On June 15, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the company has accepted an invitation from the U.S. Food and Drug Administration (FDA) to participate in a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee on June 29, 2016 (Press release, Loxo Oncology, JUN 15, 2016, View Source [SID:1234513370]). The purpose of the meeting is to improve and encourage the development of oncology and hematology drugs for pediatric use. These meetings are held regularly by the FDA, with various invited sponsors. At the meeting, Loxo Oncology plans to present an overview of LOXO-101, with an emphasis on opportunities for pediatric development. Schedule your 30 min Free 1stOncology Demo! Background material for this meeting will be available on the FDA website approximately 2 days prior to the meeting.
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Clinical Development of LOXO-101 in Pediatric Cancers
Loxo Oncology is conducting an ongoing Phase 1 multicenter, open-label clinical trial in pediatric patients with advanced solid or primary CNS tumors. In order to meet the criteria for enrollment, patients must be between one year of age and 21 years of age with a locally advanced or metastatic solid tumor or primary CNS tumor that has progressed, or was nonresponsive to available therapies, and for which no standard or available curative therapy exists. Patients at least one month old are eligible for enrollment if they have a diagnosis of infantile/congenital fibrosarcoma or congenital mesoblastic nephroma, with a documented NTRK fusion that has progressed, or was nonresponsive to available therapies, and for whom no standard or available curative therapy exists. The primary endpoint of the trial is to explore the safety of LOXO-101. Secondary endpoints include the characterization of pharmacokinetic properties, the identification of the maximum tolerated dose and/or the Phase 2 dose, a description of antitumor activity and a description of pain and health related quality of life impact.
In April 2016, Loxo Oncology announced the publication of a case report in the online edition of Pediatric Blood and Cancer, co-authored with Nemours Children’s Hospital, Northwestern University and St. Jude Children’s Research Hospital, describing a partial response in the first patient with a TRK fusion cancer enrolled in the pediatric Phase 1 dose-escalation trial of LOXO-101. The 16-month old female patient with advanced infantile fibrosarcoma (IFS), a rare pediatric cancer, experienced a 90 percent tumor regression, and repeat scans showed continued decrease in tumor volume. As of the preparation of the manuscript, the patient was in study cycle 5 with a RECIST confirmed partial response, and was beginning to achieve normal developmental milestones.
LOXO-101 has shown objective partial responses in adult patients with tumors harboring TRK gene fusions in a Phase 1 trial. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in adult patients with solid tumors that harbor TRK gene fusions.
About LOXO-101
LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions and a Phase 1 trial in pediatric patients. For additional information about the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov or www.loxooncologytrials.com. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.