On April 27, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported a duration of response of nearly four years from a long-term follow-up study with JELMYTO (mitomycin) for pyelocalyceal solution, which is FDA-approved for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients (Press release, UroGen Pharma, APR 27, 2025, View Source [SID1234652198]).

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Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with JELMYTO (n=41), the median duration of response was 47.8 months, irrespective of whether their cancer was new-onset or recurrent (median follow-up 28.1 months [95% CI 13.1, 57.5]). Of these patients, 21 had new-onset UTUC, and 20 had recurrent UTUC at baseline; there were no significant differences in durability between groups, with 8 patients in each group experiencing recurrence or death not due to treatment. Twenty patients entered long-term follow-up with a median follow-up of 53.3 months (95% CI 27.9, 65.3); median duration of response was not estimable (95% CI 43.5, not estimable) due to the low event rate.

"This sub-analysis highlights new evidence for the impressive long-term benefits of JELMYTO, in both new-onset and recurrent low-grade upper tract urothelial cancer patients," said Brian Hu, MD, Associate Professor of Urology at Loma Linda University Health, CA. "These findings further establish JELMYTO as an effective treatment, providing patients with durable responses and a significant reduction in recurrence rates."

LG-UTUC is a challenging disease often managed through endoscopically guided ablation, but recurrence is common, and patients face a lifetime of surveillance and potential complications. The OLYMPUS Phase 3 trial evaluated JELMYTO, a reverse thermal gel containing mitomycin (4 mg/mL), as a primary treatment for adults with LG-UTUC. While the overall trial demonstrated the potential of JELMYTO to significantly eradicate disease, this sub-analysis focuses specifically on patients with new-onset and recurrent LG-UTUC who achieved a complete response, providing new insights into the durability and long-term effectiveness of the treatment. Limitations of this study include the post-hoc nature of the analysis and potential selection bias regarding entry of patients into long-term follow-up.

"We are encouraged by the long-term outcomes evidence observed in both new-onset and recurrent LG-UTUC patients," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "The sub-analysis provides further compelling evidence that JELMYTO offers durable disease control and clinically meaningful responses, which could significantly reduce the need for repeated interventions. We look forward to expanding our understanding of JELMYTO through the ongoing uTRACT Registry and further evaluating its potential in real-world settings."

To further explore the potential of JELMYTO in treating patients with LG-UTUC, investigators are currently enrolling participants in the JELMYTO uTRACT Registry (NCT05874921) to gather longitudinal real-world usage data. As of April 2025, 22 sites have been activated with 251 patients enrolled.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel approved for the treatment of adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through a nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

About Upper Tract Urothelial Cancer

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as UTUC. In the U.S., there are approximately 6,000 – 7,000 new or recurrent LG-UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often have multiple comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). Treatment with endoscopic surgery can be associated with a high rate of recurrence and relapse.

On April 27, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the presentation of three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25–30 in Chicago, IL (Press release, Molecular Partners, APR 27, 2025, View Source [SID1234652200]). The first poster includes positive Investigational New Drug (IND)-enabling data for MP0712, a Radio-DARPin targeting DLL3 and labeled with 212Pb for small cell lung cancer patients. The second poster presents initial preclinical data on the second 212Pb-based Radio-DARPin, targeting mesothelin (MSLN) in solid tumors – both programs are co-developed with Orano Med. The third poster includes additional preclinical proof-of-concept data on the logic-gated CD3 Switch-DARPin T cell engager with CD2 co-stimulation in solid tumors.

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"Our presentations at AACR (Free AACR Whitepaper) highlight the breadth of Molecular Partners’ DARPin innovation and the progress in our strategic Radio-DARPin partnership with Orano Med. Our first Radio-DARPin program, MP0712, targeting DLL3, is well advanced and on track to provide initial clinical data in the second half of 2025. Additionally, we are proud to present the first preclinical data from our second program with Orano Med, targeting MSLN. The results show substantial uptake into MSLN-positive tumors, with limited accumulation in other organs, justifying continued investment in our RDT x MSLN program for solid tumors," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

"Furthermore, we continue to advance our wholly-owned logic-gated and co-stimulated T cell engager program. Our SWITCH approach activates CD3/T-cells only when binding to tumor-associated antigens, while remaining inactive in circulation. This gating allows us to add a CD2 DARPin for co-stimulation without the risk of fratricide. This project demonstrates the value of our platform, which can be used for any target combination."

