Hengrui PD-1 nasopharyngeal carcinoma indication is about to be approved

On April 20, the official website of the State Food and Drug Administration showed that Hengrui's new indication for carrelizumab for injection (registration classification: 2.

The indications to be approved this time are: for the treatment of advanced nasopharyngeal carcinoma patients who have previously received second-line or above chemotherapy and have advanced or intolerable disease.

Carrelizumab indications and approval status

At the 2020 ESMO meeting, Hengrui announced the single-agent treatment of carrelizumab, which has previously received a second-line and above platinum-containing regimen and failed the treatment, and the disease has progressed and recurred/metastasis.

From August 14, 2018 to December 30, 2019, a total of 156 eligible patients received carrelizumab treatment.

In terms of safety, the incidence of treatment-related adverse events (TRAEs) of any grade was 96.

Currently, among the PD-1/L1 drugs approved in China, only Junshi Biologics’ Tereprizumab and Hengrui’s Karelizumab have been declared and marketed for nasopharyngeal cancer indications.

In addition, according to the NextClinTrial database of Medicine Rubik's Cube, the key phase II clinical study (AK105-202) of the third-line treatment of nasopharyngeal carcinoma with penpulimab PD-1 therapy by Zhengda Tianqing/Kangfang has achieved positive results with an ORR of 27%.

In addition, Junshi, Hengrui, and Xinda have registered their respective key clinical studies of PD-1 combined with radiotherapy and chemotherapy in the treatment of high-risk patients with nasopharyngeal cancer.