Ivy Brain Tumor Center announces Phase 0/2 clinical readout of niraparib indicating significant improvement in overall survival of newly diagnosed glioblastoma patients
23 Mayo 2024 - 4:09PM
- Results will be presented at American Society of Clinical
Oncology (ASCO) Annual Meeting
- Median overall survival was 20.3 months, nearly doubling the
median OS historically observed with standard of care in similar
patient population
- GSK to support the initiation of a global, registrational
head-to-head Phase 3 clinical trial of niraparib vs standard of
care
The Ivy Brain Tumor Center at Barrow Neurological Institute
today announced a clinical readout of a Phase 0/2 ‘trigger’
clinical trial of niraparib in patients with newly diagnosed
MGMT-unmethylated glioblastoma. As one of the deadliest human
cancers, an estimated 250,000 cases of glioblastoma are newly
diagnosed each year worldwide with a current 5-year survival rate
of 6.9 percent.1 In approximately 60% of glioblastoma tumors,
the MGMT promoter is unmethylated,2 and, for this population, the
standard of care first-line chemotherapy, temozolomide, has shown
to have limited effect.
The study concluded that niraparib achieved pharmacologically
relevant concentrations, in excess of any other PARP inhibitor in
glioblastoma tumor tissue and led to a median overall survival of
20.3 months, a significant advance beyond the historical control of
12.7 months3,4. Safety was constant with known safety profile of
niraparib and no new safety signal was identified. These results
will be presented in an oral presentation (Abstract #2002) on June
3, 2024, at the American Society of Clinical Oncology (ASCO) Annual
Meeting in Chicago.
"This hybrid Phase 0/2 study provides simultaneous biological
and clinical data identifying niraparib as a best-in-class
brain-penetrant molecule with promising radiosensitizer effects in
glioblastoma. In less than two years, from concept to completion,
our team at the Ivy Center generated proof-of-concept data in
partnership with GSK and we are now working to deliver a potential
new standard of care for MGMT-unmethylated glioblastoma patients,"
said Dr. Nader Sanai, director of the Ivy Brain Tumor Center.
The positive results of this supported collaborative study
between the Ivy Brain Tumor Center and GSK have prompted the
acceleration of the Gliofocus Study, a global, multi-center,
open-label, randomized head-to-head Phase 3 trial (NCT06388733)
that will evaluate niraparib, a PARP1/2 selective inhibitor, in
adult patients with newly diagnosed MGMT-unmethylated glioblastoma
compared to temozolomide. The trial is expected to enroll 450
participants at more than 100 clinical sites across 11 countries
worldwide.
For more information on this study, including eligibility
criteria, visit NCT06388733.
The Ivy Center is home to the largest Phase 0 drug development
program for brain cancer worldwide. Click here for a complete
list of Ivy Center clinical trials.
About Niraparib
The drug, niraparib is an oral, once-daily PARP inhibitor with
current indications in first-line maintenance for advanced ovarian
cancer. GSK continues to assess the potential for niraparib in
several pivotal trials across multiple tumor types and in
combination with other therapeutics.
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About Ivy Brain Tumor Center
Ivy Brain Tumor Center at Barrow Neurological Institute in
Phoenix, AZ, is a tertiary care and nonprofit translational
research program that employs bold, early-phase clinical trial
strategies to identify new treatments for aggressive brain tumors,
including glioblastoma. Our leading experts in neurosurgical
oncology, neuro-oncology, radiation oncology, neuroradiology,
neuropathology and neuroscience nursing treat more patients
annually than any other brain tumor center in the United States.
The Ivy Center’s Phase 0 clinical trials program is the largest in
the world and enables personalized care in a fraction of the time
and cost associated with traditional drug development. In addition,
unlike conventional clinical trials focusing on single drugs, the
Ivy Center’s accelerated program tests therapeutic combinations
matched to individual patients. We leave no stone unturned in the
pursuit of hope and healing. Learn more at IvyBrainTumorCenter.org.
Follow the Ivy Brain Tumor Center on Facebook, Instagram, Twitter,
and LinkedIn.
1. Global Cancer Statistics 2020: GLOBOCAN
Estimates of Incidence and Mortality Worldwide for 36 Cancers in
185 Countries
2. Taylor JW, Schiff D. Treatment considerations for
MGMT-unmethylated glioblastoma. Curr Neurol Neurosci Rep.
2015;15(1):507.
3. Hegi ME, Diserens AC, Gorlia T, et al. MGMT gene silencing
and benefit from temozolomide in glioblastoma.
4. Annavarapu S, Gogate A, Pham T, et al. Treatment patterns and
outcomes for patients with newly-diagnosed glioblastoma multiforme:
a retrospective cohort study. CNS Oncol. 2021;10(3):CNS76.
- Director of the Ivy Brain Tumor Center and director of
neurosurgical oncology at Barrow Neurological Institute
Jennifer Keeler
Ivy Brain Tumor Center
602-670-4400
jennifer.keeler@ivybraintumorcenter.org