IDM Pharma’s antitumor drug achieves superior results in Phase III trial

The trial was part of a National Cancer Institute funded cooperative group study conducted by the Children’s Oncology Group (COG). The data is based on long-term follow up of patients originally treated in the Phase III trial.

The results showed that mifamurtide (L-MTP-PE) added to chemotherapy during treatment for osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults, achieved statistically superior overall survival (OS) rates.

The multicenter, open-label, randomized, factorial, four parallel treatment group Phase III study evaluated the effects of the addition of L-MTP-PE to chemotherapy in patients with resectable osteosarcoma without metastatic disease. There were 672 with newly diagnosed, non-metastatic, resectable osteosarcoma included in the COG’s analyses.

In the analyses by the COG investigators, event free survival, including secondary malignancies, after six years in patients treated with chemotherapy and L-MTP-PE was 67%, compared to 61% in patients treated only with chemotherapy and no L-MTP-PE. Overall survival after six years in patients treated with chemotherapy and L-MTP-PE was 78%, compared to 70% in patients treated only with chemotherapy and no L-MTP-PE.

Timothy Walbert, president and CEO of IDM Pharma, said: “We are very pleased to see that the overall survival benefit shown in the primary analysis of the Phase III clinical trial data was further strengthened by the statistically superior findings in long-term patient follow-up. As we announced, we are currently in the process of amending the L-MTP-PE new drug application with more complete long-term survival data from the same study, with the goal of obtaining regulatory approval and bringing L-MTP-PE to the patients who haven’t had an improvement in treatment outcomes for the last 20 years.”