July 17, 2024

Medical Trend

Medical News and Medical Resources

10-Fold Increase in Survival with New Combination Therapy for Glioblastoma

10-Fold Increase in Survival with New Combination Therapy for Glioblastoma



10-Fold Increase in Survival with New Combination Therapy for Glioblastoma

Recently, German biotechnology company TME Pharma announced the final survival data from the Phase 1/2 GLORIA trial: the frontline drug Olaptesed pegol (NOX-A12) combined with the anti-cancer drug Bevacizumab and radiotherapy showed promising efficacy in treating glioblastoma (GBM).

Key points are as follows:

  1. The average total survival period for patients in the standard treatment group was 10.5 months, while for the combination therapy group, it was 19.9 months. This data, nearly doubling the survival period of the standard treatment group, is unprecedented!

  2. The survival rate for patients in the standard treatment group was 5%, whereas for the combination therapy group, it was 50%, marking a remarkable tenfold increase in survival rate!

Research Details (For Professionals)

Based on the final survival data from the Phase 1/2 GLORIA trial (NCT04121455): Olaptesed pegol (NOX-A12), a CXCL12 inhibitor, combined with the VEGF inhibitor Bevacizumab (Avastin) and radiotherapy, demonstrated promising efficacy in newly diagnosed glioblastoma (GBM) patients compared to standard treatment:

The average overall survival (OS) for patients in the combination therapy group reached 19.9 months, unprecedented compared to the standard treatment group with an OS of 10.5 months, nearly doubling the survival period!

At the 21-month mark of treatment, the survival rate for patients in the combination therapy group was 50%, compared to 5% for the standard treatment group, indicating a remarkable tenfold increase in survival rate!

Olaptesed pegol (NOX-A12) is developed by the German biotechnology company TME Pharma, which has submitted applications for new drug clinical trials (IND) and Fast Track designation (FTD) to the U.S. Food and Drug Administration (FDA), expected to be approved by March of this year.

10-Fold Increase in Survival with New Combination Therapy for Glioblastoma

About the GLORIA Trial

The GLORIA trial (NCT04121455) is a Phase 1/2 dose escalation trial primarily evaluating the efficacy of Olaptesed pegol (NOX-A12) combined with radiotherapy as first-line treatment for newly diagnosed glioblastoma (GBM) patients who are ineligible for surgical resection or have undergone partial resection.

Enrolled patients have World Health Organization (WHO) Grade IV glioblastoma (GBM); MGMT status is unmethylated, indicating a potentially favorable response to treatment; ECOG performance status is up to 2, indicating some restriction in daily activities but still capable of light work; predicted short survival of 3 months or less; effective contraception measures are taken.

Patients ineligible for MRI (magnetic resonance imaging), with a history of other cancers, clinically significant or uncontrolled cardiovascular diseases, or uncontrolled complications are excluded from the study.

The study also includes a three-arm expanded treatment group for glioblastoma (GBM) patients with complete tumor resection, primarily investigating the treatment efficacy of Olaptesed pegol (NOX-A12) in combination with Bevacizumab (Avastin) or Pembrolizumab (Keytruda) with concurrent radiotherapy.

The primary endpoint of the study is safety. Secondary endpoints include progression-free survival (PFS) at 6 months, median PFS, tumor vascularization changes, plasma concentration of Olaptesed pegol (NOX-A12), patient’s quality of life, and neurological function.

Currently, Olaptesed pegol (NOX-A12) combined with radiotherapy has been granted orphan drug designation by regulatory agencies in the United States and Europe for glioblastoma (GBM).

Additionally, clinical trials combining Olaptesed pegol (NOX-A12) with Pembrolizumab (Keytruda) for metastatic colorectal and pancreatic cancer patients have demonstrated favorable overall survival and safety data, published in the Cancer Immunotherapy Journal in October 2021.

10-Fold Increase in Survival with New Combination Therapy for Glioblastoma

References:

[1]https://www.targetedonc.com/view/brain-cancer-hope-19-9-month-median-survival-with-new-combo
[2]https://www.businesswire.com/news/home/20240201188459/en/TME-Pharma-Announces-Final-Median-Overall-Survival-Data-Reaching-19.9-Months-for-NOX-A12-Combination-Regimen-in-GLORIA-Brain-Cancer-Trial-and-Survival-Rate-10-Fold-Greater-Than-Standard-of-Care

(source:internet, reference only)


Disclaimer of medicaltrend.org


Important Note: The information provided is for informational purposes only and should not be considered as medical advice.