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Last Updated: April 20, 2025

CLINICAL TRIALS PROFILE FOR JELMYTO


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All Clinical Trials for Jelmyto

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01004978 ↗ Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery Active, not recruiting National Cancer Institute (NCI) Phase 3 2009-10-28 This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.
NCT03775265 ↗ Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer Recruiting National Cancer Institute (NCI) Phase 3 2019-04-19 This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.
NCT04216290 ↗ A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes (The INSPIRE Study) Recruiting National Cancer Institute (NCI) Phase 2 2020-08-25 This phase II trial studies the benefit of adding an immunotherapy drug called MEDI4736 (durvalumab) to standard chemotherapy and radiation therapy in treating bladder cancer which has spread to the lymph nodes. Drugs used in standard chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with durvalumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy and radiation therapy with the addition of durvalumab may work better in helping tumors respond to treatment compared to chemotherapy and radiation therapy alone. Patients with limited regional lymph node involvement may benefit from attempt at bladder preservation, and use of immunotherapy and systemic chemotherapy.
NCT04858009 ↗ Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis Not yet recruiting National Cancer Institute (NCI) Phase 2 2021-11-15 This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves "heated" chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.
NCT04858009 ↗ Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis Not yet recruiting Mayo Clinic Phase 2 2021-11-15 This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves "heated" chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.
NCT04929028 ↗ Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer Not yet recruiting National Cancer Institute (NCI) Phase 2 2022-02-01 This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.
NCT05672108 ↗ Transarterial Chemoembolization for the Treatment of Lung Cancer Not yet recruiting National Cancer Institute (NCI) Phase 2 2023-05-24 This phase II trial evaluates how well transarterial chemoembolization (TACE) works in treating patients with non-small cell lung cancer. TACE involves the injection of a blocking agent (tris-acryl gelatin microspheres [embospheres]) and a chemotherapy agent (mitomycin) directly into the artery that supplies oxygen to lung tumors. Mitomycin works by inhibiting deoxyribonucleic acid synthesis. At the same time, the artery is blocked (embolized) with a blocking agent called tris-acryl gelatin microspheres (embospheres). This traps the chemotherapy inside the tumor and also cuts off the tumor's blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. An imaging agent called ethiodized oil (lipiodol) is also used during the procedure for help visualizing the tumor. TACE with mitomycin, lipiodol, and embospheres may be effective at controlling or stopping the growth of lung tumors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Jelmyto

Condition Name

Condition Name for Jelmyto
Intervention Trials
Bladder Urothelial Carcinoma 2
Stage III Bladder Cancer AJCC v8 2
Stage IIIA Bladder Cancer AJCC v8 2
Stage IIIB Bladder Cancer AJCC v8 1
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Condition MeSH

Condition MeSH for Jelmyto
Intervention Trials
Carcinoma 3
Urinary Bladder Neoplasms 2
Carcinoma, Transitional Cell 2
Pleural Neoplasms 1
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Clinical Trial Locations for Jelmyto

Trials by Country

Trials by Country for Jelmyto
Location Trials
United States 115
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Trials by US State

Trials by US State for Jelmyto
Location Trials
California 4
Minnesota 4
Michigan 3
Louisiana 3
Kentucky 3
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Clinical Trial Progress for Jelmyto

Clinical Trial Phase

Clinical Trial Phase for Jelmyto
Clinical Trial Phase Trials
Phase 3 2
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Jelmyto
Clinical Trial Phase Trials
Not yet recruiting 3
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Jelmyto

Sponsor Name

Sponsor Name for Jelmyto
Sponsor Trials
National Cancer Institute (NCI) 6
Mayo Clinic 1
City of Hope Medical Center 1
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Sponsor Type

Sponsor Type for Jelmyto
Sponsor Trials
NIH 6
Other 2
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JELMYTO: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to JELMYTO

JELMYTO, developed by UroGen Pharma, is a groundbreaking treatment for low-grade upper tract urothelial cancer (LG-UTUC). It is a mitomycin-based formulation designed for pyelocalyceal solution, offering a non-surgical alternative for patients with this challenging condition.

Clinical Trials and Efficacy

OLYMPUS Trial Outcomes

The OLYMPUS trial has been pivotal in establishing JELMYTO's efficacy. Among the 71 patients enrolled, 41 achieved a complete response after treatment. The median duration of response for these complete responders was an impressive 47.8 months, with a median follow-up of 28.1 months[1][4].

