It’s my pleasure to present this first result and mature follow-up of more than 20 years of our phase two single center, single arm, a trial on urachal and non-urachal adenocarcinoma. We enrolled 46 patients, 18 urachal and 28 non-urachal. And what we have done so far is evaluating GEMFLIP as frontline therapy for locally advanced and resectable and metastatic patients...
It’s my pleasure to present this first result and mature follow-up of more than 20 years of our phase two single center, single arm, a trial on urachal and non-urachal adenocarcinoma. We enrolled 46 patients, 18 urachal and 28 non-urachal. And what we have done so far is evaluating GEMFLIP as frontline therapy for locally advanced and resectable and metastatic patients. And what we find is with the primary outcome overall survival and objective response rate and secondary outcome have been PFS and safety, we found that we had an objective response rate of 44% in this rare disease that represents less than 1% of the patients. And we had a median progression-free survival of 4.6 months and a duration of response among the patients that responded with CR and PR of 8.6 months, with a median overall survival of 21.4 months. So it represents the first benchmark in a field where we don’t have, again, frontline therapy in this setting. It’s been manageable, safety, nothing unexpected of what we expected to have with this regimen. And what we also have found is, on the biomarker side, the CA-125 expression with HR for doubling has been associated with worse outcome.
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