Nov. 2, 2009 (PR Newswire) --
- Follow-On Results from a Randomized Phase IIb Head & Neck Trial
Demonstrate Efficacy of Nimotuzumab Without Severe, Class-Associated
Toxicities -
MISSISSAUGA, ON, Nov. 2 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Amex: YMI; TSX: YM), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, announced that an oral presentation at the American Society for Therapeutic Radiology and Oncology (ASTRO) 2009 Annual Meeting reported positive 48-month survival data for its EGFR-targeting antibody, nimotuzumab. The "BEST" trial was a randomized four-arm study treating patients with inoperable, locoregionally-advanced, stage III/IVa head and neck cancer with radiation alone, chemoradiation alone, or radiation or chemoradiation in combination with nimotuzumab. These data were a follow-up to 30-month survival data presented at ASCO 2009 and demonstrate that the benefit of adding nimotuzumab to radiation and chemoradiation is durable and persists for several years.
"These data are convincing evidence that nimotuzumab is an efficacious and safe drug and highlight its potential in the head and neck cancer indication. In this respect we note that the National Cancer Centre of Singapore has initiated a global Phase III trial with nimotuzumab in the adjuvant setting for head and neck cancer patients," said David Allan, Chairman and CEO of YM BioSciences. "Activity of nimotuzumab in the BEST trial was similar to that demonstrated in separate trials with cetuximab in locally advanced head and neck cancer but there was no evidence that nimotuzumab's activity was accompanied by the advanced toxicities of the class."
In the ASTRO presentation, Dr. Lokesh Viswanth, Kidwani Memorial Institute of Oncology, Bangalore, India described that the addition of nimotuzumab to radiotherapy (RT) and chemoradiotherapy (CRT) had an important effect on overall survival. At 48 months, 41% of the patients in the nimotuzumab+CRT arm were alive compared to 21% in CRT-alone arm, and 34.7% in the nimotuzumab+RT arm were alive compared to 13% in the RT-alone arm. The difference at 48 months between CRT and nimotuzumab+CRT arms reached statistical significance (p=0.0149). Kaplan-Meier curves for survival maintained a consistent separation at the 48-month update, demonstrating that the benefit of adding a fixed course of nimotuzumab to RT and CRT persists for an extended period. Because efficacy results in the control groups in this trial were similar to those published in contemporaneous international trials in this indication, and because imbalances between the study arms were minor, authors concluded that the benefit presented in this proof of principle trial must be attributable to the activity of nimotuzumab.
The trial contained no reports of late toxicity with nimotuzumab and its benign side-effect profile continued to be demonstrated.
