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1. Long-term outcomes of patients with large B-cell lymphoma treated with axicabtagene ciloleucel and prophylactic corticosteroids

Author

Oluwole, Olalekan O., Forcade, Edouard, Muñoz, Javier, de Guibert, Sophie, Vose, Julie M., Bartlett, Nancy L., Lin, Yi, Deol, Abhinav, McSweeney, Peter, Goy, Andre H., Kersten, Marie José, Jacobson, Caron A., Farooq, Umar, Minnema, Monique C., Thieblemont, Catherine, Timmerman, John M., Stiff, Patrick, Avivi, Irit, Tzachanis, Dimitrios, Zheng, Yan, Vardhanabhuti, Saran, Nater, Jenny, Shen, Rhine R., Miao, Harry, Kim, Jenny J., and van Meerten, Tom

Published
2024
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2. Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma in Standard-of-Care Practice: Results From the US Lymphoma CAR T Consortium.

Author

Wang, Yucai, Jain, Preetesh, Locke, Frederick, Maurer, Matthew, Frank, Matthew, Munoz, Javier, Dahiya, Saurabh, Beitinjaneh, Amer, Jacobs, Miriam, Mcguirk, Joseph, Vose, Julie, Goy, Andre, Hill, Brian, Dorritie, Kathleen, Oluwole, Olalekan, Deol, Abhinav, Paludo, Jonas, Shah, Bijal, Wang, Trent, Banerjee, Rahul, Miklos, David, Rapoport, Aaron, Lekakis, Lazaros, Ghobadi, Armin, Neelapu, Sattva, Lin, Yi, Wang, Michael, Jain, Michael, and Andreadis, Charalambos

Subjects
Adult, Humans, Receptors, Chimeric Antigen, Lymphoma, Mantle-Cell, Bendamustine Hydrochloride, Neoplasm Recurrence, Local, Immunotherapy, Adoptive, Lymphoma, Large B-Cell, Diffuse, Antigens, CD19
Abstract

PURPOSE: Brexucabtagene autoleucel (brexu-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory mantle cell lymphoma (MCL). This therapy was approved on the basis of the single-arm phase II ZUMA-2 trial, which showed best overall and complete response rates of 91% and 68%, respectively. We report clinical outcomes with brexu-cel in the standard-of-care setting for the approved indication. PATIENTS AND METHODS: Patients who underwent leukapheresis between August 1, 2020 and December 31, 2021, at 16 US institutions, with an intent to manufacture commercial brexu-cel for relapsed/refractory MCL, were included. Patient data were collected for analyses of responses, outcomes, and toxicities as per standard guidelines. RESULTS: Of 189 patients who underwent leukapheresis, 168 (89%) received brexu-cel infusion. Of leukapheresed patients, 79% would not have met ZUMA-2 eligibility criteria. Best overall and complete response rates were 90% and 82%, respectively. At a median follow-up of 14.3 months after infusion, the estimates for 6- and 12-month progression-free survival (PFS) were 69% (95% CI, 61 to 75) and 59% (95% CI, 51 to 66), respectively. The nonrelapse mortality was 9.1% at 1 year, primarily because of infections. Grade 3 or higher cytokine release syndrome and neurotoxicity occurred in 8% and 32%, respectively. In univariable analysis, high-risk simplified MCL international prognostic index, high Ki-67, TP53 aberration, complex karyotype, and blastoid/pleomorphic variant were associated with shorter PFS after brexu-cel infusion. Patients with recent bendamustine exposure (within 24 months before leukapheresis) had shorter PFS and overall survival after leukapheresis in intention-to-treat univariable analysis. CONCLUSION: In the standard-of-care setting, the efficacy and toxicity of brexu-cel were consistent with those reported in the ZUMA-2 trial. Tumor-intrinsic features of MCL, and possibly recent bendamustine exposure, may be associated with inferior efficacy outcomes.

Published
2023

4. Integrative analysis of clinicopathological features defines novel prognostic models for mantle cell lymphoma in the immunochemotherapy era: a report from The North American Mantle Cell Lymphoma Consortium

Author

Vose, Julie M., Fu, Kai, Wang, Lu, Mansoor, Adnan, Stewart, Douglas, Cheng, Hongxia, Smith, Lynette, Yuan, Ji, Qureishi, Hina Naushad, Link, Brian K., Cessna, Melissa H., Barr, Paul M., Kahl, Brad S., Mckinney, Matthew S., Khan, Nadia, Advani, Ranjana H., Martin, Peter, Goy, Andre H., Phillips, Tycel J., Mehta, Amitkumar, Kamdar, Manali, Crump, Michael, Pro, Barbara, Flowers, Christopher R., Jacobson, Caron A., Smith, Sonali M., Stephens, Deborah M., Bachanova, Veronika, Jin, Zhaohui, Wu, Shishou, Hernandez-Ilizaliturri, Francisco, Torka, Pallawi, Anampa-Guzmán, Andrea, Kashef, Farshid, Li, Xing, Sharma, Sunandini, Greiner, Timothy C., Armitage, James O., Lunning, Matthew, Weisenburger, Dennis D., Bociek, Robert G., Iqbal, Javeed, Yu, Guohua, and Bi, Chengfeng

Published
2023
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5. Recognizing Unmet Need in the Era of Targeted Therapy for CLL/SLL: “What's Past Is Prologue” (Shakespeare)CLL/SLL Unmet Need

