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Last update 27 Jun 2026

Abemaciclib

Last update 27 Jun 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Abemaciclib (JAN/USAN), Abemaciclib mesylate, Bemaciclib

+ [8]

Target

CDK4 x CDK6

Action

inhibitors

Mechanism

CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesRespiratory Diseases+ [7]

Active Indication

ER-positive/HER2-negative/ ESR1-mutated breast cancerAdvanced breast cancerMetastatic breast cancer+ [71]

Inactive Indication

Adenocarcinoma of EsophagusAdenocarcinoma of prostateAdvanced biliary tract cancer+ [28]

Originator Organization

Eli Lilly & Co.

Active Organization

Eli Lilly & Co.

GSK Plc

Lilly Asia Shanghai Representative Office

+ [12]

Inactive Organization

Roche Pharma AG

Oncoinvent ASA

Merck Sharp & Dohme Corp.

+ [3]

License Organization

Agilent Technologies, Inc.

Sermonix Pharmaceuticals LLC

Veru, Inc.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (28 Sep 2017),

Hormone receptor positive HER2 negative breast cancer

RegulationBreakthrough Therapy (United States), Fast Track (United States), Special Review Project (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC27H32F2N8

InChIKeyUZWDCWONPYILKI-UHFFFAOYSA-N

CAS Registry1231929-97-7

264

Clinical Trials associated with Abemaciclib

NCT07410559

/ Not yet recruitingPhase 2IIT

Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer: A Randomized Phase 2 Trial (IMPATIENS)

This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer.

Start Date01 Jul 2026

Sponsor / Collaborator

Fudan University

NCT07441369

/ Enrolling by invitationPhase 2IIT

Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Two or Three-line Therapy

This is a single-center, single-arm, open-label clinical study, to explore the efficacy and safety of abemaciclib combined with FOLFOX/FOLFIRI regimen in patients with advanced colorectal liver metastases cancer who failed standard two or three-line therapy.

Start Date01 May 2026

Sponsor / Collaborator

Fudan University

NCT07191717

/ Not yet recruitingPhase 2IIT

Phase II Minimal Residual Disease Study of Selective Estrogen Receptor Degrader Imlunestrant With Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor Abemaciclib in Patients With ER+ Breast Cancer (MIRI)

This phase II trial studies how well imlunestrant and abemaciclib work in treating patients with estrogen receptor positive (ER+) breast cancer who have tumor remaining in the blood following treatment (minimal residual disease). Estrogen can cause the growth of breast cancer cells. Imlunestrant lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Imlunestrant and abemaciclib may be effective in treating patients with ER+ breast cancer who have minimal residual disease.

Start Date30 Apr 2026

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

100 Clinical Results associated with Abemaciclib

100 Translational Medicine associated with Abemaciclib

100 Patents (Medical) associated with Abemaciclib

1,479

Literatures (Medical) associated with Abemaciclib

31 Dec 2026·Journal of Pharmaceutical Policy and Practice

Economic evaluation of cyclin-dependent kinases 4 and 6 inhibitors in advanced hormonal receptor-positive and human epidermal growth factor receptor 2 negative breast cancer: a nationwide budget impact analysis

Article

Author: Hamad, Anas ; Shafei, Laila ; Hisham Al-Ziftawi, Nour ; Mohamed Ibrahim, Mohamed Izham ; Bojassoum, Salha ; Elazzazy, Shereen

Background:

Several trials demonstrated improvements in clinical outcomes associated with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors in breast cancer patients. The challenge remains regarding their high costs. Ribociclib and Abemaciclib are cost-effective in Qatar. Yet, their affordability was not studied. This budget impact analysis (BIA) is to assess the affordability of adopting CDK4/6 inhibitors in Qatar over five years duration (2024-2028).

Methods:

We ran a BIA to evaluate two scenarios: (1) Increasing abemaciclib's market share from 20% to 60%, replacing both palbociclib and ribociclib. (2) Assuming equal market share for both ribociclib and abemaciclib up to 80%, reducing palbociclib's share. The analysis considered treatment costs, patient population, and disease prevalence. All data were retrieved from the National Center for Cancer Care and Research, and costs were presented in Qatari Riyals (QAR). Sensitivity analyses were run to ensure the robustness of the conclusion. All results were compared to Qatar's budget threshold, which is QAR 453,822.

