leuprolide acetate for depot suspension / Generic mfg. - LARVOL DELTA

Eugonadal Progression-Free Survival Following Intensification of Metastasis-Directed Stereotactic Body Radiotherapy with Radioligand Therapy or Androgen Annihilation Therapy: A Comparison of Two Phase II Trials (ASTRO 2026) - P2 | "Whether an alternative strategy of adding androgen annihilation therapy (AAT; apalutamide plus abiraterone plus leuprolide) to SBRT would improve euPFS remains unknown. Both SBRT+RLT and SBRT+AAT improved euPFS over SBRT alone, while SBRT+RLT and SBRT+AAT achieved comparable euPFS. Given the numerical trend in grade =3 AEs favoring SBRT+RLT, in addition to the known quality of life impacts of hormonal therapy, SBRT+RLT appears to be a clinically attractive hormone-therapy sparing intensification strategy in men with oligorecurrent prostate cancer."

P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Relugolix vs. Leuprolide in Combination with Radiotherapy for Localized Prostate Cancer: Analysis of Patient-Reported Quality of Life in a Randomized Trial (ASTRO 2026) - P2 | "In men receiving definitive RT plus ADT for localized prostate cancer, relugolix results in comparable short-term testosterone suppression with faster recovery and improved obstructive urinary, bowel, and vitality quality-of-life measures at 12 months versus leuprolide. These findings are exploratory and support prospective validation."

Clinical • Combination therapy • HEOR • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Comparison of Patient-Reported Side Effects Between Leuprolide and Relugolix in Prostate Cancer Patients Receiving Radiation Therapy (ASTRO 2026) - "Overall post-ADT symptom burden was comparable between agents; however, differences in mood were observed beyond 6 months following treatment completion. Although relugolix and leuprolide have different mechanisms of action, whether there is a difference in quality-of-life impact post ADT cessation remains unclear."

Adverse events • Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Severe Delayed Ribociclib-Induced Liver Injury Despite Prolonged Drug Interruption (ACG 2026) - "She had been receiving ribociclib with letrozole & leuprolide since Oct 2025. Although hepatotoxicity from CDK4/6 inhibitors is recognized, progression after prolonged drug interruption is uncommon and warrants vigilant monitoring. Figure: Trend of Liver Function Tests and Bilirubin during Hospitalization Figure: Laboratory values during the admission"

Breast Cancer • Hepatitis B • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Infectious Disease • Liver Failure • Pancreatitis • Solid Tumor • ER • HER-2 • PGR

More Than Meets the EUS: An Unusual Case of Mass-Forming Autoimmune Pancreatitis (ACG 2026) - "Interestingly, the patientâs jaundice resolved spontaneously without receiving treatment for AIP with the only interval change being initiation of his prostate cancer medications, lupron and enzalutamide. Pancreatic mass extending from the body to tail, visualized on (a) EUS and (b) on ERCP Figure: Figure 2. (a) Histology showing storiform fibrosis (a distinctive, swirl-like pattern of scar tissue) in low power on the left-hand side, and high power on the right-hand side, and (b) Plasma cells with immunohistochemical staining positive for IgG4, both characteristic of autoimmune pancreatitis."

Clinical • Fibrosis • Genito-urinary Cancer • Hepatology • Immunology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Pancreatitis • Prostate Cancer • Rare Diseases • Solid Tumor

Larimichthys crocea-Derived Calcium-Chelating Peptides Attenuate Leuprorelin-Induced Bone Loss and Lipid Metabolic Alterations in Mice. (PubMed, Mar Drugs) - "Collectively, LCP attenuated estrogen deficiency-induced bone loss together with favorable changes in indicators related to bone formation, adipogenesis, and lipid metabolism. These findings support further investigation of LCP as a food-derived nutritional ingredient for supporting bone health under estrogen-deficient conditions."

Journal • Preclinical • Metabolic Disorders • Obesity • Osteoporosis • LEP

Myomatous erythrocytosis syndrome associated with an 8-kg uterine leiomyoma: a case report of diagnostic evaluation and perioperative management. (PubMed, Case Rep Womens Health) - "A 55-year-old woman with a giant uterine mass that had continued to enlarge despite long-term leuprorelin treatment was referred for marked erythrocytosis...Although tumor EPO expression was not evaluated, postoperative normalization of serum EPO and resolution of erythrocytosis supported the clinical diagnosis of MES. MES should be considered in patients with uterine leiomyoma and unexplained erythrocytosis; hematologic evaluation, preoperative phlebotomy, and multidisciplinary surgical planning may enable safe treatment."