Author

Mato, Anthony R, Davids, Matthew S, Sharman, Jeff, Roeker, Lindsey E, Kay, Neil, Kater, Arnon P, Rogers, Kerry, Thompson, Meghan C, Rhodes, Joanna, Goy, Andre, Skarbnik, Alan, Schuster, Stephen J, Tam, Constantine S, Eyre, Toby A, O'Brien, Susan, Nabhan, Chadi, Lamanna, Nicole, Sun, Clare, Shadman, Mazyar, Pagel, John M, Ujjani, Chaitra, Brander, Danielle, Coombs, Catherine C, Jain, Nitin, Cheah, Chan Y, Brown, Jennifer R, Seymour, John F, and Woyach, Jennifer A

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Clinical Research, Hematology, Lymphoma, Cancer, Humans, Immunotherapy, Leukemia, Lymphocytic, Chronic, B-Cell, Phosphatidylinositol 3-Kinases, Protein Kinase Inhibitors, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

The management of chronic lymphocytic leukemia (CLL) has undergone unprecedented changes over the last decade. Modern targeted therapies are incorporated into clinical practice. Unfortunately, patients have begun to develop resistance or intolerance to multiple classes. Symptomatic patients previously treated with a BTK inhibitor (BTKi) and venetoclax represent a new and rapidly growing unmet need in CLL. Here, we define unmet needs in a modern treatment context. We also critically review the literature for PI3K inhibitors and chemoimmunotherapy and lack of data to support their utility following BTKis and venetoclax. Finally, we suggest opportunities to ensure the continued innovation for patients with CLL.

Published
2022

6. Bridging therapy with axicabtagene ciloleucel for large B-cell lymphoma: results from the US Lymphoma CAR-T Consortium

Author

Jain, Michael D., Jacobs, Miriam T., Gao, Feng, Nastoupil, Loretta J., Spiegel, Jay Y., Lin, Yi, Dahiya, Saurabh, Lunning, Matthew, Lekakis, Lazaros, Reagan, Patrick, Oluwole, Olalekan, McGuirk, Joseph, Deol, Abhinav, Sehgal, Alison R., Goy, Andre, Hill, Brian T., Andreadis, Charalambos, Munoz, Javier, Chavez, Julio C, Bennani, N. Nora, Rapoport, Aaron P., Vose, Julie M., Miklos, David, Neelapu, Sattva S., Locke, Frederick L., and Ghobadi, Armin

Published
2024
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7. Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B‐cell lymphoma

Author

Oluwole, Olalekan O, Bouabdallah, Krimo, Muñoz, Javier, De Guibert, Sophie, Vose, Julie M, Bartlett, Nancy L, Lin, Yi, Deol, Abhinav, McSweeney, Peter A, Goy, Andre H, Kersten, Marie José, Jacobson, Caron A, Farooq, Umar, Minnema, Monique C, Thieblemont, Catherine, Timmerman, John M, Stiff, Patrick, Avivi, Irit, Tzachanis, Dimitrios, Kim, Jenny J, Bashir, Zahid, McLeroy, Jeff, Zheng, Yan, Rossi, John M, Johnson, Lisa, Goyal, Lovely, and Meerten, Tom

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Lymphoma, Rare Diseases, Cancer, Hematology, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adrenal Cortex Hormones, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological, Biological Products, Cytokine Release Syndrome, Dexamethasone, Female, Humans, Immunotherapy, Adoptive, Lymphoma, Large B-Cell, Diffuse, Male, Middle Aged, large B-cell lymphoma, axi-cel, chimaeric antigen receptor-T cell, prophylaxis, corticosteroids, cytokine release syndrome, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

ZUMA-1 (NCT02348216) examined the safety and efficacy of axicabtagene ciloleucel (axi-cel), an autologous CD19-directed chimaeric antigen receptor (CAR)-T cell therapy, in refractory large B-cell lymphoma. To reduce treatment-related toxicity, several exploratory safety management cohorts were added to ZUMA-1. Specifically, cohort 6 investigated management of cytokine release syndrome (CRS) and neurologic events (NEs) with prophylactic corticosteroids and earlier corticosteroid and tocilizumab intervention. CRS and NE incidence and severity were primary end-points. Following leukapheresis, patients could receive optional bridging therapy per investigator discretion. All patients received conditioning chemotherapy (days -5 through -3), 2 × 106  CAR-T cells/kg (day 0) and once-daily oral dexamethasone [10 mg, day 0 (before axi-cel) through day 2]. Forty patients received axi-cel. CRS occurred in 80% of patients (all grade ≤2). Any grade and grade 3 or higher NEs occurred in 58% and 13% of patients respectively. Sixty-eight per cent of patients did not experience CRS or NEs within 72 h of axi-cel. With a median follow-up of 8·9 months, objective and complete response rates were 95% and 80% respectively. Overall, prophylactic corticosteroids and earlier corticosteroid and/or tocilizumab intervention resulted in no grade 3 or higher CRS, a low rate of grade 3 or higher NEs and high response rates in this study population.

