Galera Rucosopasem Shows Early Anti-Cancer Activity, Pulmonary Function Preservation
- Galera Therapeutics Inc announced results from the open-label Phase 1 stage of the GRECO-1 trial of rucosopasem in combination with stereotactic body radiation therapy (SBRT) for non-small cell lung cancer (NSCLC).
- Enrollment is ongoing in the randomized, double-blinded, placebo-controlled Phase 2 stage of the trial, with completion of enrollment anticipated in 2H of 2023.
- Rucosopasem, in combination with SBRT, appeared well tolerated. The most frequent adverse events were fatigue, cough, and nausea, common in patients with lung cancer receiving radiotherapy.
- In-field partial responses or stable disease was seen in six of the seven patients at six months follow-up, including target tumor reductions in five patients of 61%, 58%, 33%, 29%, and 27% from baseline.
- All seven patients are alive through a minimum of nine months of follow-up.
- Early evidence of protection of pulmonary function was observed compared to the literature.
- No Grade 2-4 declines in DLCO were seen in any of the seven patients receiving rucosopasem compared to a prospective trial (n=127) evaluating pulmonary function after four to five fractions of lung SBRT, in which 7-12% of patients had Grade 2-4 decline in DLCO.
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