Lilly soon seeks regulatory approval for RET fusion-positive NSCLC treatment

Eli Lilly aims to submit the NDA later this year for oral selpercatinib monotherapy for the treatment of RET fusion-positive Non-small lung cancer, and expect selpercatinib to receive regulatory approval, said the CEO of Lilly’s subsidiary Loxo Oncology, Josh Bilenker

Eli Lilly’s test of oral selpercatinib monotherapy for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC) saw a 68 percent objective response rate (ORR), and also showed that 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.

Lilly said in its press release Monday that 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), Lilly said.

Selpercatinib has received breakthrough therapy designation from the U.S. Food and Drug Administration.

Alexander Drilon, lead investigator, said that selpercatinib’s response rate, durability, robust CNS activity, and safety show promise. He said that this continues to confirm that RET fusions are clinically targetable alterations, placing them in the company of activating EGFR/ALK/ROS1 alterations. “We are encouraged by these data as there is currently an unmet need to provide genomically-tailored therapy to patients with RET fusion-positive NSCLCs.”

Additional Data in Treatment-Naïve RET Fusion-Positive NSCLC Patients
Lilly reported in the press release Monday that the investigators also presented the results of selpercatinib in treatment-naïve RET fusion-positive NSCLC patients.

Anne White, president of Lilly Oncology, said that the importance of precision medicines, designed for specific patients, grow in oncology is seen, and that the data from LIBRETTO-001 show that selpercatinib, also known as LOXO-292, represents an important new advance for patients with RET fusion-positive non-small cell lung cancer, emblematic of the kinds of new oncology medicines we hope to continue to bring forward at Lilly Oncology.

“We’re very excited to partner with Loxo Oncology to continue to accelerate this important medicine. In two and half years, Loxo Oncology advanced this molecule from first human dose to submission ready data, demonstrating the power of precision oncology to rapidly translate scientific discovery into treatments for patients,” said White.

The CEO of Lilly’s subsidiary Loxo Oncology, Josh Bilenker, interim senior vice president of oncology research and early phase development at Lilly, said that when the selpercatinib discovery program was first started, the hopes were to build a RET inhibitor that would deliver for patients with RET-altered cancers in the way that medicines such as osimertinib and alectinib have delivered for EGFR-mutated and ALK-fusion patients, respectively. Now, it is expected that the selpercatinib data presented at World Lung validate those efforts, Bilenker said.