PMV Pharma: 46% ORR in der Ovarialkarzinom-Kohorte der Phase-2-Studie PYNNACLE

Interim Phase 2 data show 46% ORR and 10-month median DOR in 76 platinum-resistant/refractory ovarian cancer patients. FDA feedback supports NDA submission for accelerated approval in Q1 2027. Full ovarian-cohort primary analysis and other cohorts will be presented at a medical conference in Q4 2026.

Kernfakten

Eingereicht: 31. Aug. 2026, 20:06
Ereignis: Topline-Ergebnisse
Richtung: Positiv
Unternehmen: PMVPPMV Pharmaceuticals
Asset: rezatapopt
Quelle: SEC 8-K
Belegstatus: Belegt
ORR Ovarial: 46% (22/48)
Medianes DOR alle: 7,6 Monate
ORR alle Kohorten: 34% (35/103)
Medianes DOR Ovarial: 8,0 Monate

Auszug aus der Quelle

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