goserelin acetate / Generic mfg. - LARVOL DELTA

Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 5-year outcomes (ESMO 2025) - "Methods Pts with HR+/HER2− EBC were randomized 1:1 to RIB (400 mg/d; 3 weeks on/1 week off for 3 y) + NSAI (letrozole 2.5 mg/d or anastrozole 1 mg/d for 5 y) or NSAI alone. Men and premenopausal women received goserelin...Conclusions In this 5-year landmark analysis with mature efficacy data, RIB + NSAI reduced the risk of invasive and distant disease recurrence compared with NSAI alone, including in pts with high-risk N0 disease. A positive trend for OS in favor of RIB + NSAI continues to emerge."

Clinical • Late-breaking abstract • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

600- vs 400-mg First-Line Ribociclib in Hormone Receptor-Positive/ERBB2-Negative Advanced Breast Cancer: The AMALEE Randomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "Randomization 1:1 to ribociclib, 400 mg + a nonsteroidal aromatase inhibitor or ribociclib, 600 mg + a nonsteroidal aromatase inhibitor (premenopausal patients also received goserelin). The final results confirmed the standard ribociclib, 600 mg starting dose in HR+/ERBB2- ABC while supporting dose reduction to manage dose-dependent AEs. ClinicalTrials.gov Identifier: NCT03822468."

Clinical • Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Primary endpoint of ROSALINE: A phase II neoadjuvant study of endocrine therapy (ET) and entrectinib in invasive lobular breast carcinoma (ILBC) (ESMO-BC 2025) - P2 | "ROSALINE is the first neoadjuvant trial focused on ILBC, evaluating ET and entrectinib in HR+/HER2- disease. This investigator-initiated, single-arm, phase II trial enrolled women with stage IIA–IIIA HR+/HER2– ILBC treated with 4 cycles of letrozole (2.5 mg/day) + entrectinib (600 mg/day), + goserelin for premenopausal women, followed by surgery. The primary endpoint was not met and dose reductions were frequent. However, neoadjuvant entrectinib with ET showed activity. Correlative analyses are ongoing to clarify role of ROS1 inhibition in ILBC and identify predictive biomarkers."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDH1 • HER-2

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery (clinicaltrials.gov) - P2 | N=74 | Recruiting | Sponsor: University of Chicago | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

NATALEE update: Safety and treatment (tx) duration of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC) (ESMO-BC 2024) - "Methods Pts in NATALEE were randomized 1:1 to RIB (400 mg/d 3 wk on/1 wk off, 36 mo) + NSAI (letrozole or anastrozole, ≥60 mo) or NSAI alone. Men and premenopausal women also received goserelin...Table: 113MO Most common AEs (>10% in RIB + NSAI arm in the safety set) AEs, n (%) RIB + NSAI n = 2525 NSAI alone n = 2442 Neutropeniaa 1579 (62.5) 113 (4.6) Infectionsa 1253 (49.6) 883 (36.2) Arthralgia 942 (37.3) 1058 (43.3) Hepatobiliary toxicitya,b 667 (26.4) 273 (11.2) Leukopeniaa 595 (23.6) 111 (4.5) Nausea 588 (23.3) 190 (7.8) Headache 575 (22.8) 415 (17.0) Fatigue 564 (22.3) 322 (13.2) Hot flush 486 (19.2) 489 (20.0) Asthenia 428 (17.0) 291 (11.9) Alopecia 380 (15.0) 109 (4.5) Diarrhea 366 (14.5) 135 (5.5) Constipation 335 (13.3) 123 (5.0) Cough 332 (13.1) 201 (8.2) Insomnia 292 (11.6) 281 (11.5) Pyrexia 280 (11.1) 147 (6.0) Back pain 272 (10.8) 247 (10.1) Pain in extremity 261 (10.3) 219 (9.0) aGrouped term per MedDRA v. 26.0bAST, ALT, ALP, bilirubin, and GGTP..."

Clinical • Alopecia • Back Pain • Breast Cancer • CNS Disorders • Constipation • Cough • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hepatology • HER2 Positive Breast Cancer • Immunology • Infectious Disease • Insomnia • Leukopenia • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Respiratory Diseases • Sleep Disorder • Solid Tumor • HER-2

A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-positive, HER2-negative Breast Cancer with a Combination Regimen of Ribociclib and Optimized Endocrine Therapy - SELECT Trial (SABCS 2025) - P2 | "Optimized ET includes an oral aromatase inhibitor (letrozole or anastrozole) for all participants, with the addition of a GnRH agonist (goserelin) to achieve gonadal suppression in all men and premenopausal women. Recruitment is ongoing. Clinical trial information: NCT06953882."

