goserelin acetate / Generic mfg. - LARVOL DELTA

Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial) (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: German Oncology Center, Cyprus | Trial primary completion date: Aug 2026 ➔ Aug 2027

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

Hypo-Combi Trial: Hypofractionated EBRT Plus HDR-BT Boost for Prostate Cancer (clinicaltrials.gov) - P1/2 | N=40 | Active, not recruiting | Sponsor: German Oncology Center, Cyprus | Trial completion date: Aug 2026 ➔ Aug 2027

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

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

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

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

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

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

Adjuvant abemaciclib use and outcomes in patients with high-risk hormone receptor-positive, HER2-negative breast cancer: a real-world analysis. (SABCS 2024) - "Adjuvant endocrine therapy consisted of tamoxifen in 6% of patients, goserelin + tamoxifen in 2%, aromatase inhibitors (AI) in 39%, and AI + goserelin in 31%. This cohort was composed of younger premenopausal patients with a high prevalence of overweight and low frequency of germline BRCA1/2 mutations. Tumors were predominantly HG2, T2, N, and stage II. Most received adjuvant chemotherapy with anthracyclines and taxanes, adjuvant radiotherapy, and double hormonal blockade with AI."

Clinical • Real-world • Real-world evidence • 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 • BRCA1 • BRCA2 • ER • HER-2 • PGR

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

Palbociclib plus tamoxifen ± goserelin in women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer (BC): PATHWAY, an Asian international double-blind randomized phase 3 trial—Final overall survival (OS) analysis. (ASCO 2026) - P3 | "With longer follow-up, palbociclib plus tamoxifen (± goserelin) provided durable PFS benefit and a favorable OS trend with manageable safety, supporting this regimen as an effective option regardless of menopausal status."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • 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

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

Cribriform-morular variant of thyroid carcinoma with aggressive behavior: new successful therapeutic approaches (ETA 2026) - "The use of lenvatinib followed by letrozole combined with goserelin yielded a reduction in pulmonary metastases in aggressive CMV-TC. The underlying molecular mechanisms are currently under investigation."

Gastrointestinal Disorder • Genetic Disorders • Oncology • Solid Tumor • Thyroid Gland Carcinoma • APC • BRAF • MUTYH • NRAS • PGR • TERT • TG

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

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

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

Final results of RIGHT Choice: Ribociclib plus endocrine therapy vs combination chemotherapy in premenopausal women with clinically aggressive HR+/HER2- advanced breast cancer. (PubMed, J Clin Oncol) - "In this open-label, multi-center, randomized phase 2 trial, pre/perimenopausal women with clinically aggressive HR+/HER2- ABC were randomized 1:1 to first-line ribociclib (600 mg daily; 3-weeks-on, 1-week-off) plus letrozole/anastrozole and goserelin or investigator's choice of combination CT (docetaxel plus capecitabine, paclitaxel plus gemcitabine, or capecitabine plus vinorelbine). Lower rates of symptomatic adverse events were observed in the ribociclib versus CT arm. First-line ribociclib plus ET showed a significant PFS benefit, similar response rates, and better tolerability over combination CT in patients with clinically aggressive HR+/HER2- ABC."

Journal • Metastases • 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

Prognostic and predictive impact of baseline gene expression (exp) in the NATALEE trial of adjuvant (adj) ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in HR+/HER2− early breast cancer (EBC). (ASCO 2026) - P3 | "Men and premenopausal women received goserelin. In this analysis of NATALEE, which examined the largest dataset of surgical tumor samples from any adj CDK4/6i trial in HR+/HER2− EBC, RIB had benefit across all PAM50 subtypes, with a trend for increased benefit in pts with higher genomic risk signature or proliferation signature scores. Baseline exp levels of several genes were associated with differential RIB benefit in EBC, showing potential predictive and prognostic value. The findings reinforce the therapeutic benefit of RIB in combination with ET across HR+/HER2− EBC populations."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • CEACAM6 • GATA3 • HER-2 • MAPT • SLC39A6

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

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

Primary results from the randomized Phase II RIGHT Choice trial of premenopausal patients with aggressive HR+/HER2− advanced breast cancer treated with ribociclib + endocrine therapy vs physician’s choice combination chemotherapy (SABCS 2022) - P2 | " Pre/perimenopausal pts with HR+/HER2− ABC (>10% estrogen receptor–positive [ER+]) and no prior systemic therapy for ABC were randomized 1:1 to receive either RIB (600 mg daily, 3 weeks on/1 week off) with letrozole/anastrozole + goserelin or investigator’s choice of CT (docetaxel + capecitabine, paclitaxel + gemcitabine, or capecitabine + vinorelbine). This analysis demonstrated a statistically significant and clinically meaningful PFS benefit with RIB + ET over combination CT in the first-line pre/perimenopausal pt population with aggressive HR+/HER2− ABC disease. This is the first study comparing a CDK4/6i + ET vs combination CT and demonstrating the superiority of RIB + ET in aggressive HR+/HER2− ABC. This evidence supports RIB+ ET use as a preferred option for this pt population."

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

Updated Overall Survival of Ribociclib Plus Endocrine Therapy vs Endocrine Therapy Alone in Pre- and Perimenopausal Patients With HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial. (PubMed, Clin Cancer Res) - P3 | "Ribociclib plus ET continued to show significantly longer OS than ET alone in pre-/perimenopausal patients, including patients aged <40 years, with HR+/HER2- ABC with 53.5 months of median follow-up. (ClinicalTrials.gov, NCT02278120)."

Clinical • Journal • P3 data • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A pilot phase II study of neoadjuvant fulvestrant plus abemaciclib in women with advanced low-grade serous carcinoma. (ASCO 2022) - P2 | "Pre/perimenopausal patients also received goserelin 10.8 mg subcutaneously every 12 weeks for ovarian suppression...Following ICS, patients receive 4 cycles of adjuvant fulvestrant and abemaciclib and then transition to maintenance letrozole... Neoadjuvant treatment with fulvestrant and abemaciclib was tolerable and demonstrated unprecedented response and CGR rates in this pilot study. These results compare favorably to published outcomes of neoadjuvant chemotherapy in LGSOC. Further studies are planned to explore this new treatment option in a larger study population."

Clinical • P2 data • Acute Kidney Injury • Breast Cancer • Hematological Disorders • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Nephrology • Neutropenia • Oncology • Renal Disease • Solid Tumor