Preclinical data presented on MP0712, a DLL3-targeting and 212Pb-labeled Radio-DARPin, show a high tumor uptake and a favorable safety profile for MP0712, with good efficacy and tumor reduction in mouse models matching clinically relevant DLL3 expression levels. With these data, the IND-enabling package is complete; IND filing and initial first-in-human clinical data are expected in 2025. DLL3 is a promising target for radioligand therapy as it is highly upregulated in small cell lung cancer and other high-grade neuroendocrine tumors, while not expressed in healthy tissues.

The MSLN x 212Pb Radio-DARPin poster outlines how MSLN may be a promising target for ovarian cancer due to its differentiated expression profiles – high in tumor, and lower in healthy tissues. High levels of shed MSLN, however, can act as a decoy receptor and have historically hampered the development of MSLN-targeted therapeutics. Molecular Partners has leveraged the unique properties of DARPins to develop a Radio-DARPin able to selectively bind membrane-bound MSLN without being impacted by shed MSLN. In vivo results show a favorable biodistribution with strong tumor accumulation of the Radio-DARPin in a MSLN-overexpressing model in mice.

Preclinical proof-of-concept data on Molecular Partners’ conditionally activated CD3 Switch-DARPin shows it activates T cells specifically in the presence of cells co-expressing MSLN and epithelial cell adhesion molecule (EpCAM), increasing tumor specificity. Concurrent CD2 co-engagement leads to sustained T cell activation and cytotoxic capacity, preventing T cell dysfunction. The Switch-DARPin effectively induces significant tumor regression in mice engrafted subcutaneously with MSLN- and EpCAM-expressing cells, without signs of T cell activation in the periphery, indicating a favorable safety profile.

Click here to access the poster presentations, which will be made available on Molecular Partners’ website.

Details of the presentations:

MP0712, the first anti-DLL3 212Pb Radio-DARPin (RDT) candidate for targeted radiotherapy of small cell lung cancer (SCLC)
Session Category: Experimental and Molecular Therapeutics
Session Title: Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies
Session Timing: Sunday April 27 at 2:00pm – 5:00pm CST
Location: Poster Section 16, Poster Board Number: 13
Published Abstract Number: 346

Development of 212Pb-based Radio-DARPin therapy (RDT) for the treatment of mesothelin (MSLN)-positive solid tumors
Session Category: Experimental and Molecular Therapeutics
Session Title: Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies
Session Timing: Sunday April 27 at 2:00 – 5:00pm CST
Location: Poster Section 16, Poster Board Number: 6
Published Abstract Number: 339

Next-generation multi-specific and conditionally activated CD3 Switch-DARPins with CD2 co-stimulation to tackle the current limitations of T cell engagers in solid tumors
Session Category: Experimental and Molecular Therapeutics
Session Title: Therapeutic Approaches to Attack the Tumor Microenvironment
Session Timing: Monday April 28 at 2:00pm – 5:00pm CST
Location: Poster Section 24, Poster Board Number: 3
Published Abstract Number: 3119

On April 27, 2025 Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, reported the 18-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis (Press release, Oncoinvent, APR 27, 2025, https://www.oncoinvent.com/press-release/oncoinvent-reports-updated-18-month-data-from-phase-1-ovarian-cancer-trial-with-radspherin-no-new-recurrences-demonstrate-continued-promise-of-preventing-disease-progression/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234652202]). The trial was closed for recruitment at the end of 2023 and patients are currently in long-term follow-up.

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In this trial, 10 patients received a single intraperitoneal dose of 7 MBq Radspherin. Oncoinvent reported 12-month data in November 2024, where only 1 out of the 10 receiving the selected dose had peritoneal recurrence. At the 18-month follow-up, no further patient had experienced recurrence. i.e., only 10% of patients treated have so far had a recurrence. In similar populations, receiving best standard of care, it is expected that approximately 40% of patients would have had disease recurrence at this time point , , .

"Ovarian cancer’s characteristic peritoneal metastasis lead to frequent recurrences despite a comprehensive treatment approach," commented Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "I am proud to be part of a study program exploring whether Radspherin may become a novel therapy that can prevent disease progression, offering hope for a better and longer life for my patients."

"These compelling results underscore Radspherin’s potential to significantly reduce peritoneal recurrence in ovarian cancer patients," said Øystein Soug, CEO of Oncoinvent. "The data not only reinforce our confidence in Radspherin but also support its advancement in Phase 2 trials, including the ongoing randomized controlled Phase 2 trial assessing progression-free survival in patients with peritoneal metastasis from ovarian cancer."

To discuss these promising clinical results, provide an update on operations, and discuss the ongoing Phase 2 trial, Oncoinvent has decided to move up its Quarterly Update from the previously announced May 27 to April 30 at 11:00 CEST.

