First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma
Standard 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. After surgery and chemoradiotherapy, patients wer...
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| Published in | Journal of translational medicine Vol. 16; no. 1; pp. 142 - 9 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
BioMed Central Ltd
29.05.2018
BioMed Central BMC |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1479-5876 1479-5876 |
| DOI | 10.1186/s12967-018-1507-6 |
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| Abstract | Standard 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.
After 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).
For 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.
Addition 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. |
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| AbstractList | Background Standard 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. Methods After 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). Results For 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. Conclusions Addition 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 Standard 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.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.After 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).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).For 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.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.Addition 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.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. Standard 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. After 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). For 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. Addition 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. Background Standard 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.sup.[R]-L) to standard therapy for newly diagnosed glioblastoma. Methods After 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). Results For 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 [greater than or equai to] 30 months past their surgery date; 67 of these (30.0%) have lived [greater than or equai to] 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are [greater than or equai to] 36 months past surgery; 44 of these (24.2%) have lived [greater than or equai to] 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. Conclusions Addition 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; Keywords: Glioblastoma, Immunotherapy, Dendritic cell, Vaccine Abstract Background Standard 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. Methods After 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). Results For 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. Conclusions Addition 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 Standard 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.sup.[R]-L) to standard therapy for newly diagnosed glioblastoma. After 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). For 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 [greater than or equai to] 30 months past their surgery date; 67 of these (30.0%) have lived [greater than or equai to] 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are [greater than or equai to] 36 months past surgery; 44 of these (24.2%) have lived [greater than or equai to] 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. Addition of DCVax-L to standard therapy is feasible and safe in glioblastoma patients, and may extend survival. |
| ArticleNumber | 142 |
| Audience | Academic |
| Author | Baskin, David S. Brenner, Andrew J. Tran, David D. Duic, Paul Cobbs, Charles S. Avigan, David E. Elinzano, Heinrich Salacz, Michael Taylor, Sarah Davis, Raphael P. Dropcho, Edward J. Maida, Anthony E. Westphal, Manfred Walter, Kevin A. Campian, Jian L. Khagi, Simon Ewend, Matthew G. Thompson, Reid C. Fink, Karen L. Moshel, Yaron A. D’Andre, Stacy D. Pillainayagam, Clement P. Goldlust, Samuel A. Portnow, Jana Lacroix, Michel Meisel, Hans-Jorg Lillehei, Kevin O. Krex, Dietmar Chaudhary, Rekha Sloan, Andrew E. Liau, Linda M. Tse, Victor Pearlman, Michael Schulder, Michael Walbert, Tobias Etame, Arnold B. Pluard, Timothy J. Grewal, Jai Kim, Lyndon J. Petrecca, Kevin May, Sven-Axel Abram, Steven R. Duma, Christopher Brem, Steven Lutzky, Jose Taylor, Lynne P. Bota, Daniela A. Geoffroy, Francois J. Prins, Robert M. Loudon, William G. Iwamoto, Fabio M. Trusheim, John E. Mulholland, Paul Wu, Julian Mathieu, David New, Pamela Z. Aiken, Robert Piccioni, David Bosch, Marnix L. Heth, Jason A. Schackert, Gabriele Toms, Steven A. Mikkelsen, Tom Lindhorst, Scott V |
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Lindhorst fullname: Lindhorst, Scott – sequence: 40 givenname: Jose surname: Lutzky fullname: Lutzky, Jose – sequence: 41 givenname: Andrew E. surname: Sloan fullname: Sloan, Andrew E. – sequence: 42 givenname: Gabriele surname: Schackert fullname: Schackert, Gabriele – sequence: 43 givenname: Dietmar surname: Krex fullname: Krex, Dietmar – sequence: 44 givenname: Hans-Jorg surname: Meisel fullname: Meisel, Hans-Jorg – sequence: 45 givenname: Julian surname: Wu fullname: Wu, Julian – sequence: 46 givenname: Raphael P. surname: Davis fullname: Davis, Raphael P. – sequence: 47 givenname: Christopher surname: Duma fullname: Duma, Christopher – sequence: 48 givenname: Arnold B. surname: Etame fullname: Etame, Arnold B. – sequence: 49 givenname: David surname: Mathieu fullname: Mathieu, David – sequence: 50 givenname: Santosh surname: Kesari fullname: Kesari, Santosh – sequence: 51 givenname: David surname: Piccioni fullname: Piccioni, David – sequence: 52 givenname: Manfred surname: Westphal fullname: Westphal, Manfred – sequence: 53 givenname: David S. surname: Baskin fullname: Baskin, David S. – sequence: 54 givenname: Pamela Z. surname: New fullname: New, Pamela Z. – sequence: 55 givenname: Michel surname: Lacroix fullname: Lacroix, Michel – sequence: 56 givenname: Sven-Axel surname: May fullname: May, Sven-Axel – sequence: 57 givenname: Timothy J. surname: Pluard fullname: Pluard, Timothy J. – sequence: 58 givenname: Victor surname: Tse fullname: Tse, Victor – sequence: 59 givenname: Richard M. surname: Green fullname: Green, Richard M. – sequence: 60 givenname: John L. surname: Villano fullname: Villano, John L. – sequence: 61 givenname: Michael surname: Pearlman fullname: Pearlman, Michael – sequence: 62 givenname: Kevin surname: Petrecca fullname: Petrecca, Kevin – sequence: 63 givenname: Michael surname: Schulder fullname: Schulder, Michael – sequence: 64 givenname: Lynne P. surname: Taylor fullname: Taylor, Lynne P. – sequence: 65 givenname: Anthony E. surname: Maida fullname: Maida, Anthony E. – sequence: 66 givenname: Robert M. surname: Prins fullname: Prins, Robert M. – sequence: 67 givenname: Timothy F. surname: Cloughesy fullname: Cloughesy, Timothy F. – sequence: 68 givenname: Paul surname: Mulholland fullname: Mulholland, Paul – sequence: 69 givenname: Marnix L. orcidid: 0000-0002-8831-8456 surname: Bosch fullname: Bosch, Marnix L. |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29843811$$D View this record in MEDLINE/PubMed |
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| Snippet | Standard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an autologous tumor... Background Standard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an autologous tumor... Abstract Background Standard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an... |
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| SubjectTerms | Brain cancer Cancer therapies Cancer vaccines Chemoradiotherapy Clinical trials Dendritic cell Dendritic cells Enrollments Gene expression Genetic aspects Glioblastoma Glioblastomas Immunotherapy Medical prognosis Patients Physiological aspects Prevention Radiation therapy Surgery Temozolomide Vaccine Vaccines |
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| Title | First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma |
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