Breakthroughs in Bladder Cancer Treatment: Protara and CG Oncology Report Encouraging Outcomes
Protara Therapeutics' TARA-002:
Demonstrated a 72% complete response (CR) rate at six months across 18 evaluable patients with non-muscle invasive bladder cancer (NMIBC), regardless of prior Bacillus Calmette-Guérin (BCG) exposure134.
Showed a 100% CR rate at six months in BCG-unresponsive patients, a critical subgroup for registration134.
Had a favorable safety profile with no treatment-related adverse events grade 2 and above134.
CG Oncology's Cretostimogene Grenadenorepvec:
Achieved a 75.2% CR rate in a late-stage trial among 105 evaluable patients with NMIBC, with no grade 3 or higher adverse events reported25.
Patients who achieved a complete response did not require bladder removal, and 29 patients maintained a complete response for at least a year5.
The therapy is differentiated by working without BCG, addressing supply issues and offering a new approach to treating NMIBC25.
Market Impact:
Protara surged 87% in premarket trading following the announcement of TARA-002's positive results1.
CG Oncology plans to submit a new drug application to the FDA in the second half of 2025, confident in the drug's potential and its competitive edge in the market5.
Sources:
1. https://www.biospace.com/drug-development/protara-cg-oncology-tout-promising-bladder-cancer-outcomes
3. https://www.biospace.com/press-releases/protara-announces-positive-results-from-the-ongoing-phase-2-advanced-2-trial-of-tara-002-in-patients-with-nmibc
4. https://ir.protaratx.com/news-releases/news-release-details/protara-announces-positive-results-ongoing-phase-2-advanced-2
5. https://www.fiercebiotech.com/biotech/cg-sets-new-bar-bladder-cancer-validating-rare-biotech-ipo-success-story