Temozolomide is marketed as TEMODAR, an alkylating antineoplastic drug used in adults with newly diagnosed glioblastoma (with radiotherapy then maintenance) and anaplastic astrocytoma settings. It is a prodrug that converts nonenzymatically to MTIC, which alkylates DNA and induces tumor cell death. U.S. initial approval was in 1999.
UVA Health found gliomas may be more receptive to focused ultrasound drug delivery. Related research covers miRNA therapy, low-intensity focused ultrasound, and 3D organoid drug testing.
Alliance launches Phase III trial for stage I NSCLC immunotherapy; Allarity starts Phase 2 SCLC trial. Phase I NSCLC trial sites consolidate at top U.S. sites, prompting FDA representation concerns.
Allarity Therapeutics will present a Trial-in-Progress poster at the ESMO Gynaecological Cancers Congress 2026 on its Phase 2 ovarian cancer trial of stenoparib. The company also dosed first patients in February 2026 in a VA-funded Phase 2 trial of stenoparib plus temozolomide for relapsed small cell lung cancer.
BioNTech presented phase 2 data for HER2-directed ADC Trastuzumab Pamirtecan showing 47.9% response rate in endometrial cancer, with FDA submission planned for 2026. BioLineRx dosed first patient in phase 1/2a GLIX1 trial for glioblastoma and reported new preclinical data. Both companies presented at ASCO 2026.
A phase I trial and a preclinical study found viral immunotherapy triggered T cell responses in glioblastoma. The clinical study enrolled 41 patients; the mouse study showed prolonged survival and immunologic memory.
WHO in January 2024 launched its first list of priority childhood cancer drug formulations, naming six medicines that still lack optimal child-friendly versions. The agency says about 400,000 children and adolescents develop cancer each year and is working to expand access to safe, effective paediatric formulations.
Cabozantinib plus metronomic temozolomide showed a 15% response rate and 28.5-month median progression-free survival in a phase 2 NET study. A separate analysis found cabozantinib cost-effective for pancreatic NETs, but not extrapancreatic NETs, in China and the U.S.
Researchers have developed new immunotherapy approaches including internal immune cell reprogramming and CD40-based therapies showing promising results in early trials. Meanwhile, glioblastoma remains resistant to current immunotherapies due to blood-brain barrier constraints, though advances in antibody engineering offer new potential strategies.
The blood-brain barrier continues to block most treatments for glioblastoma and central nervous system diseases, with only 0.01% of biologic drugs reaching the brain. New intellectual property coverage and synthetic methods aim to address delivery challenges.
Researchers have developed a remote-controlled CAR T-cell therapy that can be switched off on demand using venetoclax, while new engineering strategies aim to overcome barriers in treating glioblastoma and other solid tumors.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07732413 |
Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer |
NOT_YET_RECRUITING | PHASE1 |
| NCT07708961 |
Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype Glioblastoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07707973 |
Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07675070 |
Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors |
RECRUITING | |
| NCT07670026 |
Intensified Adjuvant Therapy for High-Risk Newly Diagnosed Glioblastoma With Subtotal Resection or Short-Term Progression |
RECRUITING | PHASE2 |
| NCT07569042 |
A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma |
RECRUITING | PHASE1/PHASE2 |
| NCT07492680 |
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) |
RECRUITING | PHASE2 |
| NCT07457307 |
Integrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac |
NOT_YET_RECRUITING | PHASE1 |
| NCT07452458 |
Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, IDH Wildtype, MGMT-Unmethylated Glioblastoma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07347210 |
Evaluation of UCPVax Vaccine +/- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma |
NOT_YET_RECRUITING | PHASE2 |
