Nanobiotix has presented complete outcomes from the dose escalation and dose expansion phases of the Phase I trial of JNJ-1900 (NBTXR3) in treating individuals with locally advanced or borderline resectable pancreatic cancer (LAPC or BRPC).
The University of Texas MD Anderson Cancer Center (MD Anderson), US, carried out the study.
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The study aimed to assess this radiotherapy-activated treatment in overcoming the radioresistance typically seen in these patients.
The majority of the trial’s subjects had locally advanced, unresectable disease. The treatment replaced the standard concurrent chemoradiation with JNJ-1900 (NBTXR3) following induction chemotherapy.
According to the company, the results showed a median overall survival of 23 months and a median local progression-free survival of 13.3 months, with a favourable safety profile and injection feasibility.
For context, an MD Anderson historical review indicated a median overall survival of 19.2 months for patients treated with the standard approach.
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By GlobalDataAdditionally, exploratory biomarker analyses revealed that 40% of patients exhibited increased circulating tumour mutational burden (cTMB), which was associated with improved survival outcomes.
Moreover, 59% of subjects saw normalisation of cancer antigen 19-9 (CA19-9) levels, and was linked with longer survival in the study.
Based on the preliminary efficacy and safety outcomes, investigators of the trial concluded that further assessment of the therapy is warranted in a randomised trial.
MD Anderson has obtained clearance from the Food and Drug Administration (FDA) to broaden the study to include a new cohort combining the therapy with standard of care concurrent chemoradiation post-induction chemotherapy.
The first subject in this new cohort has already been injected, and recruitment is underway.
MD Anderson Radiation Oncology associate professor Eugene Koay said: “Patients with locally advanced or borderline resectable pancreatic cancer face a particularly urgent unmet need for therapeutic innovation that can provide a meaningful survival benefit with an acceptable safety profile.
“We are encouraged by the results from the completed cohorts and look forward to the continued evaluation of JNJ-1900 (NBTXR3) in combination with standard-of-care chemoradiation after induction chemotherapy.”
The company noted that JNJ-1900 (NBTXR3) consists of functionalised hafnium oxide nanoparticles, delivered via a one-time intratumoural injection.
