YM BioSciences Inc. has announced data from two clinical trials of nimotuzumab, its humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Preliminary results from the two trials which are evaluating nimotuzumab in combination with radiation therapy for the treatment of brain metastases and high-grade gliomas, conducted by YM's licensor, were presented at the 2008 EORTC-NCI-AACR annual meeting recently held in Geneva, Switzerland.
"YM's program for registration of nimotuzumab is focused on cancers that are typically treated with radiation-containing regimens and will target brain metastases as one of its initial indications. These data further support this strategy and have served to reinforce the designs of our upcoming trials for this drug," said David Allan, Chairman and CEO of YM BioSciences.
Phase II Brain Metastases Trial - Preliminary Results
In the poster entitled "Preliminary results of a phase II clinical trial of the anti EGFR monoclonal antibody nimotuzumab in combination with whole brain radiation therapy in patients diagnosed with advanced non-small cell lung cancer (NSCLC) and unresectable brain metastases", data were reported for a randomized, open controlled trial of 30 patients who received nimotuzumab (200 mg administered as weekly IV infusions over weeks 1-6) plus palliative radiation (40 Gy in four weeks) or palliative radiation alone. The primary endpoint was disease control rate (DCR = Complete Response + Partial Response + Stable Disease) and secondary endpoints included overall survival and safety.
The poster reports data from the first 21 patients. DCR was 91.6% for the nimotuzumab plus radiation arm compared to 44.4% for the radiation alone arm. Patients treated with the combination had a mean and median survival of 7.32 and 7.00 months respectively (five patients still alive), compared to the control group for whom the mean and median survival was 3.03 and 2.47 months respectively (one patient still alive). This difference reached statistical significance (p= 0.0039, Log Rank test).
"In this exploratory study, nimotuzumab administered concurrently with whole brain radiation therapy yielded substantial radiological responses and meaningful clinical responses in these late-stage patients. Furthermore, consistent with all other trials to date, nimotuzumab did not provoke skin rash or GI adverse events," noted Dr. Leonardo Viana Nicacio, Director of Clinical Affairs for YM BioSciences. "While this was only a modestly sized study, we believe it provides a reasonable indication of the potential value of the combination of nimotuzumab and radiation for the treatment of brain metastases."
Phase II High Grade Glioma Trial - Preliminary Results