Exelixis, Inc. Announces Initiation Of Cabozantinib Investigator-Sponsored Trials In Non-Small Cell Lung Cancer And Multiple Myeloma

Exelixis, Inc. announced the initiation of two investigator-sponsored trials (ISTs) of cabozantinib, which simultaneously targets MET, VEGFR2 and RET. Naiyer Rizvi, M.D., a lung cancer specialist at Memorial Sloan Kettering Cancer Center (MSKCC), is conducting a phase II clinical trial of cabozantinib in non-small cell lung cancer (NSCLC) patients who have tested positive for gene fusions that activate RET. Anuj Mahindra, MBBS, member of the hematology staff at Massachusetts General Hospital (MGH), is conducting a pilot phase I clinical trial of cabozantinib in patients with relapsed or refractory multiple myeloma, a disease for which there is evidence of MET’s role in pathogenesis. The phase II NSCLC trial is designed to enroll 25 patients with KIF5B/RET or related variant RET fusions in their tumors. These patients will receive a daily 60 mg dose of cabozantinib administered orally. The primary endpoint of the trial is overall response rate. Secondary endpoints include progression-free survival, overall survival, and safety. Investigators will also seek to determine the frequency of KIF5B/RET and related variant RET fusions in patients whose tumors are negative for previously identified oncogenic activating mutations or translocations (including those involving EGFR, KRAS, and ALK).