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1. 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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2. Volumetric response quantified using T1 subtraction predicts long-term survival benefit from cabozantinib monotherapy in recurrent glioblastoma

Author

Ellingson, Benjamin M, Aftab, Dana T, Schwab, Gisela M, Hessel, Colin, Harris, Robert J, Woodworth, Davis C, Leu, Kevin, Chakhoyan, Ararat, Raymond, Catalina, Drappatz, Jan, de Groot, John, Prados, Michael D, Reardon, David A, Schiff, David, Chamberlain, Marc, Mikkelsen, Tom, Desjardins, Annick, Holland, Jaymes, Ping, Jerry, Weitzman, Ron, Wen, Patrick Y, and Cloughesy, Timothy F

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Rare Diseases, Biomedical Imaging, Orphan Drug, Clinical Trials and Supportive Activities, Neurosciences, Clinical Research, Brain Disorders, Brain Cancer, 6.1 Pharmaceuticals, Adult, Aged, Anilides, Brain Neoplasms, Contrast Media, Female, Follow-Up Studies, Glioblastoma, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Protein Kinase Inhibitors, Pyridines, Retrospective Studies, Survival Rate, Tumor Burden, Young Adult, cabozantinib, GBM, XL184, recurrent glioblastoma, T1 subtraction, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundTo overcome challenges with traditional response assessment in anti-angiogenic agents, the current study uses T1 subtraction maps to quantify volumetric radiographic response in monotherapy with cabozantinib, an orally bioavailable tyrosine kinase inhibitor with activity against vascular endothelial growth factor receptor 2 (VEGFR2), hepatocyte growth factor receptor (MET), and AXL, in an open-label, phase II trial in patients with recurrent glioblastoma (GBM) (NCT00704288).MethodsA total of 108 patients with adequate imaging data and confirmed recurrent GBM were included in this retrospective study from a phase II multicenter trial of cabozantinib monotherapy (XL184-201) at either 100 mg (N = 87) or 140 mg (N = 21) per day. Contrast enhanced T1-weighted digital subtraction maps were used to define volume of contrast-enhancing tumor at baseline and subsequent follow-up time points. Volumetric radiographic response (>65% reduction in contrast-enhancing tumor volume from pretreatment baseline tumor volume sustained for more than 4 wk) was tested as an independent predictor of overall survival (OS).ResultsVolumetric response rate for all therapeutic doses was 38.9% (41.4% and 28.6% for 100 mg and 140 mg doses, respectively). A log-linear association between baseline tumor volume and OS (P = 0.0006) and a linear correlation between initial change in tumor volume and OS (P = 0.0256) were observed. A significant difference in OS was observed between responders (median OS = 20.6 mo) and nonresponders (median OS = 8.0 mo) (hazard ratio [HR] = 0.3050, P < 0.0001). Multivariable analyses showed that continuous measures of baseline tumor volume (HR = 1.0233, P < 0.0001) and volumetric response (HR = 0.2240, P < 0.0001) were independent predictors of OS.ConclusionsT1 subtraction maps provide value in determining response in recurrent GBM treated with cabozantinib and correlated with survival benefit.

Published
2018

3. Phase II study of cabozantinib in patients with progressive glioblastoma: subset analysis of patients with prior antiangiogenic therapy

Author

Cloughesy, Timothy F, Drappatz, Jan, de Groot, John, Prados, Michael D, Reardon, David A, Schiff, David, Chamberlain, Marc, Mikkelsen, Tom, Desjardins, Annick, Ping, Jerry, Holland, Jaymes, Weitzman, Ron, and Wen, Patrick Y

