ESMO Immuno-oncology Conference 2021 announces the latest data on the combination therapy of Sofantinib and Teriplizumab

*Only for medical professionals' reference The latest and updated analysis results of the ongoing combination therapy for multiple indications
.

Hong Kong, Shanghai, and New Jersey, USA: December 10, 2021 (Friday): Hutchison Medicine (China) Co.
, Ltd.
(abbreviated as "Hutchison Medicine" or "HUTCHMED") (Nasdaq/London Stock Exchange: HCM; Hong Kong Stock Exchange: 13) today announced that Sofatinib and Teriplizumab will be announced in the form of a poster at the 2021 European Society of Medical Oncology (ESMO) Immuno-oncology Conference to be held from December 8 to 11, 2021 The latest and updated analysis results of the ongoing combination therapy for multiple indications
.

▌ The report details are as follows: ■ Title: Surufatinib plus toripalimab in patients with advanced small cell lung cancer (SCLC) after failure of 1L systemic chemotherapy Patient ■ First author: Cheng Ying, Doctor of Medicine, Jilin Cancer Hospital ■ Abstract Number: 157P ■ Date and Time: December 9, 2021, 11:30-11:50 (Central European Time) ■ Title: Surufatinib plus toripalimab for 2L treatment of advanced gastric orgastroesophageal junction (G/GEJ) adenocarcinoma, esophageal squamous cellcarcinoma (ESCC) and neuroendocrine carcinoma (NEC): A multicenter, single-armphase 2 study Treatment of advanced gastric or gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, and neuroendocrine carcinoma: a multicenter, one-arm phase II study ■ First author: Lu Ming, MD, Peking University Cancer Hospital ■ Abstract number: 155P■ Date and time: December 9, 2021, 10:50-11:10 am (Central European Time) About Sofatinib Sofatinib (surufatinib) is a new type of oral tyrosine kinase inhibitor , It has dual activities of anti-angiogenesis and immune regulation
.

Sofatinib can block tumor angiogenesis by inhibiting vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), and can inhibit colony stimulating factor 1 receptor (CSF-1R).
Regulate tumor-associated macrophages and promote the body's immune response to tumor cells
.

Sofatinib's unique dual mechanism can produce synergistic anti-tumor activity, making it an ideal choice for combined use with other immunotherapies
.

 Hutchison Medicine currently owns all rights of Sofatinib worldwide
.

Sofatinib development plan China non-pancreatic neuroendocrine tumor research: Sofatinib was approved by the China National Medical Products Administration ("SFDA") on December 29, 2020 for the treatment of non-pancreatic neuroendocrine tumors
.

Sofantinib is sold under the trade name Sutaida in the Chinese market
.

This approval is based on the results of a Chinese phase III clinical trial SANET-ep (clinicaltrials.
gov registration number NCT02588170) of Sofatinib in the treatment of patients with advanced non-pancreatic neuroendocrine tumors
.

The study successfully reached the pre-specified primary endpoint of PFS in the interim analysis, and the results of the study have been published in The Lancet Oncology [1]
.

The median PFS of patients in the sofatinib treatment group was significantly prolonged to 9.
2 months, compared with 3.
8 months for patients in the placebo group (HR 0.
334; 95% CI 0.
223–0.
499; p <0.
0001)
.

Sofatinib has acceptable safety characteristics, and the most common treatment-related adverse events of grade 3 or above are hypertension (Sofatinib group: 36%; Placebo group: 13%), proteinuria (Sofantinib group: 36%; placebo group: 13%).
Patients in the vantinib group: 19%; patients in the placebo group: 0%) and anemia (patients in the Sofatinib group: 5%; patients in the placebo group: 3%)
.

 China Pancreatic Neuroendocrine Tumor Research: Sofatinib was approved by the National Food and Drug Administration on June 16, 2021 for the treatment of pancreatic neuroendocrine tumors
.

This approval is based on the results of a Chinese Phase III clinical trial SANET-p (clinicaltrials.
gov registration number NCT02589821) of Sofatinib for the treatment of patients with advanced pancreatic neuroendocrine tumors
.

The study successfully reached the preset primary efficacy endpoint of PFS in the preset interim analysis, and the results of the study have been published in The Lancet Oncology [2]
.

The study showed that sofatinib reduced the risk of disease progression or death by 51%, with a median PFS of 10.
9 months, compared with 3.
7 months for patients in the placebo group (HR 0.
491; 95% CI: 0.
391-0.
755; p= 0.
0011)
.

Sofatinib exhibits controllable safety and is consistent with observations in previous studies
.

 Immune combination therapy: Hutchison Medicine has reached several cooperation agreements to evaluate the safety, tolerability and efficacy of the combination therapy of Sofatinib and PD-1 monoclonal antibody, including the characteristics of monotherapy that has been approved in China.
Riprolizumab, tislelizumab, and sintilizumab
.

 US and European neuroendocrine tumor research: Sofatinib's US new drug marketing application was accepted by the US Food and Drug Administration ("FDA") in June 2021, and the application for marketing authorization was submitted to the European Medicines Agency (EMA) It was also confirmed in July 2021
.

The above applications are based on the completed SANET-ep and SANET-p studies, as well as the existing data on the treatment of non-pancreatic and pancreatic neuroendocrine tumors by Sofantinib in the United States (clinicaltrials.
gov registration number NCT02549937)
.

In the United States, Sofatinib was granted Fast Track designation in April 2020 for the treatment of pancreatic and non-pancreatic neuroendocrine tumors, and was awarded the "Orphan Drug" designation in November 2019 for the treatment of pancreatic neuroendocrine tumors
.

 Hutchison Medicine has launched an Expanded Access Protocol in the United States to ensure that neuroendocrine tumor patients with limited treatment options can receive this therapy
.

The extended treatment program has been approved by the FDA, and the project has been opened to the center (clinicaltrials.
gov registration number: NCT04814732)
.

    About Teriplimumab Teriplimumab Injection (Tuoyi) was independently developed by Junshi Biotech.
So far, more than 30 clinical studies covering more than 15 indications have been carried out around the world, and the product is actively explored in The efficacy and safety of melanoma, nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, liver cancer, cholangiocarcinoma, breast cancer, kidney cancer and other indications
.

 As the first domestically-made monoclonal antibody targeting PD-1 approved for marketing in China, teriprizumab has been approved for 4 indications in the fields of melanoma, nasopharyngeal carcinoma, and urothelial carcinoma
.

In the United States, the FDA's first marketing application (BLA) for tereprizumab has been accepted and has been granted priority review.
Tereprizumab is also the first domestic anti-PD-1 monoclonal antibody to submit a BLA to the FDA
.

At present, Teriplizumab has been granted 2 breakthrough therapy designations, 1 fast track designation and 4 orphan drug designations granted by the FDA
.

References: [1]Xu J, Shen L, Zhou Z, et al.
Surufatinib in advancedextrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind,placebo-controlled, phase 3 study.
Lancet Oncol.
2020;21 (11):1500-1512.
doi: 10.
1016/S1470-2045(20)30496-4.
[2]Xu J, Shen L, Bai C, et al.
Surufatinib inadvanced pancreatic neuroendocrine tumours (SANET-p): a randomised ,double-blind, placebo-controlled, phase 3 study.
Lancet Oncol.
2020; 21(11):1489-1499.
doi: 10.
1016/S1470-2045(20)30493-9.
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