FDA approves Merck's PD-1 tumor immunotherapy Keytruda for the treatment of patients with hepatocellular carcinoma

Source: Drug Information Network

Recently, Merck announced that the US FDA has approved a new indication for its PD-1 tumor immunotherapy Keytruda (Chinese trade name: cerida, generic name: pabolizumab) for the previously accepted targeted drug sorafenib (Sorafenib) in patients with hepatocellular carcinoma (HCC). The approval is based on accelerated approval of tumor remission rates and mitigation persistence data, and further approval will depend on validation and description of clinical benefits in confirmatory clinical studies.

At the end of last month, the FDA also approved the first-line treatment of Keytruda combined with chemotherapy (carboplatin plus paclitaxel or albumin-conjugated paclitaxel [nab-paclitaxel] in patients with metastatic squamous NSCLC, regardless of tumor PD -L1 expression status. This approval made Keytruda the first first-line treatment of squamous NSCLC regardless of the PD-L1 expression status of the tumor. The related study of Keytruda HCC indication was based on KEYNOTE -224 research data.

The study was a single-group open-label study that evaluated the efficacy and safety of Keytruda treatment in 104 HCC patients who underwent or after treatment with sorafenib or who were intolerant to sorafenib.

The data showed that the overall response rate (ORR) for Keytruda treatment was 17% (95% CI: 11-26), the complete response rate was 1%, and the partial response rate was 16%. Among patients with remission (n=18), 89% had a duration of remission (DOR) of 6 months or longer, and 56% had a DOR of 12 months or longer.