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Brain Disorders, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Rare Diseases, Brain Cancer, Neurosciences, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Adult, Aged, Angiogenesis Inhibitors, Anilides, Data Analysis, Disease-Free Survival, Female, Glioblastoma, Humans, Male, Middle Aged, Pyridines, Treatment Outcome, antiangiogenic, cabozantinib, pretreated, progressive glioblastoma, recurrent, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundCabozantinib is a potent, multitarget inhibitor of MET and vascular endothelial growth factor receptor 2 (VEGFR2). This open-label, phase II trial evaluated cabozantinib in patients with recurrent or progressive glioblastoma (GBM).MethodsPatients were initially enrolled to a starting cabozantinib dose of 140 mg/day, but the starting dose was amended to 100 mg/day because of safety concerns. Treatment continued until disease progression or unacceptable toxicity. The primary endpoint was objective response rate, assessed by an independent radiology facility using modified Response Assessment in Neuro-Oncology criteria. Additional endpoints included duration of response, 6-month and median progression-free survival, overall survival, glucocorticoid use, and safety.ResultsAmong 222 patients enrolled, 70 had received prior antiangiogenic therapy. Herein, we report results in this subset of 70 patients. The objective response rate was 4.3%, and the median duration of response was 4.2 months. The proportion of patients alive and progression free at 6 months was 8.5%. Median progression-free survival was 2.3 months, and median overall survival was 4.6 months. The most common adverse events reported in all patients, regardless of dose group, included fatigue (74.3%), diarrhea (47.1%), increased alanine aminotransferase (37.1%), headache (35.7%), hypertension (35.7%), and nausea (35.7%); overall, 34 (48.6%) patients experienced adverse events that resulted in dose reductions.ConclusionsCabozantinib treatment appeared to have modest clinical activity with a 4.3% response rate in patients who had received prior antiangiogenic therapy for GBM.Clinical trials registration numberNCT00704288 (https://www.clinicaltrials.gov/ct2/show/NCT00704288).

Published
2018

4. Phase II study of cabozantinib in patients with progressive glioblastoma: subset analysis of patients naive to antiangiogenic therapy

Author

Wen, Patrick Y, Drappatz, Jan, de Groot, John, Prados, Michael D, Reardon, David A, Schiff, David, Chamberlain, Marc, Mikkelsen, Tom, Desjardins, Annick, Holland, Jaymes, Ping, Jerry, Weitzman, Ron, and Cloughesy, Timothy F

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Rare Diseases, Neurosciences, Clinical Research, Brain Disorders, Brain Cancer, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Adult, Aged, Angiogenesis Inhibitors, Anilides, Data Analysis, Disease-Free Survival, Female, Glioblastoma, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Protein Kinase Inhibitors, Pyridines, Treatment Outcome, antiangiogenic, cabozantinib, naive, progressive glioblastoma, recurrent, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundCabozantinib is a tyrosine kinase inhibitor with activity against vascular endothelial growth factor receptor 2 (VEGFR2) and MET that has demonstrated clinical activity in advanced solid tumors. This open-label, phase II trial evaluated cabozantinib in patients with recurrent or refractory glioblastoma (GBM).MethodsPatients were initially enrolled at a starting dose of 140 mg/day, but the starting dose was amended to 100 mg/day because of toxicity. Treatment continued until disease progression or unacceptable toxicity. The primary endpoint was objective response rate assessed by an independent radiology facility using modified Response Assessment in Neuro-Oncology criteria. Additional endpoints included duration of response, 6-month and median progression-free survival, overall survival, and safety.ResultsAmong 152 patients naive to prior antiangiogenic therapy, the objective response rate was 17.6% and 14.5% in the 140 mg/day and 100 mg/day groups, respectively, which did not meet the predefined statistical target for success. The proportions of patients alive and progression free at 6 months were 22.3% and 27.8%, respectively. Median progression-free survival was 3.7 months in both groups, and median overall survival was 7.7 months and 10.4 months, respectively. The incidence of grade 3/4 adverse events (AEs) was 79.4% and 84.7% in the 140 mg/day and 100 mg/day groups, respectively, and dose reductions due to AEs were experienced by 61.8% and 72.0%, respectively. Common grade 3/4 AEs included fatigue, diarrhea, and palmar-plantar erythrodysesthesia syndrome.ConclusionsCabozantinib showed evidence of clinical activity in patients with recurrent GBM naive to antiangiogenic therapy, although the predefined statistical target for success was not met. At the starting doses assessed, AEs were frequently managed with dose reductions.Clinical trials registration numberNCT00704288 (https://www.clinicaltrials.gov/ct2/show/NCT00704288).