Published
2021

8. Five-year follow-up of ZUMA-1 supports the curative potential of axicabtagene ciloleucel in refractory large B-cell lymphoma

Author

Neelapu, Sattva S., Jacobson, Caron A., Ghobadi, Armin, Miklos, David B., Lekakis, Lazaros J., Oluwole, Olalekan O., Lin, Yi, Braunschweig, Ira, Hill, Brian T., Timmerman, John M., Deol, Abhinav, Reagan, Patrick M., Stiff, Patrick, Flinn, Ian W., Farooq, Umar, Goy, Andre H., McSweeney, Peter A., Munoz, Javier, Siddiqi, Tanya, Chavez, Julio C., Herrera, Alex F., Bartlett, Nancy L., Bot, Adrian A., Shen, Rhine R., Dong, Jinghui, Singh, Kanwarjit, Miao, Harry, Kim, Jenny J., Zheng, Yan, and Locke, Frederick L.

Published
2023
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10. Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium.

Author

Nastoupil, Loretta J, Jain, Michael D, Feng, Lei, Spiegel, Jay Y, Ghobadi, Armin, Lin, Yi, Dahiya, Saurabh, Lunning, Matthew, Lekakis, Lazaros, Reagan, Patrick, Oluwole, Olalekan, McGuirk, Joseph, Deol, Abhinav, Sehgal, Alison R, Goy, Andre, Hill, Brian T, Vu, Khoan, Andreadis, Charalambos, Munoz, Javier, Westin, Jason, Chavez, Julio C, Cashen, Amanda, Bennani, N Nora, Rapoport, Aaron P, Vose, Julie M, Miklos, David B, Neelapu, Sattva S, and Locke, Frederick L

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Lymphoma, Hematology, Good Health and Well Being, Adult, Aged, Aged, 80 and over, Antigens, CD19, Biological Products, Clinical Trials, Phase II as Topic, Comorbidity, Cytokine Release Syndrome, Female, Humans, Immunotherapy, Adoptive, L-Lactate Dehydrogenase, Leukapheresis, Lymphoma, Large B-Cell, Diffuse, Male, Middle Aged, Organizational Policy, Patient Selection, Progression-Free Survival, Recurrence, Retrospective Studies, Severity of Illness Index, Standard of Care, Survival Rate, Young Adult, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

PurposeAxicabtagene ciloleucel (axi-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory large B-cell lymphoma (LBCL) on the basis of the single-arm phase II ZUMA-1 trial, which showed best overall and complete response rates in infused patients of 83% and 58%, respectively. We report clinical outcomes with axi-cel in the standard-of-care (SOC) setting for the approved indication.Patients and methodsData were collected retrospectively from all patients with relapsed/refractory LBCL who underwent leukapheresis as of September 30, 2018, at 17 US institutions with the intent to receive SOC axi-cel. Toxicities were graded and managed according to each institution's guidelines. Responses were assessed as per Lugano 2014 classification.ResultsOf 298 patients who underwent leukapheresis, 275 (92%) received axi-cel therapy. Compared with the registrational ZUMA-1 trial, 129 patients (43%) in this SOC study would not have met ZUMA-1 eligibility criteria because of comorbidities at the time of leukapheresis. Among the axi-cel-treated patients, grade ≥ 3 cytokine release syndrome and neurotoxicity occurred in 7% and 31%, respectively. Nonrelapse mortality was 4.4%. Best overall and complete response rates in infused patients were 82% (95% CI, 77% to 86%) and 64% (95% CI, 58% to 69%), respectively. At a median follow-up of 12.9 months from the time of CAR T-cell infusion, median progression-free survival was 8.3 months (95% CI, 6.0 to15.1 months), and median overall survival was not reached. Patients with poor Eastern Cooperative Oncology Group performance status of 2-4 and elevated lactate dehydrogenase had shorter progression-free and overall survival on univariable and multivariable analysis.ConclusionThe safety and efficacy of axi-cel in the SOC setting in patients with relapsed/refractory LBCL was comparable to the registrational ZUMA-1 trial.

Published
2020

11. The iR2 regimen (ibrutinib plus lenalidomide and rituximab) for relapsed/refractory DLBCL: a multicentre, non-randomised, open-label phase 2 study

Author

Ramchandren, Radhakrishnan, Johnson, Peter, Ghosh, Nilanjan, Ruan, Jia, Ardeshna, Kirit M., Johnson, Roderick, Verhoef, Gregor, Cunningham, David, de Vos, Sven, Kassam, Shireen, Fayad, Luis, Radford, John, Bailly, Sarah, Offner, Fritz, Morgan, David, Munoz, Javier, Ping, Jerry, Szafer-Glusman, Edith, Eckert, Karl, Neuenburg, Jutta K., and Goy, Andre

Published
2023
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14. Andre H. Goy, MD, on Unresolved Questions in Mantle Cell Lymphoma

Author

Goy, Andre H.

Subjects
Antineoplastic agents, Lymphomas -- Care and treatment, Physicians, Antimitotic agents, Health
Abstract

'It's time to dissect MCL and account for its molecular heterogeneity when refining our treatment.' Andre H. Goy, MD, is physician-in-chief of the Hackensack Meridian Health Oncology Care Transformation Service; [...]

Published
2022

15. Defining low-HER2 cancers using RNA quantification by next generation sequencing.

Author

Ip, Andrew, primary, Albitar, Maher, additional, Zhang, Hong, additional, Charifa, Ahmad, additional, Agersborg, Sally, additional, Mohtashamian, Arash, additional, Graham, Deena Mary Atieh, additional, McNamara, Donna M., additional, Waintraub, Stanley E., additional, Gutierrez, Martin, additional, Pecora, Andrew L., additional, and Goy, Andre, additional

Published
2024
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16. Multiple alternative splicing of HER2 transcripts and exon skipping with potential consequences on function and antibody-based therapy.

