ATLAS-IT-05 is a Phase II open label clinical trial with LTX-315 in combination with Keytruda® (pembrolizumab) in stage III-IV melanoma patients refractory to treatment with PD-1 / PD-L1 inhibitors.
The poster presents early preliminary clinical data from 20 patients (14 patients for efficacy) with advanced melanoma who have failed a checkpoint inhibitor and have a poor prognosis. Most of the enrolled patients have failed on several lines of treatment, including combined checkpoints or BRAF/MEK inhibition. The results are based on an early read out from the study with a median follow-up of 15 weeks.
The combination with LTX-315 and pembrolizumab demonstrates prolonged stabilization in this heavily pre-treated patient population with a disease control rate of 43% and at this early time point showing one patient achieving a partial response. Almost half of the patients are continuing on the trial.
Some patients have shown impressive evidence of significant tumor shrinkage in both injected and non-injected lesions, and LTX-315 was well-tolerated with general mild to moderate treatment related adverse events.
The trial is currently ongoing, and the interim data are considered immature - further details will be shared in a future presentation. The patients are still early in the treatment course, and conclusions drawn from this interim report could change over time.
Dr. Øystein Rekdal, Chief Executive Officer at
"Even though these data are early, we are encouraged by the promising signs of efficacy seen so far. We are looking forward to seeing the results from the full cohort of patients enrolled in the study, followed over a longer time period. We expect to report top line data from 20 patients in Q1 2024. We are also in the process of submitting an amendment for the initiation of an expansion cohort with up to 20 additional patients."
Details for the poster session are as follows:
Poster Title: Intratumoral injection of LTX-315 in combination with pembrolizumab in patients with advanced melanoma refractory to prior PD-1/PD-L1 therapy: interim results from the ATLAS-IT-05 trial
Presenter:
Poster Number: 1051P
Session: Investigational immunotherapy
Session Date and Time:
Session Location: Hall 8
The poster and webcast presentation are available on Lytix's website; https://www.lytixbiopharma.com
Webcast and Q&A
Øystein Rekdal, Chief Executive Officer, and
The webcast and subsequent Q&A session will be held in English and may be viewed live by registering here: https://forms.office.com/e/aiR9KtDQKL
For more information, please contact:
Gjest Breistein, CFO: gjest.breistein@lytixbiopharma.com
Lytix in brief:
Based in
https://news.cision.com/lytix-biopharma-as/r/encouraging-preliminary-data-from-lytix-biopharma-s-atlas-it-05-study-presented-at-esmo-2023,c3858450
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