FDA-Approved Phase 2 Basket Trial Shows Promise in Targeting Cancer with PRL3-zumab

Strategic Insights -

Research conducted by the Agency for Science Technology and Research (A*STAR) in Singapore has led to a novel approach in cancer treatment, using the PRL3-zumab to target intracellular oncoproteins. The study, published in Cell Reports Medicine, demonstrated the efficacy of PRL3-zumab in prolonging progression-free survival in patients with late-stage solid cancers, outperforming prior anti-PD-(L)1 therapies. This breakthrough has significant implications for cancer treatment, offering a potential new avenue for patients who have exhausted other treatment options.

Key Takeaways:

  • The study used a phase 2 basket trial design, which allowed for the evaluation of multiple cancers and the targeting of intracellular oncoproteins.
  • PRL3-zumab, a first-in-class humanized antibody, demonstrated high affinity to PRL3, an intracellular oncotarget expressed in multiple cancers.
  • The study highlighted the proof of concept of targeting intracellular oncoproteins with antibody-based therapy, with a full analysis set (FAS) used for pharmacokinetic and safety studies.
  • 20 patients were eligible to constitute the efficacy evaluable set (EES), with PRL3-zumab showing longer progression-free survival than prior anti-PD-(L)1 therapies.
  • The study demonstrated excellent safety and clear clinical benefits in late-stage IV solid cancer patients.
  • The trial was registered at ClinicalTrials.gov as NCT04452955, and additional information may be obtained from Min Thura at the Agency for Science Technology and Research (A*STAR).
  • The study included a team of researchers from the Agency for Science Technology and Research (A*STAR), led by David J. Park and Min Thura.

Statistics:

  • The study evaluated 51 patients, with the full analysis set (FAS) used for pharmacokinetic and safety studies.
  • 20 patients were eligible to constitute the efficacy evaluable set (EES).
  • PRL3-zumab demonstrated a progression-free survival rate of longer than prior anti-PD-(L)1 therapies.
  • The study showed 80.6% expression of PRL3 in multiple cancers.
  • The study highlighted a high affinity of PRL3-zumab to PRL3, with a Kd of 7.57 pM.

Sources:

  • NewsRx. Reports Outline Cancer Findings from Agency for Science Technology and Research (A*STAR) (The Prl3-zumab Paradigm: a Multicenter, Single-dose-level Phase 2 Basket Clinical Trial Design of an Unconventional Cancer Immunotherapy). Cancer Weekly. July 22, 2025; p 719.
  • The Prl3-zumab Paradigm: a Multicenter, Single-dose-level Phase 2 Basket Clinical Trial Design of an Unconventional Cancer Immunotherapy. Cell Reports Medicine, 2025;6(5).