Abstract 310P
Background
Currently, the standard 1L treatment for pts with ES-SCLC is immunotherapy (IO) plus chemo, providing an initially robust response but lacking durability. This unmet medical need prompted exploration of novel maintenance therapies following the 1L treatment. A multicentre, open-label, phase II study (NCT05509699) evaluated the efficacy and safety of surufatinib plus IO as a maintenance therapy following 1L standard of care in pts with ES-SCLC.
Methods
A total of 21 pts with cytologically or pathologically confirmed ES-SCLC, without disease progression (PD) after for 4 to 6 cycles (21-day a cycle) of 1L therapy, were enrolled in the single arm phase IIa part to receive surufatinib (250 mg, orally, once daily) plus PD-1/PD-L1 antibodies (durvalumab, sintilimab, toripalimab, or serplulimab), until PD or intolerable toxicity. The maximum IO duration were 24 months (m). The efficacy and safety data have been previously reported. Herein, the final OS data are presented. Exploratory subgroup analyses of prognostic factors potentially impacting OS were also performed.
Results
As of Jul 31, 2024, the majority of pts (81.0% [17/21]) had discontinued study treatments, primarily due to PD (71.4% [15/21]), while four pts remained on treatment, and nine died. The median follow-up duration was 17.1 m for maintenance and 22.5 m for 1L (induction + maintenance) therapy. The OS rates for maintenance therapy at 12- and 18-m were both 57.1%; for 1L therapy at 12- and 18-m were 85.7% and 57.1%, respectively. Subgroup results of OS rate at 18-m for 1L- and at 15-m for maintenance therapy are provided.
Table 310PSubgroup analysis of OS
1L (Induction + Maintenance) OS rate at 18-m (%) | Maintenance OS rate at 15-m (%) | |
Cycles of 1L therapy | ||
4 (N=8) | 37.5 | 37.5 |
5–6 (N=13) | 69.2 | 69.2 |
BMI (kg/m2) | ||
ConclusionsThis exploratory study suggests surufatinib plus IO as maintenance therapy following 1L therapy (IO + chemo) demonstrated durable survival benefit for pts with ES-SCLC, warranting further investigation. Clinical trial identificationNCT05509699. Legal entity responsible for the studyHUTCHMED Limited. FundingHUTCHMED Limited. DisclosureX. Zhang, D. Chen, S. Fan, C. Zhong, M. Shi: Financial Interests, Personal, Full or part-time Employment: HUTCHMED Limited. W. Su: Financial Interests, Personal and Institutional, Stocks/Shares: HUTCHMED Limited; Financial Interests, Personal and Institutional, Member of Board of Directors: HUTCHMED Limited. All other authors have declared no conflicts of interest. This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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