BeiGene (NASDAQ:
BGNE) and Mirati Therapeutics (NASDAQ:
MRTX)
announces preliminary data from an ongoing
Phase 1b trial of anti-PD-1 antibody tislelizumab in combination with tyrosine kinase inhibitor sitravatinib in patients with platinum-resistant ovarian cancer.
The results presented at European Society for Medical Oncology Immuno-Oncology (ESMO I-O) were from cohort E in 20 patients.
At the data cutoff of July 17, 2019, 17 patients were evaluable and preliminary results included:
Seven patients achieved a partial response; the overall response rate was 23.5% (4/17, 95% CI: 6.8%, 49.9%); eight patients achieved stable disease.
The median duration of response was not reached (95% CI: 12.29 weeks, not reached).
The median progression-free response (PFS) was 18 weeks (95% CI: 12.29 weeks, not reached), and the PFS rate at 3 months and 6 months was 88.2% (95% CI: 60.6%, 96.9%) and 35.3% (95% CI: 9.0%, 63.8%), respectively.
All 20 patients experienced treatment-emergent adverse events (TEAEs) of any grade.
Immune-related TEAEs were hypothyroidism (20%), diarrhea (15%), and rash (15%).
Six patients (30%) discontinued the study treatment due to TEAEs; and
Two patients experienced TEAEs leading to death, abdominal pain and respiratory failure, both of which were considered unrelated to treatment by the study investigator.
BeiGene and Mirati entered into an exclusive license agreement for the development, manufacturing and commercialization of Mirati’s sitravatinib in Asia (excluding Japan), Australia, and New Zealand in January 2018.