Long-Term Follow-Up

A long-term follow-up study presented at the Society for Urologic Oncology annual meeting further reinforced JELMYTO's durability. Despite some limitations, including a post-hoc analysis and selection bias due to only 20 of the 41 complete responders participating, the data showed sustained disease control. This study highlighted that 75% of the patients in the 5-year rollover trial showed no disease recurrence, indicating potential for extended disease-free periods[1][2].

Real-World Data and Registry

In addition to clinical trials, real-world data is being collected through the JELMYTO uTRACT Registry. As of July 2024, 191 patients have been enrolled across 19 activated sites, aiming to further understand the treatment's potential in diverse patient populations[4].

Market Analysis

Revenue Growth

JELMYTO has demonstrated strong market performance. In the first quarter of 2024, net product revenues reached $18.8 million, representing a 10% year-over-year growth compared to $17.2 million in the first quarter of 2023. For the full year 2023, JELMYTO generated $82.7 million in net product revenue, a 28% increase from $64.4 million in 2022[2][5].

Market Expansion and Adoption

The increasing adoption of JELMYTO is supported by a growing database of real-world outcomes data. This has translated into notable revenue growth, indicating a favorable market reception. The drug's use in a diverse LG-UTUC population has been a key factor in its success[3][5].

Future Projections and Developments

ENVISION Study and NDA Submission

UroGen Pharma is set to discuss 12-month duration of response data from the ENVISION study of UGN-102, a related mitomycin-based formulation, during a company-sponsored virtual event. This data is expected to support the completion of the NDA submission for UGN-102 in Q3 2024, which could further expand the company's treatment offerings for urothelial cancers[2][5].

Next-Generation Formulations

In January 2024, UroGen announced a license and supply agreement with medac GmbH to develop next-generation novel mitomycin-based formulations for urothelial cancers. This includes UGN-103 and UGN-104, which combine UroGen’s RTGel technology with medac’s licensed mitomycin formulation. This development could offer manufacturing efficiencies and IP protection until December 2041[2][5].

Expert Insights and Patient Impact

Clinical Significance

"The median duration of response of 47.8 months in patients who achieved a complete response with JELMYTO demonstrates robust long-term control of LG-UTUC," said Brian Hu, M.D., Associate Professor of Urology at Loma Linda University School of Medicine and study investigator. This sustained response is crucial for managing relapse and preserving kidney function, key treatment goals for LG-UTUC[1].

Patient Quality of Life

Mark Schoenberg, M.D., Chief Medical Officer at UroGen, emphasized that "the study’s findings are compelling, as they support the potential of JELMYTO to offer patients long-lasting benefits, with evidence of an extended response duration that may improve quality of life and reduce the need for more invasive treatments."[1]

Key Takeaways

  • Efficacy and Durability: JELMYTO has shown a median duration of response of 47.8 months in complete responders, indicating robust long-term disease control.
  • Market Growth: The drug has achieved significant revenue growth, with a 28% increase in net product revenue from 2022 to 2023.
  • Future Developments: UroGen is advancing next-generation formulations and is on track to complete the NDA submission for UGN-102.
  • Clinical and Patient Impact: JELMYTO offers a valuable treatment option for LG-UTUC, potentially improving patient quality of life and reducing the need for invasive treatments.

FAQs

What is JELMYTO used for?

JELMYTO is used for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.

What are the key findings from the OLYMPUS trial?

The OLYMPUS trial showed that 41 out of 71 patients achieved a complete response, with a median duration of response of 47.8 months.

How is JELMYTO administered?

JELMYTO is administered as a pyelocalyceal solution, providing a non-surgical treatment option for LG-UTUC.

What are the future developments for JELMYTO and related treatments?

UroGen is developing next-generation mitomycin-based formulations and is on track to complete the NDA submission for UGN-102.

What is the impact of JELMYTO on patient quality of life?

JELMYTO offers long-lasting benefits, improving patient quality of life by reducing the need for more invasive treatments and preserving kidney function.

Sources

  1. UroGen Pharma, "Long-Term Follow-up Study to the OLYMPUS Trial Presented at SUO 2024 Reports Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO®", Stock Titan, December 5, 2024.
  2. UroGen Pharma, "UroGen Pharma Announces Date for ENVISION Data, New Long-Term Jelmyto Durability Data, and Reports 2024 First Quarter Financial Results and Business Highlights", Investors.UroGen, May 13, 2024.
  3. UroGen Pharma, "UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments", Business Wire, August 10, 2023.
  4. Clinical Trials Arena, "UroGen reports long-term data from study of JELMYTO", November 28, 2024.
  5. UroGen Pharma, "UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102", Investors.UroGen, March 14, 2024.

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