month of follow-up. Bristol Myers, as well as the biotech companies Cabaletta and Kyverna, presented their respective clinical data over the weekend and on Monday at the American College of Rheumatology annual meeting. “There has been a burst of clinical studies in this field, and that’s very exciting,” said Georg Schett, the pioneering rheumatologist from the University Hospital Erlangen who first treated autoimmune patients with CAR-T cell therapy. “Nothing can grow within a day, right? It needs to be set up. But when you look at the field now, two years ago at the ACR, nobody spoke about cell therapy. And now this is really [something] everybody knows about.” Schett presented the Bristol Myers data at the conference and also sits on the scientific advisory boards of both Kyverna and Cabaletta. Safety of these cell therapies has become more closely watched after Cabaletta reported in August that a patient experienced grade 4 ICANS, which is a form of neurotoxicity associated with immunotherapy treatments like CAR-T cells. Bristol Myers also reported one case of grade 3 ICANS in a lupus patient that it said was “transient and resolved completely.” The patient experienced symptoms including “waxing and waning mental status” and “decreased level of consciousness,” according to the company’s presentation. But perhaps most intriguing was that one patient in the Bristol Myers study became pregnant within a few months after treatment. Schett highlighted that the case shows that fertility was not impaired by the conditioning treatment needed to receive the cell therapy. He added that the patient’s lupus did not flare up despite the fact lupus can be exacerbated in pregnancy. The patient was not taking any treatments for lupus after receiving the CAR-T cell therapy. The baby was born with normal counts of B and T cells. Cabaletta also shared new data showing that eight patients, including four lupus patients, treated with its cell therapy were able to stop immunosuppressants. As for Kyverna, it said Monday that it has now treated over 50 patients with its experimental CAR-T cell therapy across over 15 autoimmune conditions. But it’s actively running clinical trials for five diseases: lupus nephritis, systemic sclerosis, myasthenia gravis, multiple sclerosis and stiff person syndrome, its new CEO Warner Biddle told Endpoints News in an interview Monday. In lupus, it reported responses in all four patients who received its target dose of 100 million cells with at least 6 months of follow-up, and that none of the patients have required immunosuppressants following treatment. Kyverna also reported no cases of grade 3 or 4 cytokine release syndrome and no grade 2 to 4 ICANS across its 50+ patients. The company in September hired Biddle , who was previously head of commercial at Gilead’s cell therapy subsidiary Kite. Biddle said, “A big part of me coming to the organization is shifting the foundational work that we’ve done across these 50 initial patients, starting to focus in on the clinical trials that can get us to the first BLAs and getting access to a broader set of patients.” Kyverna expects to provide more details on its path to commercial approval in 2025 Biddle said.

BOULDER, Colo.--( BUSINESS WIRE )-- Foresight Diagnostics , a leader in ultrasensitive minimal residual disease (MRD) testing, today announced the presentation of multiple studies showcasing Foresight CLARITY™ MRD at the upcoming 66 th American Society of Hematology Annual Meeting and Exposition taking place December 7-10 in San Diego, California. The presentations span various lymphoma types and treatment settings, demonstrating the broad applicability of the Foresight CLARITY MRD detection technology for monitoring treatment response and predicting patient outcomes. The studies include collaborations with multiple pharmaceutical companies and research institutions, including AstraZeneca, Bristol Myers Squibb (BMS), Daiichi Sankyo (DSI), Stanford University, Washington University, and others. "These studies add to the growing body of evidence supporting ultra-sensitive MRD testing as a critical tool in lymphoma care and drug development," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "We see in these studies that MRD measurement with Foresight CLARITY consistently enables earlier and more accurate treatment response assessment than conventional imaging-based methods. The ability to monitor disease status in real-time with ultra-sensitive MRD assays like Foresight CLARITY may help accelerate clinical trials and lead to more personalized decision-making for patient care." Results utilizing Foresight CLARITY MRD technology are featured in six abstracts, including three that are co-authored by Foresight. Presentation highlights include: LBCL/DLBCL: ctDNA-MRD as a surrogate endpoint for 2L CAR T – Analysis of the Phase 3 TRANSFORM trial in second-line treatment for large B-cell lymphoma (LBCL) reinforced the potential of circulating tumor DNA (ctDNA) as an earlier endpoint for response assessment and assessment of clinical trial results. In the TRANSFORM study, patients receiving lisocabtagene maraleucel (liso-cel) had significantly improved event-free survival compared to standard of care. Consistent with this result, patients receiving liso-cel also demonstrated higher rates of MRD clearance, demonstrating CLARITY's ability to measure differential treatment responses. MRD Response with novel first-line therapy in high-risk DLBCL – Analysis of a Phase 1b trial CC-220-DLBCL-001 combining golcadomide with R-CHOP in previously untreated aggressive B-cell lymphoma showed promising MRD clearance rates. The data demonstrated that 90% of patients achieved MRD negativity at end of treatment with golcadomide 0.4mg + R-CHOP, with strong responses observed even in high-risk patients. These data further support the ongoing Phase 3 GOLSEEK-1 study investigating this novel combination therapy in high-risk 1L LBCL. Enhanced risk stratification by MRD vs. traditional methods – New research investigates the predictive value of the International Prognostic Index (IPI), currently the primary pre-treatment risk assessment tool for DLBCL. The study revealed that pre-treatment IPI scores did not significantly correlate with end-of-treatment MRD status, with MRD testing being a superior predictor of progression-free survival. Follicular Lymphoma: MRD-based response assessment of novel FL therapies – Two studies demonstrated the value of MRD assessment in follicular lymphoma trials, with new treatment approaches showing early clearance. The CD19xCD3 bispecific antibody AZD0486 achieved 89% MRD negativity in relapsed or refractory FL patients by 12 weeks in complete responders. In the 1L setting, the chemotherapy-free combination of mosunetuzumab and polatuzumab vedotin showed similar early MRD clearance, with 7 of 8 complete responders achieving MRD negativity before cycle 3. These results highlight the potential for MRD as an early indicator of therapeutic response in FL clinical trials. PTCL: ctDNA as a prognostic biomarker for T-cell lymphoma – Analysis from the VALENTINE-PTCL01 Phase 2 trial in relapsed/refractory peripheral T-cell lymphoma (PTCL) revealed that patients achieving early, deep ctDNA reduction (>5-fold decrease by Cycle 2 Day 1) experienced significantly longer progression-free survival, establishing ctDNA monitoring as a powerful tool for early response assessment. Information on abstract presentation time and dates can be found below. To meet with Foresight Diagnostics, visit booth #3423 or contact us at BD@foresight-dx.com. Oral Presentations: Circulating Tumor DNA (ctDNA) as an Early Outcome Predictor in Patients with Second-Line Large B-Cell Lymphoma After Lisocabtagene Maraleucel Versus Standard of Care Treatment from the Phase 3, Randomized TRANSFORM Study Presenter: Ash Alizadeh, MD, PhD (Stanford University) Session 628 Date/Time: Saturday, December 7, 2024, 10:45 a.m. Sponsor: Bristol Myers Squibb Co-authored by Foresight Diagnostics Escalating Doses of AZD0486, a Novel CD19xCD3 T-Cell Engager, Result in High Complete Remissions with Rapid Clearance of Minimal Residual Disease in Patients with Relapsed/Refractory Follicular Lymphoma Presenter: Jing-Zhou Hou, MD, PhD (UPMC Hillman Cancer Center) Session 623 Date/Time: Saturday, December 7, 2024, 5 p.m. Sponsor: AstraZeneca Golcadomide (GOLCA) Plus R-CHOP Has High Minimal Residual Disease (MRD) Negativity across High-Risk, Untreated Aggressive B-Cell Lymphoma (a-BCL) Presenter: Jason R. Westin, MD (MD Anderson) Session 627 Date/Time: Sunday, December 8, 2024, 12:30 p.m. Sponsor: Bristol Myers Squibb International prognostic index poorly predicts EOT ctDNA MRD status in DLBCL and has limited impact on its predictive value for outcomes Presenter: Jordan S. Goldstein, MD, MS (Stanford University) Session 626 Date/Time: Sunday, December 8, 2024, 5 p.m. Co-authored by Foresight Diagnostics Poster Presentations: Prediction of Clinical Response by Phased Variants in Circulating Tumor DNA (ctDNA) in the VALENTINE-PTCL01 trial of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Presenter: Neha Mehta-Shah, MD, MSCI (Washington University) Abstract #4342, Session 621 Date/Time: Monday, December 9, 2024, 6-8 p.m. Sponsor: Daiichi Sankyo Co-authored by Foresight Diagnostics Mosunetuzumab Plus Polatuzumab Vedotin Induces Early Complete Responses in Previously Untreated High Tumor Burden Follicular Lymphoma Presenter: David A Russler-Germain, MD, PhD (Washington University) Abstract #4414, Session 623 Date/Time: Monday, December 9, 2024, 6-8 p.m. About Foresight Diagnostics Foresight Diagnostics is a privately-held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million 1. The improved sensitivity of Foresight CLARITY has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on Twitter and LinkedIn. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use. 1 Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.