With support of strong data, CStone Pharmaceuticals will be seeking a new indication approval in China for its Gavreto (pralsetinib) as first-line treatment in patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC).
Gavreto is CStone’s first product approved in China and the country’s first selective RET inhibitor. In March this year, it was approved for treating adult patients with locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy.
The company reported the data in RET fusion-positive NSCLC from the global phase I/II ARROW study, in which 68 Chinese patients received 400mg of the drug once daily, for the first time at the IASLC 2021 World Conference on Lung Cancer on Sep. 9.
For patients who have previously received platinum-based chemotherapy, the confirmed overall response rate was 66.7%, including one complete response and 21 partial responses. The disease control rate was 93.9%.
And for patients who have not received prior systemic treatment, the confirmed overall response rate was 80%, including two complete responses and 22 partial responses. The disease control rate was 86.7%.
In these two groups of patients, the median time to first response was 1.89 months and 1.87 months, respectively.
CStone added that Gavreto was generally well-tolerated. The overall safety in Chinese patients was manageable, with no new safety signal detected.
CStone’s Chief Medical Officer Jason Yang said the RET inhibitor demonstrated “remarkable tumor response, rapid onset of efficacy, and duration of response in Chinese patients with RET fusion-positive advanced NSCLC in both first-line and second-line treatment settings, with a manageable safety profile.”
Gavreto is a selective and potent RET inhibitor discovered by Blueprint Medicines Corporation, from which CStone licensed in the Greater China rights to the drug in June 2018.