Lilly launches first of its kind trial for RET fusion-positive NSCLC at Peter Mac

Eli Lilly has initiated the first ever randomised Phase III study in treatment-naïve RET fusion-positive non-small cell lung cancer with
principal investigator at the Peter MacCallum Cancer Centre in Melbourne.

The LIBRETTO-431 clinical trial [NCT04194944] is for selpercatinib, also known as LOXO-292, for treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC) patients. Enrolled trial participants will be randomised to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC.

“Given the remarkable results of the LIBRETTO-001 trial, I am excited to open this important Phase III trial of selpercatinib, a highly selective and potent molecule that has previously demonstrated sustained responses with a well-tolerated safety profile,” said Professor Ben Solomon, principal investigator at the Peter MacCallum Cancer Centre in Melbourne Australia.

“This trial endeavours to generate outcome data that place patients with RET fusions alongside those with EGFR mutations and ALK fusions, as driver-positive populations that should be treated with targeted therapies in the first-line setting, rather than chemoimmunotherapy.”

“This is an important milestone in the journey to further demonstrate the benefit of selpercatinib and the potential for people living with advanced or metastatic RET fusion-positive non-small cell lung cancer in the first-line setting against the current standard of care,” said Anne White, president of Lilly Oncology. “Launching a trial of this size underscores the importance of now including RET fusions in the paradigm of genomic testing in lung cancer.”

Selpercatinib was added to Lilly’s portfolio with the February 2019 acquisition of Loxo Oncology, which broadened its scope in precision medicines. 

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