This is a single-center, open-label, phase 2 study to evaluate the efficacy and safety of target therapy for patients with relapsed/metastastic salivary gland carcinoma based on molecular typing.

Start Date26 Jul 2023

Sponsor / Collaborator

Fudan University

NCT05781217

/ RecruitingPhase 3IIT

Short Versus Long-term Androgen Deprivation Therapy Combined With Salvage Radiotherapy in Prostate Cancer Patients With Biochemical Recurrence After Prostatectomy: a Multicentre Phase III Randomised Controlled Trial

The optimal indication for ADT has long been a point of controversy, at least until the results of randomised trials comparing RT with and without ADT were published. NCCN guidelines and most retrospective series and left the decision to prescribe ADT in combination with RT to the discretion of the treating physician, despite a lack of clear scientific evidence to support this recommendation. The percentage of patients in those retrospective series who received hormone therapy ranged from 33% to 71%, but generally involved patients with adverse prognostic factors (Gleason score > 7, stage pT3-T4, PSA > 1 ng/mL in cases with biochemical recurrence [BCR], and PSA doubling time [PSA-DT] < 6 months). Despite the heterogeneity in those studies in terms of treatment duration, RT dose, and treatment volumes, most of the studies found that ADT significantly prolonged biochemical relapse-free survival (BRFS), especially in patients with PSA levels > 1 ng/mL at recurrence.
The results of two randomised trials evaluating SRT with or without ADT were published in 2017, with both trials demonstrating a benefit for ADT in this clinical setting. A follow-up study confirmed the value of ADT in combination with SRT in terms of better PFS and, in the RTOG study, an improvement in overall survival (OS). Despite the lack of data from phase III trials regarding the influence of PSA-DT, the BRFS interval, and the Gleason score in terms of their effects on the clinical course of patients who develop BCR, there is strong evidence from other studies to support the use of these variables (together with age and comorbidities). Given the available evidence, we believe that these variables should be considered when determining the indications for ADT.
In line with the philosophy underlying the approach used by D'Amico to develop a risk classification system for prostate cancer patients at diagnosis, we propose three risk groups. According to Pollack et al. and Spratt et al., low-risk patients would not benefit from hormone therapy, especially long-term ADT, due to the deleterious effects of such treatment. By contrast, intermediate and high risk patients would be candidates for ADT combined with RT. However, the optimal duration of ADT in these patients (6 months vs. 2 years) remains undefined and needs to be determined prospectively in a randomised trial, similar to the approach used in the DART 05.01 trial.
SRT and ADT are widely used in routine clinical practice to treat patients who develop BCR after prostatectomy. In this context, we intend to perform a multicentre, phase III trial to define the optimal duration of ADT (6 vs. 24 months).

Start Date14 Mar 2023

Sponsor / Collaborator

Fundación de Investigación Oncológica

NCT05122377

/ CompletedNot ApplicableIIT

QoL and Treatment Compliance for Pre-menopausal Patients With HR+ Breast Cancer Using GnRHa as Ovarian Function Suppression(OFS) Treatment in the Chinese Population: a Real-world Observational Investigation

The purpose of this study is to assess the patient's feedback from using GnRHa depot formulation in postoperative, premenopausal patients with hormone receptor-positive breast cancer.

Start Date01 Mar 2022

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Leuprorelin

100 Translational Medicine associated with Leuprorelin

100 Patents (Medical) associated with Leuprorelin

1,379

Literatures (Medical) associated with Leuprorelin

20 Apr 2025·Cureus Journal of Medical Science

Unusual Axillary Recurrence Observed in Breast Cancer With Bloody Nipple Discharge: A Case Report

