A new analysis of the ATLAS trial has revealed promising results for the investigational drug UGN-102 as a primary treatment option for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The study, conducted by UroGen Pharma Ltd., demonstrated that patients treated with UGN-102 achieved similar rates of durability of response (DOR) at 12 months, regardless of whether they were new or recurrent patients.
The Phase 3 ATLAS study included 282 patients with either new or recurrent LG-IR-NMIBC. These patients were randomized to receive either UGN-102 as a primary treatment with or without subsequent transurethral resection of the bladder tumor (TURBT), or TURBT alone. The data from this analysis focused specifically on the rates of DOR in new and recurrent patients within the UGN-102 arm.
The findings showed that new patients who achieved complete response (CR) at 3 months had a DOR rate of 87.5% at 12 months, while recurrent patients had a DOR rate of 69.1%. Additionally, the probabilities of disease-free survival (DFS) rates for UGN-102 at 15 months from randomization were 77.4% for new patients and 63.2% for recurrent patients.
“These insights into the efficacy of UGN-102 are encouraging and could have a significant impact on the treatment options available for LG-IR-NMIBC,” said Mark Schoenberg, M.D., Chief Medical Officer at UroGen. “Our goal is for UGN-102 to emerge as a non-surgical alternative, reducing the need for repetitive surgeries and the associated risks and burdens.”
The results from the ATLAS trial add to the growing body of evidence supporting UGN-102 as a potential breakthrough in the treatment of low-grade bladder cancer. The drug utilizes UroGen’s proprietary RTGel technology, which allows for sustained release of the drug within the bladder, providing longer exposure to the tumor without the need for surgery.
If UGN-102 continues to demonstrate positive results in the durability of response endpoint in the ongoing Phase 3 ENVISION trial, UroGen plans to submit a New Drug Application (NDA) for UGN-102 in September 2024, with the potential for FDA approval in early 2025.
Non-muscle invasive bladder cancer affects a significant number of individuals, with approximately 22,000 new cases reported in the United States each year. The current standard of care involves transurethral resection of the bladder tumor, but recurrence rates are high, leading to repetitive surgeries and their associated risks and side effects. UGN-102 offers a promising non-surgical alternative that could greatly benefit patients in terms of both outcomes and quality of life.
UGN-102, an investigational drug developed by UroGen Pharma Ltd., has shown promise as a primary treatment option for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), according to a recent analysis of the ATLAS trial. The study revealed that patients treated with UGN-102 achieved similar rates of durability of response (DOR) at 12 months, regardless of whether they were new or recurrent patients.
The Phase 3 ATLAS study included 282 patients with either new or recurrent LG-IR-NMIBC. These patients were randomized to receive either UGN-102 as a primary treatment with or without subsequent transurethral resection of the bladder tumor (TURBT), or TURBT alone. The analysis focused on the rates of DOR in new and recurrent patients within the UGN-102 arm.
The findings indicated that new patients who achieved complete response (CR) at 3 months had a DOR rate of 87.5% at 12 months, while recurrent patients had a DOR rate of 69.1%. The probabilities of disease-free survival (DFS) rates for UGN-102 at 15 months from randomization were 77.4% for new patients and 63.2% for recurrent patients.
These results highlight the potential efficacy of UGN-102 in treating LG-IR-NMIBC and may offer a non-surgical alternative to reduce the need for repetitive surgeries and their associated risks. UGN-102 utilizes UroGen’s RTGel technology, which allows for sustained release of the drug within the bladder, providing longer exposure to the tumor without the need for surgery.
The ongoing Phase 3 ENVISION trial is further evaluating the durability of response endpoint for UGN-102. If positive results continue to be observed, UroGen plans to submit a New Drug Application (NDA) for UGN-102 in September 2024, with the potential for FDA approval in early 2025.
Non-muscle invasive bladder cancer affects a significant number of individuals, with approximately 22,000 new cases reported in the United States each year. The current standard of care involves transurethral resection of the bladder tumor, which often leads to high recurrence rates necessitating repetitive surgeries with associated risks and side effects. UGN-102 presents a promising non-surgical alternative that could greatly benefit patients in terms of both outcomes and quality of life.
For more information on UroGen Pharma Ltd. and their research on UGN-102, visit their official website at UroGen.com.
To learn more about non-muscle invasive bladder cancer and its current treatment options, you can visit the website of the American Cancer Society at cancer.org.