Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer, Knight Therap - LARVOL DELTA

Unexpected Fatal Pneumocystis Jirovecii Pneumonia During Triplet Therapy for Hormone-Sensitive Prostate Cancer. (PubMed, Respirol Case Rep) - "A 75-year-old man with low-volume metastatic hormone-sensitive prostate cancer (mHSPC) received triplet therapy with relugolix, darolutamide and docetaxel...Despite appropriate trimethoprim-sulfamethoxazole and corticosteroid therapy, he died of respiratory failure ~10 days after symptom onset. This case highlights an underrecognized risk of PJP during triplet therapy for mHSPC. Prophylaxis should be considered in select high-risk patients, including elderly individuals or those with metabolic comorbidities."

Journal • Anorexia • Diabetes • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Infectious Disease • Metabolic Disorders • Oncology • Pneumonia • Prostate Cancer • Respiratory Diseases • Solid Tumor

Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Nov 2028 | Trial primary completion date: Jan 2027 ➔ Nov 2028

Enrollment closed • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Relugolix Combination Tablets in Healthy Japanese Premenopausal Women: Pharmacokinetics, Pharmacodynamics, and Safety Profile. (PubMed, Reprod Med Biol) - "To evaluate the applicability of overseas-approved dosage of relugolix combination tablets (relugolix 40 mg, estradiol [E2] 1 mg, and norethisterone acetate 0.5 mg) in healthy premenopausal Japanese women. Relugolix combination tablets have favorable safety and efficacy profiles, potentially making them suitable for long-term use in Japanese patients. The trial registration number is JapicRCT2071230042."

Clinical • Journal • PK/PD data

Potency of oral gonadotropin-releasing hormone antagonist as endometriosis-associated pain novel treatments: An updated meta-analysis of randomized controlled trials. (PubMed, Int J Reprod Biomed) - "Bone mineral density in the spine was significantly lower in the treatment group (p 0.001). This meta-analysis provides updated evidence on Elagolix, Linzagolix, and Relugolix, confirming their effectiveness in managing endometriosis-associated pain, while highlighting important considerations regarding metabolic and bone health."

Journal • Retrospective data • Review • Dyslipidemia • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Rapid Eradication of Extensive Spinal Metastases in a Prostate-Cancer Patient Taking Androgen-deprivation Therapy, Chemotherapy, and Oral Recombinant Methioninase on a Low-Methionine Diet. (PubMed, Anticancer Res) - "The patient achieved an apparent complete response of prostate-cancer spinal metastases after treatment with ADT, chemotherapy, and methionine restriction. Further studies, including controlled clinical trials are necessary to validate this new paradigm of treatment for prostate-cancer bone metastases."

Clinical • Journal • CNS Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Psychiatry • Solid Tumor

Case Report: Cutaneous metastatic mucin-producing prostate adenocarcinoma. (PubMed, Front Oncol) - "He was started on androgen deprivation therapy with relugolix...It also raises awareness of prostate cancer presenting as solitary cutaneous metastasis and calls attention to the potential value of PSA screening in select elderly patients. Recognizing uncommon cutaneous manifestations may lead to earlier diagnosis and improved management of advanced internal malignancies."

Journal • Benign Prostatic Hyperplasia • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Skin Cancer • Solid Tumor • NKX2-1 • NKX3-1 • PAX8

Clinical Effectiveness of Oral Relugolix in Advanced Prostate Cancer: A Structured Review of Current Primary Research. (PubMed, Cureus) - "In the HERO trial, Relugolix achieved castration-level testosterone (<50 ng/dL) in 96.7% of patients, outperforming Leuprolide (88.3%) in both speed (median = 4 days vs. 29 days) and magnitude of suppression...Additional studies confirmed its effectiveness when combined with radiotherapy in comparison with Degarelix...These advantages, along with oral administration, support its use as a viable alternative in clinical practice. Further long-term studies are warranted to confirm sustained outcomes and optimize treatment regimes."

