Came across a press release this morning about a new drug called cabozantinib being tested in a myeloma clinical trial. I've posted the press release below. Thought some of you might want to know about it.
Here is a link to more information about the clinical trial:
http://clinicaltrials.gov/ct2/show/NCT01582295
Exelixis Announces Initiation of Cabozantinib Investigator-Sponsored Trials in Non-Small Cell Lung Cancer and Multiple Myeloma
-- Trials match tumor molecular characteristics with cabozantinib’s target inhibition profile
SOUTH SAN FRANCISCO, Calif. (Jul. 26, 2012-- Exelixis, Inc. (NASDAQ:EXEL) today 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 2 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 1 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.
“Exelixis’ IST Program is a critical component of our strategy to evaluate cabozantinib in a broad array of indications while focusing our internal efforts and resources on medullary thyroid cancer and prostate cancer,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We are pleased to support leading oncologists such as Dr. Rizvi and Dr. Mahindra as they leverage cabozantinib’s target-inhibition profile to address specific cancer indications in which these targets are believed to play a key role. For example, in the case of NSCLC, mounting evidence suggests that the presence of the KIF5B/RET fusion may signify a new molecular subset of the disease. An IST with cabozantinib, a potent inhibitor of RET that has shown strong clinical activity in another RET-driven cancer, is a logical next step in advancing new approaches to treat the disease.”
The phase 2 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).
The phase 1 multiple myeloma trial is designed to assess the safety, tolerability, and preliminary activity of cabozantinib in patients with relapsed or refractory myeloma with bone disease. The first cohort of patients will receive 40 mg of cabozantinib daily. Based on the safety in the first cohort, a second cohort of patients will receive either 20 mg or 60 mg of cabozantinib, administered daily. Safety in the initial dosing cohorts will be used to determine a dose for an expansion phase of the trial consisting of 10 additional patients.
About Cabozantinib
Cabozantinib is a potent targeted therapy that inhibits MET, VEGFR2 and RET. Cabozantinib is an investigational agent that provides coordinated inhibition of metastasis and angiogenesis to kill tumor cells while blocking their escape pathways. The therapeutic role of cabozantinib is currently being investigated across several tumor types. MET is upregulated in many tumor types, thus facilitating tumor cell escape by promoting the formation of more aggressive phenotypes, resulting in metastasis. MET-driven metastasis may be further stimulated by hypoxic conditions in the tumor environment, which are often exacerbated by selective VEGF-pathway inhibitors. In preclinical studies, cabozantinib has shown powerful tumoricidal, antimetastatic and antiangiogenic effects, including:
• Extensive apoptosis of malignant cells
• Decreased tumor invasiveness and metastasis
• Decreased tumor and endothelial cell proliferation
• Blockade of metastatic bone lesion progression
• Disruption of tumor vasculature
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