Pliant Therapeutics Presents Positive Phase 1 Data for PLN-101095 in Solid Tumors

Combination therapy shows deepening tumor responses and increased time on treatment in difficult-to-treat cancers

Apr. 18, 2026 at 7:31pm

Got story updates? Submit your updates here. ›

A highly detailed, translucent X-ray image showing the intricate internal structures of a human lung tumor, with glowing, ghostly lines and shapes against a dark background, conveying the scientific and medical nature of this cancer research.Cutting-edge X-ray imaging technology sheds light on the complex inner workings of cancer tumors, offering new hope for patients resistant to standard immunotherapies.South San Francisco Today

Pliant Therapeutics announced the presentation of updated data from its Phase 1 trial of PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. The results showed confirmed responses with an average maximum tumor reduction of 89% and a median time on treatment of 19 months in heavily pretreated patients.

Why it matters

PLN-101095 is designed to inhibit integrins that can suppress the immune response, potentially reinvigorating the body's ability to fight cancer in patients who have become resistant to existing immunotherapies. These positive Phase 1 results demonstrate the potential of this novel combination therapy to address a significant unmet need for patients with difficult-to-treat, ICI-refractory solid tumors.

The details

The Phase 1 trial enrolled 16 patients with 10 different tumor types, including both primary and secondary refractory patients. Patients were treated with PLN-101095 monotherapy for 14 days, followed by the addition of pembrolizumab. The data showed one confirmed complete response, two confirmed partial responses, and one unconfirmed partial response in patients with cholangiocarcinoma, non-small cell lung cancer, melanoma, and head and neck squamous cell carcinoma. Responding patients experienced an average baseline tumor reduction of 89% and a median time on treatment of 19 months. Increases in interferon-gamma and PD-L1 levels were observed in responders, suggesting PLN-101095 may enhance the immune response.

  • The data was presented at the 2026 AACR Annual Meeting on April 18, 2026.
  • Pliant has initiated a Phase 1b indication expansion trial, with interim data expected in 2027.

The players

Pliant Therapeutics, Inc.

A clinical-stage biopharmaceutical company focused on the discovery and development of integrin-based therapeutics, including PLN-101095 for the treatment of ICI-refractory solid tumors.

Timothy A. Yap, MBBS, Ph.D.

Medical Oncologist and Physician-Scientist at the University of Texas MD Anderson Cancer Center, who presented the Phase 1 data on PLN-101095.

Bernard Coulie, M.D., Ph.D.

Chief Executive Officer of Pliant Therapeutics.

Got photos? Submit your photos here. ›

What they’re saying

“One of the ways that the tumor microenvironment can suppress responses to immune checkpoint inhibitors is through a process that is activated by integrins to upregulate TGF-β. PLN-101095 is designed to inhibit the integrins before they can ever do that, which gives it significant potential to stimulate or reinvigorate the immune response to cancer.”

— Timothy A. Yap, MBBS, Ph.D., Medical Oncologist and Physician-Scientist

“These encouraging results show a deepening of baseline tumor reductions in confirmed responders and an increased median time on treatment with PLN-101095 in patients with difficult-to-treat ICI refractory tumors. We have initiated the Phase 1b trial to expand this novel combination therapy in specific tumor types to address patients in need and deliver value to our investors.”

— Bernard Coulie, M.D., Ph.D., Chief Executive Officer

What’s next

Pliant has initiated a Phase 1b open-label indication expansion trial enrolling three cohorts of patients with NSCLC, tumors with high tumor mutational burden, or clear cell renal cell carcinoma. Interim data from this trial is expected in 2027.

The takeaway

These positive Phase 1 results for PLN-101095 in combination with pembrolizumab demonstrate the potential of this novel therapy to address the significant unmet need for patients with difficult-to-treat, ICI-refractory solid tumors. The upcoming Phase 1b expansion trial will further evaluate the efficacy of this combination in specific tumor types.