- TESARO (NASDAQ:TSRO) is up 69% premarket on robust volume in response to its announcement of positive results in a Phase 3 clinical trial, NOVA, assessing PARP inhibitor niraparib in women with ovarian cancer, including those who are germline BRCA mutation carriers and those who are not germline BRCA carriers but who have homologous recombination deficient (HRD) tumors [as determined by Myriad Genetics' (MYGN) myChoice HRD test].
- NOVA was a ~500-subject, double-blind, placebo-controlled study in patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy.
- Patients treated with niraparib experienced median progression-free survival (PFS) of 21.0 months compared to 5.5 months for placebo (p<0.0001) with 62% less risk of dying in the study period (hazard ratio = 0.38).
- The most common treatment-emergent grade 3 (serious) or grade 4 (disabling or life threatening) adverse events were thrombocytopenia (28.3%), anemia (24.8%) and neutropenia (11.2%). The discontinuation rate was 14.7% for niraparib versus 2.2% for placebo.
- There is no currently approved therapy in the U.S. for maintenance treatment of patients with recurrent ovarian cancer following response to platinum.
- The company plans to file regulatory submissions in the U.S. and Europe in Q4.