Eli Lilly and Company (Lilly) has initiated the phase 3 LIBRETTO-431 clinical trial to evaluate selpercatinib (LOXO-292) in RET fusion-positive non-small cell lung cancer (NSCLC) in patients who are treatment-naïve.
The US pharma company is aiming to enroll 400 patients in the late-stage clinical trial. The patients will be grouped randomly to be subjected to 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 non-small cell lung cancer.
Commenting on the LIBRETTO-431 clinical trial, Professor Ben Solomon, principal investigator at the Peter MacCallum Cancer Centre in Melbourne Australia said: “Given the remarkable results of the LIBRETTO-001 trial, I am excited to open this important Phase 3 trial of selpercatinib, a highly selective and potent molecule that has previously demonstrated sustained responses with a well-tolerated safety profile.
“This trial endeavors 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.”
The primary endpoint of the LIBRETTO-431 clinical trial is progression-free survival (PFS), while secondary endpoints are overall survival (OS), overall response rate (ORR), intracranial ORR, and duration of response (DoR).
Selpercatinib is an oral RET inhibitor had been granted breakthrough designations in RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC), and RET fusion-positive thyroid cancers. Lilly gained rights to the RET inhibitor following the acquisition of Connecticut-based biopharma company Loxo Oncology in February 2019. (Read : Lilly acquisition of Loxo Oncology)
Anne White – president of Lilly Oncology, commenting on the LIBRETTO-431 clinical trial, said: “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.
“Launching a trial of this size underscores the importance of now including RET fusions in the paradigm of genomic testing in lung cancer.”