RE: 1b resultsToday 12:13
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Responses were reported from two of the patient cohorts studied, SGC and soft tissue sarcoma (STS). In the lead indication of SGC, the data continues to mature.
The patient population in SGC (n=32) is the most mature data set from the trial and is used to assess the efficacy endpoints. Patients in this cohort were selected based on the agreed population for the pivotal study in this indication, where more rare subsets of SGC were excluded based on differing natural histories which can be challenging to control for in a trial with PFS as the primary endpoint. Previously, Avacta has reported data in the full cohort of SGC (n=38), this announcement today includes efficacy data in the subset as defined in the patient population for the pivotal study. Patients in this cohort (n=32) were assessed for best overall response with four confirmed partial responses, and eight confirmed minor responses (sum of the longest diameters -10 to -29%). Median progression-free survival data are not yet mature in this cohort, as progression events (tumor growth, etc.) continue to be collected and overall survival data continue to mature. Tumor responses are also observed in the STS cohort, where importantly, tumor cells have expression of FAP. The cohort of triple negative breast cancer continues and data will be reported when mature.
The robust clinical activity observed in both STS and SGC patient populations demonstrates the efficacy of faridoxorubicin even when FAP is only expressed in the stromal cancer associated fibroblasts (CAFs), thus validating the "bystander effect" of pre|CISION®. In STS, FAP expression is seen on the surface of tumor cells, whereas FAP is absent on SGC tumor cells, which is representative of the majority of solid tumor indications.
These updates further support the Board's belief that Avacta's pre|CISION® technology is broadly applicable across multiple cancer indications.
Translational findings in SGC
Together, translational findings from biopsy and FAPI-PET imaging data indicate two key features of the platform:
· pre|CISION® medicines can have optimal activity even in the setting of very low FAP expression.
· The expression of FAP in tumors persists, despite robust and durable tumor response.
To assess the activity of faridoxorubicin in patients with low expression of FAP, biopsy data in the full SGC cohort were available in n=26 patients and were assessed with standard FAP immunohistochemistry and tri-color immunofluorescence studies. Two different statistical analyses both demonstrate no relationship between the level of FAP expression and degree of tumor response. Importantly, these analyses and the case series presented (n=4 responders) show that the activity of faridoxorubicin in SGC is robust even to a very low level of FAP expression.
The changes in the expression of FAP over time with faridoxorubicin therapy have been assessed in a sub-study of the Phase 1a/1b usi
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