Source disclosure: March 05, 2026, 15:30 JST
Published by Pulse News Wire: March 05, 2026, 15:40 JST
Renascience Inc. [4889.T]
TOKYO, Mar 05 (Pulse News Wire) – Renascience Inc. (4889.T) reported positive interim results from its Phase II trial evaluating the combination therapy of nivolumab and PAI-1 inhibitor RS5614 for non-small cell lung cancer (NSCLC).
The study, conducted across six medical institutions since September 2023, concluded patient enrollment on July 03, 2025, with 36 patients participating. Preliminary analysis showed an overall objective response rate (ORR) of 8.3%, and a 6-month progression-free survival (PFS) rate of 22.5%. Notably, among the 11 patients who received this treatment as their third-line therapy, the ORR was 18.2% and the 6-month PFS rate was 27.5%. The safety profile demonstrated fewer severe adverse events compared to monotherapy, with Grade 3 or higher side effects occurring in just 13.8% of cases versus 20.3% for nivolumab alone.
Based on these promising outcomes, the company plans to initiate a subsequent Phase III trial targeting early-stage locally advanced NSCLC patients treated with chemoradiotherapy followed by durvalumab consolidation therapy. This next phase is expected to begin after regulatory approval in April 2026. The rationale behind the enhanced antitumor efficacy observed with RS5614 includes inhibition of epithelial-mesenchymal transition (EMT), reduction of tumor-infiltrating macrophages, increased intratumoral T-cell activity, and improved tumor immune microenvironment. The upcoming trial will involve 12 medical facilities and run from April 2026 to March 2030, aiming to evaluate whether combining RS5614 with established treatments improves cure rates and reduces treatment-related complications.
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