KEY TAKEAWAYS
- The phase I/II trial aimed to present updated results on long-term efficacy and safety of S+T and EP regimen for SCLC patients.
- The primary endpoints were RP2D of S and PFS.
- The results showed promising efficacy and tolerable toxicity in 1L advanced SCLC, potentially offering a novel therapeutic option, particularly for patients without liver or bone metastases.
In small cell lung cancer (SCLC), Surufatinib (S), a novel small-molecule inhibitor targeting VEGFR1-3, FGFR1, and CSF-1R, along with toripalimab (T), an anti-PD-1 antibody, has shown promising efficacy in phase 2 trials for patients who have failed first-line chemotherapy. Building upon previous findings, preliminary results from NCT04996771 indicated encouraging efficacy of S plus T in combination with etoposide plus cisplatin (EP) as a first-line regimen for SCLC.
Here, Wen Feng Fang and the team presented an updated result from the study showcasing the encouraging efficacy of S plus T in combination with EP as a first-line regimen for SCLC.
The study followed a 3+3 dose-escalation phase (Phase Ib) and a dose expansion phase (Phase II), enrolled patients aged ≥18 years with histologically confirmed advanced SCLC and an ECOG PS of 0-1, possessing at least one measurable lesion. Eligible patients with treated, stable, asymptomatic brain metastases were included. In Phase Ib, Surufatinib (S) was administered orally at doses ranging from 150mg to 250mg once daily every 3 weeks (Q3W), in combination with a fixed dose of T (200mg intravenously on day 1, Q3W) and EP every 3 weeks (Q3W). Maintenance therapy with S plus T was administered after 4 cycles.
The primary endpoints were the recommended phase 2 dose (RP2D) of S and progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
About 39 patients were enrolled in the study. The median age was 64 years, with 82.1% being male, and 59.0% having an ECOG PS of 1. Additionally, 89.7% of patients were categorized as TNM stage IV. Liver, bone, and brain metastases were present in 33.3%, 30.8%, and 12.8% of patients, respectively. The recommended phase 2 dose (RP2D) of S was determined to be 200mg orally once daily every 3 weeks (Q3W). Among patients with at least one post-baseline tumor assessment (n=35), the median PFS was 6.0 months (95% CI 4.7, 7.3).
Patients without liver metastases had significantly longer PFS compared to those with liver metastases (5.7 months vs 8.4 months, p=0.0169), as did patients without bone metastases compared to those with bone metastases (5.7 months vs 8.4 months, P=0.0198). The ORR was 97.1%, and the DCR was 100%. The most common (≥10%) grade ≥3 treatment-emergent adverse events (TEAEs) were neutrophil count decreased (31.6%), white blood cell count decreased (23.7%), and platelet count decreased (10.5%).
The combination of S plus T with ET demonstrated promising efficacy and manageable toxicity in first-line treatment for advanced SCLC, particularly benefiting patients without liver or bone metastases, suggesting a potential novel therapeutic approach. Research was funded by Sun Yat-sen University.
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34
Clinical Trial: https://clinicaltrials.gov/study/NCT04996771
Fang WF et al. (2023) ‘‘Surufatinib plus toripalimab combined with etoposide (E) and cisplatin (P) in patients (pts) with advanced naive small cell lung cancer (SCLC) -Updated results of a phase ?b/? Trial.’’ Presented at ESMO IO 2023 (124P).