Results:

Based on a total of 173 patients using CDK4/6 inhibitors, increasing abemaciclib's market share to 60% yielded cumulative savings of QAR 14 million over five years, which is around QAR 14,613 per patient per year. However, equally increasing ribociclib's and abemaciclib's market share to 80% resulted in a modest budget increase, remaining within acceptable thresholds. Sensitivity analyses confirmed the robustness of these findings, showing that cost reductions and higher uptake rates further enhanced savings.

Conclusion:

Abemaciclib is a budget-saving option for HR+/HER2- breast cancer in Qatar, should it replace the market share by up to 60% over five years. In addition, ribociclib and abemaciclib are affordable treatment options if they equally contributes to up to 80% of the market share for the eligible advanced breast cancer patients. The results supported the concept of allocating CDK4/6 inhibitors as they were found to be affordable to the Qatari healthcare system.

01 Aug 2026·BREAST

A mixed prebiotic/probiotic intervention (MBR-01) for the management of diarrhea during abemaciclib treatment of early breast cancer in postmenopausal patients: A single-center prospective case–control pilot study

Article

Author: Strina, Carla ; Fontana, Alessandra ; Gattazzo, Federica ; Schettini, Francesco ; Membrino, Alexandro ; Generali, Daniele ; Milani, Manuela ; Del Bianco, Sergio ; Cervoni, Valeria ; Castagnetti, Andrea ; Caltavituro, Aldo

BACKGROUND:

Adjuvant abemaciclib + endocrine therapy (ET) improves long-term outcomes in high-risk, hormone receptor-positive (HR+)/HER2-negative early breast cancer (eBC). However, treatment is frequently complicated by diarrhea, affecting adherence and quality-of-life (QoL). Increasing evidence suggests that abemaciclib-induced gastrointestinal toxicity may involve gut microbiota alterations. We conducted a prospective case-control pilot study evaluating the efficacy of MBR-01, a standardized prebiotic/probiotic formulation, in mitigating abemaciclib-induced diarrhea.

METHODS:

We enrolled 20 postmenopausal patients with high-risk HR+/HER2-negative eBC considered unfit for adjuvant chemotherapy. Patients received abemaciclib + letrozole (control, n = 10) or abemaciclib + letrozole + MBR-01 (experimental, n = 10). The primary endpoint was the incidence and severity of diarrhea; secondary endpoints included treatment adherence, QoL assessments and exploratory baseline/week-12 microbiota characterization according to treatment arm.

TRIAL REGISTRATION NUMBER:

ISRCTN11948182.

RESULTS:

Diarrhea occurred in all patients. In the control group, diarrhea was predominantly grade 1 (50%) or grade 2 (40%), with one grade 3 event (10%). In the MBR-01 group, diarrhea frequency and severity were reduced by ∼70% at the end of week-12; 90% of patients experienced only grade 1 diarrhea or none by week-12, and no grade ≥3 events. Dose modification was only required in one control. Decrease in alpha-diversity and F.prausnitzii were associated with earlier diarrhea onset and longer duration; increase in E.coli correlated with higher grade events. MBR-01 supplementation seemed to preserve microbial diversity and limited E.coli expansion. QoL was significantly improved with MBR-01.

CONCLUSION:

MBR-01 may effectively mitigate abemaciclib-induced diarrhea, likely through the achievement of stabilization of gut microbiota composition. Larger prospective studies are warranted to validate these preliminary findings.

01 Jul 2026·JHEP Reports

Clinical features and management for CDK4/6 inhibitor-DILI

Article

Author: Martín, Miguel ; Torres-Sempere, Julio ; Vega-Cano, Kreina Sharela ; Pinazo-Bandera, José ; Rodríguez, César A ; Salcedo, Magdalena ; Forns, Xavier ; Martínez-Sáez, Olga ; Alonso López, Sonia ; Morchón-Araujo, Daniel ; Jara, Pablo ; Romanos Nanclares, Álvaro ; Cejuela, Mónica ; Buti, Maria ; Mateos, Beatriz ; García-Cortés, Miren ; Ruiz-Cobo, Juan Carlos ; Zamora, Esther ; Ribelles, Nuria ; Riveiro-Barciela, Mar ; Esteban, Paula ; García-Fructuoso, Isabel ; Lozano, Rebeca ; Miranda, Elena López ; Bellet, Meritxell ; Domínguez-Gómez, Raquel ; Villagrasa, Ares

BACKGROUND & AIMS:

Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i)-ribociclib, abemaciclib, palbociclib-are the standard of care for metastatic breast cancer. Although hepatotoxicity is a frequent adverse event, data on CDK4/6i drug-induced liver injury (DILI) remain scarce. We aimed to define the incidence, clinical presentation, severity, management, and relapse of CDK4/6i-related DILI in a large real-world cohort.

