A preliminary trial indicates potential progress in treating non-muscle invasive bladder cancer (NMIBC). enGene, a biopharmaceutical company, is advancing its Phase 2 LEGEND trial to evaluate detalimogene voraplasmid, a non-viral genetic medicine, for NMIBC. In the United States, bladder cancer is linked to over 17,000 deaths as of 2025, with approximately 85,000 diagnoses annually, 75-85% of which are classified as NMIBC.
The treatment landscape for NMIBC faces challenges, primarily due to the chronic shortage of Bacillus Calmette-Guérin (BCG), the long-standing standard treatment, which has a recurrence rate of ~30-50%. New options, while promising, encounter limitations related to manufacturing complexity and the necessary storage protocols.
Preliminary results from the LEGEND trial show a favorable safety profile for detalimogene, with no severe adverse events reported. The non-viral treatment is designed for easier administration, requiring only four doses over 12 weeks and minimizing patient restrictions post-treatment. If successful, enGene plans to submit detalimogene for FDA review in the second half of 2026.
- Why it matters: This potential new treatment could ease the burden of care for NMIBC patients and improve patient outcomes, reducing reliance on more invasive procedures.
- The latest: enGene’s LEGEND trial is ongoing, with preliminary data indicating safety and tolerability, and plans for an FDA submission in late 2026.
Source: https://www.fiercehealthcare.com/sponsored/unlocking-potential-non-viral-genetic-medicine-new-approach-treating-bladder-cancer
Source: https://www.fiercehealthcare.com/sponsored/unlocking-potential-non-viral-genetic-medicine-new-approach-treating-bladder-cancer