Article

Author: Yoshikawa, Kiyoshi ; Jono, Haruka ; Oura, Shoji

After breast cancer surgery, a major part of axillary recurrences occur in lymph nodes. We report a case of breast cancer in which bloody nipple discharge spillage onto the surgical field was possibly associated with axillary recurrence. A 47-year-old woman with a history of mastectomy and sentinel node biopsy noticed an axillary mass. Her luminal breast cancer had been detected by bloody nipple discharge and pathologically diagnosed as a predominantly intraductal carcinoma seven years before. The axillary lesion was depicted as an oval mass both with indistinct margins and predominant internal high echoes on ultrasound. Magnetic resonance imaging of the mass showed slightly low signals on T1-weighted images and faint high signals on fat-suppressed T2-weighted images. Positron emission tomography showed no avid fluorodeoxyglucose uptake in the axillary mass. Due to the proven cytological malignancy of the axillary mass, the patient underwent salvage axillary dissection under the tentative diagnosis of axillary node recurrence. Post-operative pathological study, however, showed that the mass had atypical cells growing in cribriform and tubular fashions in the fibro-fatty tissue and did not have any lymph node structures, noninvasive cancer components, lympho-vascular involvement, normal mammary gland components, and metastatic foci in the dissected lymph nodes. These results suggested an association between bloody nipple discharge spillage onto the surgical field and axillary recurrence. The patient has been well on adjuvant leuprorelin and letrozole therapy for six months. Breast surgeons should note that bloody nipple discharge spillage during the operation may be a risk factor for local recurrence.

03 Apr 2025·Cureus Journal of Medical Science

Complete Response Case of Metastatic Hormone-Sensitive Prostate Cancer Treated With Triplet Therapy (Androgen Deprivation Therapy + Docetaxel + Darolutamide)

Article

Author: Urabe, Fumihiko ; Kadena, Soshi ; Kimura, Takahiro ; Muramoto, Katsuki ; Sakanaka, Keigo ; Nakata, Mana ; Furuta, Nozomu ; Shimomura, Tatsuya ; Goto, Yuma ; Onuma, Hajime

In this work, we report a complete response case of a 69-year-old male with metastatic prostate cancer (initial prostate-specific antigen (PSA)=26.3 ng/mL, Gleason score 3+4=7, cT3a, N0, M1b) treated with triplet therapy comprising leuprorelin + docetaxel (75 mg/m²/3 weeks) + darolutamide (1,200 mg/d). His PSA was checked monthly, and radiological scans (computed tomography and bone scans) were administered every three months. His PSA declined quickly, reaching <0.01 ng/mL five months after starting triplet therapy, but his bone scan index declined gradually, reaching 0.0% 13 months after starting triplet therapy. To evaluate the true efficacy of triplet therapy, regular radiological testing should be performed, similar to regular PSA testing.

04 Mar 2025·Expert Opinion On Drug Safety

Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system

Article

Author: Zheng, Fuchun ; Shen, Huilong ; Ma, Zifang ; Tang, Xiao ; Yao, Zhijun

BACKGROUND:

Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.

METHODS:

This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.

RESULTS:

A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (n = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (n = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (n = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).

CONCLUSION:

Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.

News (Medical) associated with Leuprorelin

17 Feb 2025

·www.prnewswire.com

Foresee Pharmaceuticals Receives the Third Positive Recommendation from the DSMB to Continue the Casppian Study

