Surufatinib plus toripalimab in advanced soft tissue sarcoma (STS): Results from a multicenter, single-arm, basket study.

Authors

null

Ying Cheng

Department of Oncology, Jilin Cancer Hospital, Changchun, China

Ying Cheng , Xing Zhang , Ming Lu , Si Shi , Feng Ye , Zhendong Chen , Dongmei Ji , Lijie Song , Fei Yin , Haiyan Shi , Jinghong Zhou , Panfeng Tan , Songhua Fan , Qian Xu , Michael Shi , Weiguo Su

Organizations

Department of Oncology, Jilin Cancer Hospital, Changchun, China, Biotherapy Center, Sun Yat-sen University Cancer Center, Guangzhou, China, State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China, Department of Pancreatic Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China, Department of Medical Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, China, Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China, Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China, First Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China, Department of Gastroenterology, Fourth Hospital of Hebei Medical University, Shijiazhuang, China, HUTCHMED Limited, Shanghai, China

Research Funding

Science and Technology Innovation – Biomedical Science and Technology Support Project
HUTCHMED Limited

Background: Soft tissue sarcomas (STS) are highly malignant despite their low incidence and prone to recurrence, with limited therapeutic options after failure of first-line treatment. Several antiangiogenic monotherapies have shown some efficacy but limited benefit. The open-label, multi-cohort, single-arm, basket study was performed to evaluate the efficacy and safety of the combination of surufatinib (a small-molecule inhibitor of VEGFR 1-3, FGFR1 and CSF-1R) with toripalimab (an anti-programmed death 1 [PD-1] antibody) for Chinese patients (pts) with advanced solid tumors. Here, we reported the results from the STS cohort. Methods: Pts with STS who had progressed on ≤ 2 lines of systemic chemotherapy, or were intolerant to standard treatment, or for whom there was currently no effective therapy were eligible. They received 21-day cycles of surufatinib 250 mg orally, once daily, plus toripalimab 240 mg intravenously, once every 3 weeks, until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) per RECIST 1.1. Results: As of data cutoff (Feb 28, 2023), a total of 20 pts (incl. 4 treatment-naïve pts) were enrolled and received the combination treatment (mean duration: 5.81 months [m]). Median (range) age was 50 (23-74) years, 10 pts were male, 17 pts were TNM stage IV. The pathological types include leiomyosarcoma (n=4, incl. 1 naïve patient), synovial sarcoma (n=4), alveolar soft part sarcoma (n=3, incl. 2 naïve pts), undifferentiated pleomorphic sarcoma (n=3), liposarcoma (n=2, incl. 1 naïve patient) and fibrosarcoma (n=1), malignant fibrous histiocytoma (n=1) and others (n=2). Seven (35%) pts had PD-L1 combined positive score of ≥1. The median follow-up duration was 27.14 m. Confirmed ORR and disease control rate (DCR) for 19 efficacy-evaluable pts was 10.5% and 68.4%, respectively; median duration of response was 7.05m. The median progression-free survival (mPFS) and median overall survival (mOS) was 2.69 m and 16.23 m for all dosed pts. For 16 previously treated pts, ORR and DCR was 6.3% and 62.5% respectively; median duration of response (DoR) was 7.13 m; mPFS was 2.65 m; mOS was 14.32 m. 18 (90%) pts experienced at least one treatment-related adverse event (TRAE), and 7 (35%) of them reported grade ≥3 TRAEs. The incidence of immune-related adverse events (irAEs) was 70%, only 2 pts had grade ≥3 irAEs, which were immune-related pancreatitis and immune-related diabetes. 2 pts were permanently discontinued due to TRAEs, which were grade 2 renal impairment and grade 3 hyperglycemia. No new safety signals were observed. Conclusions: Surufatinib plus toripalimab had a promising antitumor activity and a manageable safety profile in pts with advanced STS. Clinical trial information: NCT04169672.

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Abstract Details

Meeting

2024 ASCO Breakthrough

Session Type

Poster Session

Session Title

Poster Session A

Track

Gastrointestinal Cancer,Central Nervous System Tumors,Developmental Therapeutics,Genitourinary Cancer,Quality of Care,Healthcare Equity and Access to Care,Population Health,Viral-Mediated Malignancies

Sub Track

Targeted Therapies

Clinical Trial Registration Number

NCT04169672

Citation

J Clin Oncol 42, 2024 (suppl 23; abstr 42)

DOI

10.1200/JCO.2024.42.23_suppl.42

Abstract #

42

Poster Bd #

B5

Abstract Disclosures