METHODS:

Retrospective multicentre study including all patients who developed ≥grade 2 DILI (alanine aminotransferase/aspartate aminotransferase >3 × upper limit of normal) while receiving CDK4/6i between January/2018 and December/2022. Severity was assessed according to Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) and DILI-International Expert Working Group criteria.

RESULTS:

Among 2,222 CDK4/6i-treated patients, 100 (4.5%, 95% CI 3.7-5.4%) developed DILI. Incidence was significantly higher for ribociclib (8.3%, 95% CI 6.3-10.7%) and abemaciclib (6.7%, 95% CI 4.6-9.3%) than for palbociclib (1.4%, 95% CI 0.8-2.2%) (Difference, p <0.001). Most cases were grade 2 or 3 (CTCAE) and mild (DILI-International Expert Working Group), although moderate DILI (bilirubin >2 × ULN, n = 12) occurred with all three CDK4/6i. The most frequent pattern was hepatocellular, whereas cholestatic was mainly observed with abemaciclib. Liver biopsy findings (n = 11) were heterogeneous and, together with biochemical results, did not support an immune-mediated mechanism as the primary driver. Corticosteroids (n = 20) did not impact time to grade 1 or alanine aminotransferase normalisation. DILI recurred in 28.2% of CDK4/6i rechallenges (n = 85). Among patients treated with ribociclib, rechallenge with an alternative CDK4/6i was associated with lower risk of recurrence (p = 0.010).

CONCLUSIONS:

DILI caused by ribociclib and abemaciclib are more common that with palbociclib. The absence of immune-mediated features and the limited benefit of corticosteroids question their routine use. After CDK4/6i reintroduction, DILI recurrence rate was 28%. Standardised management is needed, particularly following the approval of ribociclib and abemaciclib as adjuvant therapy.

IMPACT AND IMPLICATIONS:

Although hepatotoxicity is a frequent adverse event, real-world data on CDK4/6i DILI remain scarce. DILI associated with ribociclib and abemaciclib is more common than for palbociclib, although moderate DILI (bilirubin >2 × normality) was observed with the three drugs. The absence of immune-mediated features and the limited benefit of corticosteroids question their routine use in CDK4/6i DILI. Relapse of DILI after rechallenge with a CDK4/6i was 28%, with all cases presenting as mild. The increasing use of CDK4/6i (metastatic breast cancer and ribociclib and abemaciclib as adjuvant therapy) highlights the need of standardising the management of CDK4/6i DILI.

455

News (Medical) associated with Abemaciclib

10 Jun 2026

·www.einpresswire.com

Three Reputable Pharmaceutical Intermediate Manufacturers in China 2026: Powering Global Drug Development

