On June 29, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported results from the open-label Phase 1 stage of the GRECO-1 trial of rucosopasem in combination with stereotactic body radiation therapy (SBRT) in patients with centrally located or large non-small cell lung cancer (NSCLC) (Press release, Galera Therapeutics, JUN 29, 2022, View Source [SID1234616367]). Enrollment is ongoing in the randomized, double-blinded, placebo-controlled Phase 2 stage of the trial, with completion of enrollment anticipated in the second half of 2023.

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"The initial results from the Phase 1 stage of GRECO-1 demonstrate a promising safety profile for the rucosopasem and SBRT combination in patients with NSCLC," said Mel Sorensen, M.D., Galera’s President and CEO. "We are also encouraged by the initial signs of anti-tumor activity observed and the preliminary evidence for preservation of pulmonary function compared to historical literature evaluating pulmonary function in a similar patient population with SBRT alone. We look forward to seeing how the combination performs compared to SBRT alone in the ongoing Phase 2 stage of this trial."

Key findings in this group of seven patients (median age = 72) include:

Rucosopasem in combination with SBRT appeared well tolerated. The most frequent adverse events were fatigue, cough, and nausea, which are common in patients with lung cancer receiving radiotherapy.
In-field partial responses or stable disease were 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 (RTOG scale) declines in DLCO1 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.2
GRECO-1 consists of two stages. The primary endpoint of this open-label Phase 1 stage was safety of 100 mg of rucosopasem administered intravenously over 15 minutes in combination with each of five SBRT treatments. Secondary endpoints include late toxicities through 12 months and anti-cancer efficacy through 24 months. Anti-cancer endpoints include overall and progression-free survival, as well as local tumor and distant metastasis control.

The Phase 2 stage of GRECO-1 is a randomized, double-blinded, placebo-controlled evaluation in up to 66 patients with large and/or central NSCLC tumors. Patients are being randomized in a 1:1 ratio to receive either 100 mg of rucosopasem or placebo before each fraction of SBRT. The primary endpoint of the Phase 2 stage of the trial is in-field (i.e., SBRT target) tumor response at six months post SBRT. Patients are also being followed for long-term anti-cancer endpoints and safety similar to the Phase 1 stage of the trial.

About Rucosopasem
Rucosopasem manganese (rucosopasem, or GC4711) is a selective dismutase mimetic in development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT). The molecule is currently being studied in a Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer (NCT04476797) and a Phase 2b trial in combination with SBRT in patients with locally advanced pancreatic cancer (NCT04698915).