Nanobiotix(US:NBTX)2025-09-18 13:02Summary of Nanobiotix Conference Call on Melanoma Study Results Company and Industry - Company: Nanobiotix - Industry: Oncology, specifically focused on melanoma treatment Core Points and Arguments 1. Study Overview: The conference call discussed new data from the third cohort of the Phase I 1100 study in melanoma, presented at the ImmunoRad Conference in Paris [2][4] 2. Product Focus: NBTXR3 is designed for patients receiving radiation therapy, which constitutes around 60% of cancer patients. The product aims to address unmet medical needs in patients who have failed multiple lines of treatment [4][5] 3. Patient Recruitment: A total of 21 patients were recruited for the study, with 19 evaluable for efficacy. The majority of these patients were advanced stage III and IV melanoma patients who had failed PD-1 and other treatments [6][8] 4. Efficacy Results: The study reported an overall response rate of 47%, with 9 out of 19 patients achieving complete response (CR) or partial response (PR). The disease control rate (DCR) was noted to be 78% [9][15] 5. Safety Profile: No grade four or five adverse events were reported related to NBTXR3, and the safety profile was consistent with previous trials [7][15] 6. Overall Survival: The median overall survival (OS) was reported at 14.6 months, with a confidence interval ranging from 11.6 months to non-reach [11][12] 7. Immune Response: There is a potential for NBTXR3 to prime an immune response, particularly in patients who have exhausted other treatment options. This was suggested by the correlation between injected irradiated lesions and systemic responses [11][20] 8. Future Development Plans: The company is considering further development of NBTXR3 in earlier treatment settings for melanoma and potentially in combination with other therapies [25][27] Additional Important Content 1. Regulatory Considerations: Future trials will need to be discussed with regulatory agencies like the FDA, especially regarding the control arm for randomized trials [21][22] 2. Comparative Context: The median OS of 14.6 months compares favorably to historical data for similar patient populations, where median OS after failure of PD-1 treatments is around 6.8 months [44][45] 3. Pipeline Strategy: Nanobiotix is exploring multiple indications for NBTXR3, with ongoing trials in head and neck cancer and lung cancer being run by Janssen [27][49] 4. Patient Characteristics: The study did not find significant baseline characteristics that influenced treatment outcomes, indicating a broad applicability of NBTXR3 across different patient profiles [33][39] This summary encapsulates the key findings and discussions from the Nanobiotix conference call, highlighting the potential of NBTXR3 in treating advanced melanoma and the company's strategic direction moving forward.