I was able to get a pdf of the data from the SGN-75 poster at ESMO, October 11, 2010. It is available by email request from Investor Relations at SGEN.
The numbers in this ongoing Phase I dosing study are very small, so it's quite hard to come to any solid conclusions. However, here are some of my speculative "impressions" on review.
Dosing ranged from .3mg/kg every three weeks up to 1.5mg every three weeks as well as a weekly schedule of .3mg. One patient of 16 total was reported to receive 2mg/g every three weeks. One patient did not have proper follow-up,so data is on 15 of the 16 patients.
In NHL: There were 7 patients, 2 patients had Mantle Cell histology and 5 had Follicular histology.
Of the two patients with Mantle Cell, one patient had fairly strong staining of CD70 receptors on almost 100% of the tumor cells. The other patient had only light staining of CD70 on about 85% of the cells. One of these two patients had a complete response to 1mg/kg every three weeks, with the other showing progressive disease on .3mg/kg weekly. It was not indicated, but my assumption ( I could be wrong ) is that the patient who had the complete response was the one with the stronger staining on almost 100% of the tumor cells. If that were the case, the drug would be targeting and doing exactly as intended.
Of the 5 patients who had Follicular histology none had CD70 expression / staining on more than 25% of the tumor cells. The best response in this sub-group was stable disease among 2 of 3 patients treated at the higher 1.5mg/kg every threee weeks level.
Initial Impression: SGN-75 might possibly be quite potent in the NHL setting which manifests high intensity staining of a large percentage of the tumor cell population, perhaps especially within the Mantle Cell sub-group. Exploration of higher doses is needed to see if some of the stable disease seen in lower CD70 saturated tumors can be converted to partial or better responses.
In Renal Cell Carcinoma ( RCC ) 5 of 8 patients showed high intensity staining for CD70 on almost 100% of the tumor cells. At lower doses of .3mg/kg to 1mg/kg every three weeks only progressive disease was noted in the 3 patients studied at these levels. However, at the higher dose of 1.5mg/kg 2 of 3 patiens treated exhibited stable disease. At .3mg/kg weekly, 1 of 2 patients had stable disease and the other progressed. Of note, is that at a dosage of 2mg/kg every three weeks one patient ( from another as yet unreported cohort ) reportedly had a partial response.
Initial impression: Although it is very premilinary, these scant data seems to point to a dose dependent efficacy trend. Incremental dosing above 1.5mg/kg every three weeks is clearly indicated to elucidate and define.
The study protocol indicates that the dosing may proceed as high as 4.5mg/kg every three weeks or 1.5mg/kg weekly.
There are other thoughts / impressions that I have regarding the data presented at ESMO recently, but these are my VERY limited and condensed speculative evaluations at this time.
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