On September 25, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it will showcase data from its proprietary clinical programs at the 2019 European Society for Medical Oncology Congress ("ESMO") on September 27 to October 1, 2019 in Barcelona, Spain (Press release, Hutchison China MediTech, SEP 25, 2019, View Source [SID1234539767]).

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A key highlight will be the oral presentation of a Late-Breaking Abstract reporting efficacy and safety results from the positive Phase III trial in China of surufatinib in non-pancreatic neuroendocrine tumors ("NET"), known as SANET-ep. An interim analysis in June 2019 confirmed that the study met its primary endpoint of progression-free survival ("PFS"). As a result, the independent data monitoring committee ("IDMC") recommended the study be stopped, a year ahead of schedule, and preparations are now underway for the submission of a New Drug Application ("NDA") by the end of 2019 for this indication in China.

The Late-Breaking Abstract will be published on the ESMO (Free ESMO Whitepaper) website coincident with the its presentation; the details of which are as follows:

Title:

Efficacy and Safety of Surufatinib in Patients with Well-Differentiated Advanced Extrapancreatic Neuroendocrine Tumors: Results from the Randomized Phase III Study (SANET-ep)

Presenting Author:

Jianming Xu, Head of the Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of the PLA

Abstract #:

LBA76

Date & Time:

Sunday, September 29, 2019, 16:30 CEST

Location:

Tarragona Auditorium (Hall 7), Fira de Barcelona Gran Via Conference Centre

A conference call and webcast for analysts and investors will be held on Monday September 30, 1 p.m. U.K. time (2 p.m. Barcelona time; 8 a.m. New York time; 8 p.m. Hong Kong time) to review the SANET-ep trial data presented on Sunday, September 29. Safety and tolerability data presented from an ongoing U.S. Phase Ib study of surufatinib in pancreatic NET patients who have progressed on Sutent or Afinitor treatment will also be discussed.

Participating in the call will be Dr. James Yao, Chair of GI Oncology at MD Anderson Cancer Center and one of the lead investigators for our ongoing Phase I/Ib surufatinib study in NET, as well as members of the Chi-Med management team. Dial-in details for the conference call will be available prior to the event at www.chi-med.com/event-information, and a replay will also be available shortly after.

Details of the abstract for the U.S. Phase Ib trial of surufatinib in pancreatic NET patients are as follows:

Title:

Safety and Tolerability of Surufatinib in Western Patients with Solid Tumors

Presenting Author:

Erika P. Hamilton, Director, Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute

Abstract # & Link:

1393P

Date & Time:

Sunday, September 29, 2019, 12:00 CEST

Location:

Hall 4, Fira de Barcelona Gran Via Conference Centre

Other Clinical Data Abstracts

Fruquintinib in the U.S. and Europe: Safety and tolerability of fruquintinib in Western patients with solid tumors will be presented. Fruquintinib is currently in planning for a Phase III registration study in the U.S. and Europe in metastatic colorectal cancer ("CRC") patients who are resistant to or intolerant of prior treatment with Stivarga or Lonsurf. In China, fruquintinib is currently sold under the brand name Elunate, and is for the treatment of patients with metastatic CRC that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type).

Title:

Phase 1 Trial of Fruquintinib in Patients with Advanced Solid Tumors: Results of the Dose Escalation Phase

Presenting Author:

Andrea Wang-Gillam, Associate Professor of Medicine, Division of Oncology, Section of Medical Oncology, Washington University School of Medicine

Abstract #:

467P

Date & Time:

Saturday, September 28, 2019, 12:00 CEST

Location:

Hall 4, Fira de Barcelona Gran Via Conference Centre

Chi-Med retains all rights to surufatinib worldwide. It retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company in China.

Trials-in-Progress Abstracts

Title:

A Phase 1 Study of HMPL-523, a Selective Oral Anti-Spleen Tyrosine Kinase Inhibitor, in Patients with Relapsed or Refractory Lymphoma

Lead Author:

Nathan Fowler, Associate Professor, Department of Lymphoma/Myeloma, the University of Texas MD Anderson Cancer Center

Abstract #:

1106TiP

Date & Time:

Saturday, September 28, 2019, 12:00 CEST

Location:

Hall 4, Fira de Barcelona Gran Via Conference Centre

Title:

A Phase 1 Study of HMPL-689, a Selective Oral Phosphoinositide 3-Kinase-Delta Inhibitor, in Patients with Relapsed or Refractory Lymphoma

Lead Author:

Jonathan B. Cohen, Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine

Abstract #:

1107TiP

Date & Time:

Saturday, September 28, 2019, 12:00 CEST

Location:

Hall 4, Fira de Barcelona Gran Via Conference Centre

About SANET-ep

SANET-ep is a randomized, double-blind, placebo-controlled, multi-center, Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. In June 2019, an interim analysis was conducted, leading to the IDMC determination that the study met the pre-defined primary endpoint of PFS and should be stopped early. Preparations for an NDA submission are now underway for this indication in China. In this study, patients with low- or intermediate-grade advanced extra-pancreatic neuroendocrine tumors for whom there is no effective therapy are randomized at a 2:1 ratio to receive either 300 mg of surufatinib orally daily or placebo, on a 28-day treatment cycle. The primary endpoint of the study is to evaluate the PFS, with secondary endpoints including objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DoR), overall survival (OS), safety, and tolerability. Additional details may be found at clinicaltrials.gov, using identifier NCT02588170.