On December 10, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new analyses and updates on the ongoing studies of surufatinib combined with toripalimab, in multiple disease settings, presented at the European Society for Medical Oncology’s (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, taking place virtually on December 8-11, 2021 (Press release, Hutchison China MediTech, DEC 10, 2021, View Source [SID1234596741]).
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Further details of the poster presentations are as follows:
Title: Surufatinib plus toripalimab in patients with advanced small cell lung cancer (SCLC) after failure of 1L systemic chemotherapy
First Author: Ying Cheng, MD, Jilin Cancer Hospital
Abstract No. & Link: 157P
Date & Time: Thursday, December 9, 2021, 11:30am – 11:50am CET
Title: Surufatinib plus toripalimab for 2L treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC) and neuroendocrine carcinoma (NEC): A multicenter, single-arm phase II study
First Author: Ming Lu, MD, Peking University Cancer Hospital & Institute
Abstract No. & Link: 155P
Date & Time: Thursday, December 9, 2021, 10:50am – 11:10am CET
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.
HUTCHMED currently retains all rights to surufatinib worldwide.
About Surufatinib Development
Extra-pancreatic Neuroendocrine Tumors ("epNETs") in China: On December 29, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China ("NMPA") for the treatment of epNET. Surufatinib is marketed in China under the brand name SULANDA. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of PFS at a preplanned interim analysis, and was published in The Lancet Oncology[1]. Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).
Pancreatic Neuroendocrine Tumors ("pNETs") in China: On June 16, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNET in China. The pre-defined primary endpoint of PFS was met at a preplanned interim analysis and was published in The Lancet Oncology[2], demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.
Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with toripalimab, tislelizumab and sintilimab, which are approved as monotherapies in China.
NETs in the U.S. and Europe: A U.S. Food and Drug Administration ("FDA") New Drug Application (NDA) submission was accepted in June 2021, followed by a Marketing Authorisation Application (MAA) submission to the European Medicines Agency (EMA) validated in July 2021. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019.
HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).
About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi Biosciences. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). To date, four indications of toripalimab has been approved by the NMPA for the treatment of melanoma, nasopharyngeal carcinoma ("NPC") and urothelial carcinoma. In the United States, the FDA has granted priority review for the toripalimab Biologics License Application (BLA) for the treatment of NPC, which currently has no FDA-approved immuno-oncology treatment options. Earlier, the FDA granted 2 Breakthrough Therapy designations, 1 Fast Track designation, 4 Orphan Drug designations for toripalimab.