The independent Data and Safety Monitoring Board (DSMB) recommended the continuation of patient enrollment as planned. There has been no safety concern with the use of leuprolide (FP-001) injectable Emulsion in pediatric CPP patients. TAIPEI, Feb. 17, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces the third positive safety review by the independent Data and Safety Monitoring Board for its Casppian Phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial as planned without any modification. The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg- controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). Foresee's leuprolide injectable emulsion, 42 mg (marketed under the brand name CAMCEVI®), is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer. "The third favorable review from the DSMB, received after reaching nearly 75% enrollment in the Casppian trial, reinforces the promising safety data for FP-001 42 mg administered every six months in children with CPP. Early efficacy signals further support our confidence that this therapy could represent a groundbreaking advancement for pediatric patients with CPP. We are committed to swiftly completing enrollment while upholding the utmost safety and ethical rigor standards throughout this pivotal study," said Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development of Foresee. "This DSMB recommendation again highlights the effectiveness of Foresee's innovative Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology across several disease indications, including in children with CPP," said Dr. Yuhua Li, Chief Technology Officer of Foresee. "The outcome from the third DSMB for the Casppian study represents a major advancement in our mission to enhance the standard of care and improve the quality of life for children with CPP.," said Dr. Ben Chien, CEO and Chairman of Foresee. "This positive recommendation moves us nearer to our objective of providing safe and effective treatments for children in need, as well as to the anticipated top-line results from this trial, expected in 2025." About CPP GnRH-dependent CPP is a condition that causes early sexual development in girls and boys, as their "hypothalamus - pituitary gland - gonadal axis" is activated too early, causing children to enter puberty prematurely, between 2 years and 9 years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological, and emotional issues, including lower self-esteem, stress, anxiety, and depression, which may negatively impact their quality of life. According to the NORD (National Organization for Rare Disorders) website, CPP occurs in 1 out of 5,000 to 10,000 children. It is estimated that approximately 80% - 90% of CPP cases are idiopathic, especially in females, with a female-to-male ratio of around 20. Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, are the most widely used treatment for CPP. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted and accepted for review with a PDUFA date of August 29, 2025, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Triptorelin (FP-014), aiming for the treatment of advanced prostate cancer, is ready to enter Phase 3 clinical studies, with respective trials planned for the 3-month and 6-month ready-to-use LAI formulations. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted at severe asthma, COPD, and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2 and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultPhase 1Drug ApprovalPhase 2

