Innovent, Lilly’s PD-1 Inhibitor Approved to Treat Esophageal Cancer in China

Innovent and Eli Lilly have jointly announced the NMPA approval of their TYVYT (sintilimab injection) in combination with chemotherapy for the treatment of esophageal squamous cell carcinoma (ESCC) in the first-line setting. A PD-1 inhibitor, sintilimab will be combined with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil chemotherapy to treat unresectable, locally advanced, recurrent or metastatic cases of ESCC. 

This is sintilimab’s fifth approval in China. Over the last four years, the drug has collected approvals for the treatment of Hodgkin’s lymphoma, non-squamous non-small cell lung cancer (NSCLC), squamous NSCLC, and hepatocellular carcinoma. 

Results Based on Orient-15 Study

The latest approval of sintilimab is based on the interim analysis of Orient-15, a global Phase 3 clinical trial comparing sintilimab plus chemo to placebo plus chemo in first-line ESCC. 

According to the readout from the Independent Data Monitoring Committee (IDMC), the sintilimab combo showed a statistically significant improvement in overall survival (OS) compared to the placebo combo regardless of PD-L1 expression status, meeting the primary endpoint. 

For sintilimab plus chemo, median OS and median progression-free survival (PFS) were 16.7 months (vs 12.5 months in the placebo group) and 7.2 months (vs 5.7 months for the placebo group).

The safety profile of the sintilimab combo was consistent with that observed in previous studies, with no new safety signals detected. 

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A Competitive PD-1 Inhibitor in China but Not the US

Esophageal cancer is the seventh most commonly diagnosed cancer, and the sixth leading cause of cancer death worldwide. It is especially prevalent in China, which makes up more than half of new and fatal global cases. Moreover, the five-year survival rate for the disease is only 30% in the country, highlighting the need for better first-line treatments. 

Having been approved for the first-line setting, sintilimab will have a competitive edge over other PD-1 inhibitors like Merck’s Keytruda (pembrolizumab), which has only been approved for the second-line setting.

Additionally, the NMPA is currently reviewing sintilimab for two indications: in combination with chemotherapy for the first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma, and in combination with bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment.

While sintilimab has consistently racked up approvals in China, the PD-1 inhibitor does not have as much success in the US where it is still an investigational treatment. In March, the program experienced a setback when the US FDA issued a complete response letter (CRL) to Lilly for the Biologics License Application (BLA) for sintilimab in combination with chemo in first-line non-squamous NSCLC. In the CRL, the FDA requested Lilly and Innovent conduct an additional multiregional clinical study comparing sintilimab with chemo and the standard of care for first-line metastatic NSCLC. 

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Joy Lin

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