Author

Albitar, Maher, primary, Zhang, Hong, additional, Charifa, Ahmad, additional, Ip, Andrew, additional, Agersborg, Sally, additional, Mohtashamian, Arash, additional, Graham, Deena Mary Atieh, additional, McNamara, Donna M., additional, Waintraub, Stanley E., additional, Gutierrez, Martin, additional, Pecora, Andrew L, additional, and Goy, Andre, additional

Published
2024
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17. Severity of Cytokine Release Syndrome Influences Outcome After Axicabtagene Ciloleucel for Large B cell Lymphoma: Results from the US Lymphoma CAR-T Consortium

Author

Jacobs, Miriam T., Jain, Michael D., Gao, Feng, Nastoupil, Loretta J., Spiegel, Jay Y., Lin, Yi, Dahiya, Saurabh, Lunning, Matthew, Lekakis, Lazaros, Reagan, Patrick M., Oluwole, Olalekan O., McGuirk, Joseph, Deol, Abhinav, Sehgal, Alison, Goy, Andre, Hill, Brian T., Andreadis, Charalambos, Munoz, Javier, Chavez, Julio C., Bennani, N. Nora, Rapoport, Aaron P., Vose, Julie M., Miklos, David B., Neelapu, Sattva S., Ghobadi, Armin, and Locke, Frederick L.

Published
2022
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18. Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice.

Author

Roeker, Lindsey, Fox, Christopher, Eyre, Toby, Brander, Danielle, Allan, John, Schuster, Stephen, Nabhan, Chadi, Hill, Brian, Shah, Nirav, Lansigan, Frederick, Yazdy, Maryam, Cheson, Bruce, Lamanna, Nicole, Singavi, Arun, Coombs, Catherine, Barr, Paul, Skarbnik, Alan, Shadman, Mazyar, Ujjani, Chaitra, Tuncer, Hande, Winter, Allison, Rhodes, Joanna, Dorsey, Colleen, Morse, Hannah, Kabel, Charlene, Pagel, John, Williams, Annalynn, Jacobs, Ryan, Goy, Andre, Muralikrishnan, Sivraj, Pearson, Laurie, Sitlinger, Andrea, Bailey, Neil, Schuh, Anna, Kirkwood, Amy, and Mato, Anthony

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Bridged Bicyclo Compounds, Heterocyclic, Dose-Response Relationship, Drug, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Patient Safety, Practice Patterns, Physicians, Proto-Oncogene Proteins c-bcl-2, Retrospective Studies, Sulfonamides, Treatment Outcome, Tumor Lysis Syndrome
Abstract

PURPOSE: Clinical trials of venetoclax reported negligible rates of clinical tumor lysis syndrome (TLS) in patients with chronic lymphocytic leukemia (CLL) when using an extended dose escalation schedule. We aimed to understand TLS prophylaxis, rates of select adverse events (AE), and impact of dosing modifications in routine clinical practice. EXPERIMENTAL DESIGN: This retrospective cohort study included 297 CLL venetoclax-treated patients outside of clinical trials in academic and community centers. Demographics, baseline disease characteristics, venetoclax dosing, TLS risk and prophylaxis, and AEs were collected. RESULTS: The group was 69% male, 96% had relapsed/refractory CLL, 45% had deletion chromosome 17p, 84% had unmutated IGHV, 80% received venetoclax monotherapy, and median age was 67. TLS risk was categorized as low (40%), intermediate (32%), or high (28%), and 62% had imaging prior to venetoclax initiation. Clinical TLS occurred in 2.7% of patients and laboratory TLS occurred in 5.7%. Pre-venetoclax TLS risk group and creatinine clearance independently predict TLS development in multivariable analysis. Grade 3/4 AEs included neutropenia (39.6%), thrombocytopenia (29.2%), infection (25%), neutropenic fever (7.9%), and diarrhea (6.9%). Twenty-two patients (7.4%) discontinued venetoclax due to an AE. Progression-free survival was similar regardless of number of dose interruptions, length of dose interruption, and stable venetoclax dose. CONCLUSIONS: These data provide insights into current use of venetoclax in clinical practice, including TLS rates observed in clinical practice. We identified opportunities for improved adherence to TLS risk stratification and prophylaxis, which may improve safety.

Published
2019

19. A retrospective comparison of venetoclax alone or in combination with an anti-CD20 monoclonal antibody in R/R CLL.

Author

Mato, Anthony, Roeker, Lindsey, Eyre, Toby, Nabhan, Chadi, Lamanna, Nicole, Hill, Brian, Brander, Danielle, Barr, Paul, Lansigan, Frederick, Cheson, Bruce, Singavi, Arun, Yazdy, Maryam, Shah, Nirav, Allan, John, Bhavsar, Erica, Rhodes, Joanna, Kennard, Kaitlin, Schuster, Stephen, Williams, AnnaLynn, Skarbnik, Alan, Goy, Andre, Goodfriend, Julie, Dorsey, Colleen, Coombs, Catherine, Tuncer, Hande, Ujjani, Chaitra, Jacobs, Ryan, Winter, Allison, Pagel, John, Bailey, Neil, Schuh, Anna, Shadman, Mazyar, Sitlinger, Andrea, Weissbrot, Hanna, Muralikrishnan, Sivraj, Zelenetz, Andrew, Kirkwood, Amy, and Fox, Christopher