Highlighting advanced manufacturing capabilities, stringent quality standards, and reliable supply for pharmaceutical innovation worldwide. CALIFORNIA, CA, UNITED STATES, June 10, 2026 / EINPresswire.com / -- SHANDONG, China — As global demand for cost-effective and high-quality pharmaceutical intermediates intensifies, three Chinese manufacturers have emerged as key players in supplying the building blocks for active pharmaceutical ingredients (APIs) used in anti-cancer, antiviral, and chronic disease therapies. Haohong (Qihe) Pharmaceutical Technology Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd., and CSPC Pharmaceutical Group Limited represent distinct segments of the market, each offering specialized capabilities that power drug development pipelines worldwide. Industry Context The pharmaceutical intermediate market, estimated at over $40 billion globally in 2025, is projected to grow at a compound annual growth rate of 6-7% through 2030, driven by increasing R&D investments in targeted therapies and generic drug manufacturing. Chinese manufacturers collectively account for more than 30% of global intermediate supply, leveraging integrated chemical synthesis capabilities and cost advantages. Within this landscape, companies differentiate themselves through purity standards, batch consistency, regulatory compliance, and customized synthesis services. Company Profiles and Competitive Strengths Haohong (Qihe) Pharmaceutical Technology Co., Ltd., established in 2021 and based in Shandong Province, specializes in high-grade active pharmaceutical intermediates and custom synthesis. The company employs approximately 75 staff and operates a 3,000-square-meter manufacturing facility with an annual production capacity of 1,000 tons. Export business accounts for 40% of total sales, with products reaching the United States, Europe, Japan, India, and Bangladesh. Haohong holds ISO 9001:2015 certification and was recognized as a Technology-based Small and Medium-sized Enterprise in 2024 and awarded Innovative Small and Medium-sized Enterprise of Shandong Province in 2025. Its research and development team comprises 30 engineers, supporting custom synthesis from gram scale to hundreds of kilograms. The production base in Liaocheng is equipped with 30 sets of 3,000–5,000L reactors. The company focuses on anti-cancer, anti-hepatitis C, and anti-diabetic intermediates, including key products for Apalutamide, Abemaciclib, and Alectinib. Haohong’s competitive edge lies in its ability to deliver ultra-high purity (≥98%) with strict impurity control and batch-to-batch consistency, supported by complete technical documentation compliant with ICH and GMP standards. The company also holds multiple utility model patents for production equipment, including a waste gas absorption device and a gas chromatography detection system. Zhejiang Huahai Pharmaceutical Co., Ltd. (SZSE: 600521), founded in 1998 and headquartered in Linhai, Zhejiang, is one of China’s largest API and intermediate manufacturers. Huahai specializes in cardiovascular, central nervous system, and anti-cancer drugs. It operates multiple FDA- and EMA-approved facilities and exports to over 50 countries. Huahai’s strength lies in its vertically integrated supply chain, extensive regulatory dossier library (more than 100 ANDAs), and large-scale production capacity exceeding 5,000 tons per year for certain intermediates. The company has a robust R&D pipeline and is a preferred partner for branded generic drug manufacturers in the United States and Europe. Huahai’s market capitalization exceeds $3 billion, reflecting its established position. CSPC Pharmaceutical Group Limited (HKEx: 1093), founded in 1938 and headquartered in Shijiazhuang, Hebei, is a leading Chinese pharmaceutical conglomerate with a strong presence in innovative drug development and bulk intermediates. With over 20,000 employees and annual revenue exceeding $4 billion, CSPC manufactures a wide range of chemical intermediates, APIs, and finished formulations. The company has a dedicated oncology intermediate division, producing key precursors for drugs like lenvatinib and olaparib. CSPC differentiates itself through its proprietary continuous flow chemistry technology and its ability to scale from laboratory to commercial production rapidly. The group holds multiple patents on synthesis routes and is a major supplier to multinational pharmaceutical companies for clinical trial materials. Comparative Advantages While Huahai and CSPC dominate in scale, regulatory approvals, and global brand recognition, Haohong positions itself as a specialized, high-agility partner for customers requiring high-purity custom intermediates, particularly in the oncology and targeted therapy space. Haohong’s strengths include timely delivery, stable batch quality, comprehensive technical documentation, and a flexible approach to custom synthesis—from gram-scale R&D batches to metric ton-level commercial supply. According to internal comparison data, Haohong’s product purity is on average 0.02% higher than industry peers, and batch quality stability is 10% above the industry average. The company’s self-owned factory and deep R&D capabilities allow it to offer competitive pricing without compromising quality. Market Impact and Analyst Perspective The diversification of intermediate suppliers is critical for global drug developers seeking supply chain resilience. “Companies like Haohong fill a niche for project-specific, high-purity intermediates that require close collaboration and rapid turnaround,” said a pharmaceutical supply chain analyst based in Shanghai. “While large players offer volume, smaller specialized manufacturers often provide better customization and faster response times.” The trend toward more complex targeted therapies, such as antibody-drug conjugates and protein degraders, demands higher purity intermediates with controlled chiral and steric properties—areas where dedicated Chinese manufacturers are investing heavily. Outlook As the global pharmaceutical industry continues to outsource intermediate production, the three companies highlighted are expected to capture growing demand. Haohong plans to expand its reactor capacity and pursue additional industry certifications. Huahai is investing in continuous manufacturing platforms. CSPC is accelerating its innovative drug pipeline, which in turn drives demand for proprietary intermediates. The competitive landscape in China remains fragmented, but specialized players with strong technical foundations and international traceability are well-positioned for growth. For more information about Haohong Pharmaceutical ’s product range and capabilities, download the company brochure: Haohong Corporate Brochure Contact: Xu Tianxia | Email: Xutx@haohong-pharma.com | Tel: +86 180-6854-1569 Address: Block B, building 3, accelerator, high tech Zone, Qihe County, De Zhou City, Shandong Province, China Website: www.haohong-pharma.com Xu Tianxia Haohong (Qihe) Pharmaceutical Technology Co., Ltd + +86 180-6854-1569 Xutx@haohong-pharma.com Visit us on social media: Other Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

