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A phase 2 trial found that combining carotuximab with apalutamide significantly extended progression-free survival in men with metastatic castration-resistant prostate cancer (mCRPC). The median PFS reached 17.7 months with the combo vs. just 2.0 months with apalutamide alone. The trial is now being expanded to enroll patients earlier in disease progression.
A promising new combination therapy is turning heads in the prostate cancer space. Interim data from an ongoing phase 2 trial (NCT05534646) show that carotuximab (ENV-105) — a first-in-class anti-CD105 antibody — paired with apalutamide (Erleada) delivered a dramatic improvement in progression-free survival compared to apalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC).
The results, announced by Kairos Pharma, showed a median PFS of 17.7 months with the combination vs. just 2.0 months with apalutamide monotherapy — a statistically significant difference (P = .0008). Based on this strong interim signal, the trial protocol is being amended to enroll patients earlier in disease progression, randomizing them to enzalutamide with or without carotuximab. Study completion is targeted for Q4 2027.
By the Numbers:
Why it matters: mCRPC is notoriously difficult to treat once patients progress on androgen receptor pathway inhibitors. Carotuximab's mechanism — targeting CD105 to combat drug resistance — could offer a meaningful new strategy for a patient population with limited options.