French biotechnology firm Nanobiotix unveiled clinical data at the European Society for Medical Oncology congress in Madrid, showing that its investigational intratumoral candidate JNJ-1900 achieved a 41.7 percent objective response rate in 24 heavily pre-treated patients with advanced cutaneous melanoma resistant to immunotherapies.
NBTXR3 Injections Show 41.7 Percent Objective Response Rate
- Intratumoral Injection: The experimental drug NBTXR3 is injected directly into the tumor site rather than given through the bloodstream, concentrating the physical activation where it is needed most.
- Combination Therapy: Patients received the local injection paired with stereotactic body radiation therapy, followed by standard immune checkpoint inhibitors like pembrolizumab or nivolumab.
- Objective Response Rate: In this small phase 1 trial, 41.7 percent of the participants experienced measurable shrinkage or disappearance of their tumors after exhausting other standard options.
Clinical Efficacy and Survival Benchmarks in Advanced Melanoma
According to clinical data presented by boursorama.com and abcbourse.com, the phase 1 trial evaluated 24 patients whose cutaneous melanoma had continued to progress despite prior lines of therapy, including anti-PD-1 immune checkpoint inhibitors. Investigators utilizing RECIST 1.1 evaluation criteria observed confirmed tumor responses in 10 of the 24 participants, which established the 41.7 percent objective response rate. Among those responders, four patients achieved complete responses, meaning all measurable lesions disappeared. abcbourse.com noted that the disease control rate—encompassing both partial responses and stable disease—reached 75 percent across 18 of the 24 patients.
Survival metrics from the trial indicated a median progression-free survival of 6.9 months and a median overall survival of 17.8 months. Historical literature typically points to a median progression-free survival of approximately three months and an overall survival near one year for comparable patient populations with limited alternatives. Exploratory biomarker analyses of a subset of eight patients revealed an upregulation of interleukin-1 beta (IL-1beta), a cytokine implicated in antitumor immune activation.
| Clinical Endpoint | Phase 1 Trial Results (N=24) | Historical Literature Baseline |
|---|---|---|
| Objective Response Rate (ORR) | 41.7% (10/24 patients) | Not formally established for refractory cohort |
| Disease Control Rate (DCR) | 75.0% (18/24 patients) | Variable |
| Progression-Free Survival (Median) | 6.9 months | ~3 months |
Safety Profile and Regulatory Next Steps for NBTXR3
The combination of NBTXR3, radiotherapy, and anti-PD-1 immunotherapy demonstrated an acceptable safety profile without introducing new or unexpected toxicity signals in a fragile, heavily pre-treated cohort. Dr. Louis Kayitalire, medical director of Nanobiotix, addressed the findings through boursorama.com, stating that “dans l’ensemble, le profil de sécurité acceptable et les premiers signes d’efficacité observés par les investigateurs dans ces résultats préliminaires constituent des signaux encourageants et justifient une évaluation plus approfondie dans le cadre d’essais randomisés de plus grande envergure” (overall, the acceptable safety profile and the early signs of efficacy observed by investigators in these preliminary results constitute encouraging signals and justify further evaluation within the framework of larger-scale randomized trials).
Developed in partnership with Johnson & Johnson, NBTXR3 is designed to physically destroy cancer cells when activated by radiation while simultaneously sparking a systemic immune response. Because the current phase 1 trial lacked a control group and relied on a small sample size, randomized trials of larger scale will be necessary to confirm these first signals of efficacy and determine the actual clinical benefit of this approach.
References
- European Society for Medical Oncology (ESMO) Annual Congress Proceedings, Madrid.
- Clinical Data Coverage on Nanobiotix (JNJ-1900 / NBTXR3).
- ABC Bourse Financial and Clinical Reporting on Phase 1 Cutaneous Melanoma Trial.
Disclaimer: This article is for informational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Always consult a licensed healthcare professional for individualized guidance regarding cancer care.