Subjects
Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Bridged Bicyclo Compounds, Heterocyclic, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Progression-Free Survival, Retrospective Studies, Sulfonamides
Abstract

Venetoclax (VEN) is approved for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as monotherapy (VENmono) or in combination with rituximab. Whether VEN plus anti-CD20 (VENcombo) is superior to VENmono is unknown. We conducted a multicenter, retrospective cohort analysis comparing 321 CLL patients treated with VENmono vs VENcombo across the United States and the United Kingdom. We examined demographics, baseline characteristics, dosing, adverse events, response rates, and outcomes. The primary endpoints were progression-free survival (PFS) and overall survival (OS), estimated by Kaplan-Meier method, in patients treated with VENmono vs VENcombo. Univariate and bivariate analyses were performed with COX regression. Three hundred twenty-one CLL patients were included (3 median prior treatments, 78% prior ibrutinib). The overall response rates (ORRs) were similar (VENmono, 81% ORR, 34% complete remission [CR] vs VENcombo, 84% ORR, 32% CR). With a median follow-up of 13.4 months, no differences in PFS and OS were observed between the groups. In unadjusted analyses, the hazard ratios (HRs) for PFS and OS for VENmono vs VENcombo were HR 1.0 (95% confidence interval [CI], 0.6-1.8; P = .7) and HR 1.2 (95% CI, 0.6-2.3; P = .5), respectively. When adjusting for differences between the cohorts, the addition of an anti-CD20 antibody in combination with VEN did not impact PFS (HR, 1.0; 95% CI, 0.5-2.0; P = .9) or OS (HR, 1.1; 95% CI, 0.4-2.6; P = .8). We demonstrate comparable efficacy between VENmono and VENcombo in a heavily pretreated, high-risk, retrospective cohort, in terms of both response data and survival outcomes. Prospective studies are needed to validate these findings.

Published
2019

21. Effect of Prior Therapy and Disease Refractoriness on the Efficacy and Safety of Oral Selinexor in Patients with Diffuse Large B-cell Lymphoma (DLBCL): A Post-hoc Analysis of the SADAL Study

Author

Schuster, Michael, Zijlstra, Josée, Casasnovas, Rene-Olivier, Vermaat, Joost S.P, Kalakonda, Nagesh, Goy, Andre, Choquet, Sylvain, Neste, Eric Van Den, Hill, Brian, Thieblemont, Catherine, Cavallo, Federica, De la Cruz, Fatima, Kuruvilla, John, Hamad, Nada, Jaeger, Ulrich, Caimi, Paolo, Gurion, Ronit, Warzocha, Krzysztof, Bakhshi, Sameer, Sancho, Juan-Manuel, Follows, George, Egyed, Miklos, Offner, Fritz, Vassilakopoulos, Theodoros, Samal, Priyanka, Ku, Matthew, Ma, Xiwen, Corona, Kelly, Chamoun, Kamal, Shah, Jatin, Shacham, Sharon, Kauffman, Michael G., Canales, Miguel, and Maerevoet, Marie

Published
2022
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22. Comparison of the Effectiveness and Safety of the Oral Selective Inhibitor of Nuclear Export, Selinexor, in Diffuse Large B Cell Lymphoma Subtypes

Author

Casasnovas, Rene-Olivier, Follows, George, Zijlstra, Josee M., Vermaat, Joost S.P., Kalakonda, Nagesh, Choquet, Sylvain, Neste, Eric Van Den, Hill, Brian, Thieblemont, Catherine, Cavallo, Federica, la Cruz, Fatima De, Kuruvilla, John, Hamad, Nada, Jaeger, Ulrich, Caimi, Paolo F., Gurion, Ronit, Warzocha, Krzysztof, Bakhshi, Sameer, Sancho, Juan-Manuel, Schuster, Michael, Egyed, Miklos, Offner, Fritz, Vassilakopoulos, Theodoros P., Samal, Priyanka, Ku, Matthew, Ma, Xiwen, Chamoun, Kamal, Shah, Jatin, Canales, Miguel, Maerevoet, Marie, Shacham, Sharon, Kauffman, Michael G., and Goy, Andre

Published
2022
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23. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma

Author

Neelapu, Sattva S, Locke, Frederick L, Bartlett, Nancy L, Lekakis, Lazaros J, Miklos, David B, Jacobson, Caron A, Braunschweig, Ira, Oluwole, Olalekan O, Siddiqi, Tanya, Lin, Yi, Timmerman, John M, Stiff, Patrick J, Friedberg, Jonathan W, Flinn, Ian W, Goy, Andre, Hill, Brian T, Smith, Mitchell R, Deol, Abhinav, Farooq, Umar, McSweeney, Peter, Munoz, Javier, Avivi, Irit, Castro, Januario E, Westin, Jason R, Chavez, Julio C, Ghobadi, Armin, Komanduri, Krishna V, Levy, Ronald, Jacobsen, Eric D, Witzig, Thomas E, Reagan, Patrick, Bot, Adrian, Rossi, John, Navale, Lynn, Jiang, Yizhou, Aycock, Jeff, Elias, Meg, Chang, David, Wiezorek, Jeff, and Go, William Y