On April 26, 2025 Pfizer Inc. (NYSE: PFE) reported results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC) (Press release, Pfizer, APR 26, 2025, View Source [SID1234652209]). The trial met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance): Hazard Ratio (HR) of 0.68; 95% Confidence Interval (CI), 0.49-0.94; 2-sided p=0.019; median EFS not yet reached. These findings show a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression, with the sasanlimab combination regimen as compared with SOC treatment alone. Pre-specified subgroup analyses for patients harboring higher risk disease showed consistent benefit with EFS HR of 0.63 (0.41, 0.96) for T1 disease, and EFS HR 0.53 (0.29, 0.98) for those with CIS disease.

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EFS was a composite endpoint defined as the time from randomization to the earliest of recurrence of high-grade disease, progression of disease, persistence of carcinoma in situ (CIS), or death due to any cause. The probability of being event-free at 36 months was 82.1% (95% CI, 77.4-85.9) with sasanlimab in combination with BCG (induction and maintenance), and 74.8% (95% CI, 69.7-79.2) with BCG alone (induction and maintenance). Results from the CREST trial are being presented today in a plenary oral presentation at the 2025 American Urological Association (AUA) Annual Meeting.

"New bladder cancer treatment options that help reduce rates of disease recurrence or progression are long overdue. Up to 50% of patients with high-risk non-muscle invasive bladder cancer may experience failure of BCG intravesical immunotherapy, yet it has been the standard of care after tumor resection for decades," said Neal Shore, M.D., FACS, Medical Director for START Carolina Research Center, and lead investigator for the CREST trial. "These Phase 3 results show that combining sasanlimab with BCG induction and maintenance therapy earlier in the course of the disease significantly prolonged event-free survival, highlighting the value and potential of sasanlimab in combination with BCG to redefine the treatment paradigm and reduce the burden for patients."

As the ninth most common cancer worldwide, bladder cancer accounts for up to 220,000 deaths annually.1,2 NMIBC, in particular, represents approximately 75% of all bladder cancer cases.3 In the U.S., it is estimated that about 38,000 people have high-risk NMIBC.4 While BCG treatment has been shown to reduce the risk of tumor recurrence, approximately 40-50% of patients with high-risk NMIBC receiving BCG will eventually have disease recurrence or progression despite therapy.5-7

"Today’s pivotal Phase 3 CREST results offer a much-needed therapeutic breakthrough and spotlight sasanlimab as the first immunotherapy combination with BCG to significantly improve outcomes for patients with BCG-naïve, high-risk NMIBC in over three decades," said Megan O’Meara, M.D., Interim Chief Development Officer, Pfizer Oncology. "The CREST findings are especially impactful for these patients with early-stage cancer who may benefit the most from innovative treatment regimens, including a subcutaneous immune checkpoint inhibitor, that delay disease recurrence or progression. These results underscore our long-standing commitment to patients with bladder cancer across all stages of the disease. We look forward to working with global regulatory authorities to potentially bring sasanlimab as an important new treatment option to patients with high-risk NMIBC."

Sasanlimab in combination with BCG (induction only) did not result in prolongation of EFS when compared to BCG alone (induction and maintenance), a key secondary endpoint: HR of 1.16; 95% CI, 0.87-1.55; 2-sided p=0.312, underscoring the need for BCG maintenance not only as a component of SOC treatment but also in combination with sasanlimab. Early interim analysis for the key secondary overall survival (OS) endpoint suggested no difference between treatment arms, with a median follow-up of 40.9 months. The study continues for survival follow-up until the final analysis. Complete response (CR) and duration of CR were additional secondary endpoints for patients with CIS at randomization. The CR rate achieved at any time was 89.8% with sasanlimab in combination with BCG (induction and maintenance) and 85.2% with BCG alone (induction and maintenance). Notably, for those patients with CIS at randomization who achieved a CR, the probability of remaining in CR at 36 months was 91.7% with sasanlimab in combination with BCG (induction and maintenance) compared to 67.7% with BCG alone (induction and maintenance).

The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors. Pfizer has shared these data with global health authorities to support potential regulatory filings.

