Also known as: recurrent, fully resected, lung metastatic osteosarcoma
Osteosarcoma is a primary malignant bone tumor characterized by production of immature bone (osteoid) by malignant cells, most often arising in long bones of adolescents and young adults.
Moderna and Merck's personalized mRNA cancer vaccine, intismeran autogene, showed promising Phase 3 results in preventing melanoma recurrence. Combined with Keytruda, it cut recurrence risk by half and reduced spread by 59% in earlier data. The treatment could reach patients within two years pending regulatory approval.
A randomized trial shows self-acupressure reduces fatigue and improves quality of life in ovarian cancer; a systematic review finds light to moderate massage safe for cancer patients.
OS Therapies achieved FDA, MHRA, EMA and TGA alignment on the Phase 3 design for OST-HER2 in osteosarcoma. The confirmatory trial must start before BLA grant and is expected in Q3 2026.
Soft tissue sarcoma pipeline activity includes 70+ companies and 75+ therapies. A phase II ADI-PEG 20 trial with gemcitabine and docetaxel was designed for sarcomas, while other 2026 studies span synovial sarcoma and unresectable advanced disease.
Cancer care is being transformed by targeted therapy, immunotherapy, personalized medicine, and emerging mRNA-based universal cancer vaccines. Advances in immunotherapeutics and cellular therapies are improving survival rates, while an off-the-shelf mRNA vaccine from the University of Florida is already in human trials.
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
Two osteosarcoma studies identified prognostic immune biomarkers, including serum sB7-H3 and an immune cell infiltration score. Both linked immune features with survival, metastasis and treatment response.
Johnson & Johnson invests over $1 billion in a new Pennsylvania cell therapy manufacturing facility for cancer and neurological diseases. The expansion addresses growing demand for advanced therapies while highlighting workforce training challenges in GMP environments. Other developments include new cell line technology for viral vector production and CRISPR-edited CAR-T manufacturing partnerships.
FDA elevated OS Therapies' Type D meeting to Type B pre-BLA meeting for OST-HER2 in osteosarcoma, signaling transition to Accelerated Approval discussions. Clinical data submission targeted for end of Q1 2026.
OS Therapies progresses toward Accelerated Approval for OST-HER2 in osteosarcoma, with FDA elevating meeting status and global regulatory submissions on track for Q1 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07774533 |
68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma |
RECRUITING | EARLY_PHASE1 |
| NCT07725380 |
Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma |
RECRUITING | PHASE1/PHASE2 |
| NCT07648069 |
Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma |
RECRUITING | PHASE1 |
| NCT07628634 |
Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w/ Solid Tumors |
RECRUITING | EARLY_PHASE1 |
| NCT07602049 |
Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma |
RECRUITING | PHASE2 |
| NCT07593573 |
the Exploration of MTAP Deletion in Osteosarcoma by Immunohistochemistry |
ACTIVE_NOT_RECRUITING | |
| NCT07516353 |
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults |
NOT_YET_RECRUITING | NA |
| NCT07514819 |
Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma |
RECRUITING | NA |
| NCT07479732 |
Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma |
RECRUITING | PHASE1/PHASE2 |
| NCT07477457 |
A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma |
RECRUITING | PHASE2 |
