On 06 Dec 2023, the latest clinical findings of Igrelimogene litadenorepvec were unveiled at the 2023 ESMO_IO, demonstrating its potential benefit and setting the stage for subsequent investigations.
Igrelimogene litadenorepvec, also called TILT-123, is an oncolytic virus drug that targets IL-2 and TNF-α. It is being developed by TILT Biotherapeutics Oy and has reached Phase 1 of clinical trials globally. The drug is primarily focused on treating various types of cancers, including Non-Small Cell Lung Cancer, Melanoma, Squamous Cell Carcinoma of Head and Neck, Ovarian Cancer, Solid tumor, and Metastatic melanoma. These therapeutic areas cover a wide range of neoplasms, endocrinology and metabolic diseases, respiratory diseases, skin and musculoskeletal diseases, and urogenital diseases.
According to the Patsnap Synapse, Igrelimogene litadenorepvec is in Phase 1 of clinical development. And the clinical trial distributions for Igrelimogene litadenorepvec are primarily in France and Denmark. The key indication is Metastatic melanoma.
This single group assignment, open-labeled clinical trial (NCT04217473) was aimed to evaluate the safety and efficacy of combined treatment with tumor infiltrating lymphocytes (TILs) and oncolytic adenovirus TILT-123 for patients with metastatic melanoma.
In this study, patients with stage IV melanoma were treated with multiple intravenous and intratumoral injections of TILT-123 and a one- or two-time treatment with TILs. TILs were grown from resected tumor tissue and administered without pre- or post-conditioning treatment regimens. The primary endpoint of the study was safety of TILT-123. Secondary endpoints included safety and efficacy of TILT-123 in combination with TILs.
The result showed that sixteen patients with CPI resistant progressive cutaneous (7), mucosal (5) and uveal (4) metastatic melanoma were treated. Median age was 65.5 years (25-75). The most frequently reported adverse events (AEs) related to TILT-123 were fever (63%) and pain at the injection site (44%) while most frequent AEs related to TIL therapy were fever (50%) and chills (24%). No dose-limiting toxicity was observed and the combination of TILT-123 and TIL therapy did not increase the severity of AEs. 31% of patients experienced treatment related serious adverse events. In d78 imaging, RECIST1.1 responses were seen in two patients while disease control rate was 38 %. Responders included one patient (cutaneous) with an ongoing partial response and one patient (mucosal) with a durable complete response. Further, two patients (uveal and cutaneous) had long lasting stable disease (> 10 months). PET evaluation on d78 revealed disease control in 6/13 evaluable patients, including 4 partial or minor responses. On d36, after 4 injections of TILT-123 and before TILs, 4 partial or minor responses were seen in PET.
It can be concluded that the combination of TILT-123 and TIL therapy is safe and feasible in patients with metastatic melanoma. Clinical activity in hard-to-treat melanoma subtypes was observed.
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