ZymoGenetics sees positive Phase I cancer drug results

Preliminary data suggests that the combination is well tolerated, with a toxicity profile similar to known toxicities of each agent alone. The combination therapy has also shown promising anti-tumor activity.

ZymoGenetics said that 11 patients have completed at least one six-week treatment course, and 10 of these 11 patients have had measurable disease per RECIST criteria. All 10 have had a decrease in tumor mass as their best response on study, ranging from 18 to 33% per investigator assessment.

Of these, four patients had unconfirmed partial responses, with at least 30% decrease in tumor measurements per investigator assessment and 3 of these are still on treatment. Of the 11 patients who finished the first treatment course, nine continue to receive therapy on study, and two patients discontinued therapy due to disease progression.

Overall, the majority of adverse events and lab abnormalities have been mild to moderate and consistent with the known safety profiles of IL-21 and Nexavar (sorafenib).

Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: “We were very pleased to see that the combination of IL-21 and Nexavar can be safely administered for repeated courses, and that the majority of patients treated to date experience tumor shrinkage. The Phase II part of this trial should allow us to confirm these promising results.”