Pliant Reports Promising Interim Results for PLN-101095 in ICI-Refractory Tumors

Pliant Therapeutics shared interim data from its ongoing Phase I dose-escalation trial of PLN-101095 combined with pembrolizumab in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095, a dual selective oral αvβ8/αvβ1 integrin inhibitor, is the fourth clinical-stage drug from Pliant’s integrin platform.

Among ten secondary ICI-refractory participants in the three highest dose groups, four responses were observed: three partial responses (two confirmed, one unconfirmed) and one confirmed complete response, across tumor types including head and neck, cholangiocarcinoma, NSCLC, and melanoma. Median treatment duration was 15 months, with 60% achieving tumor reduction or stable disease. Responders showed 4- to 13-fold increases in plasma IFN-γ after a 14-day monotherapy run-in.

PLN-101095 was generally well tolerated, with two discontinuations due to adverse events. Pembrolizumab was administered at 200mg IV every three weeks. Pliant plans a Phase Ib expansion in NSCLC and other tumors in 2026.

08-12-2025