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142 citation(s) found for "O’Dwyer, P J".

Combination of Radiation Therapy and Irreversible Electroporation for Intermediate-Risk Prostate Cancer (RTIRE): A Phase 1 Trial
Mcclure, Timothy D. , Ballman, Karla V. , Diven, Marshall, Osborne, Joseph R. , O’Dwyer, Elisabeth , Piscopo, Jennifer, Khani, Francesca , Marciscano, Ariel, Awamlh, Bashir Al Hussein Al , Wang, Shu , Ballman, Karla , Osborne, Joseph R , Al Hussein Al Awamlh, Bashir , Barbieri, Christopher , Nagar, Himanshu , Diven, Marshall A., Marciscano, Ariel E.

Radiology | July 28, 2026 | Volume: 320 | Issue: 1 | Pages: No page available

10.1148/radiol.250848 | PMID 42517770 Get It

Treatment of participants with intermediate-risk prostate cancer with focal irreversible electroporation and radiation therapy was technically feasible and showed acceptable patient-reported outcomes and no severe adverse events over 1 year.
Consensus recommendations for CAR T-cell administration in adult acute lymphoblastic leukemia: a modified Delphi study
Muffly, Lori , Frey, Noelle V. , Roloff, Gregory W. , Park, Jae H, Advani, Anjali S. , Bachanová, Veronika , Cassaday, Ryan D. , Daunov, Michael , Dykes, Kaitlyn C. , Gatell, Vivian Irizarry , Jamy, Omer , Kota, Vamsi, Kumaran, Muthu, O’Dwyer, Kristen M. , Oliai, Caspian , Schwartz, Marc S., Solh, Melhem M., Stock, Wendy, Tsai, Stephanie B., Ulrickson, Matthew L., Vasu, Sumithira, Leonard, Jessica T., Aldoss, Ibrahim, Dholaria, Bhagirathbhai R , Advani, Anjali S , Cassaday, Ryan D , Daunov, Michael , Dykes, Kaitlyn C , Grunwald, Michael , Hilal, Talal , Hill, LaQuisa C , Jamy, Omer , Lin, Chenyu , Logan, Aaron C , Luskin, Marlise R , O'Dwyer, Kristin , Oliai, Caspian H , Oluwole, Olalekan O , Sasine, Joshua , Wang, Eunice S. , Strickland, Stephen Anthony , Leonard, Jessica T , Shah, Bijal , Bachanova, Veronika , Muffly, Lori , Frey, Noelle V , Roloff, Gregory W , Dholaria, Bhagirathbhai , Grunwald, Michael R. , Hilal, Talal , Hill, LaQuisa C. , Kota, Vamsi , Oluwole, Olalekan O. , Sasine, Joshua , Solh, Melhem , Stock, Wendy , Tsai, Dr. Stephanie B., Ulrickson, Matthew L. , Vasu, Sumithira , Yalniz, Fevzi , Shah, Bijal , Aldoss, Ibrahim

Blood | May 19, 2026 | Volume: 148 | Issue: 6 | Pages: 657-668

10.1182/blood.2026033559 | PMID 42154904 Get It

Abstract The use of chimeric antigen receptor (CAR) T-cell therapy is increasing for adult B-cell acute lymphoblastic leukemia (B-ALL), with 3 CD19 CAR T-cell products commercially available. Several key clinical questions related to best practices for CAR T-cell administration in this population exist, and limited prospective randomized trials have been conducted to fill these knowledge gaps. Thus, to help guide clinical practice, we conducted a modified Delphi study to develop and validate consensus recommendations on the administration of commercially available CAR T-cell therapy for adults with B-ALL. Consensus panelists (n = 9) included principal investigators (PIs) from Real World Outcomes Collaborative of CAR T-Cell Therapy in Adult ALL (ROCCA) consortium sites and were selected based on expertise and CAR T-cell center volume. Final panel consensus recommendations were distributed for rating by the remaining PIs from ROCCA consortium sites, which served as the validation group (n = 27). Consensus topics included patient selection, bridging and pre–CAR T-cell leukemia staging, lymphodepletion, and CAR T-cell treatment setting, specific toxicity prevention and management, post–CAR T-cell response assessment and disease monitoring, and the role of consolidation and/or maintenance therapies after CAR T-cell therapy. Initially, 58 recommendation statements were evaluated for consensus. After 2 panel meetings, a total of 34 statements achieved consensus rating among the expert panel. After rating by the validation group, all but 1 recommendation statement continued to meet consensus, for a total of 33 consensus recommendation statements on the administration of CAR T-cell therapy in adult B-ALL.
Abstract 6307: Feasibility of a survivorship app for black prostate cancer survivors: Results from a 12-week mHealth pilot study
Kumar, Gaurav, Ghasemi, Parisa , Zhao, Yan D., Dwyer, Kathleen, Kaninjing, Ernie, Young, Mary Ellen , Sabrina, Dickey, Bolajoko, Opeyemi , Ogunsanya, M., Dwyer, Kathleen , Kumar, Gaurav , Nagykáldi, Zsolt , McIntosh, Andrew G. , Dickey, Sabrina L. , Morton, Daniel J. , Kendzor, Darla E. , Ogunsanya, Motolani E.