10 Jun 2026

·www.biospace.com

ELI LILLY CANADA WELCOMES QUÉBEC PUBLIC REIMBURSEMENT OF VERZENIO® (ABEMACICLIB) FOR MBC FOLLOWING SUCCESSFUL PCPA NEGOTIATION

TORONTO , June 10, 2026 /CNW/ - Eli Lilly Canada Inc. (Lilly) is pleased to announce that Verzenio® (abemaciclib) is now publicly reimbursed in Québec for eligible patients living with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC). Following the successful completion of a pan-Canadian Pharmaceutical Alliance (pCPA) negotiations in April 2026, Régie de l'assurance maladie du Québec (RAMQ) has as of May 28, 2026, added two mBC indications for Verzenio® to the list of medications, in addition to the EBC indication. As of May 28, 2026, prescribers can submit Médicament d'exception requests to RAMQ for Verzenio® in combination with a non-steroidal aromatase inhibitor (NSAI), as an initial endocrine therapy or in combination with fulvestrant, for the treatment of HR+, HER2- locally advanced, unresectable metastatic breast cancer (for newly diagnosed cancer, or cancer that has progressed during or following endocrine therapy). This milestone is a significant achievement for providing better access to Verzenio® in Québec, bringing Canadians impacted by advanced breast cancer one step closer to timely access to innovative treatment options. Lilly is committed to working collaboratively with stakeholders across the healthcare system to help improve timely access for eligible patients living with metastatic breast cancer. "Breast cancer remains one of the most commonly diagnosed cancers among women in Canada, and metastatic breast cancer continues to have a profound impact on patients, families and caregivers," said Dr. Jamil Asselah, Medical Oncologist at McGill University Health Centre (MUHC) and Associate Professor at McGill University. "Reimbursement for these metastatic breast cancer indications marks meaningful progress in improving access to Verzenio for eligible patients in Québec, and reflects the importance of continued innovation in breast cancer care." Approximately 75 per cent of breast cancers are hormone receptor-positive (HR+) and 66 per cent to 75 per cent are HER2-negative. While early-stage breast cancer is treated with therapies of curative intent, metastatic breast cancer remains incurable, with a five-year survival rate of approximately 23 per cent. 1 In Canada, an estimated 5,400 women are expected to die from breast cancer in 2026, representing approximately 13 per cent of all cancer deaths among women. On average, 15 women in Canada die from breast cancer every day. 2 "More treatment options mean more choice for people living with metastatic breast cancer, and that matters. No two patient experiences are the same, including how people respond to treatment and the side effects they are willing or able to tolerate," said MJ DeCoteau, Founder & Executive Director, Rethink Breast Cancer. "Access to therapies like Verzenio helps support more personalized treatment decisions, giving patients and their healthcare teams greater flexibility to choose the option that best fits their lives, priorities, and goals. Today's announcement is welcome news for eligible patients in Quebec living with metastatic breast cancer." Verzenio® is a cyclin-dependent kinase (CDK) 4 and 6 inhibitor currently approved in Canada for certain patients with HR+, HER2- advanced or metastatic breast cancer. 3 Lilly remains committed to working collaboratively with healthcare systems, clinicians, patient advocacy organizations and governments to help improve quality of life and access to care for Canadians affected by metastatic breast cancer. About Verzenio® (abemaciclib) Verzenio® abemaciclib is a targeted treatment known as a CDK4/6 inhibitor. Verzenio® is a non-chemotherapy oral tablet. Verzenio® works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies). Cyclin-dependent kinases (CDK)4/6 are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation. In vitro, continuous exposure to Verzenio® inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio® dosed daily without interruption resulted in reduction of tumour size. Inhibiting CDK4/6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio® crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio® and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations. Verzenio® is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology. About Lilly Canada Lilly is a medicine company turning science into healing to make life better for people around the world. Lilly has been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Lilly's Canadian Affiliate, Eli Lilly Canada Inc. was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin. 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 about Lilly Canada, visit , or follow Lilly Canada on LinkedIn. For more information, please contact: Ethan Pigott Director of Communications & External Affairs Eli Lilly Canada Inc. 1+ 416-770-5843 pigott_ethan@lilly.com References: ______________________________ 1 Canadian Journal of Health Technologies (September 2025). Reimbursement Recommendation Abemaciclib (Verzenio. Available at: . Accessed May 2026. 2 Canadian Cancer Society (April 2026). Breast Cancer Statistics. Available at: . Accessed May 2026. 3 Verzenio® Product Monograph. Eli Lilly Canada Inc. July 24, 2025. SOURCE Eli Lilly Canada Inc.

