Nanobiotix Shares Positive Data from MD Anderson-Led Phase I Study in Pancreatic Cancer
JNJ-1900 (NBTXR3), a novel, potentially first-in-class oncology therapy, demonstrated a median overall survival of 23 months from date of diagnosis as well as a favorable safety profile.
Nanobiotix has announced full results from a Phase I study evaluating its novel therapy, JNJ-1900 (NBTXR3), in patients with locally advanced or borderline resectable pancreatic cancer (LAPC or BRPC). The trial, conducted by The University of Texas MD Anderson Cancer Center, showed a favorable safety profile and injection feasibility as well as a median overall survival (mOS) of 23 months from the date of diagnosis. Results from the trial were presented at the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025).1
In a press release, Eugene Koay, MD, PhD, associate professor of radiation oncology at MD Anderson, 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.”
In addition to the mOS mark of 23 months, JNJ-1900 (NBTXR3) demonstrated a median local progression-free survival (LPFS) of 13.3 months from completion of radiation. The biomarker analysis of the study showed normalization of CA19-9, a surrogate for overall survival benefit, was observed in 59% of patients and was associated with longer survival in the trial.
The Phase I study, sponsored by MD Anderson, evaluated the potential of radiotherapy(“RT”)-activated JNJ-1900 (NBTXR3) activated by radiation therapy (45 Gy in 15 fractions) to overcome inherent radioresistance in patients with LAPC or BRPC. In the dose escalation and dose expansion parts of the trial, the treatment regimen replaced concurrent chemoradiation with RT-activated JNJ-1900 (NBTXR3) after induction chemotherapy.
“Our collaboration with MD Anderson has always been driven by a shared commitment to exploring bold new approaches for patients with high unmet need. Given the extremely poor survival rates in LAPC and BRPC, the results from this Phase I study give us confidence in the potential of JNJ-1900 (NBTXR3) to serve as a meaningful addition to the treatment landscape. We are particularly excited about the potential to further enhance outcomes through combination of JNJ-1900 (NBTXR3) with SOC chemoradiation in the study’s new active cohort, and we look forward to advancing this program in pancreatic cancer,” Louis Kayitalire, MD, chief medical officer at Nanobiotix, said in the press release.
Nanobiotix is also evaluating JNJ-1900 (NBTXR3) in locally advanced non-small cell lung cancer. Earlier in March, the company shared its first data from another Phase I study evaluating JNJ-1900 (NBTXR3) as a second or later line therapy.2
Once again, results from the trial showed a favorable safety profile along with injection feasibility. A preliminary review of survival data showed a 12-month LPFS of 64% (median 18.6 months) and a 12-month OS of 83% (median 30.2 months).
In a press release from the time, Kayitalire said: “The Nanobiotix team is encouraged by these early findings, which suggest NBTXR3 (JNJ-1900) could offer a new therapeutic option for patients with no alternatives after prior treatments have failed. Notably, these results were observed in patients who resisted prior curative radiation doses and that were treated with JNJ-1900 (NBTXR3) activated by a lower radiation dose. As we advance the study’s expansion phase, we look forward to further evaluating NBTXR3 (JNJ-1900)’s potential to improve patient outcomes.”
References
1. Nanobiotix Announces Full Results From Completed Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Pancreatic Cancer. News release. Nanobiotix. May 5, 2025. Accessed May 6, 2025. https://ir.nanobiotix.com/news-releases/news-release-details/nanobiotix-announces-full-results-completed-phase-1-study
2. Nanobiotix Announces First Data From the Completed Dose Escalation Part of a Phase 1 Study Evaluating NBTXR3 (JNJ-1900) as a 2L+ Therapy for Patients With Locally Advanced NSCLC. News release. Nanobiotix. March 27, 2025. Accessed May 6, 2025. https://ir.nanobiotix.com/news-releases/news-release-details/nanobiotix-announces-first-data-completed-dose-escalation-part
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