“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,” says 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 study

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

Key efficacy findings from the study include: bjective 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, and 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 company states.

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.