Core Insights - Olema Pharmaceuticals announced updated data from the Phase 1b/2 study of palazestrant in combination with ribociclib for treating ER+/HER2- advanced or metastatic breast cancer, with findings to be presented at the ESMO Congress 2025 [1][2] Efficacy - The combination of palazestrant and ribociclib showed promising efficacy, with a median progression-free survival (PFS) of 15.5 months in the 120 mg palazestrant cohort across all patients [5][6] - In patients with prior CDK4/6 inhibitor treatment, median PFS was 9.2 months for those with ESR1 wild-type tumors and 13.8 months for those with ESR1 mutant tumors [5][6] Safety and Pharmacokinetics - The treatment demonstrated favorable tolerability, with no new safety signals or increased toxicity observed across the 72 patients treated [6] - The majority of treatment-emergent adverse events were grade 1 or 2, consistent with the expected safety profile of each drug [6] Ongoing Trials - Olema is conducting a second Phase 3 trial, OPERA-02, to evaluate palazestrant in combination with ribociclib in the frontline setting for advanced or metastatic breast cancer [2][5] Presentation Details - The findings will be presented in a poster session titled "Palazestrant (OP-1250) plus ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced breast cancer" at the ESMO Congress 2025 [8]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-016 江苏恒瑞医药股份有限公司 关于药品临床试验进展的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）自主研发的羟乙磺 酸达尔西利片联合内分泌治疗在激素受体（HR）阳性、人表皮生长因子受体 2 （HER2）阴性女性乳腺癌辅助治疗中的一项多中心、随机、双盲的Ⅲ期临床试验 （研究方案编号：SHR6390-Ⅲ-303），首次期中分析主要终点达到统计学显著性。 研究结果显示，达尔西利联合内分泌治疗，较安慰剂联合内分泌治疗，可显著降 低患者复发风险，提高患者无侵袭性疾病生存期（IDFS）[1]。公司已于近期向国 家药品监督管理局药品审评中心递交上市前沟通交流申请。 一、 药品的基本情况 药品名称：羟乙磺酸达尔西利片 剂型：片剂 二、 药品的临床试验情况 达尔西利已于国内获批两项适应症，即本品适用于激素受体（HR）阳性、人 表皮生长因子受体 2（HER2）阴性局部晚期或转移性乳腺癌患者：1.与芳香化酶 抑制剂联合使 ...