Oslo, 23 October 2023. Lytix Biopharma - Lytix Biopharma AS ("Lytix") (Euronext
Growth Oslo: LYTIX), a clinical stage immuno-oncology company, announces that Dr
Stephane Dalle, the top recruiting investigator of the ATLAS-IT-05 study, will
give a poster presentation today at the ESMO 2023 Congress.
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 Lytix Biopharma, commented:
"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: Stephane Dalle
* Poster Number: 1051P
* Session: Investigational immunotherapy
* Session Date and Time: Monday, October 23, 2023
* Session Location: Hall 8
The poster and webcast presentation are available on Lytix's website