Published
2018

6. Plain Language Summary of the iNNOVATE study: ibrutinib plus rituximab is well-tolerated and effective in people with Waldenström's macroglobulinemia

Author

Pharmacyclics, AbbVie Pharmaceuticals, Buske, Christian, Tedeschi, Alessandra, Trotman, Judith, García-Sanz, Ramón, MacDonald, David, Leblond, Véronique, Mahe, Beatrice, Herbaux, Charles, Matous, Jeffrey V., Heffner, Leonard T., Varettoni, Marzia, Palomba, M. Lia, Shustik, Chaim, Kastritis, Efstathios, Treon, Steven P., Ping, Jerry, Hauns, Bernhard, Arango-Hisijara, Israel, Pharmacyclics, AbbVie Pharmaceuticals, Buske, Christian, Tedeschi, Alessandra, Trotman, Judith, García-Sanz, Ramón, MacDonald, David, Leblond, Véronique, Mahe, Beatrice, Herbaux, Charles, Matous, Jeffrey V., Heffner, Leonard T., Varettoni, Marzia, Palomba, M. Lia, Shustik, Chaim, Kastritis, Efstathios, Treon, Steven P., Ping, Jerry, Hauns, Bernhard, and Arango-Hisijara, Israel

Abstract

This article provides a short summary of 5-year results from the iNNOVATE trial. The original paper was published in the Journal of Clinical Oncology in October 2021. People with Waldenström's macroglobulinemia (WM) were randomly divided into two groups of 75 people each. One group received a combination treatment composed of two drugs, ibrutinib plus rituximab, and the other group took placebo (“sugar pill”) plus rituximab. Ibrutinib (also known by the brand name Imbruvica®) is a drug that reduces cancer cells' ability to multiply and survive. Ibrutinib is an FDA-approved drug for the treatment of WM. Rituximab is a drug that helps the immune system find and kill cancer cells. Participants in the trial were treated and their health monitored for up to 5 years (63 months).

Published
2023

7. Plain Language Summary of the iNNOVATE study: ibrutinib plus rituximab is well-tolerated and effective in people with Waldenström's macroglobulinemia

Author

Buske, Christian, primary, Tedeschi, Alessandra, additional, Trotman, Judith, additional, García-Sanz, Ramón, additional, MacDonald, David, additional, Leblond, Veronique, additional, Mahe, Beatrice, additional, Herbaux, Charles, additional, Matous, Jeffrey V, additional, Tam, Constantine S, additional, Heffner, Leonard T, additional, Varettoni, Marzia, additional, Palomba, M Lia, additional, Shustik, Chaim, additional, Kastritis, Efstathios, additional, Treon, Steven P, additional, Ping, Jerry, additional, Hauns, Bernhard, additional, Arango-Hisijara, Israel, additional, and Dimopoulos, Meletios A, additional

Published
2023
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8. Supplementary files of the article Ibrutinib Plus Rituximab Versus Placebo Plus Rituximab for Waldenström’s Macroglobulinemia: Final Analysis From the Randomized Phase III iNNOVATE Study [Dataset]

Author

Buske, Christian, Tedeschi, Alessandra, Trotman, Judith, García-Sanz, Ramón, MacDonald, David, Leblond, Véronique, Mahe, Beatrice, Herbaux, Charles, Matous, Jeffrey V., Tam, Constantine S., Heffner, Leonard T., Varettoni, Marzia, Palomba, M. Lia, Shustik, Chaim, Kastritis, Efstathios, Treon, Steven P., Ping, Jerry, Hauns, Bernhard, Arango-Hisijara, Israel, Dimopoulos, Meletios A., Buske, Christian, Tedeschi, Alessandra, Trotman, Judith, García-Sanz, Ramón, MacDonald, David, Leblond, Véronique, Mahe, Beatrice, Herbaux, Charles, Matous, Jeffrey V., Tam, Constantine S., Heffner, Leonard T., Varettoni, Marzia, Palomba, M. Lia, Shustik, Chaim, Kastritis, Efstathios, Treon, Steven P., Ping, Jerry, Hauns, Bernhard, Arango-Hisijara, Israel, and Dimopoulos, Meletios A.

