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Trial data showed a 62% complete response rate at 6 months with detalimogene coraplasmid among patients with high-risk, BCG-unresponsive bladder cancer.
Early results from the phase 2 LEGEND trial showed that detalimogene coraplasmid (formerly EG-70) showed encouraging results for patients with high-risk, Bacillus Calmette-Guérin (BCG)–unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary disease, according to a news release from enGene.
“Careful selection of an appropriate bladder-sparing therapy is of utmost importance in creating a long-term strategy to maintain a patient’s disease control and quality of life, while minimizing the logistical burden on patient and practice,” Dr. Suzanne Merrill, senior physician and Urologic Oncologist and Bladder Cancer Regional Lead at Colorado Urology, said in the news release.
She continued, “I am pleased to see the positive trajectory of detalimogene’s efficacy and tolerability data. Combined with its ease of use, detalimogene would be an attractive option to both patient and a busy urology practice.”
The trial showed that 63% of patients achieved a complete response (CR) at any time after receiving detalimogene coraplasmid. At 3 months, 56% of 62 patients achieved a CR, and at 6 months, 62% of 37 patients had a CR, including 4 who converted to CR after reinduction. All 5 patients who completed the 9-month assessment remained in CR.
The preliminary analysis included 62 patients at 3 months and 37 patients at 6 months, all treated under the trial’s amended protocol, which took effect in late 2024 to better align the LEGEND trial with American Urological Association Guidelines and current standards of care.
Complete response (CR): disappearance of all visible signs of cancer following treatment.
Duration of response (DOR): length of time a treatment keeps cancer under control after it first responds.
Primary endpoint: main result measured in a clinical trial to determine if a treatment works.
Secondary endpoint: additional outcomes measured to provide more information about a treatment’s effectiveness or safety.
“We are pleased to report an improved 6-month CR rate for patients being treated with detalimogene under our amended protocol,” Dr. Hussein Sweiti, chief medical officer of enGene, said in the news release. “With a competitive preliminary efficacy profile and potential for best-in-class tolerability and ease of use, we believe detalimogene could emerge as the first-line therapy for patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer.”
Early data on detalimogene coraplasmid and its unique profile support plans to seek FDA approval in the second half of 2026.
Enrollment in the pivotal cohort reached 125 patients, exceeding the target by 25%. Treatment was generally well tolerated: 42% of patients experienced treatment-related side effects which were mostly mild or moderate, 1.6% had dose interruptions and 0.8% discontinued treatment due to side effects.
The most common side effects were fatigue (17%), painful urination (12%), bladder spasm (10%), urinary urgency (10%) and frequent urination (10%). No life-threatening or fatal side effects were reported.
Following discussions with the FDA, the primary endpoint for the pivotal cohort of the LEGEND trial was updated to complete response (CR) rate at any time, replacing the previous endpoint of 12-month CR rate. The key secondary endpoint is now duration of response for patients who achieve a CR, aligning the trial with other programs recently registered with the FDA.
The company also plans to work with the FDA on a statistical analysis plan to define which patients will be included in the final efficacy population.
As of the latest update, enrollment included 30 patients in Cohort 2a (BCG-naïve non–muscle-invasive bladder cancer with carcinoma in situ), 45 patients in Cohort 2b (BCG-exposed but inadequately treated carcinoma in situ), and 36 patients in Cohort 3 (BCG-unresponsive high-risk disease with papillary-only tumors).
“We are highly encouraged with the preliminary data from our LEGEND study, which support our planned BLA filing,” Ron Cooper, president and CEO, said in the news release. “Based on the emerging clinical profile and detalimogene’s differentiated ease of use, we continue to believe there is a substantial commercial opportunity for detalimogene if approved.”
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