Cancer Research | April 3, 2026 | Volume: 86 | Issue: 7_Supplement | Pages: 6307-6307

10.1158/1538-7445.am2026-6307 Get It

Abstract Introduction: Black prostate cancer (CaP) survivors experience unique quality-of-life (QoL) and recovery challenges after treatment compared with their White counterparts. Smartphone-delivered mobile health interventions offer promising avenues for symptom tracking and lifestyle changes; but their feasibility, user engagement, and acceptability in this population remain unclear. This study assessed the feasibility, engagement, and preliminary impact of the Survivorship App for Ethnically Diverse Black Prostate Cancer Survivors (SAFE-CaPS), designed to improve self-monitoring behaviors and health outcomes. Methods: Nine Black CaP survivors (seven U.S.-born, one African-born, and one Caribbean-born) participated in a 12-week pilot study of SAFE-CaPS. The app provided daily prompts for symptoms (pain, sleep, fatigue, sexual function, anxiety, depression) and behavior tracking (physical activity, diet), brief self-management support, and physician alerts for severe symptom reports. Mental health (GAD-7 and PHQ-9) and QoL (FACT-P) were assessed at baseline and after 12 weeks. Feasibility was evaluated based on adherence rates (i.e., ≥70% of daily diary entries). Engagement and acceptability were assessed via app analytics and qualitative interviews on usability and cultural relevance. Participants were compensated up to $125 via Greenphire ClinCard. Surveys were analyzed with SPSS v29, and interviews with Atlas.ti v23. Results: Participants’ median age at diagnosis was 56 years; six had a positive family history of CaP, and four had undergone radical prostatectomy. Four participants met the feasibility threshold, and eight completed the study. Most daily entries reflected mild pain, fatigue, bowel and urinary issues, and generally good sleep. Several participants frequently reported severe sexual dysfunction, and most diary responses indicated <20 minutes of physical activity per day. Fruit/vegetable intake was low, with about half of daily responses showing 1-2 servings. At baseline, eight participants had minimal anxiety, while five had moderate depression. Overall, QoL improved from week 1 to week 12 in physical, emotional, and functional well-being, while social well-being declined over time. Interviews emphasized the app’s user-friendly design, ease of navigation, and acceptability as key strengths, with several participants highlighting its simplicity and ease of use, with recommendations to reduce repetitive items and address minor technical issues. Conclusions: SAFE-CaPS was feasible and well accepted. Sexual dysfunction, low physical activity, and moderate depression emerged as key concerns, heightening the need for integrated mental health, activity support, and stronger engagement strategies in future mHealth interventions. Citation Format: Gaurav Kumar, Parisa Ghasemi, Yan D. Zhao, Zsolt Nagykaldi, Kathleen A. Dwyer, Andrew G. McIntosh, Ernie Kaninjing, Mary E. Young, Dickey Sabrina, Daniel Morton, Opeyemi Bolajoko, Darla E. Kendzor, Motolani Ogunsanya. Feasibility of a survivorship app for black prostate cancer survivors: Results from a 12-week mHealth pilot study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 6307.
Abstract 2483: Survivorship and sexual health: What we learned from Black men in community town halls
Ghasemi, Parisa , Kumar, Gaurav, Ayanambakkam, Adanma, Siston, Amy, Neil, Jordan M., Alexander, Adam, Zhao, Yan D., Dwyer, Kathleen, Young, Mary Ellen , Bolajoko, Opeyemi , Ogunsanya, M., Dwyer, Kathleen , Kumar, Gaurav , Kaninjing, Ernest , Ayanambakkam, Adanma , Nyame, Yaw A. , Neil, Jordan M. , McIntosh, Andrew G. , Nagykáldi, Zsolt , Dickey, Sabrina L. , Morton, Daniel J. , Kendzor, Darla E. , Ogunsanya, Motolani E.

