[Translation] A Study of LOXO-783 as Monotherapy and in Combination with Other Anticancer Therapies in Patients with Advanced Breast Cancer and Other Solid Tumors with PIK3CA H1047R Mutations

主要目的：确定在PIK3CA H1047R突变的晚期乳腺癌和其他实体瘤患者中 LOXO-783单药治疗和与其他抗癌疗法联合治疗的LOXO-783的MTD/RP2D

[Translation]

Primary Objective: To determine the MTD/RP2D of LOXO-783 as monotherapy and in combination with other anticancer therapies in patients with advanced breast cancer and other solid tumors harboring the PIK3CA H1047R mutation

Start Date27 Nov 2023

Sponsor / Collaborator

Eli Lilly Suzhou Pharmaceutical Co. Ltd.

[+2]

CTR20230192

/ RecruitingPhase 3

EMBER-4：一项在既往接受过2-5年辅助内分泌治疗的ER+、HER2-早期乳腺癌且具有较高复发风险的患者中比较Imlunestrant辅助治疗和标准辅助内分泌治疗的随机、开放性、III期研究

[Translation] EMBER-4: A randomized, open-label, phase III study comparing adjuvant IMLUNESTRANT with standard adjuvant endocrine therapy in patients with ER+, HER2- early breast cancer at high risk of recurrence who have received 2-5 years of adjuvant endocrine therapy

本研究的主要目的是在雌激素受体阳性（ER+）和人表皮生长因子受体2阴性（HER2-）早期乳腺癌受试者中评价Imlunestrant相比标准内分泌治疗的疗效。入组研究的受试者必须符合以下条件：既往接受过2-5年的内分泌治疗、具有较高的复发风险。受试者参与研究的持续时间可能长达10年。

[Translation]

The primary objective of this study is to evaluate the efficacy of Imlunestrant compared with standard endocrine therapy in subjects with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) early breast cancer. Subjects enrolled in the study must meet the following criteria: they have received 2-5 years of endocrine therapy in the past and have a high risk of recurrence. The duration of the subject's participation in the study may be up to 10 years.

Start Date12 May 2023

Sponsor / Collaborator

Eli Lilly Suzhou Pharmaceutical Co. Ltd.

[+2]

CTIS2022-501007-28-00

/ RecruitingPhase 3

J2J-MC-JZLH EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence - 18459

Start Date27 Apr 2023

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Imlunestrant

100 Translational Medicine associated with Imlunestrant

100 Patents (Medical) associated with Imlunestrant

Literatures (Medical) associated with Imlunestrant

01 Jan 2025·Journal of Clinical Oncology

Erratum: 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

Article

10 Dec 2024·Journal of Clinical Oncology

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

Article

Author: Larson, Timothy ; Ismail-Khan, Roohi ; Bhave, Manali ; Smyth, Lillian ; Kaufman, Peter A. ; Rodrik-Outmezguine, Vanessa ; Harnden, Kathleen ; Sohn, Joohyuk ; Parajuli, Ritesh ; Kim, Sung-Bae ; Aftimos, Philippe ; Hamilton, Erika P. ; Lim, Elgene ; Bardia, Aditya ; Im, Seock-Ah ; Jhaveri, Komal L. ; Tao, Jessica J. ; Manso Sanchez, Luis ; Nguyen, Bastien ; Ma, Cynthia X. ; Beck, J. Thaddeus ; Sammons, Sarah L. ; Jeselsohn, Rinath ; Wang, Hwei-Chung ; Sideras, Kostandinos ; Pierga, Jean-Yves ; Neven, Patrick ; Saura, Cristina ; Dhakal, Ajay ; Jerez, Yolanda ; Yuen, Eunice ; Li, Yujia ; Osborne, Cynthia ; Yonemori, Kan ; Lu, Yen-Shen ; Beeram, Muralidhar ; Estrem, Shawn T. ; Bacchion, Francesca

PURPOSE Imlunestrant is a next-generation oral selective estrogen receptor (ER) degrader designed to deliver continuous ER target inhibition, including in ESR1- mutant breast cancer. This phase Ia/b trial determined the recommended phase II dose (RP2D), safety, pharmacokinetics, and efficacy of imlunestrant, as monotherapy and in combination with targeted therapy, in ER-positive (ER+) advanced breast cancer (ABC) and endometrial endometrioid cancer. The ER+/human epidermal growth factor receptor 2–negative (HER2–) ABC experience is reported here. METHODSAn i3+3 dose-escalation design was used, followed by dose expansions of imlunestrant as monotherapy or in combination with abemaciclib with or without aromatase inhibitor (AI), everolimus, or alpelisib. Imlunestrant was administered orally once daily and with the combination partner per label.RESULTS Overall, 262 patients with ER+/HER2– ABC were treated (phase Ia, n = 74; phase Ib, n = 188). Among patients who received imlunestrant monotherapy (n = 114), no dose-limiting toxicities or discontinuations occurred. At the RP2D (400 mg once daily), patients (n = 51) reported grade 1-2 nausea (39.2%), fatigue (39.2%), and diarrhea (29.4%). Patients at RP2D had received previous cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; 92.2%), fulvestrant (41.2%), and chemotherapy (29.4%) for ABC and achieved a median progression-free survival (mPFS) of 7.2 months (95% CI, 3.7 to 8.3). Among patients who received imlunestrant + abemaciclib (n = 42) and imlunestrant + abemaciclib + AI (n = 43), most (69.4%) were treatment-naïve for ABC; all were CDK4/6i-naïve. Patients treated with imlunestrant + everolimus (n = 42)/alpelisib (n = 21) had received previous CDK4/6i (100%), fulvestrant (34.9%), and chemotherapy (17.5%) for ABC. No new safety signals or interactions with partnered drugs were observed. The mPFS was 19.2 months (95% CI, 13.8 to not available) for imlunestrant + abemaciclib and was not reached for imlunestrant + abemaciclib + AI. The mPFS with imlunestrant + everolimus/alpelisib was 15.9 months (95% CI, 11.3 to 19.1)/9.2 months (95% CI, 3.7 to 11.1). Antitumor activity was evident regardless of ESR1 mutation status. CONCLUSIONImlunestrant, as monotherapy or in combination with targeted therapy, had a manageable safety profile with evidence of preliminary antitumor activity in ER+/HER2– ABC.

02 Dec 2024·Clinical Cancer Research

A Preoperative Window-of-Opportunity Study of Oral SERD, Imlunestrant, in Newly Diagnosed ER-Positive, HER2-Negative Early Breast Cancer: Results from the EMBER-2 Study

Article

Author: Rodrik-Outmezguine, Vanessa ; Bhave, Manali ; Neven, Patrick ; Hamilton, Erika ; Kulkarni, Swati ; Aft, Rebecca ; Ismail-Khan, Roohi ; Schmid, Peter ; Stahl, Nicole ; Bidard, Francois-Clement ; Aftimos, Philippe ; Harbeck, Nadia ; Fasching, Peter A. ; Wheatley, Duncan ; Hunt, Kelly K. ; Estrem, Shawn T. ; Nguyen, Bastien ; Kaufman, Peter A. ; Ciruelos, Eva ; Yuen, Eunice ; Vidal, Maria ; Ozbek, Umut ; Martín, Miguel ; Carter, Stacey ; Karacsonyi, Claudia

AbstractPurpose:Imlunestrant is an oral selective estrogen receptor degrader with favorable safety and preliminary efficacy in patients with advanced breast cancer. Pharmacodynamic (PD) biomarker data can optimize drug dosing; in this study, we present PD data from the EMBER-2 study.Patients and Methods:Postmenopausal women with untreated, operable estrogen receptor (ER)–positive, HER2-negative early breast cancer were randomized to 400 versus 800 mg of imlunestrant daily for ∼2 weeks before surgery. A single arm study tested a daily dose of 200 mg. PD biomarker changes (ER, progesterone receptor, Ki-67 by IHC, and mRNA expression of ER-related genes) were evaluated in paired tumor samples (pre-/posttreatment). Safety and pharmacokinetics were also assessed.Results:Among evaluable paired samples (n = 75), PD profiles demonstrated consistent ER targeting between 400- and 800-mg doses, with less toxicity at the 400-mg dose. Although inducing the lowest rate of complete cell-cycle arrest, PD and pharmacokinetic results were similar for the 200-mg dose.Conclusions:EMBER-2 combined with existing phase I data has identified 400 mg as the optimal imlunestrant dose.

