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NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD & NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS
Date:6/1/2009

gression Free Survival (Months) 6.90 20.71 21.30 NR ------------------------------------------------------------------------- Median Overall Survival at 30 months (Months) 15.07 NR 25 NR ------------------------------------------------------------------------- * Statistically significant; NR = Not reached at 30 months

The response rates observed by the authors compare favorably with previous studies of cetuximab in combination with RT alone or CRT. Bonner JA et al (N. Engl J Med. 2006 Feb 9;354(6); 567-78) published on a randomized Phase III study with 424 patients comparing radiotherapy alone to radiotherapy plus cetuximab in locally-advanced squamous cell carcinoma of the head and neck, reporting a 74% ORR in the cetuximab plus radiotherapy arm. "Notwithstanding limitations in inter-study comparisons, the comparative data are reassuring," noted Dr. Leonardo Viana Nicacio, M.D., Director, Clinical Affairs for YM BioSciences.

Pfister DG et al (J Clin Oncol. 2006 Mar 1;24(7): 1072-8) presented the first study combining cetuximab with chemoradiotherapy. That 22 patient pilot Phase II study combined cetuximab with a chemoradiotherapy regimen (cisplatin 100mg/m2 d1, 22) in Stage III or IV, M0, squamous cell carcinoma patients. The population in that study was similar to the Reddy BK et al study although the chemotherapy dose intensity had slight differences in favor of the Pfister DG et al study (Table 2). The ORR in both studies were similar: 94% for cetuximab + CRT and 100% for nimotuzumab + CRT. Although the Pfister DG et al study had a longer follow-up, overall survival curves at 30 months are similar to the data in the Reddy BK et al study. The major difference between the studies is the benign toxicity profile reported with nimotuzumab. No deaths in the nimotuzumab trial were attributable to the treatment and no additional serious adverse
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