First Patient with Colorectal Cancer Received Nanrilkefusp Alfa in Phase 2 Trial


The multicenter study is evaluating the safety and efficacy of nanrilkefusp alfa combined with Erbitux.

The first patient has been dosed in a phase 2 trial evaluating nanrilkefusp alfa, an IL-15, in colorectal cancer, according to a press release from SOTIO Biotech, the drug’s manufacturer.

“The initiation of this phase 2 study is an important step in the clinical development of nanrilkefusp alfa,” said Dr. Richard Sachse, chief medical officer of SOTIO, in the release. “In addition to our previous and ongoing studies to determine the efficacy of nanrilkefusp alfa in combination with checkpoint blockers, we now aim to determine its ability to enhance the antibody dependent cellular cytotoxicity exerted by (Erbitux) cetuximab. If replicated in patients, the increased anti-tumor activity and proliferation of CD8+ T-cells that has been observed in colorectal cancer models treated with IL-15 superagonists could position nanrilkefusp alfa as a safe and effective therapy in combination with (Erbitux) in this indication. We look forward to evaluating this potential benefit.”

The phase 2 AURELIO-5 clinical trial will evaluate the efficacy and safety of nanrilkefusp alfa in combination with Erbitux in 52 patients with RAS wild-type colorectal cancer. Patients included also have relapsed refractory disease or are intolerant to prior treatment with rinotecan- and oxaliplatin-containing chemotherapy. The trial is being conducted across 20 specialized sites in Europe.

“Despite recent advances in oncology, patients with advanced refractory colorectal cancer still have poor long term survival rates,” said Dr Eric van Custem, head of Digestive Oncology at the University Hospital in Leuven in Belgium and coordinating investigator of the trial, in the release. “Having already demonstrated promising signs of safety and efficacy not only in monotherapy, but also in combination with another approved monoclonal antibody, (Keytruda), we are pleased to have initiated this critical study to evaluate the potential benefit of nanrilkefusp alfa in combination with (Erbitux) in this highly underserved patient population.”

Nanrilkefusp alfa has previously demonstrated strong preclinical efficacy in other tumor types, increasing long-term survival and tumor regression —in addition to a favorable toxicity, according to the release.

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