Cancer Research | April 3, 2026 | Volume: 86 | Issue: 7_Supplement | Pages: 2483-2483

10.1158/1538-7445.am2026-2483 Get It

Abstract Background: Prostate cancer (CaP) is among the most common cancers in U.S. men, with Black men experiencing a 1.7-fold higher incidence and nearly twice the mortality rate compared with non-Hispanic White men. While early detection has improved survival, differences remain in recovery and quality of life (QoL). Sexual dysfunction after treatment affects identity, relationships, and well-being, yet stigma, cultural norms, and limited access to patient-centered care prevent open discussion. Few initiatives address the intersection of identity, stigma, and survivorship in this population. Community town halls provide a trusted, culturally responsive space for shared learning, peer connection, and open dialogue on survivorship and sexual health. Methods: Two community-engaged CaP town halls were convened by the Multidisciplinary Health Outcomes Research and Economics (MORE) Lab at the University of Oklahoma Health Campus (OUHC) to explore survivorship issues among Black CaP survivors. The first, held virtually in June 2024, included watch parties in Georgia and Texas. The second, in November 2024, was hybrid, hosted at OUHC and via Teams with a watch party at the Willa D. Johnson Recreation Center, a community center in Oklahoma City. Panelists included oncologists, psychologists, survivors, partners, and Community Advisory Board members. Both town halls featured survivor storytelling, provider Q&A, and interactive discussion. Post-event surveys captured demographics, satisfaction, and impact. Open-discussion transcripts were analyzed using Braun and Clarke’s reflexive thematic analysis, guided by a constructivist framework. Results: A total of 124 participants attended both town halls. Survey respondents (n=17; 13.7%) provided demographic and satisfaction data; remaining insights came from all participants who engaged in open dialogue. Respondents ranged in age from 19-76 years (mean=48.7 ± 21.8). Of the 17 respondents, 93% rated the events as very good or excellent; 23.5% were CaP survivors, all identifying as Black. Five themes emerged: (1) Masculinity, stigma, and silence limit help-seeking; (2) Sexual dysfunction and identity loss cause major emotional burdens; (3) Navigation challenges highlight systemic barriers; (4) Spousal and psychological support aid coping; and (5) Survivorship empowerment. Participants valued hearing “real stories from real men,” validating their experiences. Conclusions: Community town halls are a feasible and culturally relevant strategy to engage Black CaP survivors in survivorship and sexual health discussions. By centering lived experiences and facilitating two-way communication between survivors, clinicians, and researchers, these events build trust and reduce stigma. Future work will assess changes in knowledge, engagement, and confidence in care navigation and explore scaling this community-academic model to improve survivorship QoL. Citation Format: Parisa Ghasemi, Gaurav Kumar, Ernest T. Kaninjing, Adanma Ayanambakkam, Yaw A. Nyame, Amy Siston, Jordan M. Neil, Adam C. Alexander, Andrew G. McIntosh, Yan Zhao, Zsolt Nagykaldi, Kathleen A. Dwyer, Mary Ellen Young, Sabrina Dickey, Daniel Morton, Opeyemi Bolajoko, Darla E. Kendzor, Motolani E. Ogunsanya. Survivorship and sexual health: What we learned from Black men in community town halls [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 2483.
NCCN Guidelines® Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 2.2026
Wierda, William G., Brown, Jennifer, Abramson, Jeremy, Bociek, Greg, Boyer, Daniel F. , Cortese, Matthew J , Cripe, Larry D., D’Angelo, Christopher R. , Darnell, Elijah P., Davis, Randall S. , Eradat, Herbert, Esteghamat, Naseem , Fitzgerald, Lindsey , Fletcher, Christopher D., Gaballa, Sameh , Kamdar, Manali, Kipps, Thomas J., Ma, Shuo, Nakhoda, Shazia, Schorr, Andrew, Schuster, Stephen, Seshadri, Madhav, Shanafelt, T., Ujjani, Chaitra, Wagner-Johnston, Nina, Woyach, Jennifer A. , Dwyer, Mary, Sundar, Hema, Shanafelt, Tait D. , Shanafelt, Tait D , Wierda, William G. , Abramson, Jeremy S. , Awan, Farrukh T. , Huntington, Scott F. , Kahl, Brad S. , Kamdar, Manali , Kipps, Thomas J. , Ma, Shuo, Mosse, Claudio A. , Nakhoda, Shazia , Parikh, Sameer A. , Riedell, Peter A. , Seshadri, Madhav , Siddiqi, Tanya , Sitlinger, Andrea Phillips , Thompson, Meghan C , Ujjani, Chaitra S. , Wagner‐Johnston, Nina D. , Dwyer, Mary A.

