Inluriyo (imlunestrant) / Eli Lilly - LARVOL DELTA

Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Updated efficacy results from the phase 3 EMBER-3 trial (SABCS 2025) - "Background: At the primary progression-free survival (PFS) analysis, the phase 3 EMBER-3 trial in patients (pts) with ER+, HER2- ABC demonstrated significant PFS benefit with imlunestrant (imlu) vs standard therapy (SOC: fulvestrant or exemestane) in pts with ESR1 mutations (ESR1m), and with imlunestrant+abemaciclib (imlu+abema) vs imlu in all pts, regardless of ESR1m status. At a median follow-up of 28.5 months, a clinically meaningful improvement in OS was observed with imlu vs SOC in pts with ESR1m (corresponding to a numeric increase in mOS of 11.4 months), however, the boundary for significance was not achieved. Also, a favorable OS trend emerged with imlu+abema vs imlu in all pts, regardless of ESR1m. Sustained benefit in PFS, with clinically meaningful improvement in TTC, and PFS2 further highlight the efficacy of imlu-based regimens."

Clinical • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Circulating Tumour DNA (ctDNA) Dynamics From Patients With ER+, HER2- Advanced Breast Cancer in the Phase 3 EMBER-3 Trial (SABCS 2025) - "Background: The EMBER-3 trial, which included patients with ER+/HER2- advanced breast cancer previously treated with endocrine therapy (ET), demonstrated a significant improvement in progression-free survival (PFS) with imlunestrant (imlu) over standard ET (SOC ET, fulvestrant or exemestane) in patients with ESR1 mutations (ESR1m). Analyses of early ctDNA dynamics from EMBER-3 demonstrated greater early ctDNA reduction with imlunestrant compared with SOC ET in patients with ESR1m. The addition of abemaciclib to imlunestrant enhanced ctDNA decline in all patients, consistent with the primary study outcomes. Furthermore, while a ≥50% decline in ctDNA at C2D21 was associated with improved PFS, the allocated treatment remained a key determinant of patient outcomes."

Circulating tumor DNA • Clinical • Metastases • P3 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Imlunestrant with or without Abemaciclib in Advanced Breast Cancer. (PubMed, N Engl J Med) - P3 | "Among patients with ER-positive, HER2-negative advanced breast cancer, treatment with imlunestrant led to significantly longer progression-free survival than standard therapy among those with ESR1 mutations but not in the overall population. Imlunestrant-abemaciclib significantly improved progression-free survival as compared with imlunestrant, regardless of ESR1-mutation status. (Funded by Eli Lilly; EMBER-3 ClinicalTrials.gov number, NCT04975308.)."

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

Imlunestrant (Imlu) with or without abemaciclib (Abema) in advanced breast cancer (ABC): A subgroup analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients (pts) from EMBER-3 (ESMO-BC 2025) - P3 | "The EMBER-3 trial reported significant PFS improvement with imlu over standard therapy (SOC; fulvestrant [fulv] or exemestane) in pts with ESR1 mutations (m), as well as with imlu + abema over imlu in all pts, regardless of ESR1m. In pts with ER+, HER2- ABC who have progressed on prior CDK4/6i, imlu+abema showed a consistent benefit over imlu, regardless of clinico-genomic factors. EMBER-3 is the 1st phase III trial to show benefit of an oral SERD + CDK4/6i after disease progression on prior CDK4/6i."

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

Patient-reported outcomes in patients with ER+, HER2- advanced breast cancer treated with imlunestrant, investigator's choice standard endocrine therapy, or imlunestrant+abemaciclib: Results from the phase III EMBER-3 trial (DKK 2026) - No abstract available

Clinical • Metastases • P3 data • Patient reported outcomes • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Imlunestrant (imlu) with or without abemaciclib (abema) in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial (DKK 2026) - No abstract available

Clinical • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor

Imlunestrant plus abemaciclib versus fulvestrant plus abemaciclib in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC): An indirect treatment comparison (ITC) of three phase 3 trials (DKK 2026) - No abstract available

Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Imlunestrant with or without Abemaciclib in Advanced Breast Cancer (ABC): A Subgroup Analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients from EMBER-3 (DKK 2026) - No abstract available

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor

Imlunestrant (imlu) with or without abemaciclib (abema) in advanced breast cancer (ABC): Updated efficacy results from the phase 3 EMBER-3 trial (DKK 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor

Oral SERDs: Transforming the treatment of advanced breast cancer-Insights from EMBER-3. (PubMed, Med) - "The phase 3 EMBER-3 trial1 demonstrated that when compared to standard therapy, imlunestrant improved progression-free survival (PFS) in advanced ER+/HER2- breast cancer with ESR1 mutations. When combined with abemaciclib, it significantly improved PFS for the entire population. However, the absence of a biomarker-based control group limits broader conclusions, highlighting the need for trials incorporating specific standards in ER+/HER2- breast cancer."

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

Imlunestrant, an oral selective estrogen receptor degrader (SERD), in combination with human epidermal growth factor receptor 2 (HER2) directed therapy, with or without abemaciclib, in estrogen receptor (ER) positive, HER2 positive advanced breast cancer (aBC): EMBER phase 1a/1b study. (ASCO 2024) - P1 | "Key eligibility (Part C): ≥ 2 prior HER2 directed regimens, no prior CDK4/6i or fulvestrant; (Part E): received 1 st line induction taxane chemotherapy (any duration) + H + P, without disease progression and ≤1 prior therapy for aBC. Imlunestrant in combination with trastuzumab ± abemaciclib or pertuzumab was well tolerated, showed no drug-drug interactions, and demonstrated preliminary antitumor activity in pts with ER+/HER2+ aBC."

Combination therapy • Metastases • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Musculoskeletal Pain • Neutropenia • Oncology • Solid Tumor • CDK4 • ER • GATA3 • PIK3CA • TP53

Imlunestrant with or without everolimus or alpelisib, in ER+, HER2- advanced breast cancer (aBC): Results from the phase Ia/b EMBER study (ESMO 2023) - P1a/1b | "In the first-in-human phase 1a/b EMBER study, imlunestrant demonstrated favorable safety, pharmacokinetics (PK), and clinical benefit rate when administered as monotherapy (Jhaveri ASCO 2022) or with abemaciclib (Jhaveri SABCS 2022)...Median number of prior aBC therapies in combination cohorts was: 1 (range 1-2); including prior ET (100%), CDK4/6i (100%), fulvestrant (35%) and chemo (17%)...Conclusions Imlunestrant alone or in combination with everolimus or alpelisib demonstrated robust efficacy in pts with pre-treated ER+, HER-2 aBC. Toxicities were consistent with the known safety profile of both alpelisib and everolimus."

Metastases • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2 • PIK3CA

Imlunestrant, an Oral Selective Estrogen Receptor Degrader, as Monotherapy and in Combination With Targeted Therapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Phase Ia/Ib EMBER Study. (PubMed, J Clin Oncol) - "Imlunestrant, as monotherapy or in combination with targeted therapy, had a manageable safety profile with evidence of preliminary antitumor activity in ER+/HER2- ABC."

Combination therapy • Journal • Metastases • Monotherapy • P1 data • Breast Cancer • Endometrial Cancer • Fatigue • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Patient-reported outcomes (PROs) in patients with ER+, HER2- advanced breast cancer (ABC) treated with imlunestrant, investigator's choice standard endocrine therapy, or imlunestrant + abemaciclib: Results from the phase III EMBER-3 trial. (ASCO 2025) - P3 | "The EMBER-3 trial, in patients (pts) with ER+, HER2- ABC who had disease progression on or after aromatase inhibitor-based therapy, showed significant progression free survival (PFS) improvement with imlu vs standard therapy (SOC, fulvestrant or exemestane) in pts with ESR1 mutations (ESR1m), and with imlunestrant+abemaciclib (imlu+abema) vs imlu in all pts, regardless of ESR1m. PROs from EMBER-3 demonstrated that patients with ESR1m had better GHS/QOL and PF with imlu vs SOC, mirroring efficacy results. While the frequency of CTCAE defined ISRs was low, the high rate of PRO-CTCAE ISR demonstrates that this clinically relevant adverse event is underappreciated by physicians. Additionally, all pts had generally comparable GHS/QOL and PF with imlu+abema vs imlu."

