Eli Lilly and Company has reported that first-time data from the Phase I/II LIBRETTO-001 trial of Retevmo (selpercatinib) treatment showed promising antitumour activity and safety in various RET fusion-positive advanced solid tumours.
The latest data shows the activity is beyond lung and thyroid cancers and includes multiple treatment-refractory gastrointestinal (GI) malignancies as well.
A selective and potent RET kinase inhibitor, Retevmo is a US FDA-approved oral prescription medicine taken twice daily until disease progression or unacceptable toxicity.
The trial enrolled 32 adult subjects with 12 unique RET fusion-positive advanced cancer types including pancreatic, colon, breast, salivary, sarcoma, carcinoid, rectal neuroendocrine, small intestine, xanthogranuloma, ovarian, pulmonary carcinosarcoma, and unknown primary cancers.
Being carried out in 16 countries at 89 sites, the trial has a dose-escalation phase (Phase 1) and a dose-expansion phase (Phase 2).
Data showed that a confirmed objective response rate (ORR) of 47% was observed in all subjects with confirmed responses noted in nine unique RET fusion-positive advanced cancer types.
With a 13-month median follow-up period, the median duration of response (DoR) was not reached, while responses were progressing in 73% of the responding subjects.
Furthermore, safety among the trial subjects in this cohort was in line with Retevmo’s already established safety profile.
Eli Lilly oncology chief medical officer David Hyman said: “We are excited to broaden the body of evidence for Retevmo in RET fusion-positive cancers beyond lung and thyroid tumours.
“These encouraging outcomes, including in difficult-to-treat GI malignancies, support a growing body of evidence that RET fusions are potentially actionable in a wide range of tumour types.”
The trial is currently enrolling patients with RET-altered tumours which are beyond lung cancer.
Last month, Lilly, Vir Biotechnology and GlaxoSmithKline (GSK) reported topline data from the expanded Phase II BLAZE-4 trial of bamlanivimab (LY-CoV555) co-administered with VIR-7831 (GSK4182136) in low-risk adult patients with mild to moderate Covid-19.