Nidlegy (darleukin/fibromun) / Philogen, Sun Pharma - LARVOL DELTA

Real-world outcomes of intralesional immunocytokines (daromun) in patients with advanced melanoma: the Daromel study, a multicenter observational study of the French Group of Skin Cancers (Groupe de Cancérologie Cutanée) (ESMO 2026) - No abstract available

Clinical • Metastases • Observational data • Real-world • Real-world evidence • Melanoma • Oncology • Skin Cancer • Solid Tumor

Daromun as neoadjuvant therapy in resectable melanoma: influence on PD-L1 expression and increased response rate to adjuvant immunotherapy (ADO 2026) - No abstract available

Clinical • IO biomarker • Melanoma • Solid Tumor • PD-L1

Daromun as neoadjuvant therapy in resectable melanoma: influence on PD-L1 expression and increased response rate to adjuvant immunotherapy (ADO 2026) - No abstract available

Clinical • IO biomarker • Melanoma • Solid Tumor • PD-L1

Daromun in clinical practice: from study success to real-world challenges – a case study (ADO 2026) - No abstract available

Case study • Clinical • Real-world • Real-world evidence • Melanoma • Oncology • Solid Tumor

Daromun in clinical practice: from study success to real-world challenges – a case study (ADO 2026) - No abstract available

Case study • Clinical • Real-world • Real-world evidence • Melanoma • Oncology • Solid Tumor

Neoadjuvant intralesional Daromun therapy in the early access program for resectable stage III melanoma: Real-world data to identify potential prognostic factors and predictors (ADO 2026) - No abstract available

Biomarker • Clinical • Real-world • Real-world evidence • Melanoma • Solid Tumor

Neoadjuvant intralesional Daromun therapy in the early access program for resectable stage III melanoma: Real-world data to identify potential prognostic factors and predictors (ADO 2026) - No abstract available

Biomarker • Clinical • Real-world • Real-world evidence • Melanoma • Solid Tumor

Intralesional neoadjuvant therapy with immunocytokines (Daromun) in recurrent melanoma after adjuvant immunotherapy: a case series (ADO 2026) - No abstract available

Clinical • Melanoma • Solid Tumor

Intralesional neoadjuvant therapy with immunocytokines (Daromun) in recurrent melanoma after adjuvant immunotherapy: a case series (ADO 2026) - No abstract available

Clinical • Melanoma • Solid Tumor

Efficacy and safety of Daromun as neoadjuvant intralesional immunotherapy in locally advanced, resectable melanoma: experiences from a compassionate use program (ADO 2026) - No abstract available

Clinical • Metastases • Melanoma • Solid Tumor

Efficacy and safety of Daromun as neoadjuvant intralesional immunotherapy in locally advanced, resectable melanoma: experiences from a compassionate use program (ADO 2026) - No abstract available

Clinical • Metastases • Melanoma • Solid Tumor

Daromun as neoadjuvant therapy for stage III melanoma: a comparison of two contrasting case courses regarding treatment response and side effects (ADO 2026) - No abstract available

Adverse events • Clinical • Melanoma • Solid Tumor

Systemic effect of intratumoral therapy with Daromun in locally advanced and lymphogenously metastatic malignant melanoma (ADO 2026) - No abstract available

Metastases • Melanoma • Oncology • Solid Tumor

Intralesional Daromun therapy in melanoma: Effect of standardized premedication on tolerability (ADO 2026) - No abstract available

Melanoma • Solid Tumor

Neoadjuvant intralesional daromun (L19IL2/L19TNF) in resectable locally advanced melanoma: An update on the primary outcome and sensitivity analyses (EFS) from the PIVOTAL phase 3 trial. (ASCO 2026) - P3 | "With longer FU the highly significant reduction in the risk of recurrence or death with neoadjuvant daromun in pts with locally advanced stage III melanoma is confirmed. The sensitivity EFS analyses provide consistent, confirmatory evidence of daromun's efficacy across the entire trial population and, more importantly, in the subgroup of pts with recurrent disease, regardless of any prior ST. No new safety signals were reported."

