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2. Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma

Author

Liau, Linda M, Ashkan, Keyoumars, Brem, Steven, Campian, Jian L, Trusheim, John E, Iwamoto, Fabio M, Tran, David D, Ansstas, George, Cobbs, Charles S, Heth, Jason A, Salacz, Michael E, D’Andre, Stacy, Aiken, Robert D, Moshel, Yaron A, Nam, Joo Y, Pillainayagam, Clement P, Wagner, Stephanie A, Walter, Kevin A, Chaudhary, Rekha, Goldlust, Samuel A, Lee, Ian Y, Bota, Daniela A, Elinzano, Heinrich, Grewal, Jai, Lillehei, Kevin, Mikkelsen, Tom, Walbert, Tobias, Abram, Steven, Brenner, Andrew J, Ewend, Matthew G, Khagi, Simon, Lovick, Darren S, Portnow, Jana, Kim, Lyndon, Loudon, William G, Martinez, Nina L, Thompson, Reid C, Avigan, David E, Fink, Karen L, Geoffroy, Francois J, Giglio, Pierre, Gligich, Oleg, Krex, Dietmar, Lindhorst, Scott M, Lutzky, Jose, Meisel, Hans-Jörg, Nadji-Ohl, Minou, Sanchin, Lhagva, Sloan, Andrew, Taylor, Lynne P, Wu, Julian K, Dunbar, Erin M, Etame, Arnold B, Kesari, Santosh, Mathieu, David, Piccioni, David E, Baskin, David S, Lacroix, Michel, May, Sven-Axel, New, Pamela Z, Pluard, Timothy J, Toms, Steven A, Tse, Victor, Peak, Scott, Villano, John L, Battiste, James D, Mulholland, Paul J, Pearlman, Michael L, Petrecca, Kevin, Schulder, Michael, Prins, Robert M, Boynton, Alton L, and Bosch, Marnix L

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Prevention, Brain Disorders, Brain Cancer, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Rare Diseases, Neurosciences, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Humans, Glioblastoma, Temozolomide, Prospective Studies, Brain Neoplasms, Recurrence, Dendritic Cells, Vaccination, Public Health and Health Services, Oncology and carcinogenesis
Abstract

ImportanceGlioblastoma is the most lethal primary brain cancer. Clinical outcomes for glioblastoma remain poor, and new treatments are needed.ObjectiveTo investigate whether adding autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) to standard of care (SOC) extends survival among patients with glioblastoma.Design, setting, and participantsThis phase 3, prospective, externally controlled nonrandomized trial compared overall survival (OS) in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) treated with DCVax-L plus SOC vs contemporaneous matched external control patients treated with SOC. This international, multicenter trial was conducted at 94 sites in 4 countries from August 2007 to November 2015. Data analysis was conducted from October 2020 to September 2021.InterventionsThe active treatment was DCVax-L plus SOC temozolomide. The nGBM external control patients received SOC temozolomide and placebo; the rGBM external controls received approved rGBM therapies.Main outcomes and measuresThe primary and secondary end points compared overall survival (OS) in nGBM and rGBM, respectively, with contemporaneous matched external control populations from the control groups of other formal randomized clinical trials.ResultsA total of 331 patients were enrolled in the trial, with 232 randomized to the DCVax-L group and 99 to the placebo group. Median OS (mOS) for the 232 patients with nGBM receiving DCVax-L was 19.3 (95% CI, 17.5-21.3) months from randomization (22.4 months from surgery) vs 16.5 (95% CI, 16.0-17.5) months from randomization in control patients (HR = 0.80; 98% CI, 0.00-0.94; P = .002). Survival at 48 months from randomization was 15.7% vs 9.9%, and at 60 months, it was 13.0% vs 5.7%. For 64 patients with rGBM receiving DCVax-L, mOS was 13.2 (95% CI, 9.7-16.8) months from relapse vs 7.8 (95% CI, 7.2-8.2) months among control patients (HR, 0.58; 98% CI, 0.00-0.76; P

Published
2023

10. Introduction

Author

Wilson, John F., primary, Jones, Ian G., additional, and Toms, Steven, additional

Published
2022
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12. First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma

Author

Liau, Linda M, Ashkan, Keyoumars, Tran, David D, Campian, Jian L, Trusheim, John E, Cobbs, Charles S, Heth, Jason A, Salacz, Michael, Taylor, Sarah, D’Andre, Stacy D, Iwamoto, Fabio M, Dropcho, Edward J, Moshel, Yaron A, Walter, Kevin A, Pillainayagam, Clement P, Aiken, Robert, Chaudhary, Rekha, Goldlust, Samuel A, Bota, Daniela A, Duic, Paul, Grewal, Jai, Elinzano, Heinrich, Toms, Steven A, Lillehei, Kevin O, Mikkelsen, Tom, Walbert, Tobias, Abram, Steven R, Brenner, Andrew J, Brem, Steven, Ewend, Matthew G, Khagi, Simon, Portnow, Jana, Kim, Lyndon J, Loudon, William G, Thompson, Reid C, Avigan, David E, Fink, Karen L, Geoffroy, Francois J, Lindhorst, Scott, Lutzky, Jose, Sloan, Andrew E, Schackert, Gabriele, Krex, Dietmar, Meisel, Hans-Jorg, Wu, Julian, Davis, Raphael P, Duma, Christopher, Etame, Arnold B, Mathieu, David, Kesari, Santosh, Piccioni, David, Westphal, Manfred, Baskin, David S, New, Pamela Z, Lacroix, Michel, May, Sven-Axel, Pluard, Timothy J, Tse, Victor, Green, Richard M, Villano, John L, Pearlman, Michael, Petrecca, Kevin, Schulder, Michael, Taylor, Lynne P, Maida, Anthony E, Prins, Robert M, Cloughesy, Timothy F, Mulholland, Paul, and Bosch, Marnix L