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

A prospective, randomized, cross-over trial to assess patient preference for goserelin microsphere versus goserelin implant in prostate cancer: Interim results of the GOMIMP study. (ASCO-GU 2026) - "The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

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

Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival. (PubMed, ESMO Open) - "This prespecified 5-year follow-up of efficacy outcomes from NATALEE demonstrated that ribociclib + NSAI continued to reduce the risk of recurrence beyond the 3-year treatment window, supporting its use as adjuvant therapy in patients with HR-positive/HER2-negative EBC. An ongoing positive trend for improved OS in favor of ribociclib + NSAI was observed."

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

US Food and Drug Administration Approval Summary: Ribociclib With an Aromatase Inhibitor in the Adjuvant Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Stage II and III High-Risk Early Breast Cancer Treatment Setting. (PubMed, J Clin Oncol) - "Addition of adjuvant ribociclib to NSAI for adults with high-risk stage II and III hormone receptor-positive, HER2-negative EBC demonstrated a favorable benefit-risk profile with a statistically significant iDFS advantage. OS data remain immature."

FDA event • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients (clinicaltrials.gov) - P2/3 | N=119 | Completed | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ Sep 2025

Trial completion • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Xiao X. Wei, MD | Trial completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • ABRAXAS1 • BRCA1 • BRIP1 • CD8 • CDK12 • CHEK2 • GEN1 • MLH1 • MSH2 • MSH6 • MSI • NBN • PD-L1 • RAD51C • RAD51D

CASPAR: A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy (clinicaltrials.gov) - P3 | N=61 | Active, not recruiting | Sponsor: Alliance for Clinical Trials in Oncology | Trial primary completion date: Mar 2026 ➔ Mar 2027

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Shanghai Changzheng Hospital

New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Challenges in analyzing real-world evidence: analysis of androgen deprivation therapy use for prostate cancer in the REASSURE study. (PubMed, ESMO Real World Data Digit Oncol) - "Study objectives included patient demographics, clinical characteristics, and ADT treatment duration by treatment received [goserelin or other ADTs (leuprorelin, degarelix, or triptorelin)]. While some patterns of ADT use in REASSURE were consistent with recommendations from clinical practice guidelines, there were also some inconsistencies. Findings from REASSURE highlighted the importance of considering potential differences in health care systems, population coverage, and patient data collection between regions, as well as incorporating data from multiple sources to capture data from more diverse patient populations, thus improving the quality of outputs from real-world studies."

HEOR • Journal • Real-world evidence • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Shanghai Changzheng Hospital

New P1 trial • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

EndomMASLD: Effect of a GnRH Analog on Hepatic Steatosis (clinicaltrials.gov) - P4 | N=62 | Recruiting | Sponsor: Aristotle University Of Thessaloniki | Trial completion date: Apr 2027 ➔ Oct 2027 | Trial primary completion date: Oct 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Endometriosis • Gynecology • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Women's Health • LEP

Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in NATALEE: Analysis across menopausal status and age. (ASCO 2025) - P3 | " Pts were treated with RIB + NSAI or NSAI alone in NATALEE; premenopausal (PreM) women also received goserelin. RIB + NSAI provides treatment benefit to a broad range of pts with stage II/III HR+/HER2− EBC across menopausal status and age. In younger PreM pts, who typically have more aggressive disease characteristics, treatment favored RIB + NSAI, and these pts were least likely to discontinue RIB due to AEs."

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

Baseline (BL) characteristics and efficacy endpoints for patients (pts) with node-negative (N0) HR+/HER2− early breast cancer (EBC): NATALEE trial. (ASCO 2024) - P3 | "Background: NATALEE assessed ribociclib (RIB) + non-steroidal aromatase inhibitor (NSAI) vs NSAI alone in pts with HR+/HER2− EBC at increased risk of recurrence, including pts with N0 disease, and showed a statistically significant invasive disease-free survival (iDFS) benefit... Pts with stage II/III HR+/HER2− EBC were randomized (R) 1:1 to RIB 400 mg/d (3 wk on/1 wk off for 36 mo) + NSAI (letrozole or anastrozole for ≥60 mo) or NSAI alone. Men and premenopausal women received goserelin... This analysis showed a consistent efficacy benefit and manageable safety profile of RIB + NSAI vs NSAI alone in pts with N0 disease in NATALEE. The 3y iDFS, DDFS, and DRFS rates in the control arm at this early follow-up underscore the risk of recurrence for the N0 subgroup. These findings support the use of RIB in pts with HR+/HER2− EBC at increased risk of recurrence, including pts with N0 disease."

