Phase 2 Study of M6620 (VX-970) in Combination With Gemcitabine Versus Gemcitabine Alone in Subjects With Platinum-Resistant Recurrent Ovarian or Primary Peritoneal Fallopian Tube Cancer

Trial ID # NCT02595892
Phase II
Drug Class DNA Damage Repair Pathway Inhibitors: ATR
Drug Name Berzosertib
Alternate Drug Names M6620, VE-822, ATR kinase inhibitor VX-970
Drugs in Trial Berzosertib, Gemcitabine
Eligible Participant

Platinum-resistant ovarian cancer

Patients Enrolled

70

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

PFS, evaluated per RECIST

Biomarkers

Exploratory: Platinum-free Interval (PFI)

Efficacy

Ber+Gem (n=36) vs Gem (n=34):

PFS: 5.7 vs 3.7 months, HR: 0.57 (0.33-0.997, p = 0.047)

Exploratory analysis:
Ber+Gem vs Gem:
PFI<3: HR : 0.31 (0.13-0.77, p = 0.013)
PFI>3: HR:  0.95 (0.46-1.97, p = 0.45)

Clinically Significant Adverse Events

Ber+Gem vs Gem:
Serious AE:
Grade 3-4 AE:

Conclusion

Addition of berzosertib to gemcitabine increased PFS without additional toxicity, the benefit was observed mainly in patients with platinum-free interval less than 3 months

Reference

Konstatinopoulos PA et al. Randomized phase II (RP2) study of ATR inhibitor M6620 in combination with gemcitabine versus gemcitabine alone in platinum-resistant high grade serous ovarian cancer (HGSOC). ESMO (2019) Abstr LBA60
https://cslide.ctimeetingtech.com/esmo2019/attendee/confcal/presentation/list?q=M6620