Kairos Pharma Presents Positive Interim Efficacy Data on Combination Therapy of ENV-105 and Apalutamide in Metastatic Castration-Resistant Prostate Cancer

Strategic Insights -

Kairos Pharma, Ltd., a clinical-stage biopharmaceutical company, has presented positive interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) at the European Society of Medical Oncologists meeting in Berlin, Germany. The data highlights the potential value of combination therapy with ENV-105 and apalutamide, a hormone therapy, in treating mCRPC.

Key Takeaways:

  • The trial showed a clinical benefit when combining ENV-105 with apalutamide in 86% of treated patients, with all responders remaining progression-free for at least four months and half remaining progression-free beyond one year.
  • Seven of nine evaluable patients experienced a reduction in PSA levels from baseline, indicating potential therapeutic efficacy.
  • The 13.7 median progression-free survival (PFS) achieved by imaging with the ENV-105 and apalutamide combination suggests an improvement over current alternatives of chemotherapy and radioligand therapy in terms of disease control and tolerability.

Statistics:

  • 86% of treated patients showed clinical benefit with the combination therapy of ENV-105 and apalutamide.
  • 7 of 9 evaluable patients experienced a reduction in PSA levels from baseline.
  • 13.7 median PFS achieved by imaging with the ENV-105 and apalutamide combination.

Sources:

  • Kairos Pharma, Ltd. press release, Oct 20, 2025
  • European Society of Medical Oncologists meeting, Berlin, Germany
  • Businesswire.com: "Kairos Pharma Presents Positive Interim Efficacy Data on Combination Therapy of ENV-105 and Apalutamide in Metastatic Castration-Resistant Prostate Cancer"