Lytix Biopharma ASA Reports Promising Final Phase II Results for Ruxotemitide (LTX-315) in Combination with Pembrolizumab in PD-1/PD-L1 Refractory Advanced Melanoma

21 Apr 2026 07:00 CEST

6 patients achieved disease stabilization with several durable responses ongoing
at the time of analysis (24 months)

Oslo, Norway, April 21, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”), a
clinical-stage immuno-oncology company developing novel intratumoral cancer
therapies, today announced final efficacy and safety results from its Phase II
ATLAS-IT-05 study evaluating intratumoral ruxotemitide (LTX-315) in combination
with pembrolizumab in patients with advanced melanoma who have progressed
following prior checkpoint inhibitor therapy. These data were presented at the
American Association for Cancer Research (AACR) Annual Meeting 2026, taking
place in San Diego, California.

The open-label, single-arm Phase II study enrolled primarily patients with
unresectable stage IIIB to IV metastatic melanoma accessible for intratumoral
injection, most of whom were heavily pretreated, with 52.1% having received
three or more prior lines of therapy and all having received prior
immunotherapy.

Treatment with ruxotemitide in combination with pembrolizumab demonstrated
clinically meaningful antitumor activity and a manageable safety profile in this
difficult-to-treat population.

Key efficacy findings from the study include:
• Objective response rate (ORR): 13.6% among evaluable patients (n=22)
• Clinical benefit rate (CBR): 40.9%
• Durable responses lasting beyond 24 months in responding patients
• Median progression-free survival (PFS): 6.3 months

These outcomes highlight the potential of ruxotemitide to enhance immune
responses in patients with PD-1/PD-L1 refractory melanoma, a population with
limited therapeutic options.

“The final results from the ATLAS-IT-05 study reinforce our confidence in the
ability of ruxotemitide to stimulate anti-tumor immune responses in patients who
have progressed after checkpoint inhibitor therapy,” said Øystein Rekdal, Chief
Executive Officer of Lytix Biopharma. “Importantly, the durability of responses
observed in this heavily pretreated population underscores the potential of our
intratumoral approach to generate sustained systemic immunity.”

The safety profile observed in the study was consistent with the known effects
of intratumoral immunotherapy and pembrolizumab. The most common
treatment-related adverse events were injection-site reactions (95.7%), fatigue
(30%), pruritus (26.1%), hypotension (26.1%), and anemia (21.7%). No
treatment-emergent adverse events led to discontinuation of pembrolizumab.

About the ATLAS-IT-05 Study
ATLAS-IT-05 is a Phase II clinical trial evaluating intratumoral ruxotemitide in
combination with pembrolizumab including in patients with advanced melanoma who
have progressed following prior anti-PD-1 or anti-PD-L1 therapy (NCT04796194).
Patients received up to seven intratumoral injections of ruxotemitide alongside
pembrolizumab administered every three weeks until disease progression or for up
to 24 months. Key endpoints of the study were objective response rate per RECIST
v1.1 criteria, with secondary endpoints including duration of response,
progression-free survival, overall survival and safety.

About Ruxotemitide (LTX-315)
Ruxotemitide (LTX-315) is a first-in-class oncolytic peptide designed for
intratumoral administration. The molecule disrupts tumor cells locally, leading
to the release of tumor antigens and danger-associated molecular signals that
may activate systemic anti-tumor immune responses. This mechanism has the
potential to convert immunologically “cold” tumors into “hot” tumors and enhance
responses to checkpoint inhibitor therapies.

About Lytix Biopharma
Based in Oslo, Norway, Lytix Biopharma is a clinical-stage biotech company
developing a highly differentiated oncolytic molecule platform derived from
host-defense peptides. The Company’s lead product, ruxotemitide (formerly
LTX-315), represents a novel approach to inducing durable anti-cancer immunity
across multiple cancer indications and treatment settings. Lytix is listed on
Euronext Growth Oslo under the ticker LYTIX.

More information:
Access the news on Oslo Bors NewsWeb site

671007_Lytix_AACR Poster_Final_2026.pdf