Kairos Pharma has reported encouraging interim efficacy data from its Phase II study assessing the CD105 antagonist, ENV105 (carotuximab), in individuals with metastatic castration-resistant prostate cancer (mCRPC).
The trial consisted of those who had not responded to at least one form of hormone therapy previously.
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This predetermined analysis included data from ten subjects who were part of the trial’s safety arm and had all experienced failure with at least one androgen receptor inhibitor hormone therapy before joining the study.
The company said that two of ten subjects exited the study due to events not connected to the trial.
Among the remaining eight, the median progression-free survival (PFS) extended beyond 13 months, with five patients continuing treatment with no progression. Furthermore, seven out of nine subjects exhibited a reduction in prostate-specific antigen levels from the outset.
The analysis highlighted that the combination of ENV105, in conjunction with apalutamide, a standard-of-care hormone treatment, led to a median PFS of 13 months.
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By GlobalDataThe trial’s design aims for a 45% improvement in PFS, which would raise the median PFS from 3.7 to 6.7 months.
The results from the ENV105 and apalutamide combination are said to have surpassed this target.
The company noted that the time frame of four months is noteworthy considering that second or third-line standard hormone therapies typically show a 3.7-month median efficacy, as per the CARD trial, which also indicated that chemotherapy with cabazitaxel could yield an eight-month PFS but with increased toxicity.
The ongoing randomised Phase II study aims to recruit a total of 100 subjects and is actively enrolling participants at US institutions including City of Hope, Cedars-Sinai Medical Center and Huntsman Cancer Center.
The trial’s objective is to assess the tolerability, preliminary efficacy and safety of ENV105 in men who have progressed after standard hormone-based treatments.
An earlier safety analysis released in July revealed that the first ten patients tolerated the combination of ENV105 with apalutamide well.