Journal of the National Comprehensive Cancer Network | March 12, 2026 | Volume: 24 | Issue: 3 | Pages: 68-80

10.6004/jnccn.2026.0012 | PMID 41825137 Get It

Bruton tyrosine kinase inhibitors (BTKis) and BCL2 inhibitor (BCL2i)–containing regimens significantly improve survival outcomes in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Results from randomized clinical trials have demonstrated that time-limited treatment with BCL2i-containing regimens resulted in higher rates of undetectable measurable residual disease (uMRD) than BTKi monotherapy or chemoimmunotherapy (CIT). Pirtobrutinib (a noncovalent BTKi) and lisocabtagene maraleucel (CD19-directed CAR T-cell therapy) are newer options for relapsed or refractory disease after prior therapy with BTKi and BCL2i-contining regimens. Histologic transformation of CLL/SLL to diffuse large B-cell lymphoma (Richter transformation) is associated with a poor prognosis. Molecular analysis to determine whether there is clonal relationship between CLL/SLL and transformed diffuse large B-cell lymphoma is useful to select an appropriate treatment option. These NCCN Guideline Insights highlight significant updates to the NCCN Guidelines for the treatment of CLL/SLL and Richter transformation.
NCCN Guidelines® Insights: Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate, Version 2.2026
Cheng, Heather H., Goggins, Michael, Yurgelun, Matthew B. , Karlan, Beth Y., Norquist, Barbara S., Daly, MB, Pal, Tuya, AlHilli, Zahraa, Arun, Banu , Churpek, Jane, Colonna, Sarah, Domchek, Susan M., Escobar, Mauricio R., Friedman, S, Hagemann, Andrea, Hendrix, Ashley, Huo, Dezheng, Hutton, Mollie L., Kassem, Nawal , Kurian, Allison W., Laronga, Christine , Mak, Julie S, McDonnell, Kevin, Mersch, Jacqueline, Offit, Kenneth, Plichta, Jennifer K. , Rash, Dominique , Reiser, Gwen , Senter-Jamieson, Leigha, Shannon, K. McWeeney, Welborn, Jeanna, Wick, Myra , Wood, Marie , Darlow, Susan, Diwan, Zeenat, Dwyer, Mary, Churpek, Jane E. , Kurian, Allison W. , Kurian, Allison W , Plichta, Jennifer K , Churpek, Jane E , Churpek, Jane , Giri, Veda N. , Goggins, Michael, Karlan, Beth Y , Norquist, Barbara, Pal, Tuya , Al‐Hilli, Zahraa , Arun, Banu , Colonna, Sarah V. , Domchek, Susan M. , Fejerman, Laura , Hagemann, Andrea, Huo, Dezheng , Khan, Seema A. , Mak, Julie , Maxwell, Kara N. , McDonnell, Kevin , Merajver, Sofía D. , Mersch, Jacqueline A, Offit, Kenneth , Darlow, Susan

Journal of the National Comprehensive Cancer Network | February 9, 2026 | Volume: 24 | Issue: 2 | Pages: 2-10

