Aiming to Transform Radiation Therapy With Rucosopasem

  • Rucosopasem manganese (GC4711) is a next-generation investigational selective dismutase mimetic infused over 15 minutes
  • Rucosopasem is in development as a radiosensitizer in combination with stereotactic body radiation therapy (SBRT), with the goal of improving overall survival for patients
  • Synergistic activity of selective dismutase mimetics was observed in combination with SBRT in preclinical models
  • A pilot Phase 1/2 clinical trial conducted with a rucosopasem analogue appears to demonstrate acceptable safety in combination with SBRT, as well as suggesting improvements in overall survival, progression-free survival, locoregional control, and time to distant metastases
  • Rucosopasem anticancer efficacy in combination with SBRT is being studied in pancreatic cancer and non-small cell lung cancer through the Galera Radiotherapy Efficacy Cancer Optimization (GRECO) clinical trial program

 

Pilot Trial Suggested Improvement in All Efficacy Endpoints for Pancreatic Cancer

  • A pilot trial (N=42) of a rucosopasem analogue + SBRT versus placebo + SBRT following initial chemotherapy in patients with locally advanced pancreatic cancer found the combination to be well tolerated with similar tolerability profiles across arms. The addition of a selective dismutase mimetic to SBRT appears to demonstrate encouraging results in secondary and exploratory endpoints including overall survival, progression-free survival, locoregional control, and time to distant metastases.
  • These findings supported the design of our Galera Radiotherapy Efficacy Cancer Optimization-2 (GRECO-2) clinical trial with rucosopasem.
  • For more information related to this trial, please see the Galera corporate presentation on the Investors page.
Overall Survival chart - slide 1
Overall Survival chart - slide 2 showing Placebo + RT line
Overall Survival chart - slide 3 showing DM + RT line
Progression-Free Survival - Slide 1
Progression-Free Survival - Slide 2 showing placebo + RT (n=18) line over time
Progression-Free Survival - Slide 3 showing DM + RT (n=24) line over time

Rucosopasem combined with SBRT is being studied as it may improve survival in patients with locally advanced pancreatic cancer.

GRECO-2: A Randomized, Phase 2b Study of Rucosopasem in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer1

  • GRECO-2 is part of the Galera Radiotherapy Efficacy Cancer Optimization (GRECO) clinical trials program
  • This is a multicenter, double-blind, placebo-controlled trial to determine the effect of rucosopasem on overall survival when added to SBRT following chemotherapy in patients with locally advanced pancreatic cancer
  • GRECO-2 plans to enroll at least 160 patients randomized to receive rucosopasem or placebo in combination with SBRT
  • The primary endpoint of the trial is to improve overall survival
  • For more information, visit: NCT04698915

GRECO-2 Phase 2b study Flowchart (slide 1) - Key inclusion criteria: Adult patients with borderline resectable or unresectable pancreatic cancer. Key exclusion criteria: Patients with documented metastatic disease.
GRECO-2 Phase 2b study Flowchart (slide 2) - "Chemotherapy"
GRECO-2 Phase 2b study Flowchart (slide 3) - "Screening and response evaluation*"
GRECO-2 Phase 2b study Flowchart (slide 4) - "1:1 randomization"
GRECO-2 Phase 2b study Flowchart (slide 5) - two paths "5 days SBRT + rucosopasem" and "5 days SBRT + placebo"
GRECO-2 Phase 2b study Flowchart (slide 6) - both paths lead to "Response evaluation"
GRECO-2 Phase 2b study Flowchart (slide 7) - two possible paths "Resectable" or "Unresectable"
GRECO-2 Phase 2b study Flowchart (slide 8) - on the Resectable path "Surgery"
GRECO-2 Phase 2b study Flowchart (slide 9) - both paths "Additional Chemo"
GRECO-2 Phase 2b study Flowchart (slide 10) - both paths "Follow-up for OS (primary endpoint), PFS, tumor control, and late toxicity"

*Disease must remain non-metastatic after initial chemotherapy.
OS=overall survival; PFS=progression-free survival; SBRT=stereotactic body radiation therapy.

 

GRECO-1: Phase 1/2 Study of Stereotactic Body Radiation Therapy (SBRT) With or Without Rucosopasem for Early-Stage, Peripheral or Centrally Localized Non-Small Cell Lung Cancer (NSCLC)3

  • GRECO-1 is a randomized, placebo-controlled, multicenter Phase 1/2 trial comparing the safety and efficacy of rucosopasem + SBRT to SBRT alone
  • The trial plans to enroll 71 patients with peripheral or centrally localized NSCLC tumors without nodal or metastatic disease with the objective of improving outcomes for these patients
  • For more information, visit: NCT04476797

 

For additional details on ongoing clinical trials, please visit clinicaltrials.gov.

References:

  1. Clinicaltrials.gov. NCT04698915.
  2. Hoffe S, Kim D, Mafalda M, et al. GRECO-2: a randomized, phase 2 study of stereotactic body radiation therapy (SBRT) in combination with GC4711 in the treatment of unresectable or borderline resectable nonmetastatic pancreatic cancer (PC). Abstract presented at: 63rd Annual Meeting of the American Society for Radiation Oncology; October 24-27, 2021; Chicago, IL.
  3. Clinicaltrials.gov. NCT04476797.

 

Investigational Drug – Not for Commercial Distribution