- Data Presented at the 44th American Society for Clinical Oncology (ASCO)
Annual Meeting -
IRVINE, Calif., June 2 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI) today announced the presentation of an analysis from the Phase 3 mifamurtide (L-MTP-PE) clinical trial (INT-0133). The results suggest that the addition of L-MTP-PE to chemotherapy improved overall survival with a 25% reduction in the risk of death in newly diagnosed patients with metastatic osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.
"These data in a difficult-to-treat metastatic patient population are encouraging, especially given the limited treatment options available," said Timothy P. Walbert, president and chief executive officer, IDM Pharma. "We continue to believe the data from non-metastatic patients in the L-MTP-PE Phase 3 study warrants regulatory approval in Europe and the United States and are optimistic that the overall survival benefit seen with L-MTP-PE will be the clinical evidence needed to support bringing this important treatment to market."
The Phase 3 L-MTP-PE trial (INT-0133) is National Cancer Institute (NCI) funded cooperative group study conducted by the Children's Oncology Group (COG) and is the largest study completed in osteosarcoma, enrolling approximately 800 patients. The multicenter, open label, randomized, factorial, four parallel treatment group Phase 3 study was designed to evaluate patient outcomes with the addition of L-MTP-PE to adjuvant three- or four-drug chemotherapy (cisplatin, doxorubicin, and methotrexate with or without ifosfamide).
The analysis evaluated 91 newly diagnosed patients with metastatic
osteosarcoma who
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