KEY TAKEAWAYS
- The (20139157 T-VEC) phase 1 research investigated intralesional T-VEC in patients with CBLC.
- The response criteria for intratumoral therapies and CTCAE v5 criteria were used to assess the effectiveness and safety of injected and non-injected lesions.
- The results show that intralesional T-VEC can effectively induce clinical responses and activate the immune response in CBCL lesions.
Ihis single center, single-arm, open-label phase I clinical trial involved patients (pts) with cutaneous B-cell lymphoma (CBCL) who received intralesional oncolytic virotherapy with Talimogene laherparepvec (T-VEC). The first injection of ≤4ml x 106 PFU/ml was followed by a higher dose of ≤4ml x 108 PFU/ml after 3 weeks, and subsequent injections were given every two weeks for 8 injections.
Researchers assessed the effectiveness and safety of injected and non-injected lesions by using the response criteria for intratumoral therapies and CTCAE v5 criteria. They also collected tumor biopsies before and during treatment to assess T-VEC-induced tissue changes. To evaluate these changes, multiplex immunohistochemistry for CD3, CD8, CD79a, CD56, CD11c, and FoxP3, and Akoya Bioscience technology were used.
Nineteen patients with three different subtypes of primary cutaneous B-cell lymphomas (pCBCL) were part of the trial, including marginal zone lymphoma (8 patients), follicle center lymphoma (8 patients), and diffuse large B-cell lymphoma (3 patients). The median age of the patients was 60 y, with a range of 33-85y. Of the 19 patients, 18 received at least one T-VEC injection, with a median of seven injections. One patient withdrew consent before treatment started. Twelve (67%) had a positive response to the injected lesions among the patients who received injections, while two (11%) had complete responses.
The study reported treatment-related adverse events (trAEs) in 73% of patients, with one of them being grade 3. The most common trAEs reported were fever and flu-like symptoms, with each affecting 32% of patients. In terms of tissue analysis, 12 cases were examined, and it was found that CD79a+ cells decreased across the board after two T-VEC injections. Additionally, CD8+ cells increased, and FoxP3+ cells decreased in responding lesions, whereas non-responding lesions only showed marginal changes. Finally, it was found that T-VEC led to an increase of CD56+ cells in all analyzed samples.
Intralesional T-VEC proved to be effective in inducing clinical responses and activating immune responses in CBCL lesions. It is well tolerated without unexpected toxicities and should be investigated in more extensive clinical trials.
Source: https://eado2023.com/wp-content/uploads/2023/04/Abstract-Band_EADO2023_Stand-21-04-2023-kl.pdf
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03458117
MD PhD Egle Ramelyte1,2, MD Natalia Maria Roshardt Prieto1,2, Laura Pawlik1,2, MD Ramon Staeger1,2, MD Julia-Tatjana Maul1,2, Federica Sella1,2, PhD Patrick Turko1, Prof Reinhard Dummer1,2 1 University Hospital Zurich, Zurich, Switzerland / 2 Medical Faculty, University of Zurich, Zurich, Switzerland.