About CREST

The CREST trial is a Phase 3, multinational, randomized, open-label, three parallel-arm study of sasanlimab, an anti-PD-1 mAb, in combination with BCG (BCG induction with or without BCG maintenance) versus BCG (induction and maintenance) in participants with BCG-naïve, high-risk NMIBC. Patients were randomized to receive sasanlimab 300 mg by subcutaneous (SC) injection every four weeks up to cycle 25 (cycle = four weeks), in combination with BCG once weekly for six consecutive weeks (induction period) followed (Arm A; n=352) or not (Arm B; n=352) by maintenance with BCG, or BCG induction and maintenance up to cycle 25 (Arm C; n=351). The primary endpoint is EFS as assessed by the investigator, between Arm A and C, defined as a composite endpoint that combines time from randomization to the earliest of recurrence of high-grade disease, progression of disease, persistence of CIS, or death. Key secondary endpoints include EFS as assessed by the investigator between Arm B and Arm C, between Arms A/B and Arm C. In patients with CIS, CR and duration of CR were secondary endpoints. For more information on the CREST trial (NCT04165317), go to www.clinicaltrials.gov.

About Sasanlimab

Sasanlimab is a humanized immunoglobulin G4 (IgG4) mAb that binds to human PD-1 to block its interaction with PD-1 and PD-L1/PD-L2. PD-1 is a protein expressed on T cells, dendritic cells, natural killer cells, macrophages, and B cells, that functions as an immune checkpoint that negatively regulates T-cell activation and effector function when activated by its ligands and may play an important role in tumor evasion from host immunity. It can be administered through a once every four weeks SC injection by prefilled syringe (2mL).

In early-stage clinical studies, sasanlimab administered at 300 mg SC every four weeks showed clinical efficacy in advanced solid tumors and advanced urothelial cancer. In addition to NMIBC, sasanlimab is being evaluated in several ongoing clinical trials in combination with Pfizer’s antibody drug conjugate (ADC) portfolio.

On April 26, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported updated results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company’s investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ, or CIS (± Ta/T1), who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve (Press release, Protara Therapeutics, APR 26, 2025, View Source [SID1234652191]). The results will be featured today during an interactive poster session at the American Urological Association 2025 Annual Meeting in Las Vegas.

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"For patients with high-risk NMIBC, there are few effective and durable therapies available other than radical cystectomy, which we know is quite difficult for patients to tolerate," said Tom Jayram, M.D., Director of the Advanced Therapeutics Center at Urology Associates, and ADVANCED-2 study investigator. "TARA-002 has shown impressive efficacy, safety profile, and 12-month durability in its Phase 2 trial. In the clinic, we have seen TARA-002 become easily integrated into workflow without major hurdles for the patients or staff. This combination of clinical activity and ease of use makes me optimistic about TARA-002 having a meaningful impact in clinical practice."

Interim Results

BCG-Unresponsive Cohort

The BCG-Unresponsive dataset includes a total of five patients, all of whom were six- and nine-month evaluable, and three of whom were evaluable at 12 months as of an April 16, 2025 data cutoff.

The complete response (CR) rate at any time in BCG-Unresponsive patients was 100% (5/5).
The CR rate in BCG-Unresponsive patients was 100% (5/5) at six months, 80% (4/5) at nine months, and 67% (2/3) at 12 months.
BCG-Naïve Cohort

The BCG-Naïve dataset includes a total of 21 patients, including 16 evaluable at six months, eight at nine months, and seven at 12 months as of an April 16, 2025 data cutoff.

The CR rate at any time in BCG-Naïve patients was 76% (16/21).
The CR rate in BCG-Naïve patients was 63% (10/16) at six months, 63% (5/8) at nine months, and 43% (3/7) at 12 months.
Safety

The majority of adverse events were Grade 1 and transient with no Grade 3 or greater treatment-related adverse events (TRAEs) as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most common adverse events were in line with typical responses to bacterial immunopotentiation, such as flu-like symptoms. The most common urinary symptoms reflect urinary tract instrumentation effects, such as bladder spasm, burning sensation, and urinary tract infection. Most bladder irritations resolved shortly after administration or within a few hours to a few days.

"The durable results shared today continue to support our conviction that TARA-002 has the potential to make a meaningful difference in the lives of patients with NMIBC," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "Notably, we are particularly pleased with the competitive 12-month CR rates observed in the registrational BCG-Unresponsive cohort as well as the BCG-Naïve cohort. We look forward to continuing to advance this important trial as we work toward our mission of bringing transformative therapies to patients."

The Company continues to expect to present an interim update with results from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025.

Conference Call and Webcast

Protara will host a conference call and webcast to discuss the data on Monday, April 28, 2025, at 8:30 am ET. The live call can be accessed by registering as a participant here. Upon registration, participants will receive conference call dial-in information. A live webcast of the event can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived for a limited time following the presentation.

About ADVANCED-2

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive (n≈100) and BCG-Naïve (n=31). The BCG-Unresponsive cohort has been designed to be registrational in alignment with the U.S. Food and Drug Administration’s 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment, Draft Guidance for Industry.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.