Keytruda was approved by the National Medical Products Administration in China as monotherapy for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by a fully validated test, following failure of one prior line of systemic therapy.
This new indication was granted full approval based on the overall survival findings from the global phase 3 KEYNOTE-181 trial, including data from an extension of the global study in Chinese patients. With this new approval,
Keytruda is sponsored by Merck.
Keytruda is now approved for five indications across three cancer types in China, including as a first-line treatment for appropriate patients with advanced non-small cell lung cancer (monotherapy and in combination with chemotherapy) and as a second-line treatment for advanced melanoma. The FDA approval in July 2019 was based upon the global KEYNOTE-181 trial.
“In China, more than 90% of esophageal cancers are squamous cell carcinomas, and patients with advanced types of this disease face a poor prognosis and have few treatment options,” Shen Lin, vice president of Clinical Oncology at Beijing Cancer Hospital and Peking University and deputy director of Beijing Institute for Cancer Research, said in a statement.
In the KEYNOTE-181 trial, an improvement in OS was observed in patients who were treated with Keytruda monotherapy compared with chemotherapy in previously treated patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10) (HR=0.64 [95% CI, 0.46-0.90]). The median OS was 10.3 months for Keytruda compared with 6.7 months for chemotherapy.
In the extension of the KEYNOTE-181 study in Chinese patients, consistent with the KEYNOTE-181 global study, there was an improvement in OS for patients who were treated with Keytruda monotherapy compared with chemotherapy in previously treated patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10) (HR=0.38 [95% CI, 0.19-0.77]). The median OS was 12.0 months for KEYTRUDA compared with 5.4 months for chemotherapy.
