PMV Pharma：PYNNACLE II期卵巢癌队列中ORR达46%

II期中期数据显示，76例铂类耐药/难治性卵巢癌患者中ORR为46%，中位DOR为10个月。FDA反馈支持2027年第一季度加速批准NDA提交。卵巢队列主要分析及其他队列数据将于2026年第四季度在医学会议上公布。

关键事实

申报时间: 2026年8月31日 20:06
事件: 顶线结果
方向: 积极
公司: PMVPPMV Pharmaceuticals
资产: rezatapopt
来源: SEC 8-K
可信度: 有来源
卵巢癌ORR: 46% (22/48)
全部患者中位DOR: 7.6个月
全部队列ORR: 34% (35/103)
卵巢癌中位DOR: 8.0个月

来源摘录

EX-99.1 2 d441751dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 PMV Pharmaceuticals Announces Updated Promising Rezatapopt Monotherapy Interim Ovarian Cancer Data From PYNNACLE Phase 2 Pivotal Trial • 46% ORR observed among 76 evaluable patients in the ovarian cancer cohort with a median duration of response of 10.0 months • Recent FDA interaction supports NDA submission strategy for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer, with submission planned in first quarter of 2027 • PMV plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts at a medical conference in fourth quarter of 2026 PRINCETON, N.J. , August 31, 2026 (GLOBE NEWSWIRE) — PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology

SEC 8-K