Published
2022

9. Ibrutinib Plus Rituximab Versus Placebo Plus Rituximab for Waldenström’s Macroglobulinemia: Final Analysis From the Randomized Phase III iNNOVATE Study

Author

Pharmacyclics, AbbVie Pharmaceuticals, Buske, Christian, Tedeschi, Alessandra, Trotman, Judith, García-Sanz, Ramón, MacDonald, David, Leblond, Véronique, Mahe, Beatrice, Herbaux, Charles, Matous, Jeffrey V., Tam, Constantine S., Heffner, Leonard T., Varettoni, Marzia, Palomba, M. Lia, Shustik, Chaim, Kastritis, Efstathios, Treon, Steven P., Ping, Jerry, Hauns, Bernhard, Arango-Hisijara, Israel, Dimopoulos, Meletios A., Pharmacyclics, AbbVie Pharmaceuticals, Buske, Christian, Tedeschi, Alessandra, Trotman, Judith, García-Sanz, Ramón, MacDonald, David, Leblond, Véronique, Mahe, Beatrice, Herbaux, Charles, Matous, Jeffrey V., Tam, Constantine S., Heffner, Leonard T., Varettoni, Marzia, Palomba, M. Lia, Shustik, Chaim, Kastritis, Efstathios, Treon, Steven P., Ping, Jerry, Hauns, Bernhard, Arango-Hisijara, Israel, and Dimopoulos, Meletios A.

Abstract

[Purpose]: The double-blind, randomized, placebo-controlled phase III iNNOVATE study showed sustained efficacy of ibrutinib-rituximab in Waldenström's macroglobulinemia (WM). Here, we present the final analysis from iNNOVATE. [Methods]: Patients had confirmed symptomatic WM, either previously untreated or previously treated; patients with prior rituximab had at least a minor response to their last rituximab-based regimen. Patients were randomly assigned to once-daily ibrutinib 420 mg plus rituximab or placebo plus rituximab (n = 75 per arm). The primary end point was progression-free survival (PFS). Secondary end points included response rate, time to next treatment, hemoglobin improvement, overall survival, and safety. [Results]: With a median follow-up of 50 (range, 0.5-63) months, median (95% CI) PFS was not reached (57.7 months to not evaluable) with ibrutinib-rituximab versus 20.3 months (13.0 to 27.6) with placebo-rituximab (hazard ratio, 0.250; P < .0001). PFS benefit was regardless of prior treatment status, MYD88 and CXCR4 mutation status, or key patient characteristics. Higher response rates (partial response or better) were observed with ibrutinib-rituximab (76% v 31% with placebo-rituximab; P < .0001) and were sustained over time. Median time to next treatment was not reached with ibrutinib-rituximab versus 18 months with placebo-rituximab. More patients receiving ibrutinib-rituximab versus placebo-rituximab had sustained hemoglobin improvement (77% v 43%; P < .0001). Median overall survival was not reached in either arm. Ibrutinib-rituximab maintained a manageable safety profile; the prevalence of grade ≥ 3 adverse events of clinical interest generally decreased over time. [Conclusion]: In the final analysis of iNNOVATE with a median follow-up of 50 months, ibrutinib-rituximab showed ongoing superiority across clinical outcomes in patients with WM regardless of MYD88 or CXCR4 mutation status, prior treatment, and key patient characteristics.

