The abstract describes the first two patients with RET-fusion lung cancer with and without brain metastases treated with LOXO-292. Both patients had disease progression while receiving prior multi-kinase inhibitors (MKIs). On LOXO-292, both patients achieved partial responses. The first patient was previously treated with RXDX-105, enrolled on the first dose cohort of the Phase 1 trial, received LOXO-292 20 mg daily, and demonstrated a RECIST confirmed partial response. The second patient was previously treated with alectinib (starting at 600 mg twice daily and increased to 900 mg twice daily) and experienced disease progression systemically and in the brain. Due to the rapidly progressive nature of the brain metastases, the patient was ineligible for the Phase 1 trial and received LOXO-292 in doses ranging from 20-100 mg twice daily under an intra-patient dose escalation single patient protocol. The patient demonstrated a RECIST unconfirmed partial response, including a response in the brain, with a confirmatory response assessment pending as of the abstract’s writing. Both patients remained on LOXO-292 as of the abstract’s writing; additional patient follow-up for these two cases will be discussed in the oral presentation. In this early, two patient data set, LOXO-292 has been well-tolerated, with no adverse events attributed to LOXO-292.
“We are excited to present LOXO-292 proof-of-concept clinical data to the clinical community,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. “Just four months after initiating a Phase 1 trial, LOXO-292 is already achieving clinically meaningful levels of RET target coverage in patients, as evidenced by anti-tumor activity in pretreated patients. With our Phase 1 trial continuing to dose escalate, we look forward to providing a more comprehensive trial update in 2018.”
Arriba, Abajo, al Centro, y pa’dentro!