Subjects
Rare Diseases, Orphan Drug, Lymphoma, Patient Safety, Clinical Research, Hematology, Clinical Trials and Supportive Activities, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Adult, Aged, Antigens, CD19, Biomarkers, Disease-Free Survival, Female, Humans, Immunotherapy, Adoptive, Interleukins, Lymphoma, Large B-Cell, Diffuse, Male, Middle Aged, Nervous System Diseases, Neutropenia, Receptors, Antigen, T-Cell, Survival Rate, T-Lymphocytes, Young Adult, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundIn a phase 1 trial, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, showed efficacy in patients with refractory large B-cell lymphoma after the failure of conventional therapy.MethodsIn this multicenter, phase 2 trial, we enrolled 111 patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma who had refractory disease despite undergoing recommended prior therapy. Patients received a target dose of 2×106 anti-CD19 CAR T cells per kilogram of body weight after receiving a conditioning regimen of low-dose cyclophosphamide and fludarabine. The primary end point was the rate of objective response (calculated as the combined rates of complete response and partial response). Secondary end points included overall survival, safety, and biomarker assessments.ResultsAmong the 111 patients who were enrolled, axi-cel was successfully manufactured for 110 (99%) and administered to 101 (91%). The objective response rate was 82%, and the complete response rate was 54%.With a median follow-up of 15.4 months, 42% of the patients continued to have a response, with 40% continuing to have a complete response. The overall rate of survival at 18 months was 52%. The most common adverse events of grade 3 or higher during treatment were neutropenia (in 78% of the patients), anemia (in 43%), and thrombocytopenia (in 38%). Grade 3 or higher cytokine release syndrome and neurologic events occurred in 13% and 28% of the patients, respectively. Three of the patients died during treatment. Higher CAR T-cell levels in blood were associated with response.ConclusionsIn this multicenter study, patients with refractory large B-cell lymphoma who received CAR T-cell therapy with axi-cel had high levels of durable response, with a safety profile that included myelosuppression, the cytokine release syndrome, and neurologic events. (Funded by Kite Pharma and the Leukemia and Lymphoma Society Therapy Acceleration Program; ZUMA-1 ClinicalTrials.gov number, NCT02348216 .).

Published
2017

25. Tocilizumab among patients with COVID-19 in the intensive care unit: a multicentre observational study

Author

Biran, Noa, Ip, Andrew, Ahn, Jaeil, Go, Ronaldo C, Wang, Shuqi, Mathura, Shivam, Sinclaire, Brittany A, Bednarz, Urszula, Marafelias, Michael, Hansen, Eric, Siegel, David S, Goy, Andre H, Pecora, Andrew L, Sawczuk, Ihor S, Koniaris, Lauren S, Simwenyi, Micky, Varga, Daniel W, Tank, Lisa K, Stein, Aaron A, Allusson, Valerie, Lin, George S, Oser, William F, Tuma, Roman A, Reichman, Joseph, Brusco, Louis, Jr, Carpenter, Kim L, Costanzo, Eric J, Vivona, Vincent, and Goldberg, Stuart L

Published
2020
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27. Determining clinical course of diffuse large B-cell lymphoma using targeted transcriptome and machine learning algorithms

Author

Albitar, Maher, Zhang, Hong, Goy, Andre, Xu-Monette, Zijun Y., Bhagat, Govind, Visco, Carlo, Tzankov, Alexandar, Fang, Xiaosheng, Zhu, Feng, Dybkaer, Karen, Chiu, April, Tam, Wayne, Zu, Youli, Hsi, Eric D., Hagemeister, Fredrick B., Huh, Jooryung, Ponzoni, Maurilio, Ferreri, Andrés J. M., Møller, Michael B., Parsons, Benjamin M., van Krieken, J. Han, Piris, Miguel A., Winter, Jane N., Li, Yong, Xu, Bing, and Young, Ken H.

Published
2022
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28. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial

Author

Kalakonda, Nagesh, Maerevoet, Marie, Cavallo, Federica, Follows, George, Goy, Andre, Vermaat, Joost S P, Casasnovas, Olivier, Hamad, Nada, Zijlstra, Josée M, Bakhshi, Sameer, Bouabdallah, Reda, Choquet, Sylvain, Gurion, Ronit, Hill, Brian, Jaeger, Ulrich, Sancho, Juan Manuel, Schuster, Michael, Thieblemont, Catherine, De la Cruz, Fátima, Egyed, Miklos, Mishra, Sourav, Offner, Fritz, Vassilakopoulos, Theodoros P, Warzocha, Krzysztof, McCarthy, Daniel, Ma, Xiwen, Corona, Kelly, Saint-Martin, Jean-Richard, Chang, Hua, Landesman, Yosef, Joshi, Anita, Wang, Hongwei, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Van Den Neste, Eric, and Canales, Miguel A

Published
2020
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29. Predicting PD-L1 Status in Solid Tumors Using Transcriptomic Data and Artificial Intelligence Algorithms

Author

Charifa, Ahmad, primary, Lam, Alfonso, additional, Zhang, Hong, additional, Ip, Andrew, additional, Pecora, Andrew, additional, Waintraub, Stanley, additional, Graham, Deena, additional, McNamara, Donna, additional, Gutierrez, Martin, additional, Jennis, Andrew, additional, Sharma, Ipsa, additional, Estella, Jeffrey, additional, Ma, Wanlong, additional, Goy, Andre, additional, and Albitar, Maher, additional

