Replies to post #194120 on Biotech Values

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MRTX > up 14%... MGCD265 DEMONSTRATES CLINICAL EFFICACY WITH CONFIRMED RESPONSES IN NSCLC PATIENTS WITH MET AND AXL GENE AMPLIFICATION


- First Ever Confirmed Response in NSCLC Patient, with Axl Gene Amplification, Treated with an Orally Administered Small Molecule Inhibitor of MET and Axl to be Presented at IASLC 16th World Conference on Lung Cancer
- Company Announces a Confirmed Response in a NSCLC Patient with MET Gene Amplification and Provides Interim Update on Ongoing MGCD265 Phase 1b Expansion Cohort

http://finance.yahoo.com/news/mgcd265-demonstrates-clinical-efficacy-confirmed-120000879.html

"Out of four non-small cell lung cancer patients whom have had at least one scan in the ongoing MGCD265 expansion cohort, two patients have RECIST-confirmed PRs. Those PRs, together with tumor regressions seen in all four of these patients, demonstrate the potentially significant clinical benefit of MGCD265 in patients with lung cancer," said Charles M. Baum, M.D., Ph.D., President and CEO, Mirati.

NSCLC Patient with Axl Gene Amplification
The male patient was diagnosed with metastatic adenocarcinoma of the lung, with multiple tumors in both lungs which had spread to the lung cavity and lymph nodes. Prior to treatment with MGCD265, he had received multiple chemotherapies, as well as an experimental agent combined with chemotherapy, with the best response being disease progression. After 2 cycles of treatment with MGCD265, tumor imaging showed a PR with a tumor reduction of 42.3% compared to baseline. After 4 cycles of treatment, the PR was confirmed with a tumor reduction of 48.8% based on RECIST criteria. The patient, who remains on study in Cycle 7, also showed improvement in clinical symptoms. Prior to starting treatment with MGCD265, the patient was oxygen dependent. Shortly after treatment with MGCD265, he was off oxygen and able to ride his bike up to seven miles per day.

"To our knowledge, this is the first reported case of an objective response in a patient with a tumor harboring AXL gene amplification," said Geoffrey Shapiro, Principal Investigator and Director of the Early Drug Development Center, Department of Medical Oncology, Dana-Farber Cancer Institute. "This response, coupled with the patient's significant symptomatic improvement, provides clinical validation that AXL genomic alterations can result in oncogene addiction in patients with non-small cell lung cancer. We will continue to explore MGCD265, a potent kinase inhibitor, in patients with MET or AXL genomic alterations, in an effort to improve cancer treatment by targeting genetic drivers of cancer."