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Brain Cancer, Neurosciences, Immunization, Clinical Research, Cancer, Brain Disorders, Rare Diseases, Patient Safety, Prevention, Vaccine Related, Orphan Drug, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Brain Neoplasms, Cancer Vaccines, Dendritic Cells, Endpoint Determination, Female, Glioblastoma, Humans, Male, Middle Aged, Prognosis, Survival Analysis, Treatment Outcome, Young Adult, Immunotherapy, Dendritic cell, Vaccine, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundStandard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax®-L) to standard therapy for newly diagnosed glioblastoma.MethodsAfter surgery and chemoradiotherapy, patients were randomized (2:1) to receive temozolomide plus DCVax-L (n = 232) or temozolomide and placebo (n = 99). Following recurrence, all patients were allowed to receive DCVax-L, without unblinding. The primary endpoint was progression free survival (PFS); the secondary endpoint was overall survival (OS).ResultsFor the intent-to-treat (ITT) population (n = 331), median OS (mOS) was 23.1 months from surgery. Because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L. For patients with methylated MGMT (n = 131), mOS was 34.7 months from surgery, with a 3-year survival of 46.4%. As of this analysis, 223 patients are ≥ 30 months past their surgery date; 67 of these (30.0%) have lived ≥ 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are ≥ 36 months past surgery; 44 of these (24.2%) have lived ≥ 36 months and have a KM-derived mOS of 88.2 months. A population of extended survivors (n = 100) with mOS of 40.5 months, not explained by known prognostic factors, will be analyzed further. Only 2.1% of ITT patients (n = 7) had a grade 3 or 4 adverse event that was deemed at least possibly related to the vaccine. Overall adverse events with DCVax were comparable to standard therapy alone.ConclusionsAddition of DCVax-L to standard therapy is feasible and safe in glioblastoma patients, and may extend survival. Trial registration Funded by Northwest Biotherapeutics; Clinicaltrials.gov number: NCT00045968; https://clinicaltrials.gov/ct2/show/NCT00045968?term=NCT00045968&rank=1 ; initially registered 19 September 2002.

Published
2018

13. Correction to: First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma

Author

Liau, Linda M, Ashkan, Keyoumars, Tran, David D, Campian, Jian L, Trusheim, John E, Cobbs, Charles S, Heth, Jason A, Salacz, Michael, Taylor, Sarah, D’Andre, Stacy D, Iwamoto, Fabio M, Dropcho, Edward J, Moshel, Yaron A, Walter, Kevin A, Pillainayagam, Clement P, Aiken, Robert, Chaudhary, Rekha, Goldlust, Samuel A, Bota, Daniela A, Duic, Paul, Grewal, Jai, Elinzano, Heinrich, Toms, Steven A, Lillehei, Kevin O, Mikkelsen, Tom, Walbert, Tobias, Abram, Steven R, Brenner, Andrew J, Brem, Steven, Ewend, Matthew G, Khagi, Simon, Portnow, Jana, Kim, Lyndon J, Loudon, William G, Thompson, Reid C, Avigan, David E, Fink, Karen L, Geoffroy, Francois J, Lindhorst, Scott, Lutzky, Jose, Sloan, Andrew E, Schackert, Gabriele, Krex, Dietmar, Meisel, Hans-Jorg, Wu, Julian, Davis, Raphael P, Duma, Christopher, Etame, Arnold B, Mathieu, David, Kesari, Santosh, Piccioni, David, Westphal, Manfred, Baskin, David S, New, Pamela Z, Lacroix, Michel, May, Sven-Axel, Pluard, Timothy J, Tse, Victor, Green, Richard M, Villano, John L, Pearlman, Michael, Petrecca, Kevin, Schulder, Michael, Taylor, Lynne P, Maida, Anthony E, Prins, Robert M, Cloughesy, Timothy F, Mulholland, Paul, and Bosch, Marnix L

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Neurosciences, Brain Disorders, Medical and Health Sciences, Immunology, Biomedical and clinical sciences, Health sciences
Abstract

Following publication of the original article [1], the authors reported an error in the spelling of one of the author names. In this Correction the incorrect and correct author names are indicated and the author name has been updated in the original publication. The authors also reported an error in the Methods section of the original article. In this Correction the incorrect and correct versions of the affected sentence are indicated. The original article has not been updated with regards to the error in the Methods section.

Published
2018

19. Business history

Author

Wilson, John F., primary, Jones, Ian G., additional, Toms, Steven, additional, Tilba, Anna, additional, Buchnea, Emily, additional, and Wong, Nicholas, additional

Published
2022
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20. A history of business history

Author

Wilson, John F., primary, Jones, Ian G., additional, Toms, Steven, additional, Tilba, Anna, additional, Buchnea, Emily, additional, and Wong, Nicholas, additional

Published
2022
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22. Conclusions

Author

Wilson, John F., primary, Jones, Ian G., additional, Toms, Steven, additional, Tilba, Anna, additional, Buchnea, Emily, additional, and Wong, Nicholas, additional

Published
2022
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34. Cladophialophora bantiana

Author

Ozgun, Hurriyet Deniz, Jacobs, Darren L., Toms, Steven A., Turgut, Mehmet, editor, Challa, Sundaram, editor, and Akhaddar, Ali, editor

Published
2019
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39. Introduction

Author

Wilson, John F., primary, Toms, Steven, additional, and Jones, Ian, additional

Published
2021
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48. Introduction

Author

Wilson, John F., primary, Toms, Steven, additional, and Wong, Nicholas D., additional

Published
2020
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