Clinical • Metastases • P3 data • Patient reported outcomes • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • ER • HER-2

Imlunestrant: Completion of P3 EMBER-3 trial (NCT04975308) with ER+, HER2- advanced breast cancer in Aug 2027 (Eli Lilly) - Q4 2025 Results: Primary completion of P3 EMBER-4 trial (NCT05514054) for breast neoplasms in Oct 2027; Completion of P3 EMBER-4 trial for breast neoplasms in Mar 2032

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Oncology

EMBER-4: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (clinicaltrials.gov) - P3 | N=8000 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Imlunestrant, an Oral Selective Estrogen Receptor Degrader (SERD), as Monotherapy and Combined with Abemaciclib, for Patients w/ ER+, HER2- Advanced Breast Cancer (ABC), Pretreated w/ Endocrine Therapy (ET): Results of the Phase 3 EMBER-3 trial. (SABCS 2024) - P3 | "Pts were randomized 1:1:1 to imlunestrant (400 mg once daily [QD]), physician’s choice standard-of-care (SOC) ET (fulvestrant or exemestane per label), or imlunestrant (400 mg QD) + abemaciclib (150 mg twice daily). Imlunestrant significantly improved PFS vs SOC in pts with ESR1m, and imlunestrant + abemaciclib significantly improved PFS vs imlunestrant in all pts regardless of ESR1m status. Imlunestrant had a favorable safety profile alone and combined with abemaciclib, thus providing an all-oral targeted therapy option for ET-pretreated pts with ER+, HER2- ABC."

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

PIKASSO-01: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (clinicaltrials.gov) - P1 | N=193 | Active, not recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA

PreEMBER: A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer (clinicaltrials.gov) - P2 | N=600 | Not yet recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jan 2029 ➔ Dec 2029

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

Imlunestrant in ER+ advanced breast cancer - bridging innovation and clinical reality. (PubMed, Ann Med Surg (Lond)) - No abstract available

Journal • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Oncology • Solid Tumor

Imlunestrant (Inluriyo) for advanced breast cancer. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Breast Cancer • Oncology • Solid Tumor

PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; imlunestrant for breast cancer, tafasitamab for follicular lymphoma, atezolizumab for thymic carcinoma, retifanlimab for anal canal squamous cell carcinoma, and tagraxofusp for blastic plasmacytoid dendritic cell neoplasm. (PubMed, Int J Clin Oncol) - No abstract available

Japanese regulatory • Journal • Anal Carcinoma • Breast Cancer • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Thymic Carcinoma • Thymus Cancer

Inluriyo (imlunestrant) for ESR1-mutant breast cancer: modest gains, unmet concerns. (PubMed, Ann Med Surg (Lond)) - No abstract available

Journal • Breast Cancer • Oncology • Solid Tumor • ER

Guardant Health Japan receives regulatory approval of Guardant360 CDx liquid biopsy as companion diagnostic for imlunestrant in metastatic or recurrent breast cancer previously treated with endocrine therapy (PRNewswire-Asia) - "In a randomized multicenter trial, ESR1 mutations were detected approximately 20 to 40% of patients with locally advanced or metastatic breast cancer previously treated with an aromatase inhibitor, and it has been reported ESR1 mutation prevalence increased with additional lines of therapy. This regulatory approval of the Guardant360 CDx test, which identifies ESR1 mutations using a blood sample, is expected to increase targeted treatment options for patients with hormone receptor–positive, HER2-negative breast cancer who have developed resistance to aromatase inhibitors."

Diagnostic • Japan approval • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Imlunestrant, an oral selective estrogen receptor degrader, in combination with HER2 directed therapy, with or without abemaciclib, in ER-positive, HER2-positive advanced breast cancer: results from the phase 1a/1b EMBER study. (PubMed, Breast Cancer Res) - No abstract available

Journal • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER