On October 21, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported the completed stage 1 safety and efficacy data from the ongoing Phase 1b clinical trial of single agent sitravatinib in patients with certain classes of oncogenic mutations (Press release, Mirati, OCT 21, 2018, View Source [SID1234530009]). The data for a cohort of patients harboring CBL mutations were presented in a proffered poster session (oral presentation) on Sunday, October 21st, 2018, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich, Germany.

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"For patients whose tumors are driven by the CBL mutation, there are limited viable treatment options," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer, Mirati Therapeutics, Inc. "Our sitravatinib single agent program will focus on NSCLC and melanoma patients with CBL inactivating mutations, who we believe could benefit most from single agent sitravatinib therapy."

Update from Sitravatinib Single Agent Study with CBL Inactivating Mutations

The presentation provided an update from the pre-planned expansion cohort of the Phase 1b clinical trial of single agent sitravatinib in patients with CBL inactivating mutations. Eight patients were evaluable as of the data cut-off on August 27, 2018.

In the subset of evaluable NSCLC patients, 1/2 confirmed partial responses were observed with 2/2 patients experiencing tumor regression.

In the subset of evaluable melanoma patients, 1/2 confirmed partial responses in evaluable patients were observed with 1/2 patients experiencing tumor regression.

In the subset of evaluable patients with other solid tumors, 2/4 had stable disease with 2/4 experiencing tumor regression.
CBL mutations are present in 1.5% of NSCLC, 3.5% of melanoma, and 2% of cancers of unknown origin.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial enrolling patients whose tumors harbor specific mutations in the CBL kinase. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.