10.6004/jnccn.2026.0007 | PMID 41671423 Get It

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate are intended to serve as a resource for health care providers to identify individuals who may benefit from cancer risk assessment and genetic counseling and testing; help guide decisions related to genetic testing; and facilitate a multidisciplinary approach in the comprehensive care of individuals at increased risk for hereditary breast, ovarian, pancreatic, and prostate cancer. The current guidelines focus primarily on assessment of pathogenic and likely pathogenic (P/LP) variants associated with increased risk of breast, ovarian, pancreatic, and prostate cancer and recommended approaches to genetic counseling/testing and care strategies in individuals with these P/LP variants associated with increased risk of these cancers. These NCCN Guidelines Insights summarize the panel’s most recent recommendations regarding screening for prostate cancer and pancreas cancer, as well as testing criteria for nonepithelial ovarian cancer.
Blinatumomab nonresponse correlates with poor survival after brexucabtagene autoleucel in B-cell ALL
Srinagesh, Hrishikesh K. , Zhang, Amy, Grunwald, Michael R, Connor, Matthew P, Kota, Vamsi, Boccucci, Jacob , Ulrickson, M., Pradeep, Roshini , Hill, L, Tsai, Stephanie B., O'CONNOR, TIMOTHY E., Sandhu, Karamjeet , Gordillo, Christian , Chen, Evan C., Lin, Chenyu, Kopmar, Noam E. , Majhail, Navneet S. , Lee, C F, Bobillo, Silvina Odstrcil, Park, Jae H, Valtis, Yannis K. , Solh, Melhem M, Guzowski, Caitlin, Vasu, Sumithira, Tan, Virginia, McCauley, Ross , Sasine, Joshua , Tang, Kevin, Kk, Miller, Sutherland, Katherine C. , Mohty, Razan , Jamy, Omer , Hoeg, Rasmus T., Logan, Aaron, Stock, Wendy A, Schwartz, Marc S., Byrd, Kenneth, Bachanova, Veronika, Tracy, Sean , Yaghmour, George , Gatell, Vivian Irizarry , Jackson, Clayton, Dholaria, Bhagirathbhai, O'Dwyer, Kristen M, Moore, Jozal , Aldoss, Ibrahim, Shah, B. D., Oliai, Caspian , Muffly, Lori, Grunwald, Michael R. , Kota, Vamsi , Bachanová, Veronika , Muffly, Lori , Hill, LaQuisa C. , Zhang, Amy , Connor, Matthew P. , Zhang, Amy , Grunwald, Michael , Connor, Matthew , Kota, Vamsi , Ulrickson, Matthew , Pradeep, Roshini , Hill, LaQuisa C , Advani, Anjali S , Reshef, Ran , Luskin, Marlise R , Chen, Evan , Lin, Chenyu , Cassaday, Ryan D , Kopmar, Noam E , Majhail, Navneet S , Battiwalla, Minoo , Strickland, Stephen Anthony , Lee, Catherine J , Odstrcil Bobillo, Silvina , Hilal, Talal , Faramand, Rawan , Leonard, Jessica T , Wang, Eunice S. , Sasine, Joshua , Sutherland, Katherine , Daunov, Michael , Jamy, Omer , Dykes, Kaitlyn C , Logan, Aaron C , Othman, Tamer , Stock, Wendy , Yalniz, Fevzi , Bachanova, Veronika , Irizarry Gatell, Vivian M , Oluwole, Olalekan O , Dholaria, Bhagirathbhai R , O'Dwyer, Kristin , Moore, Jozal , Roloff, Gregory W , Frey, Noelle V , Shah, Bijal , Oliai, Caspian H , Muffly, Lori , Gupta, Vishal , Ulrickson, Matthew L. , Tsai, Stephanie, Advani, Anjali S. , Reshef, Ran , Lin, Chenyu , Cassaday, Ryan D. , Battiwalla, Minoo , Bobillo, María Silvina Odstrcil , Hilal, Talal , Park, Jae H. , Faramand, Rawan , Solh, Melhem , Vasu, Sumithira , Daunov, Michael , Kumaran, Muthu Sendhil , Hoeg, Rasmus T. , Dykes, Kaitlyn C. , Othman, Tamer , Stock, Wendy , Byrd, Kenneth, Yalniz, Fevzi , Jackson, Clayton W., Oluwole, Olalekan O. , Dholaria, Bhagirathbhai , Roloff, Gregory W. , Frey, Noelle V. , Aldoss, Ibrahim

Blood | February 5, 2026 | Volume: 147 | Issue: 17 | Pages: 2011-2017

10.1182/blood.2025031734 | PMID 41643192 Get It

Abstract In a real-world analysis of brexucabtagene autoleucel recipients with relapsed/refractory B-cell acute lymphoblastic leukemia (N = 278), lack of response to prior blinatumomab correlates with significantly worse following chimeric antigen receptor T-cell therapy outcomes.
Intergroup randomized phase III study of adjuvant FOLFIRI, FOLFOX, or 5-FU/leucovorin for stage II/III rectal cancer: ECOG-ACRIN E3201
Kam, Audrey E , Meropol, Neal J. , Giantonio, Bruce J. , Diasio, Robert B. , Flynn, Patrick J. , Catalano, Paul J. , Hartner, Lee , Rowland, Kendrith M. , Song, Wei , Mulcahy, Mary F. , Whitehead, Robert P. , Petrelli, Nicholas J. , O’Dwyer, Peter J , Cella, David , Benson, Al B. , Catalano, Paul J , Cella, David , Benson, Al , Kam, Audrey E , Zhao, Fengmin , Sinicrope, Frank A. , Mayer, Robert J. , O’Dwyer, Peter J. , Hamilton, Stanley R.

The Oncologist | December 13, 2025 | Volume: 31 | Issue: 1 | Pages: No page available