Published
2022

10. Ibrutinib Plus Rituximab Versus Placebo Plus Rituximab for Waldenström's Macroglobulinemia: Final Analysis From the Randomized Phase III iNNOVATE Study

Author

Buske, Christian, primary, Tedeschi, Alessandra, additional, Trotman, Judith, additional, García-Sanz, Ramón, additional, MacDonald, David, additional, Leblond, Veronique, additional, Mahe, Beatrice, additional, Herbaux, Charles, additional, Matous, Jeffrey V., additional, Tam, Constantine S., additional, Heffner, Leonard T., additional, Varettoni, Marzia, additional, Palomba, M. Lia, additional, Shustik, Chaim, additional, Kastritis, Efstathios, additional, Treon, Steven P., additional, Ping, Jerry, additional, Hauns, Bernhard, additional, Arango-Hisijara, Israel, additional, and Dimopoulos, Meletios A., additional

Published
2022
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11. Five-Year Follow-Up of Ibrutinib Plus Rituximab Vs Placebo Plus Rituximab for Waldenstrom's Macroglobulinemia: Final Analysis From the Randomized Phase 3 iNNOVATETM Study

Author

Buske, Christian, Tedeschi, Alessandra, Trotman, Judith, García-Sanz, Ramón, MacDonald, David, Leblond, Veronique, Mahé, Béatrice, Herbaux, Charles, Matous, Jeffrey V., Tam, Constantine S., Heffner, Leonard T., Varettoni, Marzia, Palomba, M. Lia, Shustik, Chaim, Kastritis, Efstathios, Treon, Steven P., Ping, Jerry, Hauns, Bernhard, Arango-Hisijara, Israel, and Dimopoulos, Meletios A

Published
2020
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12. Single-Agent Ibrutinib for Rituximab-Refractory Waldenstrom Macroglobulinemia: Final Analysis of the Substudy of the Phase III Innovate (TM) Trial

Author

Trotman, Judith Buske, Christian Tedeschi, Alessandra and Matous, Jeffrey V. MacDonald, David Tam, Constantine S. and Tournilhac, Olivier Ma, Shuo Treon, Steven P. Oriol, Albert and Ping, Jerry Briso, Eva M. Arango-Hisijara, Israel and Dimopoulos, Meletios A.

Abstract

Purpose: The first report from the open-label substudy of the phase III iNNOVATE study (PCYC-1127; NCT02165397) demonstrated that single-agent ibrutinib was efficacious and well tolerated in patients with heavily pretreated, rituximab-refractory Waldenstrom macroglobulinemia. Results from the final analysis are now reported. Patients and Methods: Ibrutinib 420 mg was administered once daily to patients (N = 31) who failed to achieve at least a minor response (MR) or who relapsed = partial response) rates increasing from 61% at 6 months to 77% at 60 months. Median OS was not reached. Seventeen of 21 patients (81%) with baseline hemoglobin

Published
2021

13. Single-Agent Ibrutinib for Rituximab-Refractory Waldenström Macroglobulinemia: Final Analysis of the Substudy of the Phase III InnovateTM Trial

Author

Trotman, Judith, primary, Buske, Christian, additional, Tedeschi, Alessandra, additional, Matous, Jeffrey V., additional, MacDonald, David, additional, Tam, Constantine S., additional, Tournilhac, Olivier, additional, Ma, Shuo, additional, Treon, Steven P., additional, Oriol, Albert, additional, Ping, Jerry, additional, Briso, Eva M., additional, Arango-Hisijara, Israel, additional, and Dimopoulos, Meletios A., additional

Published
2021
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14. Phase 1b/2 study of ibrutinib and lenalidomide with dose-adjusted EPOCH-R in patients with relapsed/refractory diffuse large B-cell lymphoma*

Author

Wilson, Wyndham H., primary, Phillips, Tycel, additional, Popplewell, Leslie, additional, de Vos, Sven, additional, Chhabra, Saurabh, additional, Kimball, Amy S., additional, Beaupre, Darrin, additional, Huang, Da Wei, additional, Wright, George, additional, Kwei, Kevin, additional, Ping, Jerry, additional, Neuenburg, Jutta K., additional, and Staudt, Louis M., additional