Journal • Review • Cardiovascular • Genito-urinary Cancer • Oncology • Oral Cancer • Prostate Cancer • Solid Tumor

Relugolix in treatment of prostate cancer: a review. (PubMed, Arch Ital Urol Androl) - "Relugolix represents a significant advancement in ADT, offering a potent, oral alternative with a rapid onset of action, a superior cardiovascular safety profile, and improved testosterone recovery. It provides clinicians with a valuable option for treating advanced prostate cancer, particularly in patients with cardiovascular comorbidities."

Journal • Cardiovascular • 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

Retrospective Analysis of Racial Differences in Treatment Patterns and Prostate-Specific Antigen Responses Among Patients with Prostate Cancer Treated with Relugolix in the Veterans Health Administration. (PubMed, Adv Ther) - P | "Adherence to relugolix was very high during the first year of treatment. These data support that in the real world, patients can adhere to relugolix with PSA responses on par with clinical trials regardless of race. Black patients were more likely to discontinue or switch to another ADT than White patients, but the reasons for this require further study."

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

Preoperative relugolix combination therapy in laparoscopic myomectomy: a case series evaluating impact on surgical planes and operative outcomes. (PubMed, Arch Gynecol Obstet) - "This case series suggests that preoperative Relugolix-CT does not adversely affect surgical planes or operative outcomes. Although preliminary, these findings suggest benefits for surgical optimisation and support further investigation in larger, controlled studies."

Journal • Fibrosis • Gynecology • Immunology • Solid Tumor • Uterine Leiomyoma • Women's Health

Accelerated Coronary Atherosclerosis Following Relugolix Versus Leuprolide Androgen Deprivation Therapy in Men with Prostate Cancer (REVELUTION): An Open-Label Randomized Controlled Trial (AHA 2025) - P2 | "ADT for PCa is associated with accelerated coronary atherosclerosis within 12 months and is significantly 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

Statin Use Mitigates Androgen Deprivation Therapy-Associated Coronary Atherosclerosis in Prostate Cancer: A Secondary Analysis of the REVELUTION Randomized Clinical Trial (AHA 2025) - P2 | "Concurrent statin therapy at the time of leuprolide initiation for PCa was significantly associated with decreased coronary atherosclerosis progression when compared to those not on statins at baseline. Future prospective study should analyze the impact of concurrently initiated statin therapy on leuprolide-associated coronary atherosclerosis."

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

Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: OHSU Knight Cancer Institute | N=32 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • IO biomarker • Trial withdrawal • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • PD-L1

OPTIMAS: Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: University of Utah | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A multicenter, randomized, parallel-group, controlled trial comparing the efficacy of preoperative administration of relugolix with leuprorelin in laparoscopic myomectomy (MyLacR study) (ESGE 2025) - "Other surgical outcomes, percent change of myoma size, menopausal-like symptoms, and disease-specific quality of life did not differ between the two groups, however, postoperative menstrual recovery and bone density recovery tended to be earlier in the relugolix group. Conclusions This study demonstrated that the non-inferiority of preoperative relugolix compared with leuprorelin for the efficacy of reducing intraoperative blood loss in laparoscopic myomectomy."

Clinical • Solid Tumor • Uterine Leiomyoma • Women's Health

ARPI-based triple and double therapy in metastatic hormone-sensitive prostate cancer: a real-world analysis (ESMO 2025) - "Darolutamide and relugolix had a positive effect on OS whereas lung/liver metastases and the use of docetaxel worsened the prognosis in the metachronous population (p<0.0001). Limitations include retrospective nature, potential selection and confounding biases. Legal entity responsible for the study The authors."

