Saturday, April 27, 2024 10:39:59 AM
The study (NCT00045968) was initially designed in 2007 as a prospective multicentric placebo-controlled randomized phase III trial. Patients with newly diagnosed glioblastoma were to be randomized in a 2:1 ratio to standard radiochemotherapy with either placebo or DCVax-L. With cross-over to the active treatment for the patients in the control arm at the time of progression being part of the study protocol, the primary endpoint had to be progression-free survival (PFS). The trial was conducted at 94 sites in 4 countries (US, Canada, UK, and Germany) and enrolled a total of 331 patients (232 patients randomized to the DCVax-L group, and 99 patients randomized to the placebo group) over a period of eight years (August 2007 until November 2015), with the vast majority of patients (n = 303, 91.5%) accrued between 2012 and 2015. An initial report on the trial in 2018 reported only on the combined overall survival (OS) data of both study arms and failed to report on PFS, the primary study endpoint.3 The argument for not publishing the primary endpoint was an ambiguous statement about an expert panel being required because of the complex determination of progression. Nonetheless, the authors concluded that the patients in this trial were living longer than expected. Now, more than four years later, a second report is available, which is surprisingly named “A Phase 3 Prospective Externally Controlled Cohort Trial”. This is a remarkable title, as the investigators have re-analyzed the OS data of the study against published external controls and present this as a prospective trial. It is obvious, however, that this is not a prospective analysis but a post hoc retrospective analysis: the investigators had seen the data, both of their own study and of the cohorts taken for comparison and then decided to go ahead with cross-trial comparisons. The authors state that the PFS endpoint became infeasible because of pseudo-progression issues, however, to the best of our knowledge in no other study that issue has resulted in abandoning the primary endpoint. Fortunately, the numerical PFS data are now presented: the median PFS was 6.2 (95% confidence interval CI 5.7–7.4) months for patients receiving DCVax-L and 7.6 (95% CI 5.6–10.9) months for the placebo group and not statistically significantly different (P = .47). Thus, the clinical trial did not reach its prospectively defined primary endpoint and with that, the investigators de facto declare the randomized trial in its original and prospective
design to be negative.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10076936/
Recent NWBO News
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
Avant Technologies Engages Wired4Tech to Evaluate the Performance of Next Generation AI Server Technology • AVAI • May 23, 2024 8:00 AM
Branded Legacy, Inc. Unveils Collaboration with Celebrity Tattoo Artist Kat Tat for New Tattoo Aftercare Product • BLEG • May 22, 2024 8:30 AM
"Defo's Morning Briefing" Set to Debut for "GreenliteTV" • GRNL • May 21, 2024 2:28 PM
North Bay Resources Announces 50/50 JV at Fran Gold Project, British Columbia; Initiates NI 43-101 Resources Estimate and Bulk Sample • NBRI • May 21, 2024 9:07 AM
Greenlite Ventures Inks Deal to Acquire No Limit Technology • GRNL • May 17, 2024 3:00 PM
Music Licensing, Inc. (OTC: SONG) Subsidiary Pro Music Rights Secures Final Judgment of $114,081.30 USD, Demonstrating Strength of Licensing Agreements • SONGD • May 17, 2024 11:00 AM