MSD reveals first results for pembrolizumab in Chinese esophageal cancer subgroup

Merck, Sharp & Dohme (MSD; NYSE.MRK) released the results of clinical study KEYNOTE-181 for its programmed death-1 (PD-1) inhibitor pembrolizumab (Keytruda) in a Chinese subgroup at the European Society for Medical Oncology (ESMO) annual meeting, trailing its third indication approval in China. The results show that pembrolizumab significantly prolonged overall survival in patients with recurrent locally advanced or metastatic esophageal squamous cell carcinoma (from 5.6 months to 8.4 months), with a 45% reduction rate in death or disease progression risk and an increased 1-year survival rate from 16.7% to 36.3%, while reducing adverse reactions incidence rate by half.

There are 572,000 new esophageal cancer cases worldwide each year, with 509,000 deaths, half of which occur in China. 90% of esophageal cancer patients in China fall under the squamous cell carcinoma category and do not respond to existing treatments. Among them, the 5-year survival rate of inoperable patients is only 15% to 20%, indicating a huge amount of unmet clinical needs.

Pembrolizumab first got market approval in July 2018 to treat locally advanced or metastatic melanoma, following Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab), and went on to gain the nod as first-line treatment against epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK)-negative metastatic non-squamous non-small cell lung cancer (NSCLC) in combination with pemetrexed plus platinum-based chemotherapy, and as first-line NSCLC treatment in March and September 2019 respectively. The first-line NSCLC treatment approval marks the first immunotherapy as a first-line treatment of NSCLC as a monotherapy. KEYNOTE-181’s results could serve as a key reference for other pembrolizumab indication filings.


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