Clinical • Metastases • Real-world • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Influence of GnRH agonist and GnRH antagonist initiation on platelet activity in patients with prostate cancer (ESMO 2025) - "Compared to the GnRH agonist leuprolide, the GnRH antagonist relugolix was associated with fewer CV events. Enrollment continues and additional analyses will investigate changes in the platelet transcriptome and correlate the platelet phenotype with clinical response. Legal entity responsible for the study The authors."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ITGB3 • PTPRC

OPTIMAS: Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: University of Utah

New P2 trial • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Relugolix's impact on endometriosis-associated pain and quality of life: a meta-analysis of EHP-30 outcomes. (PubMed, Front Endocrinol (Lausanne)) - "Subgroup analysis by control type showed significant differences (p<0.0001): Relugolix was highly effective against placebo (MD = 15.31, 95% CI: 12.18 to 18.45) and placebo-matching combination therapy (MD = 8.86, 95% CI: 5.03 to 12.69), but numerically less effective than leuprorelin (MD = -3.79, 95% CI: -6.27 to -1.31). Oral relugolix significantly improves EHP-30 pain domain scores and patient response rates in endometriosis, particularly when compared to placebo. It also positively impacts emotional well-being, social support, and self-image."

Clinical • HEOR • Journal • Retrospective data • Review • Endometriosis • Gynecology • Pain • Women's Health

Efficacy of Elagolix and Relugolix for the Treatment of Pelvic Pain in Patients With Endometriosis: A Systematic Review. (PubMed, Cureus) - "Importantly, the strongest and most consistent evidence supports the use of relugolix in combination with add-back therapy, which appears to provide sustained efficacy and a more favorable long-term safety profile than monotherapy. Thus, relugolix with hormonal add-back therapy emerges as a safe and effective long-term treatment option for endometriosis-related symptoms, offering significant clinical benefits while mitigating hypoestrogenic side effects."

Clinical • Journal • Review • Endometriosis • Gynecology • Infertility • Musculoskeletal Pain • Pain • Sexual Disorders • Women's Health

Knight Therapeutics Announces Relaunch of ORGOVYX in Canada (GlobeNewswire)

Relaunch • Prostate Cancer

PRESCRIPTION TRENDS AND THE ACCEPTANCE OF NEW ORAL GNRH ANTAGONISTS; USING OPEN DATABASE IN JAPAN (FIGO 2025) - " We collected prescription data of the oral GnRH antagonist, relugolix, from the NDB Open Database... Economic factors significantly impact the prescription of high-cost medications, such as oral GnRH antagonists. The disparity in access to approved treatments due to economic inequality highlights the need for potential financial assistance to ensure equitable treatment access nationwide."

Endometriosis • Gynecology • Obstetrics • Solid Tumor • Uterine Leiomyoma • Women's Health

Radiation Oncology Drug Prescription Patterns in Medicare Part D (ASTRO 2025) - "While differences exist between male and female prescribing patterns, they may reflect variations in disease sites managed rather than true prescribing differences. The notable costs associated with female prescribers and diabetes medications, including Semaglutide & insulins, raise questions about the growing role of metabolic management in cancer care. Table 1 Claims - Female Claims - Male $ Cost - Female $ Cost - Male 1 Tamsulosin (13835) Tamsulosin (107146) Relugolix (564,524) Enzalutamide (13,652,547) 2 Mometasone (3522) Hydrocodone Acetaminophen (14492) Insulin (Glargine, Aspart, Lispro) (478,317) Apalutamide (13,090,914) 3 Dexamethasone (3389) Dexamethasone (12741) Semaglutide (413,559) Relugolix (7,883,362) 4 Naloxone (2869) Lidocaine (11480) Leuprolide (386,005) Tamsulosin (1,882,331) 5 Silver Sulfadiazine (2842) Ciprofloxacin (8973) Dulaglutide (285,559) Lenalidomide (1,728,589) 6 Lidocaine (2764) Bicalutamide (8463) Naloxone (283,125) Abiraterone..."

Medicare • Reimbursement • US reimbursement • Hematological Malignancies • Oncology

PSMA-PET Guided Metastasis-Directed Therapy (ASTRO 2025) - "The most common type of systemic therapy at time of SBRT consisted of leuprolide acetate or relugolix (18/25) with or without intensification (17/25). The majority of patients experienced a decrease in PSA level following PSMA-PET guided MDT. These findings support the ability of PSMA-PET to identify lesions driving biochemical progression and suggest further exploration of molecular imaging guided MDT as a consolidation or salvage strategy to enhance disease control among patients with a low burden of PSMA-PET avid disease on systemic therapy."

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