Biomarker-independent real-world effectiveness and safety of toripalimab in advanced esophageal squamous cell carcinoma: A multicentre Indian experience.

Abstract

131 Background: Toripalimab has demonstrated survival benefit in advanced esophageal squamous cell carcinoma (ESCC) in randomized trials. However, real-world data from India, particularly in patients with low or undocumented PD-L1 expression, remain limited. We evaluated the real-world effectiveness and safety of toripalimab in advanced ESCC across multiple tertiary care centres in India. Methods: This retrospective multicentre study reviewed electronic medical records of adults with advanced or metastatic ESCC treated with toripalimab between February 2025 and January 2026. Outcomes included objective response rate (ORR), disease control rate (DCR), real-world progression-free survival (rwPFS), and treatment-related adverse events. Subgroup analyses were performed by line of therapy and PD-L1 status. Results: Thirty-one patients were identified, of whom 30 were evaluable for efficacy (median age 59 years; 54.8% female). Most patients had ECOG performance status 0-1 (70.9%) and visceral metastases (74.2%). Toripalimab was administered in the first line setting in 54.8%. The ORR was 60.7% and DCR was 67.9%, with higher ORR in first-line therapy compared with later lines (68.9% vs 50%). Responses were observed across PD-L1 subgroups, including patients with PD-L1 <1% and those without PD-L1 testing. Median rwPFS was 6.1 months (95% CI 4.5-NR) for the cohort. Key clinical outcomes summarized in Table 1. Treatment-related adverse events were consistent with the known safety profile of PD-1 inhibitors, with no treatment discontinuations due to toxicity. Conclusions: In this multicentre Indian real-world cohort, toripalimab demonstrated clinically meaningful activity with manageable toxicity in advanced ESCC, including in patients with low or undocumented PD-L1 expression. These findings provide supportive real-world evidence of toripalimab activity across PD-L1 subgroups in routine clinical practice. Key clinical outcomes. Endpoint Overall(n=30) PD-L1 ≥1%(n=19) PD-L1 <1%/not done/unknown(n=11) ORR 60.7% 52.6% 77.8% DCR 67.9% 63.2% 77.8% Median rwPFS (months) 6.1 7.7 6