Journal • Gynecology • Hematological Disorders • Oncology • Solid Tumor • Uterine Leiomyoma • Women's Health • ABL1 • BCR • CALR • EPO • JAK2

Impact of leuprolide and goserelin on androgen suppression and adverse events in patients with prostate cancer. (PubMed, Can J Urol) - "ADT effectively achieves hormonal suppression in prostate cancer; however, differences between LHRH agonists influence clinical and metabolic outcomes. Leuprolide 22.5 mg showed superior PSA reduction but higher rates of vasomotor symptoms and weight gain, while goserelin 10.8 mg was associated with hormonal instability and cardiovascular risk. Genetic findings suggest that BRCA2 variants may affect lipid metabolism, reinforcing the need for personalized ADT strategies integrating metabolic and genetic profiles."

Adverse events • Clinical • Journal • Cardiovascular • Gene Therapies • Genito-urinary Cancer • Metabolic Disorders • Oncology • Prostate Cancer • Solid Tumor • ATM • BRCA1 • BRCA2 • TP53

Effects of Enzalutamide on the Sexual Activity of Patients with Biochemically Recurrent Prostate Cancer: A Post Hoc Analysis of Patient-reported Outcomes in the EMBARK Study. (PubMed, Eur Urol) - "Longitudinally, no clinically meaningful changes for any SA-related item were observed from baseline to week 205 in any group. SA-related HRQoL preservation seems to be better with enzalutamide monotherapy than with leuprolide alone."

Journal • Retrospective data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Systemic and Tumor-directed Therapy for Oligorecurrent Metastatic Prostate Cancer (SATURN): Primary Endpoint Results from a Phase 2 Clinical Trial. (PubMed, Eur Urol) - P2 | "Patients received 6 mo of androgen annihilation therapy (AAT; leuprolide, abiraterone acetate plus prednisone, and apalutamide) and metastasis-directed SBRT. Overall, this appears to be an effective therapy with acceptable side effects. This trial is registered on ClinicalTrials.gov as NCT03902951."

Journal • Metastases • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Coronary Artery Plaque Progression After Androgen Deprivation Therapy in Men with Prostate Cancer: A Randomized Controlled Trial Comparing Relugolix Versus Leuprolide (SUO 2025) - P2 | "ADT for prostate cancer is associated with accelerated coronary atherosclerosis within 12 months and is higher with GnRH-agonist leuprolide compared with GnRH-antagonist relugolix."

Clinical • Acute Coronary Syndrome • Atherosclerosis • Coronary Artery Disease • Genito-urinary Cancer • Myocardial Infarction • Oncology • Prostate Cancer • Solid Tumor

Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. (PubMed, Eur Urol) - "Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction."

HEOR • Journal • Metastases • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ARCH: Contributions to Hypertension With Androgen Deprivation Therapy (clinicaltrials.gov) - P4 | N=10 | Terminated | Sponsor: University of Colorado, Denver | Completed ➔ Terminated; Study completed

Trial termination • Cardiovascular • Genito-urinary Cancer • Hypertension • Nephrology • Oncology • Prostate Cancer • Renal Disease • Solid Tumor

A multi-center, prospective, observational study of patients with prostate cancer being treated with relugolix: OPTYX. (ASCO-GU 2023) - P=N/A | "In the phase 3 HERO trial, relugolix maintained suppression of testosterone to castration levels in 96.7% of men from Day 29 to 48 weeks, with superiority to leuprolide acetate. In addition to assessing routine clinical care and disease progression, patient reported outcomes will be assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) for HRQoL and Simplified Medication Adherence Questionnaire (SMAQ) for adherence at 3 and 6 months then every 6 months. Clinical trial information: NCT05467176."

Clinical • Observational data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Results of the Randomized Phase 3 AFU-GETUG-20 Trial Evaluating Adjuvant Leuprorelin Acetate After Radical Prostatectomy in Men with High-risk Localized Prostate Cancer. (PubMed, Eur Urol Oncol) - "Leuprorelin treatment immediately after RP in high-risk nonmetastatic PCa patients with an undetectable PSA level does not improve survival, but increases adverse events, leading to poorer quality of life compared with observation."

Journal • P3 data • CNS Disorders • Fatigue • Genito-urinary Cancer • Mental Retardation • Oncology • Pain • Prostate Cancer • Psychiatry • Solid Tumor

Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. (PubMed, N Engl J Med) - P3 | "In patients with prostate cancer with high-risk biochemical recurrence, enzalutamide plus leuprolide was superior to leuprolide alone with respect to metastasis-free survival; enzalutamide monotherapy was also superior to leuprolide alone. The safety profile of enzalutamide was consistent with that shown in previous clinical studies, with no apparent detrimental effect on quality of life. (Funded by Pfizer and Astellas Pharma; EMBARK ClinicalTrials.gov number, NCT02319837.)."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: The Second Hospital of Anhui Medical University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Prostate-specific antigen dynamics from the phase 3 EMBARK trial: A post hoc analysis (AUA 2024) - P3 | "and Astellas Pharma Inc INTRODUCTION AND OBJECTIVE: In the EMBARK trial, enzalutamide + leuprolide (enza combo) and enza monotherapy (mono) showed statistically superior and clinically meaningful improvements in metastasis-free survival (MFS) vs placebo + leuprolide (alone) while maintaining quality of life in patients (pts) with high-risk biochemically recurrent (BCR) prostate cancer. In pts with high-risk BCR, more pts who were treated with enza combo and enza mono reached undetectable PSA, they reached undetectable PSA sooner, had tx suspended at week 37, and achieved undetectable PSA following tx re-initiation vs leuprolide alone."