02 Jun 2026

·www.fiercepharma.com

ASCO: Roche, head held high, details oral SERD's first-line flop in breast cancer

A glimmer of hope in Roche's failed persevERA trial has given the Swiss pharma confidence in launching a new phase 3 study of its giredestrant in combination with CDK4/6 inhibitor in early breast cancer. To Roche, a phase 3 flop in first-line breast cancer does not erase the megablockbuster potential of its oral SERD drug giredestrant even as competition mounts.In fact, results from the failed persevERA trial in first-line HR-positive, HER2-negative metastatic breast cancer have given Roche confidence in a new study that will test the combination of giredestrant with a CDK4/6 inhibitor for the adjuvant treatment of early-stage breast cancer, Roche’s deputy chief medical officer, Stefan Frings, M.D., Ph.D., told Fierce in an interview. “What we still see is a quite attractive separation of the curve […] You will clearly see there’s a treatment effect,” Frings said of progression-free survival (PFS) data from persevERA. “This convinces us, because in the adjuvant setting, we treat for five years, and if we move a few percentage points upwards, you would have already a positive treatment effect in the adjuvant setting.”Frings wouldn’t disclose any details of the upcoming new adjuvant study, saying it’s still in the design phase. Before the persevERA result, Roche already reported a positive readout from the lidERA trial of giredestrant monotherapy in the adjuvant setting. The surprise first-line flopAfter the lidERA hit in November, the persevERA miss came as a big surprise. According to results presented at the American Society of Clinical Oncology 2026 annual meeting, the combination of giredestrant and Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) showed a numerical 11% PFS improvement by investigator analysis compared with Novartis’ aromatase inhibitor Femara (letrozole) and Ibrance, failing to meet statistical significance.The giredestrant regimen’s 33.1-month median PFS was 4.9 months longer than that of the control arm. Because metastatic patients are treated until disease progression, half of them will receive giredestrant for less than three years, or just about half of the five-year duration intended for early-stage therapy.The PFS curve separation that Frings discussed started to emerge around 16 months. At two years, 59.7% of patients in the giredestrant arm and 57.3% in the control group remained progression-free. By three years, the PFS rates were 45.8% and 41.9%, respectively. In contrast, giredestrant struggled to show any overall survival advantage, as the hazard ratio logged at 1.03, meaning death risk was marginally higher for the Roche drug, although the data were immature with a median follow-up of about 52 months. Three-year OS rates were the same at 74.1% for the two arms, and median OS was not reached in either arm. “The reason why this may not have worked is that certainly CDK4/6 [inhibitors] are very potent agents,” Frings said, “and that you don’t see early on what is really an effect of an endocrine manipulation. A dead cell is dead, and you can’t kill it better when it’s already dead.”On the safety side, adverse events (AEs) were generally comparable between the two treatment groups but were more frequent for giredestrant. Serious AEs were recorded in 23.9% of giredestrant patients, versus 18.8% in the control arm. Treatment-related adverse events led to one (0.2%) death and two (0.4%) deaths between the groups, respectively. Roche has a second first-line study, pionERA, which is testing giredestrant alongside CDK4/6 inhibitor in a more endocrine-resistant population. Patients enrolled in that study would have relapsed on adjuvant endocrine therapy or have had a treatment-free interval of less