UGN-102 Has Promising Outcomes With Or Without Bladder Cancer Surgery


UGN-102 had similar disease-free survival outcomes in non-muscle-invasive bladder cancer, regardless of whether the therapy was given with surgery.

Groups of patients with newly diagnosed and recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer (NMIBC) tended to have similar outcomes when treated with UGN-102, regardless of whether it was given with or without transurethral resection of bladder tumor (TURBT), according to an analysis from the phase 3 ATLAS trial.

Findings from the analysis of ATLAS presented at the 2024 American Urological Association Annual Meeting showed that patients with newly diagnosed disease who received UGN-102 with or without TURBT(85 patients) achieved a 15-month disease-free survival (DFS; time patients live without signs or symptoms from their cancer) rate of 77.4%. Of note, TURBT is a surgical procedure where clinicians enter through the urethra to remove the bladder cancer cells. Those with recurrent disease (57 patients) achieved a 15-month DFS rate of 63.2%.

Study Highlights:

  • Patients with newly diagnosed or recurrent low-grade, intermediate-risk bladder cancer showed similar outcomes when treated with UGN-102, whether with or without surgery to remove the tumor.
  • In the study, patients who received UGN-102 achieved a 15-month disease-free survival rate of 77.4% for newly diagnosed disease and 63.2% for recurrent disease.
  • Those who had a complete response to treatment experienced a 12-month duration of response rate of 87.5% for newly diagnosed disease and 69.1% for recurrent disease.
  • UGN-102 is a special gel treatment that delivers chemotherapy directly to the bladder, helping to eliminate cancer cells.
  • The ATLAS trial, which looked at the effectiveness of UGN-102, is leading to further research, and there are hopes for FDA approval by early 2025.

Additionally, patients who experienced a complete response (CR; meaning that all signs of cancer disappeared) in the newly diagnosed (50 patients) and recurrent (42 patients) subgroups achieved a 12-month duration of response (DOR) rate of 87.5% and 69.1%, respectively.

UGN-102 is a direct-to-bladder treatment that delivers the chemotherapy agent, mitomycin, to the cancerous cells.

READ MORE: UGN-102, a Direct-to-Bladder Therapy, Improves Bladder Cancer Outcomes

“UGN-102 is a thermal gel [that comes in an] aqueous form when it’s cold, and when it’s instilled into the body and it’s warmed it becomes a soft, semi-solid gel,” Dr. William C. Huang, the vice chair for Clinical Affairs in the Department of Urology, and the co-director of the Robotics Program at NYU Langone Health, as well as a professor in the Departments of Urology and Radiology at NYU Grossman School of Medicine, in New York, New York, explained during the presentation.

“It is linked to mitomycin and [provides] a way of delivering intravascular therapy as a form of chemoablation. One of the advantages of linking a chemotherapy agent to this reverse thermal gel is that the agent that’s instilled into the bladder can be retained for several hours, whereas other agents are primarily emptied after the first void. By linking chemotherapy agents such as mitomycin to the reverse thermal gel, it can prolong exposure for up to six hours.”

About the ATLAS Trial

ATLAS was a prospective, open-label study that enrolled patients with low-grade intermediate-risk NMIBC. Patients needed to be at least 18 years old, have visible tumor left in situ and not have any high-grade disease cells found in urine samples. Intermediate-risk disease was defined as the presence of one of two of the following: multiple tumors; solitary tumor greater than 3 cm; and/or recurrence of low-grade NMIBC within one year of current diagnosis.

Eligible patients were randomly assigned to receive six weekly intravesical instillations of UGN-102 or TURBT. After approximately three months, all patients returned for determination of response; those with a confirmed CR received no further treatment and those without a CR in both arms received TURBT.

The main goal of the trial was DFS. Key secondary end points included CR rate and DOR.

The baseline characteristics of the two groups of the subgroup analysis were generally well-balanced. The median age in the newly diagnosed and recurrent groups was 66.0 years versus 69.0 years, respectively. Most patients in both subgroups were male (72.9% versus 75.4%), had multiple tumors (52.9% versus 64.9%), and had a history of smoking (54.1% versus 57.9%).

Most patients in the recurrent group received prior TURBT (91.2%). Most patients in the newly diagnosed group had tumors measuring more than 3 cm (63.5%) compared with 22.8% of the recurrent group.

Patients in the safety population with newly diagnosed (57 patients) and recurrent disease (81 patients) experienced side effects at a rate of 74.1% versus 77.2%, respectively. Common any-grade side effects in both groups included painful urination (25.9% versus 36.8%), sudden, strong urge to urinate (14.8% versus 22.8%), frequent urination (12.3% versus 21.1%) and frequent urination during the nighttime (11.1% versus 28.1%).

“The ATLAS trial was concluded early and led to the [phase 3] ENVISION trial [NCT05243550], which is ongoing at this time assessing as a single-arm trial the efficacy of UGN-102,” Huang said in conclusion. “[We] anticipate completing the submission of the rolling new drug application for UGN-102 in 2024 with a potential FDA decision as early as quarter 1 of 2025.”

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