10.1093/oncolo/oyaf416 | PMID 41397917 Get It

Abstract Background Adjuvant 5-FU monotherapy was previously the standard treatment for stage II/III rectal cancer. This study compared adjuvant FOLFIRI, FOLFOX, and 5-FU/LV. Methods Eligible patients had T3-T4 N0 or Tany N1-3 rectal adenocarcinoma ≤12 cm from the anal verge and received pre-operative or postoperative 5-FU chemoradiotherapy (CRT). Patients were randomized to adjuvant FOLFIRI (8 cycles), FOLFOX (8 cycles), or 5-FU/LV weekly (6/8 weeks; 3 cycles). The trial planned to enroll 3,150 patients but was closed early following activation of an alternative adjuvant rectal cancer study including bevacizumab (E5204). The primary endpoint was overall survival (OS); secondary endpoints included disease-free survival (DFS), sphincter preservation, tolerability, and quality of life (QOL). Results The trial enrolled 225 patients (179 randomized) before early closure. Grade 3/4 toxicity occurred in 59%, with neutropenia, leukopenia, and diarrhea being the most common. At a median follow-up of 9.7 years, no significant OS or DFS differences were observed. The rate of sphincter preservation was numerically higher with FOLFIRI and FOLFOX versus 5-FU/LV, but the difference was not statistically significant. Conclusion FOLFOX and FOLFIRI can be safely administered after CRT in rectal cancer patients safely with expected toxicities. Due to early trial closure and small sample size, the survival analysis was underpowered to detect a significant difference between regimens. ClinicalTrials.gov identifier NCT00068692
Patient characteristics, toxicity, and response after real world administration of obecabtagene autoleucel and brexucabtagene autoleucel for relapsed acute lymphoblastic leukemia: A rocca analysis
Valtis, Yannis K. , Sandhu, Karamjeet , Zhang, Amy , Miller, Katharine, Oliai, Caspian , Lill, Georgia R. , Kopmar, Noam E. , Connor, Matthew P. , Solh, Melhem , Guzowski, Caitlin, Tan, Virginia, Jeyakumar, Nikeshan , Hoeg, Rasmus T. , Koura, Divya, Gatell, Vivian Irizarry , O'Dwyer, Kristen M., Moore, Jozal , Ulrickson, Matthew L. , Al-Darobi, Ali, Byrd, Ken, Tsai, Stephanie, O’Connor, Timothy E. , McCauley, Ross , Mohty, Razan , Sutherland, Katherine, Muffly, Lori , Frey, Noelle, Muffly, Lori , Faramand, Rawan , Hill, LaQuisa C. , Muhsen, Ibrahim N. , Othman, Tamer , Luskin, Marlise R , Chen, Evan , Oliai, Caspian H , Cassaday, Ryan D. , Logan, Aaron C , Hilal, Talal , Park, Jae H. , Leonard, Jessica T , Srinagesh, Hrishikesh K. , Kumaran, Muthu Sendhil , Dykes, Kaitlyn C. , Stock, Wendy , Jackson, Clayton, Oluwole, Olalekan O. , Dholaria, Bhagirathbhai , O'Dwyer, Kristin , Wang, Eunice S. , Jamy, Omer , Roloff, Gregory W. , Aldoss, Ibrahim , Shah, Bijal , Frey, Noelle