News (Medical) associated with Imlunestrant

14 Jan 2025

·www.prnewswire.com

Lilly provides update on 2024 revenue guidance, announces 2025 revenue guidance

2024 revenue is expected to be approximately $45.0 billion for the full year, $4.0 billion above the midpoint of first-time 2024 financial guidance Q4 2024 revenue is expected to be approximately $13.5 billion, approximately $400 million below the low end of recently issued financial guidance The company anticipates 2025 revenue to be in the range of $58.0 billion to $61.0 billion, growth of 32% at the midpoint compared to expected 2024 revenue INDIANAPOLIS, Jan. 14, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that it expects 2024 full-year worldwide revenue to be approximately $45.0 billion, which represents growth of 32% compared to the previous year. The company also shared 2025 revenue guidance, anticipating sales will be between $58.0 billion and $61.0 billion. For Q4 2024, Lilly now expects worldwide revenue to be approximately $13.5 billion, representing growth of 45% compared to Q4 2023. This includes approximately $3.5 billion for Mounjaro® and $1.9 billion for Zepbound®. In addition to the uptake of Mounjaro and Zepbound, Lilly saw strong performance from its oncology, immunology and neuroscience medicines in Q4 of 2024. In total, non-incretin revenue grew by 20% compared to Q4 2023. However, the company's expected 2024 revenue is $400 million, or about 3%, below the guidance range issued on October 30, 2024, as part of the Q3 2024 earnings call. "While the U.S. incretin market grew 45% compared to the same quarter last year, our previous guidance had anticipated even faster acceleration of growth for the quarter. That, in addition to lower-than-expected channel inventory at year-end, contributed to our Q4 results. We continued to make progress on our manufacturing build-out, and U.S. supply across all doses of tirzepatide was available throughout Q4," said David A. Ricks, Lilly chair and CEO. "The rest of our medicines performed within our expectations." Lilly anticipates revenue growth contributions in 2025 from new Lilly medicines such as Jaypirca®, Ebglyss™, Omvoh® and Kisunla™; approvals of new indications for existing Lilly medicines; launches of Mounjaro in additional worldwide markets, as well as potential launches of new medicines such as imlunestrant for metastatic breast cancer. Incretin market and channel dynamics have been factored into the 2025 revenue guidance range. "2024 was a pivotal and highly successful year for Lilly, and we expect to continue our momentum in 2025 with strong financial and operational performance," continued Ricks. "Sales of Mounjaro and Zepbound posted robust sales growth in Q4, and we expect a continuation of that trend into 2025. We'll also bring additional manufacturing capacity online and expect to produce at least 60% more salable doses of incretins in the first half of the year compared to the first half of 2024." As announced previously, Ricks will participate in a fireside chat at the J.P. Morgan Healthcare Conference later today at 5:15 p.m. Eastern time. A live audio webcast of Ricks' discussion will be available on the "Webcasts & Presentations" section of Lilly's Investor website at . A replay of the presentation will be available on this same website for approximately 30 days. The company currently plans to share its full Q4 2024 financial results, including with respect to other metrics included in its financial guidance, and 2025 financial guidance on February 6, 2025. Preliminary Information The unaudited financial information presented in this press release is preliminary and may change as a result of, among other factors, Lilly's financial closing procedures and as a result, the company's final results may vary materially from the preliminary results included in this press release. The preliminary financial information included in this press release reflects the company's current estimates based on information available as of the date of this press release and has been prepared by company management. This preliminary information should not be viewed as a substitute for full financial information prepared in accordance with GAAP and is not necessarily indicative of the results to be achieved for any future periods. This preliminary information could be impacted by the effects of financial closing procedures, final adjustments, and other developments. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. F-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains management's current intentions and expectations for the future, including with respect to Lilly's anticipated 2024 results and 2025 guidance, and specific product performance and supply, all of which are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "estimate", "project", "intend", "expect", "believe", "anticipate", "may", "could", "will", "continue", and similar expressions are intended to identify forward-looking statements. Actual results may differ materially due to various factors. The following include some but not all of the factors that could cause actual results or events to differ from those anticipated, including the financial closing procedures, final adjustments, and other developments, significant costs and uncertainties in the pharmaceutical research and development process, including with respect to the timing and process of obtaining regulatory approvals; the impact and uncertain outcome of acquisitions and business development transactions and related costs; intense competition affecting the company's products, pipeline, or industry; market uptake of launched products and indications; continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals, or reporting obligations related thereto; safety or efficacy concerns associated with the company's products; dependence on relatively few products or product classes for a significant percentage of the company's total revenue and an increasingly consolidated supply chain; the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products, and risks from the proliferation of counterfeit or illegally compounded products; the company's ability to protect and enforce patents and other intellectual property and changes in patent law or regulations related to data package exclusivity; information technology system inadequacies, inadequate controls or procedures, security breaches, or operating failures; unauthorized access, disclosure, misappropriation, or compromise of confidential information or other data stored in the company's information technology systems, networks, and facilities, or those of third parties with whom the company shares its data and violations of data protection laws or regulations; issues with product supply and regulatory approvals stemming from manufacturing difficulties, disruptions, or shortages, including as a result of unpredictability and variability in demand, labor shortages, third-party performance, quality, cyber-attacks, or regulatory actions related to the company's and third-party facilities; reliance on third-party relationships and outsourcing arrangements; the use of artificial intelligence or other emerging technologies in various facets of the company's operations which may exacerbate competitive, regulatory, litigation, cybersecurity, and other risks; the impact of global macroeconomic conditions, including uneven economic growth or downturns or uncertainty, trade disruptions, international tension, conflicts, regional dependencies, or other costs, uncertainties, and risks related to engaging in business globally; fluctuations in foreign currency exchange rates or changes in interest rates and inflation; litigation, investigations, or other similar proceedings involving past, current, or future products or activities; changes in tax law and regulations, tax rates, or events that differ from our assumptions related to tax positions; regulatory changes and developments; regulatory actions regarding the company's operations and products; regulatory compliance problems or government investigations; actual or perceived deviation from environmental-, social-, or governance-related requirements or expectations; asset impairments and restructuring charges; and changes in accounting and reporting standards. For additional information about the factors that could cause actual results or events to differ materially from forward-looking statements, please see the company's latest Form 10-K and subsequent Forms 8-K and 10-Q filed with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements, which speak only as of the date of this release. Except as is required by law, the company expressly disclaims any obligation to publicly release any revisions to forward-looking statements to reflect events after the date of this release. The U.S. incretin market includes: Mounjaro, Zepbound, Trulicity, semaglutide and liraglutide. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementBiosimilar

14 Jan 2025

·www.pharmaceutical-technology.com

Eli Lilly targets Scorpion Therapeutics to expand reach in oncology

Eli Lilly has announced plans to acquire Scorpion Therapeutics’ PI3Kα inhibitor program. Credit: Michael Vi via Shutterstock. Eli Lilly will buy Boston biotech Scorpion Therapeutics’ PI3Kα inhibitor for upto $2.5bn in cash, with the latter splitting away to form a new entity with its remaining assets. Lilly’s bid to acquire Scorpion was driven by the Scorpion’s PI3Kα inhibitor program that is centered on the drug STX-478. The drug is in clinical studies evaluating its potential in solid tumours and breast cancer in particular. As per the company, STX-478 could avoid affecting healthy human cells and selectively target cancer cells, paving the way for better tolerability. As per the deal terms outlined in a 13 January announcement, the new spinout company with its non-PI3Kα assets will be owned by Scorpion’s existing shareholders and Lilly will hold a minority equity stake in it. The news was announced amid a steady trickle of deals announced in the last few days, including one involving another oncology biotech—that of the Johnson and Johnson acquiring Intracellular Therapies . Pharma and biotech investors are expected to engage in rapid deal making in the next few days at the JP Morgan Healthcare conference 2025, which started today [13 January]. Eli Lilly already has market share in the breast cancer space with the approved drug Verzenio (abemaciclib) , and is advancing investigational drugs like the oral selective estrogen receptor degrader (SERD) imlunestrant. With its latest acquisition, Lilly will carve out a spot in the PI3K inhibitors space in breast cancer, which for long was dominated by Novartis’ Piqray (alpelisib). In October 2024, Roche had a significant win with the approval of its PI3K inhibitor Itovebi (inavolisib) in combination with Pfizer’s Ibrance (palbociclib) and AstraZeneca’s Faslodex (fulvestrant) as the first-line treatment for certain breast cancer patients. The drug is expected to yield 1.3bn in revenues as early as 2030, as per a consensus forecast by GlobalData, the parent company of Pharmaceutical Technology . PI3K inhibitors are directed toward the subset of breast cancer that are hormone receptor (HR)+. Oncology is expected to be a key area of development in 2025 having been the top therapy area with an estimated CAGR of $232,271 bn in 2024, as per GlobalData’s State of the Biopharmaceutical Industry report . Oncology trials will outnumber CNS and cardiovascular trials, with the most planned clinical trials for 2025 are for solid tumours, followed by pain, as per the report.

AcquisitionDrug ApprovalClinical Study

18 Dec 2024

·www.drugs.com

San Antonio Breast Cancer Symposium, Dec. 10 to 13

The annual San Antonio Breast Cancer Symposium was held from Dec. 10 to 13 in San Antonio. Attendees included medical oncologists, radiation oncologists, researchers, and other health care professionals. The conference highlighted recent advances in the risk, diagnosis, treatment, and prevention of breast cancer, and presentations focused on emerging treatments in hard-to-treat patient populations, including patients with metastatic breast cancer. As part of the BIG 2-04 MRC SUPREMO phase 3 clinical trial, Ian Kunkler, M.B., B.Chir., of the University of Edinburgh in the United Kingdom, and colleagues found that chest wall irradiation may be omitted among patients with intermediate-risk breast cancer who have undergone mastectomy. For the study, patients were randomly assigned to receive chest wall irradiation after mastectomy or to omit chest wall irradiation after mastectomy. The researchers found that postmastectomy radiotherapy to the chest wall among women with one to three positive axillary nodes after an axillary clearance or negative on an axillary clearance, axillary node sample, or sentinel node biopsy was not associated with an improvement in 10-year overall survival. The investigators also found that postmastectomy radiotherapy reduced chest wall recurrence by less than 2 percent at 10 years. Furthermore, the approach did not have an impact on metastasis-free survival. "Postmastectomy radiotherapy National Institute for Health and Care Excellence guidelines currently recommend radiotherapy in women with one to three positive nodes after mastectomy," Kunkler said. "So, our results should change guidelines and practice internationally." Press Release As part of the phase 3 COMET study, Ann Partridge, M.D., M.P.H., of the Dana-Farber Cancer Institute and Harvard Medical School in Boston, and colleagues found that active monitoring is a reasonable approach for the management of patients with grade 1 or 2, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative low-risk ductal carcinoma in situ (DCIS), with no evidence of a higher incidence of microinvasive or invasive disease. For the study, patients were randomly assigned to either undergo active monitoring or receive guideline-concordant care consisting of surgery with or without adjuvant radiation. During a two-year period, the authors assessed quality of life, anxiety, depression, worries about DCIS, and symptom trajectories via surveys that employed validated quality-of-life measures. Patients filled out surveys prior to randomization, at six months, at one year, and after two years. The researchers found that the overall lived experience of women randomly assigned to active monitoring was similar to that of those selected to follow the current guideline for care, which is surgery with or without radiation. During the two years of follow-up, health-related quality of life, anxiety, depression, worry, and symptom trajectories were comparable regardless of the treatment received. "If longer-term follow-up supports the safety of active management from a cancer outcome standpoint, this approach could be considered as an option for women with this condition," Partridge said. "It is critical that we understand how women feel when they are living with an active-monitoring approach and how it impacts their overall quality of life, psychosocial health, worries about DCIS, anxiety and depression, and other related symptoms. These data are reassuring in that respect." Press Release In the multicenter, double-blind OlympiA study, Judy E. Garber, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues provided further support for the benefits of olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, among patients with high-risk, HER2-negative breast cancer with germline mutations in BRCA1 or BRCA2 . The authors randomly assigned 1,836 patients with BRCA -positive, HER2-negative breast cancer (1:1) to receive either olaparib or placebo for one year following completion of chemotherapy, surgery, and radiation. The researchers found that after a median follow-up of 6.1 years, patients with high-risk, BRCA -positive breast cancer who received olaparib after standard treatment continued to have better survival outcomes than those who received placebo. The continued demonstration of the efficacy of olaparib in breast cancer patients who carry pathogenic variants in BRCA1/2 makes it important to identify these individuals when they begin their treatment, the authors noted. "The ongoing data from the OlympiA trial are reassuring in the observations of persistent and increasing benefits in the follow-up phases, improving not only recurrence, but also overall survival. Benefits are demonstrated in both triple-negative breast cancer as well as hormone receptor-positive tumors, despite the shortened follow-up and smaller numbers in the estrogen receptor-positive group," Garber said. "These data also highlight the safety of olaparib and, therefore, the possibility of moving PARP inhibitors to the treatment of BRCA -associated breast cancers that are lower risk." The study was supported by AstraZeneca and Merck, the manufacturers of olaparib. Press Release SABCS: Chest Wall Irradiation Does Not Impact Survival in Breast Cancer MONDAY, Dec. 16, 2024 -- For patients with intermediate-risk breast cancer, chest wall irradiation after mastectomy does not influence 10-year overall survival, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Risk-Reducing Surgery Improves Outcomes in Young Breast Cancer Patients With BRCA Mutations MONDAY, Dec. 16, 2024 -- Risk-reducing mastectomy and salpingo-oophorectomy are both associated with significant improvements in outcomes among young BRCA carriers with breast cancer, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Adding Camrelizumab to Neoadjuvant Chemo Beneficial in TNBC FRIDAY, Dec. 13, 2024 -- The addition of camrelizumab to neoadjuvant chemotherapy improves pathological complete response for patients with early or locally advanced triple-negative breast cancer, according to a study published online Dec. 13 in the Journal of the American Medical Association to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Active Monitoring Noninferior to Guideline Care for Ductal Carcinoma in Situ FRIDAY, Dec. 13, 2024 -- For patients with ductal carcinoma in situ, active monitoring is noninferior to guideline-concordant care that involves surgery with or without adjuvant radiation, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Omission of Axillary Staging Noninferior for Node-Negative Breast Cancer FRIDAY, Dec. 13, 2024 -- Omission of surgical axillary staging is noninferior to sentinel lymph-node biopsy for patients with clinically node-negative, T1 or T2 invasive breast cancer, according to a study published online Dec. 12 in the New England Journal of Medicine to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Imlunestrant Tied to Improved PFS for ER-Positive, HER2-Negative Breast Cancer With ESR1 Mutations THURSDAY, Dec. 12, 2024 -- For patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer, imlunestrant leads to significantly longer progression-free survival among those with ESR1 mutations, according to a study published online Dec. 11 in the New England Journal of Medicine to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultPhase 3Radiation Therapy

100 Deals associated with Imlunestrant

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	Phase 3	DE	Eli Lilly & Co.	04 Oct 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	BR	Eli Lilly & Co.	04 Oct 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	IT	Eli Lilly & Co.	04 Oct 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	UA	Eli Lilly & Co.	04 Oct 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	CN	Eli Lilly & Co.	04 Oct 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	AR	Eli Lilly & Co.	04 Oct 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	TR	Eli Lilly & Co.	04 Oct 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	NL	Eli Lilly & Co.	04 Oct 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	JP	Eli Lilly & Co.	04 Oct 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	KR	Eli Lilly & Co.	04 Oct 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04975308 (EMBER-3, Pubmed \| SABCS2024) Manual	Phase 3	Advanced breast cancer	874	Imlunestrant	(hpewuvsxyd) = hovefqwcbj qchihasyom (deziesupnj ) View more	Positive	11 Dec 2024
				Standard therapy	(hpewuvsxyd) = yadvtfvnnl qchihasyom (deziesupnj ) View more
NCT04188548 (EMBER, Pubmed \| J Clin Oncol) Manual	Phase 1	ER-positive/HER2-negative Breast Cancer \|	262	Imlunestrant monotherapy	(gikkjgrsyc) = kbxjvjyfge gyqmnvumkx (balorguylz ) View more	Positive	06 Sep 2024
				Imlunestrant + abemaciclib	(meopvuvszv) = zmyitrhixv ecmilffqfq (jphripxyyq, 13.8 - NA)
NCT04188548 (EMBER, ASCO2024) Manual	Phase 1	ER-positive/HER2-positive Breast Cancer	45	Imlunestrant + Trastuzumab	(hxgarcjpic) = goctdvocib ofbvicavlr (rjbiofhuha ) View more	Positive	24 May 2024
				Imlunestrant + Trastuzumab + Abemaciclib	(hxgarcjpic) = ogzqgxsjue ofbvicavlr (rjbiofhuha ) View more
NCT04188548 (EMBER, ESMO_BC2024) Manual	Phase 1	ER-positive/HER2-negative Breast Cancer \|	109	Imlunestrant	(okritfrlbi) = igrsnzuniz htevnbngsr (luumzarxbh, 32 - 52)	Negative	14 May 2024
				Imlunestrant (without baseline detectable ctDNA)	(okritfrlbi) = hxropdzoxl htevnbngsr (luumzarxbh )
EMBER (Biospace) Manual	Phase 1	ER-positive/HER2-negative Breast Cancer Last line \|	-	Imlunestrant + Verzenio + AI	(hrngvcfesk) = kkvpeujndb awozvstngg (bfrompfiir ) View more	Positive	05 Dec 2023
				Imlunestrant + Verzenio	(hrngvcfesk) = xrmurilbmf awozvstngg (bfrompfiir ) View more
NCT04188548 (EMBER, ESMO 12023 \| ESMO 22023) Manual	Phase 1	ER-positive/HER2-negative Breast Cancer \|	177	Imlunestrant	(urrdmgowfh) = Imlunestrant monotherapy (Nausea 40%,Fatigue 32%,Diarrhea 31%);Imlunestrant + everolimus ( Diarrhea 55%,Fatigue 45%, AST increase 38%);Imlunestrant + alpelisib (Diarrhea 86%,Rash 67 %,Hyperglycaemia 62%) wmzihdgxzr (dnfvzpijsl )	Positive	22 Oct 2023
				Imlunestrant + everolimus
NCT05307705 (PIKASSO-01, SABCS2023)	Phase 1	PIK3CA H1047R mutant Breast Cancer ESR1 D538G \| H1047R/D350G	-	LOXO-783	bljheskrwy(svvgpeoaie) = lgukfnmrbp ertlvuwrzt (uoqjbewgww )	Positive	01 Mar 2023
				Imlunestrant	bljheskrwy(svvgpeoaie) = trmplxrvrp ertlvuwrzt (uoqjbewgww )
NCT04188548 (EMBER, ASCO2022)	Phase 1	Endometrial Endometrioid Adenocarcinoma \| Estrogen receptor positive breast cancer	138	Imlunestrant	(hdgrpidoqp) = flsdcekmnz xykaxehieo (yeqydrkqku ) View more	-	02 Jun 2022
NCT04188548 (EMBER, ASCO 12021 \| ASCO 22021) Manual	Phase 1	Endometrial Endometrioid Adenocarcinoma \| Estrogen receptor positive breast cancer ER Positive	28	LY3484356	(fkiwrmylzl) = etbofwiiie igwjvqdrdw (jjjnuwofqk ) View more	Positive	20 May 2021

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