What clinical trials have investigated HMPL-813 for glioblastoma treatment?

HMPL-813 in Glioblastoma: Current Clinical Trial Status

There are currently no published clinical trials investigating HMPL-813 specifically for glioblastoma treatment. Based on the available evidence, HMPL-813 does not appear in any of the guideline-recommended treatments or clinical trials for glioblastoma.

Current Landscape of Glioblastoma Treatment

• Standard of care for newly diagnosed glioblastoma involves maximum safe surgical resection, followed by radiotherapy plus concomitant and adjuvant temozolomide, which provides a median survival of only 14-16 months 1
• Despite this treatment approach, fewer than 10% of patients survive 5 years beyond diagnosis 1
• For recurrent disease, patients with prior temozolomide exposure have progression-free survival rates at 6 months of only 20%-40% regardless of chemotherapeutic intervention 1

Established Treatments in Clinical Trials for Glioblastoma

• Only 4 drugs for glioblastoma have been approved by the FDA over the past 30 years: nitrosoureas, carmustine, temozolomide, and bevacizumab 1
• Temozolomide remains the standard chemotherapeutic agent, with studies showing improvement in median survival to 14.6 months when combined with radiotherapy versus 12.1 months with radiotherapy alone 2
• Several randomized trials have investigated bevacizumab in recurrent glioblastoma, with only EORTC 26101 showing PFS benefit but not overall survival benefit 1
• The REGOMA trial showed some benefit for regorafenib compared to lomustine in recurrent glioblastoma (median OS 7.5 months vs 5.6 months) 1

Tyrosine Kinase Inhibitors in Glioblastoma

• Approximately 45% of patients with glioblastoma carry EGFR mutations, and 13% possess altered PDGFR genes, making tyrosine kinase inhibitors (TKIs) potential therapeutic options 3
• Despite multiple clinical trials of various TKIs, none have been approved for patients with glioblastoma 3
• HMPL-813, which appears to be a tyrosine kinase inhibitor based on its designation, has not been mentioned in any of the available guidelines or research evidence as being studied specifically for glioblastoma 3

Current Research Directions

• There is an urgent need for new drug development in recurrent glioblastoma due to limited effective options 1
• Novel approaches being investigated include:
  • Targeted molecular therapies 4
  • DNA repair pathway targeted therapies 4
  • Immunotherapies and vaccine therapies 4
  • Surgically targeted radiotherapies 4
  • Combination therapies, such as temozolomide with cisplatin 5
• Clinical trials are strongly recommended for patients with recurrent glioblastoma due to limited effective treatment options 1

Clinical Trial Design Considerations

• The FDA, NCI, and neuro-oncology community have emphasized the need for standardized imaging protocols in brain tumor clinical trials 1
• Progression-free survival (PFS) and objective response rate (ORR) are considered valuable endpoints for determining treatment efficacy in glioblastoma trials 1
• MGMT promoter methylation status is an important biomarker that should be assessed, as it strongly predicts benefit from temozolomide chemotherapy 1

In conclusion, while there is significant ongoing research into novel therapies for glioblastoma, including various tyrosine kinase inhibitors, the available evidence does not indicate that HMPL-813 has been specifically studied in clinical trials for glioblastoma treatment.