Published
2023
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31. Hydroxychloroquine in the treatment of outpatients with mildly symptomatic COVID-19: a multi-center observational study

Author

Ip, Andrew, Ahn, Jaeil, Zhou, Yizhao, Goy, Andre H., Hansen, Eric, Pecora, Andrew L., Sinclaire, Brittany A., Bednarz, Urszula, Marafelias, Michael, Sawczuk, Ihor S., Underwood, III, Joseph P., Walker, David M., Prasad, Rajiv, Sweeney, Robert L., Ponce, Marie G., La Capra, Samuel, Cunningham, Frank J., Calise, Arthur G., Pulver, Bradley L., Ruocco, Dominic, Mojares, Greggory E., Eagan, Michael P., Ziontz, Kristy L., Mastrokyriakos, Paul, and Goldberg, Stuart L.

Published
2021
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32. Survival among patients with relapsed/refractory diffuse large B cell lymphoma treated with single-agent selinexor in the SADAL study

Author

Maerevoet, Marie, Zijlstra, Josee M., Follows, George, Casasnovas, Rene-Olivier, Vermaat, J. S. P., Kalakonda, Nagesh, Goy, Andre, Choquet, Sylvain, Van Den Neste, Eric, Hill, Brian, Thieblemont, Catherine, Cavallo, Federica, De la Cruz, Fatima, Kuruvilla, John, Hamad, Nada, Jaeger, Ulrich, Caimi, Paolo, Gurion, Ronit, Warzocha, Krzysztof, Bakhshi, Sameer, Sancho, Juan-Manuel, Schuster, Michael, Egyed, Miklos, Offner, Fritz, Vassilakopoulos, Theodoros P., Samal, Priyanka, Ku, Matthew, Ma, Xiwen, Corona, Kelly, Chamoun, Kamal, Shah, Jatin, Shacham, Sharon, Kauffman, Michael G., and Canales, Miguel

Published
2021
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33. Durable response with single-agent acalabrutinib in patients with relapsed or refractory mantle cell lymphoma

Author

Wang, Michael, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Casasnovas, Olivier, Smith, Stephen D., Damaj, Gandhi, Doorduijn, Jeanette K., Lamy, Thierry, Morschhauser, Franck, Panizo, Carlos, Shah, Bijal, Davies, Andrew, Eek, Richard, Dupuis, Jehan, Jacobsen, Eric, Kater, Arnon P., Le Gouill, Steven, Oberic, Lucie, Robak, Tadeusz, Jain, Preetesh, Frigault, Melanie M., Izumi, Raquel, Nguyen, Dorothy, Patel, Priti, Yin, Ming, and Długosz-Danecka, Monika

Published
2019
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37. A phase II study of interrupted and continuous dose lenalidomide in relapsed/refractory Hodgkin lymphoma

Author

Fehniger, Todd A., primary, Watkins, Marcus P., additional, Ezenwajiaku, Nkiruka, additional, Wan, Fei, additional, Hurd, David D., additional, Cashen, Amanda F., additional, Blum, Kristie A., additional, Goy, Andre, additional, Fenske, Timothy S., additional, Wagner-Johnston, Nina D., additional, Carson, Kenneth, additional, Siegel, Marilyn J., additional, Russler-Germain, David, additional, Schneider, Stephanie E., additional, Mehta-Shah, Neha, additional, Kahl, Brad, additional, and Bartlett, Nancy L., additional

Published
2023
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38. Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors

Author

Le Gouill, Steven, primary, Długosz-Danecka, Monika, additional, Rule, Simon, additional, Zinzani, Pier Luigi, additional, Goy, Andre, additional, Smith, Stephen D., additional, Doorduijn, Jeanette K., additional, Panizo, Carlos, additional, Shah, Bijal D., additional, Davies, Andrew J., additional, Eek, Richard, additional, Jacobsen, Eric, additional, Kater, Arnon P., additional, Robak, Tadeusz, additional, Jain, Preetesh, additional, Calvo, Roser, additional, Tao, Lin, additional, and Wang, Michael, additional

Published
2023
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40. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial

Author

Wang, Michael, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Casasnovas, Olivier, Smith, Stephen D, Damaj, Gandhi, Doorduijn, Jeanette, Lamy, Thierry, Morschhauser, Franck, Panizo, Carlos, Shah, Bijal, Davies, Andrew, Eek, Richard, Dupuis, Jehan, Jacobsen, Eric, Kater, Arnon P, Le Gouill, Steven, Oberic, Lucie, Robak, Taduesz, Covey, Todd, Dua, Richa, Hamdy, Ahmed, Huang, Xin, Izumi, Raquel, Patel, Priti, Rothbaum, Wayne, Slatter, J Greg, and Jurczak, Wojciech

Published
2018
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41. Data from A Phase I Study of Pelabresib (CPI-0610), a Small-Molecule Inhibitor of BET Proteins, in Patients with Relapsed or Refractory Lymphoma

Author

Blum, Kristie A., primary, Supko, Jeffrey G., primary, Maris, Michael B., primary, Flinn, Ian W., primary, Goy, Andre, primary, Younes, Anas, primary, Bobba, Suresh, primary, Senderowicz, Adrian M., primary, Efuni, Sergey, primary, Rippley, Ronda, primary, Colak, Gozde, primary, Trojer, Patrick, primary, and Abramson, Jeremy S., primary

