LSK BioPharma issued the following announcement on June 27.
LSK BioPharma (LSKB) has completed the unblinding and preliminary review of topline data from its ANGEL Study, a Phase III clinical trial for rivoceranib (apatinib) which enrolled 460 advanced or metastatic gastric cancer patients. While the rivoceranib arm did achieve better median overall survival (OS) compared with placebo, and a result comparable to other approved drugs in gastric cancer, the result was not statistically significant. Overall survival was the primary endpoint in the ANGEL study. Rivoceranib demonstrated a highly significant improvement in median progression-free survival (PFS), which was a secondary endpoint. Rivoceranib was also generally well tolerated and safety results were consistent with prior studies. LSKB will conduct analyses as additional data become available such as overall response rate (ORR) and time-to-progression, follow surviving patients, and keep an open dialogue with regulatory agencies to determine the appropriate path to approval for rivoceranib in this gastric cancer monotherapy indication. The Company plans to continue ongoing clinical development programs in other indications including, earlier lines of therapy for gastric cancer with combination therapy, colorectal cancer, and hepatocellular carcinoma.
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