Breaking News

Mirati Therapeutics announced data from the ongoing Phase 2 clinical trial of mocetinostat in combination with durvalumab in non-small cell lung cancer or NSCLC patients at the Society for Immunotherapy of Cancer 33rd Annual Meeting. As of the data cut-off date of October 2, 29 patients were evaluable for response with at least one radiographic scan. Patients had a median of two lines of previous therapy. 12/29 evaluable patients demonstrated tumor reductions. 6/29 evaluable patients demonstrated tumor reductions of greater than 30%. 5/29 evaluable patients achieved a confirmed Partial Response. 4/29 evaluable patients, including 2 responding patients, remained on treatment at the time of data cut-off. The combination has been well-tolerated and most adverse events were grade 1 or 2. The company plans to initiate a Phase 3 clinical trial comparing sitravatinib in combination with checkpoint inhibitor therapy to docetaxel in second line checkpoint inhibitor refractory NSCLC patients in 1H19. In addition, the company plans to initiate a Phase 1/2 clinical trial of MRTX849, an oral inhibitor of KRAS G12C, in patients with NSCLC, colorectal cancer, and other solid tumors that harbor the G12C mutation. Trial initiation is planned for early 2019 after the IND allowance letter is received from the FDA for the application that was filed in October.

Mirati Therapeutics announced preliminary biomarker data from the ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab in non-small cell lung cancer patients at the Society for Immunotherapy of Cancer 33rd Annual Meeting in Washington, D.C. The data will be presented today in a poster and also in an oral presentation on Saturday, November 10th. The ongoing Phase 2 clinical trial is evaluating the safety and efficacy of sitravatinib in combination with an anti-PD-1 immune checkpoint inhibitor, in patients who have experienced documented disease progression following prior checkpoint inhibitor therapy. Efficacy data were recently presented at the October 2018 European Society for Medical Oncology Congress. The data demonstrated a higher rate of durable responses than would be expected from treatment with docetaxel, the standard of care. Today's presentation, "Preliminary Biomarker Analysis of Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor", highlighted an initial assessment of correlative biomarkers for the 56 evaluable patients from the on-going clinical trial. Exploratory baseline and dynamic biomarker endpoints were evaluated for correlation with clinical outcomes. The analysis demonstrated a CD8+ T effector cell response in patients who achieved a clinical benefit, suggesting a therapy-driven restoration of the anti-tumor immune response in patients who had become refractory to prior checkpoint inhibitor treatment. The data suggest that patients with high PD-L1 at baseline may be more likely to benefit from treatment with the combination although the difference was not statistically significant. There was no difference in treatment outcomes for patients based on their baseline tumor mutational burden or other baseline biomarkers.

Mirati Therapeutics (MRTX) announced dosing of the first patient under its collaboration agreement with BeiGene, Ltd. (BGNE) in a Phase 1b clinical trial to assess the safety and tolerability, pharmacokinetics and preliminary anti-tumor activity of Mirati's sitravatinib in combination with BeiGene's investigational anti-PD1 antibody, tislelizumab, in patients with advanced solid tumors. The clinical trial is currently enrolling patients in China and Australia. Under the terms of the collaboration agreement, upon initiation of the clinical trial by BeiGene, Mirati will receive a $3M milestone payment.