Kairos Pharma, Ltd. (NYSE American: KAPA) announced positive efficacy data from its ongoing Phase 2 clinical trial of ENV105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). This predetermined interim analysis covered the same 10 patients from the safety-arm of the trial, all of whom had failed at least one prior androgen receptor inhibitor hormone therapy.
Of the eight remaining patients in the analysis (two withdrew for unrelated events), the median progression-free survival (PFS) was more than 13 months, with five of these eight patients continuing treatment without progression. Additionally, seven of nine patients demonstrated a decrease in their prostate-specific antigen (PSA) from baseline.
The trial was powered to show a 45% improvement in PFS, translating to an increase from 3.7 to 6.7 months, a mark that was significantly exceeded by the ENV105/Apalutamide combination. Standard of care hormone therapy has a 3.7-month median efficacy, while chemotherapy (cabazitaxel) provided eight months' PFS with greater toxicity, highlighting the potential value of Kairos Pharma's combination therapy.
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