JNJ-190 Plus Anti–PD-1 Immune Checkpoint Inhibitors Generate Early Antitumor Activity in HNSCC

The novel intratumoral agent JNJ-1900 (NBTXR3) activated by radiotherapy given in combination with anti–PD-1 immune checkpoint inhibitors (ICIs), including pembrolizumab (Keytruda) and nivolumab (Opdivo), demonstrated preliminary antitumor activity for the treatment of patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC), according to updated data from the phase 1 Study 1100 (NCT03589339) presented at the 2025 ASTRO Annual Meeting.1

Historically, objective response rates (ORR) in patients with recurrent and/or metastatic HNSCC treated with ICI monotherapy have remained limited, specifically with ORRs ranging from approximately 13% to 18%. Additionally, the historical median overall survival is approximately 8 to 12 months. Updated findings from Study 1100 demonstrated that among evaluable patients who were anti–PD-1 naive (n = 41), the injected-lesion disease control rate (DCR) was 95%, with an injected-lesion disease ORR of 66% and a local progression-free survival (PFS) of 34.4 months (95% CI, 12.8-not reached [NR]). Furthermore, in evaluable patients who were anti–PD-1 resistant (n = 50), the injected-lesion DCR was 94%, the injected-lesion ORR was 50%, and the local PFS was 7.3 months (95% CI, 5.7-NR).

“Through the evaluation of JNJ-1900 cohorts 1 and 2 of Study 1100, we are ensuring that we prioritize the clinical development of innovation that acts both locally and systemically to address the unmet needs of patients with recurrent/metastatic HNSCC,” lead study investigator Colette Shen, MD, PhD, stated in a news release. “Our findings from Study 1100 have consistently supported a well-tolerated safety profile with early efficacy signals, and I look forward to further investigation of JNJ-1900 as a potentially new and complementary therapeutic option for patients.”

What Were the Additional Early Efficacy and Safety Data?

In evaluable patients who were anti–PD-1 naive, the DCR per RECIST 1.1 criteria was 63%, with an ORR per RECIST 1.1 criteria of 37%. Moreover, evaluable patients with anti–PD-1 resistance experienced a DCR per RECIST 1.1 criteria of 74% and an ORR per RECIST 1.1 criteria of 32%.

Notably, overall survival (OS) data are expected to mature with additional follow-up. Early findings demonstrated that in evaluable patients who were anti–PD-1 naive, the median OS was 15.5 months (95% CI, 11.0-NR). In evaluable patients with anti–PD-1 resistance, the median OS was 11.4 months (95% CI, 7.8-16.7).

Regarding safety, JNJ-1900 activated by radiotherapy and followed by anti–PD-1 was well tolerated and feasible in a heavily pretreated patient population (n = 103). Of note, the combination had a favorable safety profile with no additional toxicities in lesions that were injected after reirradiation. Specifically, 27 patients experienced any-grade treatment-emergent adverse effects (TEAEs) related to JNJ-1900, of which 32 patients experienced TEAEs of any grade related to the injection procedure. Among these 32 patients, 5 experienced grade 3 or greater TEAEs related to JNJ-1900, and 4 experienced grade 3 or greater TEAEs related to the injection.

In the overall patient population, 71 patients experienced any-grade TEAEs related to the regimen. If patients missed more than 1 radiotherapy session and/or a post-treatment response assessment was unavailable, they were not deemed evaluable for efficacy (n = 12).

Notably, radiotherapy-activated JNJ-1900, as a single agent or as combination therapy, is currently being evaluated across multiple solid tumor indications. In February 2020, the FDA granted JNJ-1900 fast track designation for the treatment of patients with advanced HNSCC who are ineligible for platinum-based chemotherapy.2

References

1. Nanobiotix announces updated phase 1 results continuing to support JNJ-1900 (NBTXR3) plus anti-PD-1 as a potential new 1L or 2L+ option in anti-PD-1 naive or resistant R/M-HNSCC. News release. Nanobiotix. September 19, 2025. Accessed October 3, 2025. https://ir.nanobiotix.com/news-releases/news-release-details/nanobiotix-announces-updated-phase-1-results-continuing-support
2. Nanobiotix announces fast track designation granted by U.S. FDA for investigation of first-in-class NBTXR3 in head and neck cancer. News release. February 10, 2020. Accessed October 3, 2025. https://ir.nanobiotix.com/system/files-encrypted/nasdaq_kms/news/2022/03/08/19-40-22/PR_ENGLISH-Fast-Track-Designation.pdf