than a year. Frings said Roche is far more confident in this trial because most of these patients bear ESR1 mutations, for whom oral SERDs are known to work better.Roche’s first FDA application for giredestrant, bearing a target decision date of Dec. 18, 2026, is in second-line, ESR1-mutated HR+/HER2- breast cancer. The limited pursuit of the ESR1 subgroup was somewhat expected, mirroring past oral SERD approvals; but it was still disappointing given how Roche had touted a benefit in a broad, all-comers population. “We knew that an [intent-to-treat label] would be an uphill battle, therefore we filed on purpose in ESR1-mutant [patients],” Frings said. But Roche “would leave the door open, depending on the evolution of the data,” to potentially seek a broader label regardless of ESR1 status, especially if more mature OS data are strong, he added. Eyes on the prizeThe FDA has accepted giredestrant for HR+ early-stage breast cancer, Roche announced Monday. After the company spent a priority review voucher, the FDA has set a target decision date of Nov. 30.At ASCO 2026, a subgroup analysis of the lidERA trial showed the benefit of adjuvant giredestrant regardless of a patient’s menopausal status. Compared with standard endocrine therapy, giredestrant improved invasive disease-free survival (iDFS) by 35% in pre-menopausal women and by 26% in post-menopausal patients. During the investor call in April, Roche Pharmaceuticals CEO Teresa Graham defended giredestrant’s potential—with a peak sales forecast “well north of” 3 billion Swiss francs—despite the first-line persevERA setback. That’s because the adjuvant setting is a much larger market “with three times more drug-treated patients than in first-line metastatic and a much longer treatment duration [of] around five years,” she said. However, critics have pointed out that the lidERA trial does not answer how giredestrant fares either against or in combination with CDK4/6 inhibitors, which has recently become a standard treatment for certain patients with early-stage HR+/HER2- breast cancer. By a cross-trial comparison, giredestrant’s 30% iDFS improvement was comparable to the CDK4/6 drugs, although the trial populations were different. While Verzenio’s and Kisqali’s adjuvant uses—which require combination with endocrine therapy—cover patients at high risk of recurrence, single-agent giredestrant may be an attractive option for low- and medium-risk patients, Frings said.For patients who want to maximize efficacy, giredestrant could be the best backbone for a combination because it’s the more potent oral SERD, Frings argued. For now, Roche is conducting a 100-patient substudy in lidERA, evaluating the safety of giredestrant in combination with Eli Lilly’s CDK4/6 drug Verzenio in the adjuvant setting. It also recently started a separate 200-patient study evaluating the safety of giredestrant with Novartis’ Kisqali. Other companies, including Lilly, AstraZeneca and Menarini, are conducting phase 3 trials to test their oral SERDs in patients who have already received a few years of adjuvant therapy, including a CDK4/6 drug.Frings argued that this trial design is “convoluted” and “more like a 2-by-2 design” because not all patients will be exposed to a CDK4/6 inhibitor. Besides, while lidERA showed a treatment effect for the oral SERD early on, that opportunity of early intervention is gone in the competitor design, the Roche exec said. Because those trials’ participants would have previously received two to five years of adjuvant therapy, adherence may be a challenge for continued treatment, too, he added. As for Roche’s upcoming adjuvant trial, “we must just design it well, get buy-in from authorities,” Frings said. “And then, once we are able to talk about it, we will announce what precisely we will do.”

