Early NBTXR3 Trial Data in Esophageal Cancer Show 85% Disease Control Rate and Feasible Injection Approach
Study Finds High Response Rates and Tolerability in Challenging Patient Group
Newly released Phase 1 data from Nanobiotix’s JNJ-1900 (NBTXR3) clinical trial mark a significant development for patients with locally advanced esophageal adenocarcinoma. In the first two dose escalation cohorts, researchers found that endoscopic injection of NBTXR3 combined with chemoradiation not only proved feasible in all 13 treated patients but also delivered an impressive 85% disease control rate and a 69% objective response rate—including six complete and three partial responses.
Treatment Protocol Well-Tolerated with Confirmed Safety Profile
The safety data is especially notable. All participants (n=13) experienced some form of treatment-emergent adverse event, yet only two experienced more severe (grade 3+) events attributable to NBTXR3. There were no severe events tied to the injection itself, and no periprocedural or delayed adverse effects were observed. The recommended Phase 2 dose was established at 33% of the gross tumor volume (GTV).
| Efficacy/Outcome | Results (n=13) |
|---|---|
| Disease Control Rate (DCR) | 85% (11/13) |
| Objective Response Rate (ORR) | 69% (9/13) |
| Complete Responses | 6 |
| Partial Responses | 3 |
| TEAEs Related to NBTXR3 (any grade) | 6 |
| TEAEs Grade 3+ (related to NBTXR3) | 2 |
| Severe Injection-related Events | 0 |
Why These Results Matter: Clinical Context and Implications
Esophageal cancer remains among the most difficult to treat, often requiring highly invasive surgeries like esophagectomy, which can lead to substantial comorbidities and affect quality of life. The robust control and response rates observed with NBTXR3, alongside its tolerability, raise hopes for therapies that may help avoid or lessen the extent of surgical intervention. As principal investigator Dr. Steven Lin noted, these results suggest that local tumor control can be enhanced while potentially sparing patients from some of the most challenging surgical risks.
Recruitment Ongoing as Study Seeks to Expand Efficacy Evidence
The current analysis stems from the dose escalation phase, with 17 more patients slated for inclusion as part of the ongoing study expansion. Importantly, this trial may pave the way for a new indication for NBTXR3—not only with standard photon radiation but also as a radioenhancer for proton radiation therapy, broadening its clinical potential.
Next Steps for NBTXR3: From Proof-of-Concept to Broader Solid Tumor Trials
NBTXR3 is built on a physics-based mechanism, using hafnium oxide nanoparticles that, when injected and activated by radiotherapy, induce significant tumor cell death and potentially trigger longer-term anti-cancer immunity. The ongoing NANORAY-312 study in head and neck cancers and various collaborative trials with MD Anderson and Janssen underline its scalability and strategic significance.
What Should Investors and Patients Watch Next?
While these results are still early and part of a Phase 1 study, they deliver a compelling signal for the feasibility and potential efficacy of NBTXR3 in hard-to-treat cancers. Ongoing and future expansions will be critical to confirming its promise—especially regarding reduced surgical needs and long-term outcomes. For now, both clinicians and stakeholders will be watching as Nanobiotix continues to expand patient recruitment and pushes this novel therapy toward more definitive trials.
Contact:
Nanobiotix Investor Relations (US): investors@nanobiotix.com
Nanobiotix Investor Relations (EU): investors@nanobiotix.com
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