Published
2021
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15. Long-Term Follow-up of Ibrutinib Treatment for Rituximab-Refractory Waldenström's Macroglobulinemia: Final Analysis of the Open-Label Substudy of the Phase 3 iNNOVATETM Trial

Author

Trotman, Judith, primary, Buske, Christian, additional, Tedeschi, Alessandra, additional, Matous, Jeffrey V., additional, MacDonald, David, additional, Tam, Constantine, additional, Tournilhac, Olivier, additional, Ma, Shuo, additional, Treon, Steven P., additional, Oriol, Albert, additional, Ping, Jerry, additional, Briso, Eva M., additional, Arango-Hisijara, Israel, additional, and Dimopoulos, Meletios A., additional

Published
2020
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16. The combination of ibrutinib and rituximab demonstrates activity in first‐line follicular lymphoma

Author

Fowler, Nathan H., primary, Nastoupil, Loretta, additional, De Vos, Sven, additional, Knapp, Mark, additional, Flinn, Ian W., additional, Chen, Robert, additional, Advani, Ranjana H., additional, Bhatia, Sumeet, additional, Martin, Peter, additional, Mena, Raul, additional, Davis, Richard Eric, additional, Neelapu, Sattva S., additional, Eckert, Karl, additional, Ping, Jerry, additional, Co, Melannie, additional, Beaupre, Darrin M., additional, Neuenburg, Jutta K., additional, and Palomba, M. Lia, additional

Published
2020
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17. Phase 2 Results of the iR2 Regimen (Ibrutinib, Lenalidomide, and Rituximab) in Patients with Relapsed/Refractory (R/R) Non-Germinal Center B Cell-like (Non-GCB) Diffuse Large B-Cell Lymphoma (DLBCL)

Author

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

Published
2019
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18. The iR2 Regimen(Ibrutinib, Lenalidomide, and Rituximab) Is Active with a Manageable Safety Profile in Patients with Relapsed/Refractory Non-Germinal Center-like Diffuse Large B-Cell Lymphoma

Author

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

Published
2018
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19. Phase II study of cabozantinib in patients with progressive glioblastoma: subset analysis of patients with prior antiangiogenic therapy

Author

Cloughesy, Timothy F, primary, Drappatz, Jan, additional, de Groot, John, additional, Prados, Michael D, additional, Reardon, David A, additional, Schiff, David, additional, Chamberlain, Marc, additional, Mikkelsen, Tom, additional, Desjardins, Annick, additional, Ping, Jerry, additional, Holland, Jaymes, additional, Weitzman, Ron, additional, and Wen, Patrick Y, additional

Published
2017
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20. Phase II study of cabozantinib in patients with progressive glioblastoma: subset analysis of patients naive to antiangiogenic therapy

Author

Wen, Patrick Y, primary, Drappatz, Jan, additional, de Groot, John, additional, Prados, Michael D, additional, Reardon, David A, additional, Schiff, David, additional, Chamberlain, Marc, additional, Mikkelsen, Tom, additional, Desjardins, Annick, additional, Holland, Jaymes, additional, Ping, Jerry, additional, Weitzman, Ron, additional, and Cloughesy, Timothy F, additional

Published
2017
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21. A Multicenter Open-Label, Phase 1b/2 Study of Ibrutinib in Combination with Lenalidomide and Rituximab in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

Author

Goy, Andre, primary, Ramchandren, Radhakrishnan, additional, Ghosh, Nilanjan, additional, Munoz, Javier, additional, Morgan, David S., additional, Dang, Nam H., additional, Knapp, Mark, additional, Delioukina, Maria, additional, Kingsley, Edwin C., additional, Tran, Anh, additional, Ping, Jerry, additional, Beaupre, Darrin M., additional, Neuenburg, Jutta K., additional, and Ruan, Jia, additional

Published
2016
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24. Phase 3 randomized, double-blind, controlled study of cabozantinib (XL184) versus placebo in subjects with hepatocellular carcinoma who have received prior sorafenib (CELESTIAL; NCT01908426).

