AKESO(09926) 第一财经·2025-04-28 11:48Core Viewpoint - The approval of the new indication for Ivosidenib (依沃西单抗) by Kangfang Biopharma (康方生物) did not positively impact the company's stock price, which fell by 11.83% on April 28 due to concerns over the overall survival (OS) data, which showed clinical benefits compared to Keytruda (K药) but lacked statistical significance [1][4][6]. Summary by Sections Drug Approval and Clinical Data - Ivosidenib received approval for a second indication as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 positivity (TPS≥1%) and negative for EGFR and ALK mutations [4]. - The approval was based on positive results from the AK112-303/HARMONi-2 clinical trial, which demonstrated a median progression-free survival (PFS) of 11.14 months for Ivosidenib compared to 5.82 months for Keytruda, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [4][5]. Overall Survival Analysis - A mid-term analysis at 39% maturity showed that Ivosidenib reduced the risk of death by 22.3% compared to Keytruda, although this result did not achieve statistical significance [6][8]. - The total survival data is considered the gold standard for evaluating the efficacy of cancer therapies, and there are differing opinions on the interpretation of these results [6][9]. Market Reaction and Future Prospects - The market's reaction to the OS data has been viewed as misaligned with the essence of the clinical findings, according to Kangfang's chairman, Xia Yu [6][8]. - The ongoing competition with Keytruda is significant, as lung cancer remains the most prevalent and deadly cancer type in China, with Ivosidenib's performance in clinical trials being closely monitored [9][10]. Upcoming Research - The HARMONi-7 study, conducted by Summit, will further evaluate Ivosidenib against Keytruda in patients with high PD-L1 expression, with a focus on achieving statistically significant benefits in overall survival [10]. - This study is crucial for determining whether Ivosidenib can genuinely challenge Keytruda's dominant position in the market [10].