28 Jan 2025

·www.businesswire.com

Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium

NEW YORK--( BUSINESS WIRE )--Pfizer Inc. (NYSE: PFE) will present the latest results from its leading genitourinary (GU) portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 13-15 in San Francisco, California. Data from more than 20 company-sponsored, investigator-sponsored, and collaborative research abstracts, including five oral presentations, highlight advancements in developing new standards of care within prostate and bladder cancer across the company’s core scientific modalities, including small molecules and antibody-drug conjugates. “ Our long-standing commitment to the genitourinary cancer community has been foundational in our mission to transform the treatment landscapes for patients with bladder and prostate cancers,” said Karin Tollefson, Chief Oncology Medical Officer, Pfizer. “ Our strong presence at this year’s ASCO GU highlights the longer-term impacts of our approved leading medicines for patients in their respective indications. We are also looking forward to sharing updates from our rapidly growing pipeline of novel targets and combination approaches, which have the potential to help address the diverse needs of patients across various stages of disease.” Pfizer’s GU portfolio includes seven approved medicines across bladder, prostate, and kidney cancers, as well as a growing late-stage pipeline of scientific modalities and combination approaches. Key Pfizer presentations at ASCO GU include the detailed overall survival (OS) results from the Phase 3 TALAPRO-2 trial with TALZENNA ® (talazoparib) plus XTANDI ® (enzalutamide) in patients with metastatic castration-resistant prostate cancer (mCRPC), which will be featured in ASCO GU’s official Press Program . In addition, updated analysis from the Phase 3 global EV-302 study of PADCEV ® (enfortumab vedotin-ejfv) in combination with pembrolizumab in locally advanced or metastatic urothelial cancer (la/mUC) will be presented, highlighting the long-term efficacy benefits of the combination. From the pipeline, the first randomized progression-free survival (PFS) data from the ongoing Phase 1 dose-escalation study for mevrometostat plus XTANDI reinforce the potential of this investigational combination for patients with mCRPC. Additional pipeline presentations include updated data and real-world evidence for different types of bladder cancer, supporting the development of two potential transformative treatments, disitamab vedotin, an investigational antibody-drug conjugate (ADC), and sasanlimab, an investigational subcutaneous PD-1 blocker. Key ASCO GU Presentations Prostate Cancer TALZENNA plus XTANDI: Oral and poster presentations from the pivotal Phase 3 TALAPRO-2 trial of TALZENNA in combination with XTANDI will provide detailed results on the statistically significant and clinically meaningful improvement in OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone. TALZENNA in combination with XTANDI has been approved for use in over 35 countries globally for patients with certain types of mCRPC*. The OS results will be shared with global health authorities to potentially update the TALZENNA label. XTANDI: Six abstracts continue to underscore the benefit of XTANDI across its approved indications, including two posters highlighting follow-up analysis from the EMBARK trial of XTANDI in combination with leuprolide in patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high-risk for metastasis. Mevrometostat: The first randomized PFS results from the ongoing Phase 1 dose-expansion study examine the potential of mevrometostat (PF-06821497), an investigational selective inhibitor of enhancer of zeste homolog 2 (EZH2), in combination with XTANDI in patients with mCRPC, compared to XTANDI alone. Pfizer initiated two pivotal Phase 3 trials for mevrometostat plus XTANDI in 2024 and expects to start a Phase 3 study of mevrometostat plus XTANDI in first-line mCSPC during the first half of 2025. Bladder Cancer PADCEV: Long-term follow-up data from the groundbreaking Phase 3 EV-302 study of PADCEV in combination with pembrolizumab, including OS and safety data, continue to demonstrate consistent efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/muC. Disitamab vedotin: Updated efficacy and safety data from an ongoing Phase 2 study (sponsored by Remegen) evaluating the HER2-targeting ADC disitamab vedotin plus toripalimab show encouraging results as a perioperative regimen in HER2-expressing muscle-invasive bladder cancer (MIBC). These data add to the growing body of evidence supporting the continued development of disitamab vedotin across stages of bladder cancer. Sasanlimab: Three real-world evidence poster presentations highlight the need for advanced treatment options for patients with non-muscle invasive bladder cancer (NMIBC), including presentations on Bacillus Calmette-Guérin (BCG) treatment patterns, impact of BCG shortages, and outcomes and treatment patterns in patients with high-risk NMIBC. Pfizer recently reported positive topline results for sasanlimab in combination with BCG as induction therapy with or without maintenance in patients with BCG- naïve, high-risk NMIBC. Detailed results from the Phase 3 CREST trial will be presented at an upcoming congress. Additional information on key Pfizer-sponsored abstracts at ASCO GU 2025, including date and time of presentation, follow in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here . *TALZENNA in combination with XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023. Prostate Cancer Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the Phase 3 TALAPRO-2 trial (Abstract #LBA18) Agarwal, N Oral Abstract Session Thursday, February 13, 11:42 AM – 11:52 AM EST Presentation Time: 8:42 AM – 8:52 AM PST Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line (1L) treatment in patients (pts) with homologous recombination repair (HRR)-deficient metastatic castration-resistant prostate cancer (mCRPC) in the Phase 3 TALAPRO-2 trial (Abstract #LBA141) Fizazi, K Poster Session Thursday, February 13, 2:25 PM – 3:45 PM EST Presentation Time: 11:25 AM – 12:45 PM PST Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study (Abstract #LBA138) Schweizer, MT Rapid Oral Abstract Session Thursday, February 13, 8:25 PM – 8:30 PM EST Presentation Time: 5:25 PM – 5:30 PM PST Bladder Cancer EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) (Abstract #664) Powles, TB Rapid Oral Abstract Session Friday, February 14, 7:10 PM – 7:15 PM EST Presentation Time: 4:10 PM – 4:15 PM PST Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with muscle-invasive bladder cancer (MIBC) with HER2 expression: Updated efficacy and safety results from the phase II RC48-C017 trial (Abstract #665) Sheng, X Oral Abstract Session Friday, February 14, 11:57 AM – 12:07 PM EST Presentation Time: 8:57 AM – 9:07 AM PST About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. Prescribing Information for Pfizer Medicines Please read full Prescribing Information for TALZENNA ® (talazoparib) Please read full Prescribing Information for XTANDI ® (enzalutamide) Please read full Prescribing Information , including BOXED WARNING, for PADCEV ® (enfortumab vedotin-ejfv) About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of healthcare products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with healthcare providers, governments, and local communities to support and expand access to reliable, affordable healthcare around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer_News , LinkedIn , YouTube , and like us on Facebook at www.facebook.com/Pfizer/ . Disclosure notice The information contained in this release is as of January 28, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and Pfizer’s oncology pipeline, in-line products and product candidates, including XTANDI ® (enzalutamide), TALZENNA ® (talazoparib), PADCEV ® (enfortumab vedotin-ejfv), mevrometostat, disitamab vedotin and sasanlimab, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed with any regulatory authorities in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “ Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .

Clinical ResultPhase 3ASCOPhase 1Drug Approval

15 Nov 2024

·www.prnewswire.com

Foresee Pharmaceuticals Receives the Second Positive Recommendation from DSMB to Continue the Casppian Study, a Phase 3 Clinical Trial of Leuprolide (FP-001) Injectable Emulsion for the Treatment of Central Precocious Puberty

The independent Data and Safety Monitoring Board (DSMB) recommended the continuation of patient enrollment as planned. There has been no safety concern with the use of Leuprolide (FP-001) injectable Emulsion in pediatric CPP patients. TAIPEI, Nov. 15, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces the second positive safety review by the independent Data and Safety Monitoring Board for its Casppian Phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial without any modification. The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). Foresee's leuprolide injectable emulsion, 42 mg (marketed under the brand name CAMCEVI®), is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer. "With almost 50% enrollment completed, the second positive DSMB recommendation to continue the Casppian trial without any modification confirms the favorable safety profile of FP-001, 42 mg 6 month long-acting, ready-to-use, subcutaneous injectable treatment in patients with CPP. The differentiated product profile, favorable safety profile in combination with the early indications of efficacy lead us to believe this therapy will become a leading therapy for pediatric patients with CPP. We look forward to continuing to enroll patients and are dedicated to maintaining the highest standards of safety and ethical conduct throughout this clinical trial," said Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development of Foresee. "This DSMB recommendation again demonstrates the success of Foresee's pioneering Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology in several disease indications, including children with CPP," said Dr. Yuhua Li, Chief Technology Officer of Foresee. "The outcome of the second DSMB for the Casppian study is a significant step toward our mission of improving the standard of care and the quality of life of children with CPP," said Dr. Ben Chien, CEO and Chairman of Foresee. "This positive recommendation brings us closer to our goal of delivering safe and effective treatment for children with CPP. Topline results from this trial as anticipated in 2025." About CPP GnRH-dependent CPP is a condition that causes early sexual development in girls and boys, as their "hypothalamus - pituitary gland - gonadal axis" is activated too early, causing children to enter puberty prematurely, between 2 years and 9 years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological, and emotional issues, including lower self-esteem, stress, anxiety, and depression, which may negatively impact their quality of life. According to the NORD (National Organization for Rare Disorders) website, CPP occurs in 1 out of 5,000 to 10,000 children. It is estimated that approximately 80% - 90% of CPP cases are idiopathic, especially in females, with a female-to-male ratio of around 20. Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, are the most widely used treatment for CPP. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused in two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI® 42 mg or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan and Israel and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study, is ongoing. Another indication of CAMCEVI 6-month LAI formulation, premenopausal breast cancer, the Phase 3 clinical trial in China is ongoing as well. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, for which a Phase 1 study in healthy volunteers has been successfully completed, with development targeted in severe asthma, COPD and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2, and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultPhase 2Drug ApprovalPhase 1