Phase 3Clinical ResultASCOPriority ReviewDrug Approval

100 Deals associated with Abemaciclib

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KEGG	Wiki	ATC	Drug Bank
D10688	Abemaciclib	L01XE50	DB12001

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
ER-positive/HER2-negative/ ESR1-mutated breast cancer	China	Eli Lilly Nederland BV	17 Jun 2026
Advanced breast cancer	Canada	Eli Lilly Canada, Inc.	08 Apr 2019
Metastatic breast cancer	Canada	Eli Lilly Canada, Inc.	08 Apr 2019
HR Positive/HER2 Negative/Node positive breast cancer	European Union	Eli Lilly Nederland BV	26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer	Iceland	Eli Lilly Nederland BV	26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer	Liechtenstein	Eli Lilly Nederland BV	26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer	Norway	Eli Lilly Nederland BV	26 Sep 2018
Hormone receptor positive HER2 negative breast cancer	United States	Eli Lilly & Co.	28 Sep 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-sensitive prostate cancer	Phase 3	United States	Eli Lilly & Co.	14 Apr 2022
Castration-sensitive prostate cancer	Phase 3	China	Eli Lilly & Co.	14 Apr 2022
Castration-sensitive prostate cancer	Phase 3	Japan	Eli Lilly & Co.	14 Apr 2022
Castration-sensitive prostate cancer	Phase 3	Argentina	Eli Lilly & Co.	14 Apr 2022
Castration-sensitive prostate cancer	Phase 3	Australia	Eli Lilly & Co.	14 Apr 2022
Castration-sensitive prostate cancer	Phase 3	Belgium	Eli Lilly & Co.	14 Apr 2022
Castration-sensitive prostate cancer	Phase 3	Brazil	Eli Lilly & Co.	14 Apr 2022
Castration-sensitive prostate cancer	Phase 3	Canada	Eli Lilly & Co.	14 Apr 2022
Castration-sensitive prostate cancer	Phase 3	Czechia	Eli Lilly & Co.	14 Apr 2022
Castration-sensitive prostate cancer	Phase 3	France	Eli Lilly & Co.	14 Apr 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	Hormone receptor positive breast cancer Adjuvant hormone receptor-positive (HR+)	640	Abemaciclib + Abemaciclibherapy	qepafxekcu(ckylwbonor) = utnrytxump wxzttmboal (auixudgfer ) View more	Negative	29 May 2026
ASCO2026	Not Applicable	Early Stage Breast Carcinoma Adjuvant HR+ \| HER2-	39	Abemaciclib	qhemxcbopg(mvbiormtep) = poxxfryskx okjuclinow (jjccwfbxku ) View more	Negative	29 May 2026
ASCO2026	Not Applicable	Hormone receptor positive HER2 negative breast cancer Adjuvant HR+ \| HER2-	64	Abemaciclib: 150mg once daily month 1, then 150mg twice dailyZoledronic acid0mg Denosumaby month 1, then 150mg twice daily + Abemaciclib: 150mg once daily month 1, then 150mg twice dailyZoledronic aciditorDenosumab + Abemaciclib: 150mg once daily month 1, then 150mg twice dailyZoledronic acid or Denosumab	wbfzpnrhii(esjjyqbwsq) = kzzwwtphof tzbuwxmeii (rivtxvcwzg ) View more	Positive	29 May 2026
NCT06001762 (TRADE, ASCO2026)	Phase 2	Hormone receptor positive HER2 negative breast cancer Adjuvant HR+ \| HER2−	90	Abemaciclib + Abemaciclibherapy	bvjazsfxrs(uhroukotty) = increased Bacteroidota and decreased Firmicutes abundance (p < 0.002 and p = 0.001, respectively, paired T-test) dsmhguitnl (evdahgbubt ) View more	Positive	29 May 2026
NCT04469764 (ASCO2026)	Phase 2	Endometrial Carcinoma \| Recurrent ovarian cancer estrogen receptor positive (ER+)	43	Abemaciclib + hormonal therapy (ER+ EC)	nvejboqlja(todcqtiuax) = epgrvaxzmc uebxtsbqsa (erlicfcedi, 34.5 - 77.7) View more	Positive	29 May 2026
				Abemaciclib + hormonal therapy (LGSOC)	nvejboqlja(todcqtiuax) = etgzachxcs uebxtsbqsa (erlicfcedi, 47.8 - 95.1) View more
ASCO2026	Not Applicable	Hormone receptor positive HER2 negative breast cancer Second line HR+/HER2-	411	Abemaciclib±ET	idnmfuyxlx(kzgguhrchc): P-Value = 0.482 View more	Positive	29 May 2026
				ET monotherapy
ASCO2026	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2-	874	Abemaciclib 150 mg	eqlhrgdcfn(yxzoexxbkh) = ntpsysgjnu wzmhsfclpx (ggbryjxlgk, 20 - 27) View more	Negative	29 May 2026
				Abemaciclib 100 mg	eqlhrgdcfn(yxzoexxbkh) = axfpqkviba wzmhsfclpx (ggbryjxlgk, 24 - 44) View more
ASCO2026	Not Applicable	Breast Cancer	15,374	Ribociclib	dufuspknao(teatknlysk) = yruxwdubam rsyisntsdj (cgjjndwdwg ) View more	Positive	29 May 2026
				Abemaciclib	dufuspknao(teatknlysk) = pgkhwkvyhe rsyisntsdj (cgjjndwdwg ) View more
NCT05548127 (TACTIVE-U, ASCO2026)	Phase 1/2	ESR1-mutated \| ER+/human epidermal growth factor receptor 2-negative (HER2−)	37	AbemaciclibVepdegestrant + AbemaciclibVepdegestrant	rqtwlljvoc(zvwgsxlwnh) = gsgkoxpmtf mlcwlrocbr (xwpzwvxese, 18.0 - 46.9) View more	Positive	29 May 2026
				Abemaciclib (ESR1m)	rqtwlljvoc(zvwgsxlwnh) = jprlmrgggm mlcwlrocbr (xwpzwvxese, 25.8 - 65.8) View more
NCT04967521 (SARC041, ASCO2026)	Phase 3	Dedifferentiated Liposarcoma	108	Abemaciclib 200 mg PO twice a day	dehmigeqvo(netnhehnbf) = zjdezbjpxy yachgumlcx (rnztdmqvon ) View more	Positive	29 May 2026
				Placebo	dehmigeqvo(netnhehnbf) = tupzlqaepm yachgumlcx (rnztdmqvon ) View more

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