P3 data • Retrospective data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

EMBARK post hoc analysis of sexual activity (SA) patient-reported outcome (PRO) measures. (ASCO-GU 2024) - P3 | "Background: In the phase 3 EMBARK trial (NCT02319837), enzalutamide (ENZ) + leuprolide (L) and ENZ monotherapy (mono) delayed metastasis-free survival (MFS) vs placebo (P) + L without impairing global health-related quality of life (HRQoL) in high-risk biochemically recurrent (BCR) nonmetastatic hormone-sensitive prostate cancer (nmHSPC) (PSA doubling time ≤9 months). This post hoc item-level analysis of the EMBARK trial confirmed that SA was better preserved with ENZ mono vs P + L in terms of interest, activity, satisfaction, and maintaining erection. Further, the SA PROs were similar between ENZ + L and P + L, implying there is no further SA burden when adding ENZ to androgen-deprivation therapy. Clinical trial information: NCT02319837."

Clinical • Patient reported outcomes • Retrospective data • Genito-urinary Cancer • Prostate Cancer

Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary Endpoints From the EMBARK Trial. (PubMed, J Urol) - P3 | "Combined with the primary findings from EMBARK, data from non-key secondary efficacy endpoints strengthen support for enzalutamide combination as a new standard of care for patients with high-risk BCR. NCT02319837."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Suboptimal ovarian suppression during adjuvant endocrine therapy for premenopausal women with breast cancer: An exploratory analysis of the PREFER and GIM 23 studies (ESMO-BC 2024) - P | "Background Adjuvant endocrine therapy (ET) with exemestane combined with LHRH analog (LHRHa) is standard of care for premenopausal women with hormone receptor-positive breast cancer...65.4% of these patients received chemotherapy, mainly anthracycline plus taxane (93.8%), and 3 patients received adjuvant abemaciclib...Monthly leuprorelin was given in 65% of the cases, while the others received monthly triptorelin...Table: 125P Characteristics N of patients (%) TNM - Stage IA 14 (53.9) IB 3 (11.5) IIA 5 (19.2) IIB 2 (7.7) IIIA 2 (7.7) Grading 1 1 (3.8) 2 18 (69.3) 3 5 (19.2) NA 2 (7.7) Histology Ductal 21 (80.8) Lobular 1 (3.8) Other 4 (15.4) Ki67 <20 12 (46.2) ≥20 14 (53.8) HER2 status 0 12 (46.1) 1+ 5 (19.2) 2+ 2 (7.7) 2+ FISH amplified or 3+ 7 (27) Conclusions In our cohort, almost 5% of premenopausal patients did not achieve ovarian suppression with LHRHa. Oncologists should be aware that serial monitoring of estradiol levels should be performed to address this."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Enzalutamide with or without leuprolide in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis by age. (PubMed, Eur J Cancer) - P3 | "Clinically meaningful improvements in MFS were observed following enzalutamide ± leuprolide in patients with hrBCR regardless of age. TRSAEs were more common in older patients but were low regardless of age. These findings should be interpreted in light of small subgroup sizes."

Journal • Retrospective data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Urethral Cancer • Urology

Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. (PubMed, Breast Cancer Res Treat) - P3 | "The clinical benefit and overall response rates in males were consistent with the overall population. This analysis demonstrates the safety and efficacy of ribociclib in a close-to-real-world setting, supporting the use of RIB + LET in male patients with HR+, HER2- ABC."

Journal • P3 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Male Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Apalutamide + Abiraterone acetate plus Prednisone (AAP) + Leuprolide with Stereotactic, Ultra-Hypofractionated Radiation (AASUR) in Very High Risk Prostate Cancer: A Single Arm, Phase 2 Study. (PubMed, Clin Cancer Res) - "Treatment intensification with apalutamide, AAP, ADT and SBRT well-tolerated with limited impact on quality of life. While BCR rates exceed the superiority threshold, outcomes aligned with historical benchmarks, supporting further evaluation of the regimen in prospective trials."

Journal • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Treatment (tx) of high-risk biochemically recurrent prostate cancer with enzalutamide (enza) in combination with leuprolide acetate (LA): Secondary endpoints from EMBARK (ESMO 2023) - P3 | "Conclusions In pts with high-risk BCR, enza + LA vs LA alone demonstrated clinically meaningful delays in time to: distant metastasis, resumption of any hormonal therapy after tx suspension, castration resistance, symptomatic progression, and first symptomatic skeletal event. If approved, enza combination may represent a new standard of care for pts with high-risk BCR."

Combination therapy • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor