Inluriyo (imlunestrant) / Eli Lilly - LARVOL DELTA

Updated data for Lilly's Inluriyo (imlunestrant) reinforce efficacy results as monotherapy and in combination with Verzenio (abemaciclib) in ER+, HER2- advanced breast cancer (PRNewswire) - "As monotherapy, imlunestrant demonstrated a clinically meaningful 38% reduction in the risk of progression or death (median PFS 5.5 vs 3.8 months; HR=0.62 [95% CI 0.47–0.82]; nominal p=0.0007) and demonstrated an 11.4-month improvement in median OS (34.5 vs 23.1 months; HR=0.60 [95% CI 0.43–0.86]; p=0.0043; boundary for significance not met) versus endocrine therapy, in patients with ESR1-mutated disease. In all patients, imlunestrant plus abemaciclib reduced the risk of progression or death by 41% versus imlunestrant alone, demonstrated a favorable OS trend and numerically delayed time to chemotherapy (TTC) by more than a year...In all patients, median PFS was nearly doubled versus imlunestrant alone (10.9 vs 5.5 months; HR=0.59 [95% CI 0.47–0.74]; nominal p<0.0001)...The Phase 3 EMBER-4 trial completed enrollment of approximately 8,000 patients..."

Enrollment status • P3 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Current and future use of oral selective estrogen receptor degraders (SERDs) in the management of ER-positive (ER+), HER2-negative (HER2-neg) metastatic breast cancer (mBC): A survey of 20 breast cancer research leaders (RLs) (SABCS 2025) - "Background: The Jan 2023 approval of elacestrant (E) for patients with ER+ HER2-neg mBC and an ESR1 mutation (ESR1mut) with disease progression (PD) on endocrine therapy introduced new considerations for biomarker-guided decision-making. RLs have rapidly incorporated E into the management of progressive ER+ HER2-neg ESR1mut mBC, but the decision to employ this agent appears to be heavily influenced by the global disease burden and the duration of benefit from first-line treatment. Most RLs consider the newly approved imlunestrant largely equivalent to E, and all would also consider its use in combination with abemaciclib in certain situations. Many fewer would use camizestrant for patients found to have an ESR1mut without clinical PD, but an important and significant minority believe this option should be available to select patients."

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 • ER • HER-2 • PIK3CA

SS8. FDA session: HR+ Metastatic Breast Cancer in 2025: Progress, Regulatory Approvals, and the Trials Ahead (SABCS 2025) - "DESCRIPTION This FDA-led session will review recent approvals for HR+ metastatic breast cancer in 2025—including imlunestrant, Dato-DXd, and T-DXd—and explore the challenges of designing relevant clinical trials amid a rapidly evolving treatment landscape, addressing issues such as control arm selection, emerging biomarkers, patient-centered endpoints, and the regulatory outlook for novel surrogate measures like ctDNA clearance."

Metastases • Breast Cancer • Oncology • Solid Tumor

The use of oral selective estrogen receptor degraders (SERDs) by community-based general medical oncologists (GMOs) in ER-positive (ER+), HER2-negative (HER2-neg) metastatic breast cancer (mBC): A clinician survey of practice patterns and practical challenges (SABCS 2025) - "The 1/2023 approval of elacestrant (E) for patients with mBC and an ESR1 mutation (ESR1mut) whose disease progresses on endocrine therapy (ET) introduced new treatment considerations into a clinical situation which already had multiple approved therapeutic options...Regarding select other oral SERDs (imlunestrant, camizestrant, giredestrant), 46% of GMOs believe data are not sufficient to determine comparative efficacy...In terms of novel SERDs, many GMOs consider the newly approved imlunestrant equivalent to E and would consider its use with abemaciclib in certain circumstances. While GMOs are generally familiar with the key datasets, they are also highly motivated to learn more. GMOs have rapidly incorporated E into the management of progressive ER+ HER2-neg ESR1mut mBC. Similarities and differences in practice patterns were observed between GMOs and breast cancer research leaders (data available separately) for a number of clinical situations surveyed."

Clinical • 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 • ER • HER-2 • PIK3CA

Imlunestrant: First Approval. (PubMed, Drugs) - "In September 2025, imlunestrant was approved for the treatment of adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy in the USA. This article summarizes the milestones in the development of imlunestrant leading to this first approval for use in patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer."

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

A phase 1 study of LY4257496, a novel GRPR-targeted radioligand therapy, in patients with GRPR-positive metastatic ER+ breast cancer and other advanced solid tumors - OMNIRAY (Trial in Progress) (SABCS 2025) - "Dose expansion will enroll pts with ER+, HER2- MBC treated with LY4257496 monotherapy (cohort B1) and in combination with ET (cohort B2), capecitabine (cohort B3), or ET + abemaciclib (cohort B4)...Key exclusions include prior radiopharmaceutical (except 177Lu-PSMA-617 for mCRPC), recent pancreatitis, and untreated central nervous system metastases.Key study objectives: Evaluate safety, antitumor activity, optimal dose, PK, and biodistribution and dosimetry of LY4257496. Table ETa, fulvestrant or imlunestrant; ETb, investigators' choice of aromatase inhibitor, fulvestrant, or imlunestrant1Stoykow C, et al. Theranostics 2016, 6:1641-50"

Clinical • Metastases • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • GRP-10 • HER-2

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

MODULE 5: Current and Future Role of Oral Selective Estrogen Receptor Degraders (SERDs) for Progressive HR-Positive mBC (SABCS 2025) - "Sponsored by Genentech, a member of the Roche Group, Eli Lilly and Stemline Therapeutics Inc. Structural and mechanistic similarities and differences between fulvestrant and approved and investigational oral SERDs; implications for antitumor activity, tolerability and ease of use Published efficacy and safety results from the Phase III EMERALD trial evaluating elacestrant versus standard endocrine monotherapy for pretreated HR-positive, HER2-negative mBC; outcomes for patients with and without ESR1 mutations FDA approval of elacestrant for previously treated HR-positive, HER2-negative, ESR1-mutated mBC; optimal incorporation into management algorithms Key findings from the Phase III EMBER-3 study of imlunestrant alone or in combination with abemaciclib for patients with HR-positive, HER2-negative mBC pretreated with endocrine therapy with or without a CDK4/6 inhibitor Recent FDA approval of imlunestrant monotherapy for ER-positive, HER2-negative, ESR1-mutated advanced or..."

Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • ER • HER-2

Presentation Highlights: Inluriyo (imlunestrant; estrogen receptor antagonist) (PRNewswire) - "Lilly to highlight progress across key programs in early and advanced hormone receptor-positive breast cancer at the 2025 San Antonio Breast Cancer Symposium....In a late-breaking oral presentation, Lilly will share updated results from the Phase 3 EMBER-3 trial evaluating Inluriyo (imlunestrant) alone and in combination with Verzenio (abemaciclib), in patients with ER+, HER2– advanced or metastatic breast cancer. The presentation will feature a pre-specified interim overall survival (OS) analysis, with updates on progression-free survival (PFS) and time to chemotherapy (TTC). In addition, a poster presentation will provide results of an exploratory analysis of early changes in circulating tumor DNA (ctDNA) and correlation to clinical outcomes."

Late-breaking abstract • P3 data • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer

Phase 1 Study Evaluating the Effect of Food and Omeprazole-Induced Gastric pH Change on the Pharmacokinetics and Safety of Imlunestrant in Healthy Females. (PubMed, Clin Ther) - P1 | "Low-fat food intake resulted in increases of ∼2-fold in AUC and ∼3.6-fold in Cmax. Therefore, patients will be instructed to abstain from food consumption two hours before and one hour after taking imlunestrant. Concomitant use of imlunestrant and omeprazole displayed a low risk of drug-drug interaction, therefore imlunestrant may be taken with a proton pump inhibitor such as omeprazole. A single oral dose of 400 mg imlunestrant was generally well tolerated in healthy females regardless of food or omeprazole intake."

Journal • P1 data • PK/PD data • Hematological Disorders

Imlunestrant, as Monotherapy and Combined with Abemaciclib, in East Asian (EA) Patients with Advanced Breast Cancer (ABC): Results from the Phase 3 EMBER-3 trial (COSA 2025) - P3 | "The EMBER-3 trial (NCT04975308) in patients with ER+, HER2- ABC and disease progression on/after aromatase inhibitor showed significant progression-free survival (PFS) improvement with imlunestrant (400mg once daily) over standard therapy (SOC: fulvestrant or exemestane) among patients with ESR1-mutations (ESR1m) as well as with imlunestrant (400mg once daily) + abemaciclib (150mg BID) over imlunestrant in all patients regardless of ESR1m. Exposures and pharmacokinetics were similar in EA and non-EA populations. Consistent with primary EMBER-3 analysis, this EA subpopulation analysis showed PFS benefit with imlunestrant vs SOC in patients with ESR1m and with imlunestrant+abemaciclib vs imlunestrant in all patients, regardless of ESR1m status, along with generally tolerable safety profiles."

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

Imlunestrant with or without Abemaciclib as First- and Second-line Therapy in Advanced Breast Cancer (ABC): a Subgroup Analysis from the EMBER-3 trial (DGHO 2025) - "An exploratory analysis of efficacy by line of therapy is presented here. Subgroup analyses of PFS were performed by line of therapy for imlu (400mg once daily) vs SOC (fulvestrant or exemestane per label) in pts with ESR1m and imlu (400 mg once daily) + abema (150 mg twice daily) vs imlu and vs SOC in all concurrently randomized pts. Consistent with the primary EMBER-3 analyses, a benefit in PFS was observed across the 1L and 2L subgroups. Imlu alone or combined with abema, provides an all-oral targeted therapy option in the 1L or 2L setting for pts with endocrine therapy-resistant ER+, HER2- ABC.Presented at European Society for Medical Oncology - 7th ESMO Breast Cancer Congress"

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

Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Sep 2031 ➔ Apr 2031 | Initiation date: Sep 2025 ➔ Apr 2026 | Trial primary completion date: Sep 2030 ➔ Apr 2030

Minimal residual disease • Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Imlunestrant with or without Abemaciclib in Advanced Breast Cancer (ABC): a Subgroup Analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients from EMBER-3 (COSA 2025) - "The EMBER-3 trial reported significant PFS improvement with imlunestrant over standard therapy (SOC; fulvestrant or exemestane) in patients with ESR1-mutations (m), and with imlunestrant+abemaciclib over imlunestrant in all patients, regardless of ESR1m. In patients with ER+, HER2- ABC who have progressed on prior CDK4/6i, imlunestrant+abemaciclib showed a consistent benefit over imlunestrant, regardless of clinico-genomic factors. EMBER-3 is the 1st phase 3 trial to show benefit of an oral SERD+CDK4/6i after disease progression on prior CDK4/6i."

Clinical • Metastases • 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 (COSA 2025) - "In EMBER-3, patients with ER+, HER2- ABC with disease progression on or after aromatase inhibitor-based therapy, achieved significant PFS improvement with imlunestrant vs standard therapy (SOC: fulvestrant/exemestane) in patients with ESR1 mutations (ESR1m), and with imlunestrant+abemaciclib vs imlunestrant in all patients, regardless of ESR1m. The importance of ISR as a clinically relevant AE is demonstrated by the high incidence of patient-reported ISR with fulvestrant. These results support the efficacy and safety of imlunestrant as monotherapy or combined with abemaciclib as an all-oral targeted therapy option."

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 with or without Abemaciclib as First- (1L) and Second-line (2L) Therapy in Advanced Breast Cancer (ABC): a Subgroup Analysis from the EMBER-3 trial (COSA 2025) - "An exploratory analysis of efficacy by line-of-therapy is presented here.Subgroup analyses of PFS were performed by line-of-therapy for imlunestrant (400mg once daily) vs SOC (fulvestrant/exemestane per label) in patients with ESR1m, and imlunestrant (400mg once daily) + abemaciclib (150mg BID) vs imlunestrant and vs SOC in all concurrently randomized patients. A numerically longer PFS was observed in 1L patients (imlunestrant+abemaciclib: 14.4 [7.6,NR] vs 9.1 months [7.4,11.1], imlunestrant: 11.1 [4.7,11.1] vs 5.5 months [3.7,5.7], SOC: 5.7 [3.7,8.7] vs 3.8 months [3.7,5.5]).Consistent with the primary EMBER-3 analyses, a benefit in PFS was observed across 1L and 2L subgroups. Imlunestrant alone or with abemaciclib, provides an all-oral targeted therapy option in the 1L or 2L setting for patients with endocrine therapy-resistant ER+, HER2- ABC."

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

On 13 November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Inluriyo, intended for the treatment of adults with locally advanced or metastatic breast cancer with an activating ESR1-mutation. (European Medicines Agency) - "Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen. In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist."

CHMP • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer

Interim analysis of giredestrant (GIRE) + inavolisib (INAVO) in MORPHEUS breast cancer (BC): A phase Ib/II study of GIRE treatment (rx) combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative, locally advanced/metastatic BC (LA/mBC) (ESMO 2025) - P1/2 | "Results As of 9 January 2025, 40 pts with PIK3CA m tumours were enrolled in the GIRE + INAVO arm; 65% (26/40) had one prior line of therapy for LA/mBC; 35% (14/40) had two; 45% (18/40) had prior fulvestrant...With this expanded cohort (n = 40), we have confirmed preliminary results from SABCS 2023 (n = 15), comparing favourably with historical data including alpelisib, capivasertib, elacestrant, and imlunestrant in this post—CDK4/6i-treated population. Safety of GIRE + INAVO was consistent with known profiles, with good tolerability. Table: 508P GIRE + INAVO (N = 40) Confirmed ORR, n (%) Complete response Partial response 16 (40) 3 (8) 13 (33) ORR ( ESR1 mutation), n/n (%) ORR ( ESR1 no mutation detected), n/n (%) 10/13 (77) 6/25 (24) Clinical benefit rate, n (%) 28 (70) Median PFS, mo (95% confidence interval) 9.5 (7.3, 14.0) All-grade TRAEs, n (%) 39 (98) Grade 3 AEs, n (%)* 15 (38) AE leading to any rx discontinuation, n (%) 4 (10) Most common all-grade TRAEs..."

Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA

PIKALO-1: A phase I/II trial of LY4064809 (STX-478), a pan-mutant-selective PI3Kα inhibitor in PIK3CA-mutant (PIK3CAm) advanced breast cancer (ABC) and other solid tumors (Trial in Progress) (ESMO 2025) - P1/2 | "Table: 619TiP Parts Study Drug Key Eligibility Part A: Advanced solid tumors LY4064809 ≥1 prior therapy Part B: HR+, HER2- ABC LY4064809 + fulvestrant 1–2 prior therapies, ≥1 CDK4/6i and antiestrogen therapy; ≤1 prior chemotherapy *Part C/D/E: HR+, HER2- ABC LY4064809 + ET (aromatase inhibitor, fulvestrant, or imlunestrant) +CDK4/6i (ribocicblib, palbociclib, or abemaciclib) ≤2 prior regimens CDK4/6i-naive, -treatment-ongoing (up to 6 months), or –pretreated ≤1 prior chemotherapy ∗ Sub-cohorts C1, D1, and E1 will be randomized to various LY4064809 doses. 1 Martínez-Sáez, O. et al. Breast Cancer Res 2020, 22(1):45."

Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

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 (ESMO 2025) - P3 | "Baseline covariates: age, race, region, Eastern Cooperative Oncology Group Performance Status (ECOG PS), number of metastatic sites, visceral metastasis, measurable disease, menopausal status, prior CDK4/6i in any setting and prior ET in advanced setting. Conclusions In this exploratory ITC analysis, the all-oral targeted therapy imlu+abema showed a consistent numerical PFS benefit compared with fulv+abema in patients with ER+, HER2- ABC previously treated with endocrine therapy (ET) ± CDK4/6i."

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

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), NCCN Guidelines Navigator, and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Breast Cancer, Version 5.2025. (NCCN)

NCCN guideline • HER2 Negative Breast Cancer

Vepdegestrant, a PROteolysis Targeting Chimera (PROTAC) estrogen receptor (ER) degrader, induces greater ER degradation and antitumor activity relative to selective ER degraders (SERDs) in preclinical ER+ breast cancer models (AACR-NCI-EORTC 2025) - "Here, we report preclinical ER degradation and antitumor activity of vepdegestrant compared with FDA-approved (fulvestrant and elacestrant) and investigational oral SERDs (giredestrant, camizestrant, amcenestrant, and imlunestrant). Our results indicate that vepdegestrant induces greater maximal ER degradation than investigational oral SERDs, elacestrant, or fulvestrant in WT ER+ breast cancer cell lines. Vepdegestrant also demonstrated greater TGI and ER degradation in vivo compared with fulvestrant in a WT ER+ breast cancer CDX model."

Preclinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER

Onco360…has been selected as a pharmacy partner by Eli Lilly for Inluriyo (imlunestrant), indicated for the treatment of adults with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. (The Manila Times) - "This indication was approved based on the phase III, EMBER-3 study."

Commercial • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

FDA Approves Guardant360 CDx as Companion Diagnostic for Eli Lilly and Company’s Inluriyo (imlunestrant) for Treatment of ESR1-mutated Advanced Breast Cancer (Businesswire) - "Guardant360 CDx was approved in conjunction with Inluriyo for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy (ET)...Guardant360 CDx was used to identify patients who had ESR1 mutations in the Phase 3 EMBER-3 trial, in which Inluriyo was found to reduce the risk of progression or death by 38% versus ET."

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