Aurélien Marabelle, M.D., Ph.D., Immuno-Oncologist from the Drug Development Department at Gustave Roussy Cancer Center speaks about SOT101 Shows Clinical Benefit in Patients with Advanced Solid Tumors.
New data from the current Phase 1/1b AURELIO-03 study of SOT101, an IL-15 superagonist, as a monotherapy and in combination with pembrolizumab in patients with advanced/metastatic solid tumors were released today by SOTIO Biotech, a clinical-stage immuno-oncology business owned by PPF Group. The findings will be presented in three posters at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting, which will take place from November 10 to 14, 2021.
The majority of the 13 patients with advanced/metastatic solid tumors in the AURELIO-03 study received a clinical benefit from a combination of SOT101 and pembrolizumab, including checkpoint inhibitor (CPI) refractory individuals. To date, investigators have seen three confirmed partial responses and four cases of long-term stable illness in this dose-escalation research. Prior therapy had been used on these patients on a median of two occasions (range 1-6). SOT101 was also well tolerated when used in combination with pembrolizumab. In this study, dose escalation is still going on.
The study’s SOT101 monotherapy arm showed promising effectiveness signs in 30 patients with advanced/metastatic solid tumors, including those who were CPI resistant. There has been one documented clinical and radiological response, as well as four individuals with the confirmed stable illness. After having a relapse on SOT101 monotherapy, one patient showed a partial response to SOT101+pembrolizumab combination therapy. SOT101 was well tolerated, with the majority of treatment-related adverse events falling into the Grade 2 or lower category. The patients in this dose-escalation study had previously received a median of three lines of treatment (range 1-9). The suggested Phase 2 dose is 12 g/kg, and a Phase 2 monotherapy expansion study in specified tumor indications is currently underway at this level.
SOT101 promotes both innate and adaptive immunity, according to the study’s biomarker analyses. SOT101 elicited a powerful immune-stimulatory response in many types of tumor microenvironments, according to key findings. All patients in the monotherapy and SOT101+pembrolizumab arms had a dose-dependent pharmacodynamic response in the blood, and clinically responding patients had enhanced CD8+ T cell and NK cell infiltration in the tumor. Furthermore, in CPI refractory/resistant patients, SOT101 restored sensitivity to CPIs.
Link to Poster:
https://sotio.com/news-publications/media/sotio-posters-from-sitc-2021