Author

Abou-Alfa, Ghassan K., primary, Cheng, Ann-Lii, additional, Meyer, Tim, additional, El-Khoueiry, Anthony B., additional, Ikeda, Masafumi, additional, Chun, Hoo Geun, additional, Furuse, Junji, additional, Knox, Jennifer J., additional, Okusaka, Takuji, additional, Ping, Jerry, additional, Borgman-Hagey, Anne E., additional, and Kelley, Robin Kate, additional

Published
2015
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25. Phase 3 randomized, double-blind, controlled study of cabozantinib (XL184) versus placebo in subjects with hepatocellular carcinoma who have received prior sorafenib (CELESTIAL; NCT01908426).

Author

Abou-Alfa, Ghassan K., primary, Cheng, Ann-Lii, additional, Meyer, Tim, additional, El-Khoueiry, Anthony B., additional, Ikeda, Masafumi, additional, Chun, Hoo Geun, additional, Faivre, Sandrine J., additional, Furuse, Junji, additional, Knox, Jennifer J., additional, Okusaka, Takuji, additional, Ping, Jerry, additional, Borgman-Hagey, Anne E., additional, and Kelley, Robin Kate, additional

Published
2014
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26. Phase 2 Results of the iR2Regimen (Ibrutinib, Lenalidomide, and Rituximab) in Patients with Relapsed/Refractory (R/R) Non-Germinal Center B Cell-like (Non-GCB) Diffuse Large B-Cell Lymphoma (DLBCL)

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, Kwei, Kevin, Eckert, Karl, Neuenburg, Jutta K., and Goy, Andre

Abstract

Background:DLBCL is an aggressive non-Hodgkin lymphoma (NHL) with poor outcomes in the R/R setting; overall survival (OS) is 28% at 1 year and 20% at 2 years in refractory patients (Crump, Blood2017). Outcomes are particularly poor for patients ineligible for stem cell transplant (SCT). Ibrutinib is the only once-daily inhibitor of Bruton's tyrosine kinase and is approved for the treatment of various B-cell malignancies. Based on preclinical models, ibrutinib and lenalidomide, an immunomodulator that downregulates the MYD88 pathway, may synergize when combined (Yang, Cancer Cell2012). Rituximab, an anti-CD20 antibody, has shown activity combined with ibrutinib in NHL (Wang, Lancet Onc2016). PCYC-1123 is a multicenter, open-label phase 1b/2 study (NCT02077166) evaluating the combination of ibrutinib, lenalidomide, and rituximab (iR2) in R/R DLBCL.

Published
2019
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27. The iR2Regimen(Ibrutinib, Lenalidomide, and Rituximab) Is Active with a Manageable Safety Profile in Patients with Relapsed/Refractory Non-Germinal Center-like Diffuse Large B-Cell Lymphoma

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, Co, Melannie, Neuenburg, Jutta K., and Goy, Andre

Abstract

Background:Patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) typically have poor treatment outcomes, especially patients who are ineligible for stem cell transplantation (SCT). Ibrutinib, a first-in-class, once-daily inhibitor of Bruton's tyrosine kinase, is approved in the US for various B-cell malignancies. Preclinical data suggest potential synergy when combining ibrutinib with lenalidomide, a thalidomide analogue that disrupts signaling downstream of B-cell receptor and MYD88. An open-label, multicenter, phase 1b/2 study (NCT02077166) was initiated to evaluate the iR2regimen of ibrutinib, lenalidomide, and rituximab in R/R DLBCL. Results from the ongoing phase 2 portion of the study evaluating the safety and activity of the iR2regimen in SCT-ineligible adults aged ≥18 y with R/R non-germinal center B-cell-like (non-GCB) DLBCL per Hans method are presented here.

Published
2018
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