Blood | December 5, 2025 | Volume: 146 | Issue: Supplement 1 | Pages: 2715-2715

10.1182/blood-2025-2715 Get It

Abstract Introduction Obecabtagene autoleucel (obe-cel) and brexucabtagene autoleucel (brexu-cel) are CD19 targeted chimeric antigen receptor T cell (CAR-T) therapies, approved for the treatment of adults with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (ALL). Mechanistic differences between obe-cel and brexu-cel including differing costimulatory domains (4-1BB vs. CD28), CD19 binding domains (intermediate vs. high affinity) and split dose (Days 1 and 10) vs. single infusion may impact in-vivo cellular kinetics that translate into variant clinical outcomes. In pivotal trials, obe-cel resulted in lower rates of severe cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) compared to brexu-cel with comparable efficacy (Roddie et al., NEJM 2025; Shah et al., Lancet 2021). Real-world utilization and outcomes with obe-cel are unknown given the relatively recent approval. Methods The ROCCA database, comprising real world data from patients (pts) with r/r ALL treated at 40 North American institutions was utilized in this analysis. Pts with r/r ALL were eligible if they were apheresed for obe-cel since its approval (11/8/2024) or brexu-cel over a comparable period (since 8/1/24) and had at least 30 days of follow up. Data cut off was 7/15/2025. CRS/ICANS were graded per ASTCT criteria. Measurable residual disease (MRD) was assessed by flow cytometry and/or next generation sequencing per institutional standards. Results 38 pts have undergone apheresis for obe-cel (36 infused, all received both infusions) and 54 (53 infused) for brexu-cel over the study period. Pts in the obe-cel and brexu-cel cohorts had the following baseline characteristics: median age, 47 vs. 39 years; ECOG 2+, 15% vs. 26%; Ph+ disease, 24% vs 13%; KMT2Ar, 0 vs. 4%; TP53m, 11% vs 11%, and hypodiploid karyotype, 5% vs 6%. The following prior treatment patterns were observed: median lines of therapy before CAR-T 3 vs. 3; prior SCT 24% vs. 30%, prior blinatumomab 68% vs. 46%, prior inotuzumab 45% vs. 30%. At apheresis, active disease (>5% bone marrow blasts) was present in 47% vs. 55% of obe-cel and brexu-cel pts, respectively; the remainder were in CR (with 18% vs. 22% in MRD- CR, respectively). Among obe-cel (n= 35 [92% of cohort]) and brexu-cel (21 [38% of cohort] pts with disease re-assessment prior to lymphodepletion (LD), 31% vs. 43% had active BM disease, respectively; few pts (24% vs. 17%) had >20% marrow disease burden prior to LD. CAR-mediated toxicity differed significantly between the cohorts. CRS occurred in 56% of obe-cel pts compared to 94% of brexu-cel pts (p < 0.0001). There were no Gr3+ CRS events among the obe-cel pts; 3 (6%) brexu-cel pts had Gr3+ CRS (p = 0.27). ICANS occurred in 17% of obe-cel pts vs. 51% of brexu-cel pts (p = 0.001). Gr3+ ICANS occurred in 6% of obe-cel vs. 32% of brexu-cel pts (p = 0.0027). Among the obe-cel pts, CRS occurred in 31% after the first infusion and 46% after the second; ICANS occurred in 3% after the first infusion and 15% after the second. Prolonged Gr4 neutropenia (ANC < 500 cells/uL beyond day 30 from infusion) occurred in 24% of obe-cel vs. 28% of brexu-cel pts (p = 0.73). Deaths within the first 28 days of infusion occurred in 0 obe-cel pts and 4 brexu-cel pts (2 of infection, 1 of infection/brain bleed, and 1 of liver failure in the setting of Gr4 CRS and HLH). Response rates were high and did not significantly differ between cohorts (p = 0.85). Among the 31 obe-cel pts with available response data, 25 (81%) achieved an MRD- CR/CRi, 3 (10%) had an MRD+ CR/CRi, 2 (6%) had a CR/CRi with unknown MRD, and 1 (3%) did not respond. Among 41 brexu-cel pts with available response data, 33 (80%) had an MRD- CR/CRi, 4 (10%) an MRD+ CR/CRi, and 4 (10%) CR/CRi with unknown MRD. Conclusion Pts selected for obe-cel apheresis were similar to those for brexu-cel over the study period (noting that not all centers had access to obe-cel during this time). Similar to clinical trial results, obe-cel was associated with lower rates of CRS/ICANS. Rates of MRD-negative CR were high and did not differ between cohorts. A larger sample and longer follow up are required for further analyses; we anticipate a cohort of ~75 obe-cel treated pts by the annual meeting and will provide updated data.
Pre- or post-CAR-T allogeneic hematopoietic cell transplant provides relapse-free survival benefit for R/R Philadelphia negative B-cell acute lymphoblastic leukemia (B-ALL) successfully treated with brexucabtagene autoleucel in the real world
Zhang, Amy , Miller, Katharine, Sutherland, Katherine, Jeyakumar, Nikeshan , Boccucci, Jacob , Ulrickson, Matthew L. , Al-Darobi, Ali, Sandhu, Karamjeet , Kopmar, Noam E. , Solh, Melhem , Bobillo, Silvina Odstrcil, Tsai, Stephanie, O’Connor, Timothy E. , Valtis, Yannis K. , Vasu, Sumithira, Tan, Virginia, O'Dwyer, Kristen M., Moore, Jozal , McCauley, Ross , Mountjoy, Luke , Ramakrishnan, Aravind , Malik, Shahbaz A. , Shaughnessy, Paul , Mohty, Razan , Hoeg, Rasmus T. , Oliai, Caspian , Lill, Georgia R. , Schwartz, Marc S. , Koura, Divya, Byrd, Ken, Tracy, Sean , Grover, Punita , Frey, Noelle, Connor, Matthew P. , Yaghmour, George , Gatell, Vivian Irizarry , Muffly, Lori , Muffly, Lori , Logan, Aaron C , Yalniz, Fevzi , Srinagesh, Hrishikesh K. , Grunwald, Michael R. , Kota, Vamsi , Sasine, Joshua , Hill, LaQuisa C. , Muhsen, Ibrahim N. , Advani, Anjali S. , Aldoss, Ibrahim , Othman, Tamer , Reshef, Ran , Luskin, Marlise R , Chen, Evan , Lin, Chenyu , Cassaday, Ryan D. , Lee, Catherine J , Bobillo, Silvina Odstrcil, Tsai, Stephanie, Hilal, Talal , Park, Jae H. , Vasu, Sumithira , Bezerra, Evandro D. , Wang, Eunice S. , Leonard, Jessica T , O'Dwyer, Kristin , Majhail, Navneet S. , Battiwalla, Minoo , Mathews, John Abraham , Jamy, Omer , Kumaran, Muthu Sendhil , Stock, Wendy , Roloff, Gregory W. , Oliai, Caspian H , Schwartz, Marc, Dykes, Kaitlyn C. , Daunov, Michael , Bachanová, Veronika , Frey, Noelle, Jackson, Clayton, Oluwole, Olalekan O. , Dholaria, Bhagirathbhai , Faramand, Rawan