Clinical • Late-breaking abstract • Metastases • P3 data • Melanoma • Solid Tumor

Phase 3 study (PIVOTAL) of neoadjuvant intralesional daromun vs. immediate surgery in fully resectable melanoma with regional skin and/or nodal metastases. (ASCO 2024) - P2, P3 | "The analysis of the primary efficacy endpoint RFS and of secondary endpoints DMFS, pCR and safety show that neoadjuvant Daromun is an effective and safe therapeutic option for resectable, locally advanced melanoma pts."

Clinical • Late-breaking abstract • P3 data • Surgery • Cutaneous Melanoma • Immunology • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

Neoadjuvant Intralesional Targeted Immunocytokines (Daromun) in Stage III Melanoma. (PubMed, Ann Oncol) - "Neoadjuvant daromun resulted in a significantly longer RFS than upfront surgery in patients with locally advanced melanoma. TRAEs were transient and manageable. Neoadjuvant daromun is a new therapeutic option for patients with stage III melanoma, including those with locoregional recurrence after surgery and previous adjuvant therapy."

Journal • Melanoma • Oncology • Solid Tumor

Neoadjuvant Intralesional Daromun (L19IL2/L19TNF) in Resectable Locally Advanced Melanoma: An Update on the Efficacy and Safety Results of the PIVOTAL Phase III Trial. (PubMed, J Clin Oncol) - P3 | "The EFS post hoc analysis, conducted in both the overall population and the recurrent patient subgroups (with or without prior systemic therapies), provides consistency and robustness to the benefit of neoadjuvant daromun observed for the primary efficacy end point. No new safety signals of concern were recorded."

Journal • P3 data • Melanoma • Oncology • Solid Tumor

Philogen resubmits Nidlegy EMA application with 33-month follow-up data (Scanx) - "The resubmission relies primarily on data from the randomized Phase III PIVOTAL study (PH-L19IL2TNF-02/15; NCT02938299). Compared to the initial MAA filed in June 2024, the new submission extends the median patient follow-up period from 21 months to 33 months. It also includes additional post-hoc analyses focused on event-free survival....Beyond the PIVOTAL study, the dossier includes efficacy and safety data from the Phase II study PH-L19IL2TNF-02/12 (NCT02076633). It further incorporates safety data from the ongoing Phase III NeoDREAM study (PH-L19IL2TNF-01/18; NCT03567889) and safety data from the Phase II study PH-L19IL2TNFNMSC-04/19 (NCT04362722) in non-melanoma skin cancer."

EMA filing • Melanoma • Non-melanoma Skin Cancer

L19IL2/TNF in Patients With Basal Cell Carcinoma (clinicaltrials.gov) - P2 | N=92 | Recruiting | Sponsor: Philogen S.p.A. | Initiation date: Feb 2026 ➔ Sep 2026 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=92 | Recruiting | Sponsor: Philogen S.p.A. | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2026 ➔ Sep 2026

Enrollment open • Trial initiation date • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Therapy of melanoma : Current standards and future perspectives (PubMed, Pathologie (Heidelb)) - "Multimodal treatment strategies have fundamentally improved the prognosis of melanoma. Therapy selection should be individualized based on molecular markers and disease stage. Future developments aim to integrate combination strategies, personalized immunotherapeutic approaches, and the overcoming of resistance mechanisms."

IO biomarker • Journal • Review • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor • LAG3

L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC) (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Philogen S.p.A. | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2026 ➔ Jun 2026

Enrollment open • Trial initiation date • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

L19IL2/TNF in Patients With Basal Cell Carcinoma (clinicaltrials.gov) - P2 | N=92 | Recruiting | Sponsor: Philogen S.p.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Real-world evaluation of neoadjuvant Daromun (L19-IL2 and L19-TNF) within an early access program in patients with stage IIIB/C malignant melanoma (EADO 2026) - "Prior systemic adjuvant therapy with anti–PD-1 agents had been administered in 58% of patients; 3.2% had received neoadjuvant pembrolizumab. Adverse events were generally transient and clinically manageable. These findings support neoadjuvant daromun as a promising treatment approach for individuals with stage III melanoma, including patients with locoregional recurrence following prior therapies, particularly immune checkpoint inhibitors used in the adjuvant setting."

Clinical • HEOR • Real-world • Real-world evidence • Melanoma • Solid Tumor • IL2