Positive results for selpercatinib demonstrating a 68 Percent objective response rate in heavily non-small cell lung cancer

Eli Lilly and Company presented data from the LIBRETTO-001 clinical trial intended to support the registration of oral selpercatinib monotherapy, also known as LOXO-292, for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC).

In the registration dataset consisting of the first 105 enrolled RET fusion-positive NSCLC patients with prior platinum-based chemotherapy, selpercatinib treatment resulted in a 68 percent objective response rate (ORR) (95% CI: 58-76%). This population was heavily pretreated (median of three prior systemic regimens; 55 percent previously treated with an anti-PD-1/PD-L1 antibody and 48 percent previously treated with at least one multikinase inhibitor) and ORR was similar regardless of prior therapy. Up to 50 percent of RET fusion-positive NSCLCs can metastasize to the brain, and in the subset of patients with brain metastases in the registrational dataset, selpercatinib treatment demonstrated a CNS (Central Nervous System) ORR of 91 percent (95% CI: 59-100%). As of the data cut-off date of June 17, 2019, median duration of response (DOR) was 20.3 months (95% CI: 13.8-24.0) and median progression-free survival (PFS) was 18.4 months (95% CI: 12.9-24.9). Since the majority of patients remain in response or progression-free as of the data cut-off date, these medians will continue to mature over time. In a safety analysis of all 531 patients enrolled to LIBRETTO-001, selpercatinib was well-tolerated, with only 9 patients (1.7%) discontinuing therapy due to treatment-related toxicity. The most commonly observed adverse events, regardless of attribution, were dry mouth, diarrhea, hypertension, increased liver enzymes, fatigue, constipation, and headache.

These results were presented in the Presidential Symposium Session at the 2019 World Conference on Lung Cancer (WCLC) in Barcelona, Spain, hosted by the International Association for the Study of Lung Cancer (IASLC). Selpercatinib has received breakthrough therapy designation from the U.S. FDA.

Additional Data in Treatment-Naïve RET Fusion-Positive NSCLC Patients- Investigators also presented the results of selpercatinib in treatment-naïve RET fusion-positive NSCLC patients. In this analysis of 34 patients, selpercatinib treatment resulted in an 85 percent ORR (95% CI: 69-95%). Median DOR and PFS were not reached in this treatment-naïve population, as the majority of patients remain in response or progression-free.