AstraZeneca presents preliminary data from AZD6094-AZD9291 combination trial for treatment of NSCLC

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Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM), today announces that AstraZeneca AB (publ) ("AstraZeneca"), Hutchison MediPharma Limited's ("HMP") collaboration partner, presented preliminary data from the ongoing Phase Ib clinical trial of HMP's c-Met inhibitor savolitinib (AZD6094) combined with AstraZeneca's drug candidate AZD9291 in non-small cell lung cancer ("NSCLC").

AZD9291 is AstraZeneca's investigational inhibitor of the epidermal growth factor receptor (EGFR). Preliminary data on the activity of AZD9291 in patients with EGFR mutation positive NSCLC who had failed currently-approved EGFR tyrosine kinase inhibitors was presented at the American Society of Clinical Oncology (ASCO) meeting in June 2014. In mid-2014 AstraZeneca commenced the TATTON study, a multi-arm Phase Ib study of AZD9291 in combination with either savolitinib (AZD6094) (c-MET inhibitor), MEDI4736 (anti-PD-L1 mAb) or selumetinib (MEK1/2 inhibitor) in EGFR mutation positive NSCLC. For those patients who received AZD9291 and savolitinib, the primary objective of the TATTON study was to establish a safe and effective combination dose. All patients were screened for their T790M status (+/-) as well as some, if sufficient tissue samples were available, for their c-Met (+/-) status.

The following poster was presented at the American Society of Clinical Oncology annual meeting in Chicago on 30 May 2015.

Title: Preliminary results of TATTON, a multi-arm phase Ib trial of AZD9291 combined with MEDI4736, AZD6094 or selumetinib in EGFR-mutant lung cancer. Authors: Oxnard G.R., et al. Abstract: #2509 - available at abstracts.asco.org/156/AbstView_156_148945.html Session: Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics Date & Time: Saturday 30 May 8:00 AM-11:30 AM

A total of 12 patients were dosed with either 600mg or 800mg daily doses of savolitinib (AZD6094) in combination with 80mg (once daily) AZD9291. In terms of the primary aims of the study, the 600mg combination dose was well tolerated with toxicity profiles that allow for combination at doses previously demonstrated to be biologically active. Of the 11 evaluable patients in the study, 6 partial responses (confirmed and unconfirmed) have been observed to date. Responses to date include 4 of 7 patients with confirmed T790M negative status.

The presentation will be made available at http://chi-med.com/eng/irinfo/presentations.htm.

Christian Hogg, Chief Executive Officer of Chi-Med said: "Savolitinib is a highly selective c-Met inhibitor designed to eliminate the toxicities experienced by the first wave of c-Met inhibitors in their early development. We are now very pleased to see encouraging early efficacy data emerge in non-small cell lung cancer to add to the efficacy already reported in papillary renal cell carcinoma and colorectal cancer."

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