Blood | December 5, 2025 | Volume: 146 | Issue: Supplement 1 | Pages: 516-516

10.1182/blood-2025-516 Get It

Abstract Introduction: Brexucabtagene autoleucel (Brexu-cel) is a CD19-targeted chimeric antigen receptor (CAR-)T cell therapy approved for treatment of relapsed/refractory (r/r) B-ALL. Brexu-cel's approval was founded on data from the ZUMA-3 trial, in which 78 patients (pts) were treated at the pivotal dose of 1x10e6 CAR-T cells/kg, resulting in a complete remission (CR) rate of 73%. Three-year follow-up from ZUMA-3 demonstrated median relapse-free and overall survival (RFS/OS) of 11.6 and 25.6 months (mos) for all treated pts. Amongst responders, the median OS was 60.4 mos for those who did not receive a subsequent allogeneic hematopoietic cell transplant (HCT) (n=43), but only 36.3 months for those who did (n=14). This has led some to conclude that HCT may not be beneficial following brexu-cel therapy for r/r B-ALL; however, it must be noted that 29 (37%) of the pts treated on ZUMA-3 received brexu-cel for post-HCT relapse. T cells collected from individuals who relapse in the post-HCT setting are largely of donor origin, making the CAR-T product comparable to a genetically modified donor lymphocyte infusion (DLI). The immunology at play in this scenario may be different from that in which CAR-T cells are of truly autologous origin. Methods: The Real-World Outcomes Collaborative for CAR-T in ALL (ROCCA) consortium database includes pt characteristics and outcomes of brexu-cel therapy given as standard-of-care across 41 US institutions. We identified pts who achieved an MRD negative (neg) CR by either flow cytometry (minimum sensitivity 10e-4) or NGS following brexu-cel for r/r Ph neg B-ALL and categorized them into three groups with regard to use of HCT: Never HCT, Pre-CAR HCT, or Post-CAR HCT. Pts who received second HCT following brexu-cel for post-HCT relapse (n=9) were excluded. Pt/disease characteristics, RFS, and OS were assessed for each group, landmarked at 73 days after brexu-cel infusion (the median time to consolidative allogeneic HCT). Results: In the ROCCA database we identified 165 pts who achieved MRD neg CR following brexu-cel, amongst whom 69 never underwent HCT, 49 were transplanted pre-CAR (ie, brexu-cel served as a genetically modified DLI), and 47 underwent post-CAR consolidative HCT while in CR. The median follow-up is 373 days. The median age was higher in the Never HCT group (49, range 19-83) in comparison with the Pre-CAR HCT (40, 24-72) and Post-CAR HCT (34, 18-70) groups. Thirty-five percent were >60yo in the Never HCT group vs 20% in the Pre-CAR HCT and 9% in the Post-CAR HCT groups. Ph-like disease was present in 38%, 29%, and 43% of the Never HCT, Pre-CAR HCT, and Post-CAR HCT groups, respectively (p=0.35). No significant differences were observed in pre-apheresis bone marrow blasts, presence of CNS disease at apheresis, prior blinatumomab or inotuzumab treatment, or use of bridging therapy across the groups, though there was a higher prevalence of non-CNS extramedullary disease in the Pre- and Post-CAR HCT groups (32, 39%) vs the Never HCT group (13%) (p=0.004). A minority of pts in all groups were deemed to be in MRD neg CR prior to apheresis (6-20%). Median RFS was 260 days in the Never HCT group and not reached in the Pre- and Post-CAR HCT groups (p=0.002), with respective 1-yr RFS of 38%, 64%, and 67%. Median OS was not reached in any group and was similar for all at 1-yr at 68-79% (p=0.13). Characteristics of those in the Never HCT group who were least likely to relapse included age >60 (OR 0.22, CI 0.07-0.73 vs age 18-39, p=0.024) and those with non-Ph-like B-ALL (OR 0.33, CI 0.12-0.94, vs Ph-like, p=0.037) in univariate analyses. Conclusions: Real-world data regarding outcomes following brexu-cel therapy allow evaluation of the role for consolidative allogeneic HCT, which remains one of the most important unresolved questions in the use of CAR-T therapy for r/r B-ALL. This analysis demonstrates that a first consolidative HCT after achieving MRD neg CR with brexu-cel is associated with a significant decrease in relapse. Additionally, use of brexu-cel for post-HCT relapse is also associated with a significantly lower risk of relapse compared with those who never received an allogeneic HCT. With the current duration of followup, OS is not significantly different across the three groups. These data suggest there is a benefit for relapse-free survival in pts receiving an allogeneic HCT at some point in the course of treatment for r/r Ph neg B-ALL.