Published
2023
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43. Figure S2 from A Phase I Study of Pelabresib (CPI-0610), a Small-Molecule Inhibitor of BET Proteins, in Patients with Relapsed or Refractory Lymphoma

Author

Blum, Kristie A., primary, Supko, Jeffrey G., primary, Maris, Michael B., primary, Flinn, Ian W., primary, Goy, Andre, primary, Younes, Anas, primary, Bobba, Suresh, primary, Senderowicz, Adrian M., primary, Efuni, Sergey, primary, Rippley, Ronda, primary, Colak, Gozde, primary, Trojer, Patrick, primary, and Abramson, Jeremy S., primary

Published
2023
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44. Supplementary Data from A Phase I Study of Pelabresib (CPI-0610), a Small-Molecule Inhibitor of BET Proteins, in Patients with Relapsed or Refractory Lymphoma

Author

Blum, Kristie A., primary, Supko, Jeffrey G., primary, Maris, Michael B., primary, Flinn, Ian W., primary, Goy, Andre, primary, Younes, Anas, primary, Bobba, Suresh, primary, Senderowicz, Adrian M., primary, Efuni, Sergey, primary, Rippley, Ronda, primary, Colak, Gozde, primary, Trojer, Patrick, primary, and Abramson, Jeremy S., primary

Published
2023
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45. Abstract 4337: Predicting PD-L1 status in solid tumors using transcriptomic data and artificial intelligence algorithms

Author

Charifa, Ahmad, primary, Lam, Alfonso, additional, Zhang, Hong, additional, Ip, Andrew, additional, Pecora, Andrew, additional, Waintraub, Stanley, additional, Graham, Deena, additional, McNamara, Donna, additional, Gutierrez, Martin, additional, Jennis, Andrew, additional, Sharma, Ipsa, additional, Estella, Jeffrey, additional, Ma, Wanlong, additional, Goy, Andre, additional, and Albitar, Maher, additional

Published
2023
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48. Allele-specific DNA methylation is increased in cancers and its dense mapping in normal plus neoplastic cells increases the yield of disease-associated regulatory SNPs

Author

Do, Catherine, Dumont, Emmanuel L. P., Salas, Martha, Castano, Angelica, Mujahed, Huthayfa, Maldonado, Leonel, Singh, Arunjot, DaSilva-Arnold, Sonia C., Bhagat, Govind, Lehman, Soren, Christiano, Angela M., Madhavan, Subha, Nagy, Peter L., Green, Peter H. R., Feinman, Rena, Trimble, Cornelia, Illsley, Nicholas P., Marder, Karen, Honig, Lawrence, Monk, Catherine, Goy, Andre, Chow, Kar, Goldlust, Samuel, Kaptain, George, Siegel, David, and Tycko, Benjamin

Published
2020
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49. Phase 1b dose-finding study of rituximab, lenalidomide, and ibrutinib (R2I) in patients with relapsed/refractory mantle cell lymphoma.

Author

Ip, Andrew, Petrillo, Alessandra, Pia, Alexandra Della, Lee, Geeny G., Gill, Sarvarinder, Varughese, Tony, Zenreich, Joshua, Gutierrez, Martin, Zhang, Jiayu, Ahn, Jaeil, Bharani, Vishnu, Nejad, Ava S., Pascual, Lauren, Feldman, Tatyana A., Leslie, Lori A., and Goy, Andre H.

Subjects
LENALIDOMIDE, RITUXIMAB, NON-Hodgkin's lymphoma, EXANTHEMA
Abstract

Mantle cell lymphoma (MCL) is a rare non-Hodgkin lymphoma that frequently becomes chemoresistant over time. The distinct mechanisms of ibrutinib and lenalidomide provided a judicious rationale to explore the combination with anti-CD20 immunotherapy. In this phase 1b study (NCT02446236), patients (n=25) with relapsed/refractory MCL received rituximab with escalating doses of lenalidomide (days 1–21) and ibrutinib 560mg (days 1–28) of 28-day cycles. The MTD for lenalidomide was 20mg; most common grade ≥3 adverse events were skin rashes (32%) and neutropenic fever (24%). The best ORR was 88%, CR rate was 83%, and median duration of response (DOR) was 36.92months (95% CI 33.77, 51.37). Responses were seen even in refractory patients or with high-risk features (e.g. blastoid variant, TP53 mutation, Ki-67>30%). R2I was safe and tolerable in patients with R/R MCL. [ABSTRACT FROM AUTHOR]

Published
2023
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50. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience

Author

Mato, Anthony R., Nabhan, Chadi, Barr, Paul M., Ujjani, Chaitra S., Hill, Brian T., Lamanna, Nicole, Skarbnik, Alan P., Howlett, Christina, Pu, Jeffrey J., Sehgal, Alison R., Strelec, Lauren E., Vandegrift, Alexandra, Fitzpatrick, Danielle M., Zent, Clive S., Feldman, Tatyana, Goy, Andre, Claxton, David F., Bachow, Spencer Henick, Kaur, Gurbakhash, Svoboda, Jakub, Nasta, Sunita Dwivedy, Porter, David, Landsburg, Daniel J., Schuster, Stephen J., Cheson, Bruce D., Kiselev, Pavel, and Evens, Andrew M.

Published
2016
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