100 Deals associated with Leuprorelin

External Link

KEGG	Wiki	ATC	Drug Bank
D08113	Leuprorelin	L02AE02	DB00007

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 2	United Kingdom	Ardana Bioscience Ltd.	19 Aug 2003
Neoplasms	Phase 1	South Korea	Chong Kun Dang Pharmaceutical Corp.	30 Jan 2022
Puberty, Precocious	Phase 1	United States	Chong Kun Dang Pharmaceutical Corp.	01 Apr 2021
Menopausal symptoms	Phase 1	South Korea	Chong Kun Dang Pharmaceutical Corp.	01 Apr 2016
postmenopausal disorder	Phase 1	United States	Chong Kun Dang Pharmaceutical Corp.	01 Apr 2016
Premenopausal breast cancer	IND Approval	China	Foresee Pharmaceuticals Co., Ltd.	28 Dec 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05924256 (ASCO2024) Manual	Phase 2	Salivary Gland Neoplasms HER2 Negative \| ERBB2 Amplification \| HER2 Overexpression \| ... View more	21	SHR-A1811(anti-HER2) 4.8 mg/kg	uwdikitjpv(nvoumnuary) = mvldfjgynt oluztwospq (dymjtwbmfn ) View more	Positive	24 May 2024
				rezvilutamide 24leuprolided plus leuprolide 3.75mg s.c.	uwdikitjpv(nvoumnuary) = jaqpfqybeq oluztwospq (dymjtwbmfn ) View more
ASCO2024	Not Applicable	Prostatic Cancer testosterone levels	240	Leuprorelin alone	wvevnolrfa(hivwtrnqcs) = mvkjriaapb oeqbnfonnd (gayxqgjtjk, 37-1 - 136) View more	Positive	24 May 2024
				Leuprorelin + Novel Hormonal Agent	wvevnolrfa(hivwtrnqcs) = ngltkmbhem oeqbnfonnd (gayxqgjtjk, 37-1 - 136) View more
ASCO_GU2024	Not Applicable	Prostatic Cancer	240	Leuprorelin monotherapy	ifuyplzblo(efplhixlqj) = njoqxebyiq ehunazxplp (zhnghgfkce ) View more	Positive	25 Jan 2024
				Leuprorelin + Novel hormonal agent	ifuyplzblo(efplhixlqj) = nrfbkmlmbl ehunazxplp (zhnghgfkce ) View more
THU623 (ENDO2023)	Not Applicable	Hyperplasia aberrant LH receptors	-	Leuprolide 3.75mg	diqwbhgqox(ipeehqfivp) = oqmfkozbrh bixzxstphk (ubttzufwvb )	-	05 Oct 2023
				Leuprolide 7.5mg	diqwbhgqox(ipeehqfivp) = anvwxwdcfx bixzxstphk (ubttzufwvb )
PMON70 (ENDO2022)	Not Applicable	-	14	Leuprolide 1 mg (Oral)	zwuqnmxert(zswlcyckfn) = wtdxzlywyp okngsxdvay (dqvghsqpge, 2.1) View more	-	01 Nov 2022
				Leuprolide 4 mg (Oral - Fasting)	zwuqnmxert(zswlcyckfn) = jgdnaqkkif okngsxdvay (dqvghsqpge, 16.8) View more
NCT02980965 (CBCSG-036, Pubmed \| Cancer) Manual	Phase 3	ER-positive/HER2-negative Breast Cancer Neoadjuvant ER positive \| HER2 negative	249	Chemotherapy+Letrozole+Leuprorelin	qurwzcojdj(hkqmqzukmd) = lsuyrqzpzh rmqduggssb (oprqljsmkc ) View more	Superior	01 Jul 2019
				Chemotherapy	qurwzcojdj(hkqmqzukmd) = iyxiogjvym rmqduggssb (oprqljsmkc ) View more
SAT-291 (ENDO2019)	Not Applicable	Metabolic Syndrome	1	Leuprolide	aurpchfhxo(bcersehibz) = uukupowabu wxctwsubyd (rrmjoiofnw ) View more	Positive	30 Apr 2019
				Oral contraceptive	rwhckgrmrx(adbqmodvrk) = dgeikxfyxp cvwlbjubkz (wrqtvlwilb )

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