- Interim data from first 19 patients in Phase 1/2 trial evaluating Galera Therapeutics' (NASDAQ:GRTX) lead candidate, avasopasem manganese (GC4419), in combination with stereotactic body radiation therapy (SBRT), showed improvement in overall survival (OS) and multiple anti-cancer efficacy measures in locally advanced pancreatic cancer (LAPC) patients. Data will be presented at 2020 ASTRO Annual Meeting.
- In the intent-to-treat cohort (n=19), which comprises all patients followed for over a year, median OS had not yet been reached in the GC4419 arm, compared to 40.4 weeks in the placebo arm.
- The GC4419 arm also demonstrated favorable progression-free survival, locoregional control and time-to-distant metastases compared to the placebo arm. The incidence of acute (<90 days) or late (91-365 days) Grade 3+ toxicity post-SBRT was similar in both arms.
- Avasopasem is currently being studied in the ROMAN Phase 3 trial of ~450 patients to investigate the effects of the drug on radiation-induced OM in patients with locally advanced head and neck cancer.
- The product candidate is also in a Phase 2a trial for its potential to reduce the incidence of radiation-induced esophagitis in patients with lung cancer and in a Phase 2 trial in critically ill, COVID-19 hospitalized patients.
- Avasopasem manganese is a small molecule superoxide dismutase mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen, protecting normal tissue from damage associated with radiation therapy.
Monday, October 26, 2020
Galera Therapeutics' lead asset shows survival benefit in pancreatic cancer study
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