Among patients with low-grade, upper tract urothelial carcinoma, primary intracavitary chemoablation with a mitomycin reverse thermal gel (Jelmyto) was associated with favorable long-term durability, according to a press release. This announcement was based on study findings from the OLYMPUS trial, published in The Journal of Urology.
Glossary:
Chemoablation: treatment using chemotherapy to destroy cancerous tissue without surgery.
Complete Response (CR): complete disappearance of cancer signs after treatment.
Mitomycin: chemotherapy drug used to treat cancers by inhibiting DNA synthesis and slowing tumor growth.
Mitomycin Reverse Thermal Gel (Jelmyto): a gel form of mitomycin that becomes semi-solid at body temperature, used to treat low-grade upper tract urothelial carcinoma.
Median Duration of Response: the time from treatment start until disease progression or recurrence, with half of patients experiencing a longer response and half a shorter one.
Upper Tract Urothelial Carcinoma (UTUC): cancer in the kidneys, renal pelvis, or ureters.
Urothelial Cancer: cancer starting in the urothelial cells lining the bladder, ureters, and kidneys.
uTRACT Registry: a database for tracking the use of treatments like Jelmyto in patients with upper tract urothelial carcinoma.
"Prior research has emphasized that the main treatment objectives for [low-grade, upper tract urothelial cancer] should focus on preventing relapse and preserving organ function, given the low likelihood of disease progression," Dr. Mark Schoenberg, chief medical officer of UroGen, the drug’s manufacturer, said in the release. "We are pleased with the study's results, which offer strong evidence supporting the long-term effectiveness of Jelmyto as a primary treatment for [low-grade, upper tract urothelial cancer], with increasing data showing extended response duration."
Of the 71 patients enrolled in the OLYMPUS trial, 42 achieved complete response (CR) four to six weeks following completion of one or more sessions. Among the 41 patients with initial CR, the median follow-up was 28.1 months, and the median duration of response was 47.8 months. Long-term follow-up was available for 20 patients (49%), with a median of follow-up of 53.3 months. At the last follow-up, 75% of patients had no evidence of recurrence, with the median duration of response not estimable due to a low event rate.
The current report is the first to describe the long-term durability of response in patients achieving CR following primary chemoablation and adds to the growing body of literature supporting Jelmyto as a nonsurgical, kidney-sparing primary treatment for patients with low-grade, upper tract urothelial carcinoma, according to study authors.
"These results provide compelling evidence of the durability of Jelmyto in treating low-grade upper tract urothelial cancer," Dr. Phillip Pierorazio said in the release. "The median duration of response of nearly four years in patients who achieved a complete response underscores the potential of Jelmyto to offer sustained control of the disease. These data reinforce the value of Jelmyto as an important treatment option for patients with [low-grade, upper tract urothelial cancer].”
Pierorazio is chief, Section of Urology at Penn Presbyterian Medical Center, and professor of Surgery at Hospital of the University of Pennsylvania in Philadelphia.
Patients in the OLYMPUS trial who achieved a CR after six weekly doses of Jelmyto were followed for up to 12 months. Those with CR at study completion were eligible for long-term follow-up for up to five years or until disease recurrence, progression or death.
Investigators are enrolling participants in the Jelmyto uTRACT Registry to gather longitudinal real-world usage data on treating patients with low-grade, upper tract urothelial cancer. As of Jan. 27, 2025, 21 sites have been activated and 228 patients enrolled.
Jelmyto is a gel approved for treating low-grade, upper tract urothelial carcinoma in adults, as per the release. It contains 4 milligrams of mitomycin per milliliter and turns into a semi-solid gel at body temperature. The gel dissolves over four to six hours and is cleared through urine. It can be delivered via a ureteral catheter or nephrostomy tube, staying in place to provide chemoablative therapy without being washed away.
Reference:
“Long-Term Outcomes of Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma With UGN-101, a Mitomycin Reverse Thermal Gel,” by Dr. Phillip M. Pierorazio, et al., The Journal of Urology.
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