Nanobiotix Reports Disease Control in 75% of Melanoma Trial Patients
Key Facts
Nanobiotix announced on October 24 the final results of a Phase 1 study evaluating JNJ-1900 (NBTXR3) with immune checkpoint inhibitors in patients with primary cutaneous melanoma resistant to PD-1 therapies. The study recorded a disease control rate of 75%, or 18 of 24 patients, according to company data. Median progression-free survival was 6.9 months, while median overall survival reached 17.8 months. The announcement came after trading closed on October 23, so that day's prices do not represent the market's response to results published the following day. EL7 data showed the stock closed at $21.08 on October 19, then at $29.36 on October 23.
The study included 24 patients who had previously received intensive treatments, 14 of whom had stage IV disease. Participants received a single intratumoral injection of the treatment, followed by stereotactic body radiation therapy. They then received nivolumab or pembrolizumab, both immune checkpoint inhibitors evaluated in the study. The research focuses on patients who did not respond to PD-1-targeting therapies, the group identified in the company's announcement as the subject of the evaluation. These details put the disease control and survival results in the context of a small group of patients with advanced disease and extensive prior treatment.
In an exploratory analysis of plasma samples from a subgroup of 8 patients, the cytokine IL-1β recorded the largest increase from baseline among the cytokines evaluated. The company reported this change as an exploratory analysis result alongside the study's clinical findings. The analysis was limited to the subgroup from which samples were collected, while the disease control rate and survival measures were based on the 24-patient study. The measurement of change from baseline adds a biological detail to the report, but does not change the clinical outcome figures announced by the company. The company published the analysis as part of the study's final results presentation.
The investigators said, "These are early data from a single-arm study, and they support testing the approach in a randomized trial." The study design limits the ability to compare results directly with a control group, as it did not include a randomized comparison arm. The lead investigator also said responses appeared in both injected and non-injected lesions, a finding the company included in its results statement. The investigators' conclusion calls for evaluating the approach in a randomized trial, the next research step cited in the statement. The statement did not announce a new regulatory approval or a result proving the treatment's commercial success.
The company's filing with the U.S. Securities and Exchange Commission defines JNJ-1900 (NBTXR3) as a radiotherapy-activated therapeutic candidate and says its licensee, Janssen, a Johnson & Johnson subsidiary, is responsible for its global development and commercialization. On its financial resources, Nanobiotix had cash and cash equivalents of about €110.9 million on June 30, 2026, compared with €52.8 million on December 31, 2025. The company said it expects to fund its operations through 2029. These figures provide financial context for development of the candidate, while the research step identified by the investigators remains testing it in a randomized trial. The results statement did not specify a timeline for that trial.