Stéphane Champiat, MD, PhD, Reviews Results With IL-2/IL15 Superagonist SOT101 From AURELIO-03 Trial

Stéphane Champiat, MD, PhD, spoke about the results of the AURELIO-03 trial with SOT101 and pembrolizumab for patients with advanced solid tumors.

During the American Association for Cancer Research (AACR) 2022 Annual Meeting, CancerNetwork® spoke with Stéphane Champiat, MD, PhD, assistant professor in the Drug Development Department of Gustave Roussy Cancer Campus in Paris, France, about the recently reported results of the phase 2 dose-escalation AURELIO-3 trial (NCT04234113) which examined SOT101, an interleukin (IL)–2/IL-15 superagonist, in combination with pembrolizumab (Keytruda) in patients with advanced solid tumors. Safety and efficacy results were reported at the meeting.


The SOT101 study is evaluating the safety and primary results of efficacy [of the agent] in combination with pembrolizumab. SOT101 is a fusion protein containing IL-15 in the Sushi domain of IL-15 receptor α. Therefore, it has enhanced [ability] to activate T cells or NK [natural killer] cells and avoid activating Tregs [T regulatory] cells compared with classical IL-2.

[SOT101] is administered subcutaneously and pembrolizumab is administered [intravenously]. The study included multiple solid tumor typess. Most of the patients who were treated in that study had primary or secondary resistance to classical anti–PD-1 or anti–PD-L1 [agents]. The translational data has shown that SOT101 is able to activate NK cells at very early dose and activate CD8-positive T cells later with a higher dose.

There was no relevant activation of Tregs. In terms of safety, the safety profile was overall pretty good. Most of the adverse [effects] are grade 1 and 2 and are transient and do not necessarily require corticosteroids. There was no MTD [maximum tolerated dose] identified at the higher dose level. The recommended phase 2 dose was 12 mg/kg based on safety and [pharmacodynamic] data. Overall, the activity is showing several responses among the 16 evaluable patients. There was 1 complete response in [patients with] mesothelioma and 4 partial responses other tumor types. Overall, 12 of 16 of those patients were having the benefit from the treatment either through prolonged stable disease or partial or complete response. The longest response that was observed with this treatment so far is more than 14 weeks.


Champiat S, Marabelle A, Galvao V, et al. SOT101, an IL-2/IL-15 Rβγ superagonist, in combination with pembrolizumab in patients with advanced solid tumors: interim safety and efficacy results from the AURELIO-03 dose escalation trial. Presented at the 2022 American Association for Cancer Research Annual Meeting. New Orleans, LA. April 8-13, 2022.