Final results of the INFINITY precision oncology registry: non-standard targeted treatments in patients with advanced cancers in routine care

Background The INFINITY precision oncology registry evaluated biomarker-driven non-standard targeted treatment (NSTT) in a community oncology setting in Germany. We present final results including clinical outcome and patient benefit from NSTTs. Patients and methods INFINITY (NCT04389541) was a multicenter, non-interventional cohort study using routinely collected health data of patients with advanced solid or hematological malignancies, who had no standard therapy options and therefore received biomarker-informed NSTT. Endpoints were overall response rate (ORR), progression-free survival (PFS), and overall survival. The PFS ratio was calculated to quantify the potential benefit from the NSTT (cut-off ratio ≥1.3). Results From April 2020 to November 2022, 499 eligible patients (median age 62.6 years, 49.9% female) were enrolled. More than 43 different cancers have been included with 93.2% ( n = 465) solid tumors, including colorectal (16.0%, n = 80), biliary tract (8.2%, n = 41), and lung cancers (7.0%, n = 35). Patients had received a median of two prior systemic therapy lines before starting NSTT. Immunohistochemistry was the most commonly carried out biomarker testing method (68.3%), followed by next-generation sequencing (49.9%). Key decisive biomarkers were PD-(L)1 expression (30.7%), HER2 aberrations (9.8%), and BRAF mutations (9.0%). ORR was 27.3%, and 31.7% of patients had a PFS ratio ≥1.3. Conclusions In a tumor-agnostic approach, biomarker-informed NSTT was associated with clinical benefit in 31.7% of the patients, with checkpoint inhibitors being the most common treatment. The INFINITY project demonstrates the feasibility of a large-scale precision oncology project in a community oncology setting and thus supports the implementation of precision oncology into routine clinical practice in Germany.