Eli Lilly and Company recently announced that results of the LIBRETTO-001 clinical trial intended to support the registration of oral selpercatinib monotherapy, also known as LOXO-292, were presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain.
The results were presented by Lori J. Wirth, M.D., medical director of head and neck cancers at Massachusetts General Hospital Cancer Center in Boston.
LOXO-292 is intended for the treatment of RET-altered thyroid cancers, which consist of two different populations: RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers.
The registrational results of LOXO-292 showed that there was a 56-percent objective response rate (ORR) in the registration dataset of the first 55 enrolled patients with prior cabozantinib and/or vandetanib of RET-mutant MTC; 59-percent ORR in cabozantinib/vandetanib-naïve RET-mutant MTC patients; and 62-percent ORR in heavily pretreated RET fusion-positive thyroid cancer patients.
Based on the safety analysis of all 531 patients, selpercatinib was well-tolerated as shown by a low rate of discontinuation. Only nine patients (1.7 percent) will no longer continue the therapy due to treatment-related adverse events in which the most commonly observed, regardless of attribution, were fatigue, headache, increased liver enzymes, dry mouth, diarrhea, constipation and hypertension.
"Current therapeutic options are often challenging for patients with first-line RET-altered thyroid cancers and are limited for patients who relapse," Wirth said in a press release. "The data for selpercatinib show demonstrative efficacy and safety in both the first-line and relapsed settings. Patients with thyroid cancer have long sought targeted therapy tailored to the molecular nature of their disease, and we are hopeful that selpercatinib may be used as the standard of care in the future."