Dr. Reddy's Toripalimab in India: Esophageal Cancer Data

Toripalimab in India is gaining clinical relevance as Dr. Reddy’s Laboratories expands the potential use of its immunotherapy brand Zytorvi in gastrointestinal cancer.

The Central Drugs Standard Control Organization (CDSCO) approval for the additional indication brings attention to the role of immune checkpoint inhibitors in treating advanced esophageal squamous cell carcinoma (ESCC).

Beyond the regulatory development, an India-based real-world study offers another perspective on how toripalimab performs outside controlled clinical trials.

A multicenter study at the 2026 ASCO Breakthrough meeting assessed treatment outcomes in patients with advanced or metastatic ESCC, including patients with low or unrecorded PD-L1 expression.

The findings offer an early signal of treatment activity in everyday clinical practice, but it isn’t sufficient to draw any conclusion because of the small number of patients who were examined.

What Did the Indian Real-World Study Find?

The study, published in June 2026, reviewed medical records from multiple Indian tertiary care centers. Researchers examined adults treated with toripalimab between February 2025 and January 2026.

Key findings include:

• Patient population: Researchers identified 31 patients, out of which 30 were evaluable for efficacy.
• Objective response rate: The study reported a response rate of 60.7 percent.
• Disease control rate: The proportion achieving disease control was 67.9 percent.
• Progression-free survival: Median real-world progression-free survival was 6.1 months.
• Treatment settings: Toripalimab was used as first-line therapy in 54.8 percent of identified patients.

The reported objective response rate was higher in patients treated in first-line treatment compared to those treated later, at 68.9 percent vs. 50 percent.

Responses were also recorded across PD-L1 subgroups, including patients with expression below 1 percent and those testing undocumented.

However, the retrospective design, small sample size and absence of a comparison group mean the results should be interpreted as supportive evidence rather than definitive proof of comparative benefit.

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Why Does PD-L1 Status Matter for Treatment Decisions?

Toripalimab is a monoclonal antibody that blocks the programmed cell death protein 1 (PD-1) pathway, helping immune cells recognize and attack cancer cells.

The Indian study recorded response amongst patients with low or undocumented PD-L1 expression. That may matter for treatment selection, but does not mean biomarker testing can be skipped in every setting.

The study also reported that treatment-related adverse events were consistent with the known safety profile of PD-1 inhibitors, with no treatment discontinuations attributed to toxicity in the cohort.

For Dr. Reddy’s Laboratories, the expanded indication places greater emphasis on evidence generation alongside regulatory approval. For clinicians, the next priority is to understand how these outcomes translate across larger and more diverse patient populations.

Further prospective studies and longer follow-up will be important to assess durability of response, survival outcomes and safety. As toripalimab in India gains attention for advanced ESCC, real-world evidence can help guide treatment choices and identify remaining evidence gaps.