NANOBIOTIX Reports New Data for Potential First-in-Class Radioenhancer NBTXR3 in Combination With Anti-PD-1 Showing Local or Distant Tumor Regression in 76.9% of Evaluable Patients Regardless of Prior Anti-PD-1 Exposure - Seite 2

Priming Immune Response and Immunotherapy Combination in Advanced Cancers

Abstract #2590: A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD-1 Therapy

Background

The Nanobiotix phase I study of NBTXR3 activated by radiotherapy for patients with advanced cancers treated with an anti-PD-1 therapy (Study 1100), is a multicenter, open-label, non-randomized phase I dose escalation with dose expansion study to establish the recommended phase II dose (RP2D) of NBTXR3 plus radiotherapy in combination with anti-PD-1 in three (3) cohorts: (i) inoperable locoregional recurrent or recurrent and metastatic head and neck cancer (R/M head and neck squamous cell carcinoma; R/M HNSCC); (ii) lung metastasis; (iii) liver metastasis. The study is being administered in the United States.

The secondary endpoints are objective response rate (ORR), safety and feasibility, and body kinetic profile.

Updated Results

Safety

NBTXR3 administration by intratumoral injection was feasible and well-tolerated. To date, the overall adverse event (AE) profile has not differed from what is expected with radiotherapy or anti-PD-1 agents. 16 serious AEs were observed, of which four (4) were identified as NBTXR3 or injection related.

Efficacy

As of the data cut-off, 16 patients in the study received NBTXR3 plus radiotherapy and 13 were evaluable for response. Tumor regression was observed in 76.9% (10/13) of evaluable patients, regardless of prior anti-PD-1 exposure. The study reported tumor regression in 80% (4/5) of anti-PD-1 naïve patients and 60% (3/5) had investigator-assessed objective response, including one (1) complete response according to response evaluation criteria outlined in RECIST 1.1. In patients with prior primary or secondary resistance to anti-PD-1, 75% (6/8) had tumor regression and 50% (4/8) had investigator-assessed objective response. These included one (1) complete response and two (2) partial responses by RECIST 1.1, along with one (1) additional investigator-assessed pathological complete response. Some patients in the study showed delayed tumor response and/or abscopal effect, suggesting NBTXR3 may potentially prime an immune response.