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

Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (Pts) with HR+/HER2− early breast cancer (EBC): 4-year outcomes from the NATALEE trial (ESMO 2024) - P3 | "We present efficacy and safety data of an exploratory analysis with all pts now off RIB. Pts were randomized 1:1 to RIB (400 mg/d; 3 wk on/1 wk off for 3 y) + NSAI (letrozole 2.5 mg/d or anastrozole 1 mg/d, for 5 y) or NSAI alone. Men and premenopausal women received goserelin... In this 4-y landmark analysis, RIB + NSAI reduced the risk of invasive and distant disease recurrence by 28.5% compared with NSAI. This benefit was maintained after the planned 3-y RIB treatment duration, resulting in an increasing absolute benefit up to 4 y. These results further support the addition of RIB to adjuvant NSAI in a broad population of pts with HR+/HER2− EBC at risk of recurrence."

Clinical • Late-breaking abstract • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Ribociclib plus Endocrine Therapy in Early Breast Cancer. (PubMed, N Engl J Med) - P3 | "Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.)."

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

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

Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in younger patients (pts) with HR+/HER2− early breast cancer (EBC) in NATALEE (ESMO 2024) - "Premenopausal pts also received goserelin. Adjuvant RIB + NSAI showed treatment benefit in pts with HR+/HER2− EBC, including in pts <40 y, who had more aggressive disease than pts ≥40 y. Although safety profiles were consistent between age groups, pts <40 y were less likely to discontinue RIB due to AEs and were less likely to do so without prior dose reduction."

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

Clinical outcomes in patients (pts) with HR+/HER2− early breast cancer (EBC) by prior systemic treatment (tx): A subgroup analysis of the NATALEE trial (ESMO 2024) - P3 | "Background: NATALEE met its primary endpoint at second interim efficacy analysis with a significant invasive disease–free survival (iDFS) benefit with ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) vs NSAI in pts with HR+/HER2− EBC that was sustained with additional follow-up (median follow-up, 33.3 mo; HR, 0.749)...Men and premenopausal women also received goserelin... This subgroup analysis demonstrated an iDFS benefit with RIB + NSAI vs NSAI alone in pts with HR+/HER2− EBC, regardless of duration of prior ET as well as prior (neo)adjuvant CT vs no CT, underlying potential role of CDK4/6 inhibitors in therapeutic de-escalation of CT in EBC. A majority of pts with N0 disease at diagnosis had received prior (neo)adjuvant CT, highlighting that these pts had a risk of recurrence that was considered high enough to warrant CT."

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

Outcomes with first-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs physician’s choice combination chemotherapy (combo CT) by age in pre/perimenopausal patients (pts) with aggressive HR+/HER2− advanced breast cancer (ABC): A subgroup analysis of the RIGHT Choice trial. (ASCO 2023) - P2 | " Pre/perimenopausal pts (aged 18-59 y) with HR+/HER2− ABC and no prior systemic therapy for ABC were randomized 1:1 to either RIB with letrozole/anastrozole + goserelin or investigator’s choice of combo CT (docetaxel + capecitabine, paclitaxel + gemcitabine, or capecitabine + vinorelbine). This analysis demonstrated a clinically meaningful PFS benefit and improved secondary outcomes with 1L RIB + ET over combo CT along with similar treatment responses in both tx arms in pts aged * Unconfirmed."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2− early breast cancer: Primary results from the phase III NATALEE trial. (ASCO 2023) - P3 | " Men and pre- or postmenopausal women were randomized 1:1 to RIB (400 mg/day; 3 wk on/1 wk off for 3 y) + ET (letrozole 2.5 mg/day or anastrozole 1 mg/day, for ≥ 5 y) or ET alone. Men and premenopausal women also received goserelin... Ribociclib added to standard-of-care ET demonstrated a statistically significant, clinically meaningful improvement in iDFS with a well-tolerated safety profile. The NATALEE results support ribociclib + ET as the treatment of choice in a broad population of pts with stage II or III HR+/HER2− EBC, including pts with N0 disease. Clinical trial information: NCT03701334."

Clinical • Late-breaking abstract • P3 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2