Nidlegy (darleukin/fibromun)

P2, N=92, Not yet recruiting, Philogen S.p.A.

P2, N=92, Not yet recruiting, Philogen S.p.A.

P2, N=180, Not yet recruiting, Philogen S.p.A.

P=N/A, N=70, Not yet recruiting, Centre Hospitalier Universitaire de Nice

The mRNA-based treatment combined with checkpoint inhibitors have the potential to induce long-term immune responses. The efficacy of LAG-3 inhibitors in the adjuvant setting is currently under evaluation in clinical studies. The immunocytokine treatment with daromun shows promising results in the neoadjuvant setting by stimulating both local and systemic immune responses. Future studies should focus on identifying optimal combinations of treatment to improve the long-term prognosis of patients.

Diphenciprone, imiquimod and 5-florouracil were included as topical treatments and bacillus Calmette-Guerin, interleukin 2, rose bengal, talimogene laherparepvec and electrochemotherapy were included as intralesional treatments. Brief comments on other alternatives in development such as interferon-alpha, interleukin-12, ipilimumab and intralesional daromun are presented...It has also been described in a few papers that non-injected lesions may respond after the application of a local therapy in distant skin-metastases. Many of these intralesional treatments are being combined in different investigations with systemic immunotherapies, with the aim of obtaining synergic responses in those patients with refractory disease.

P2, N=162, Recruiting, Philogen S.p.A. | Active, not recruiting --> Recruiting | Initiation date: Dec 2023 --> Jul 2024

P3, N=214, Active, not recruiting, Philogen S.p.A. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2028

P3, N=214, Recruiting, Philogen S.p.A. | Trial primary completion date: Dec 2023 --> Oct 2024

P2, N=162, Active, not recruiting, Philogen S.p.A.

P2, N=40, Recruiting, Philogen S.p.A. | Trial completion date: Feb 2023 --> Sep 2024 | Trial primary completion date: Nov 2022 --> Sep 2024

In addition, results from clinical trials with Nidlegy in high-risk basal cell carcinoma patients, candidates for disfiguring surgery who experienced durable complete responses, will be shared. Other clinical trial results in “difficult-to-treat tumors” will be discussed.