Verzenio (abemaciclib)

P2, N=976, Recruiting, MedSIR | Trial completion date: Dec 2028 --> Jun 2028 | Trial primary completion date: Dec 2028 --> Jun 2028

P1, N=10, Completed, Eli Lilly and Company | Active, not recruiting --> Completed | Trial completion date: Jul 2026 --> Jan 2026

Our study demonstrates that the CDK4/6 inhibitor Abemaciclib and the BRD4 inhibitor BQ0 exert a synergistic effect in inhibiting the proliferation of triple-negative breast cancer (TNBC) cells in vitro...The kinases selectivity experimental suggested that 7f15 is a pan-BET inhibitor. In summary, 7f15, hereby designated as KWZL-7f15, is a novel dual CDK6/BET inhibitor with promising therapeutic potential for the treatment of triple-negative breast cancer.

This report is the first highlighting the imaging characteristics of rapid-onset hepatic atrophy associated with abemaciclib-induced liver injury. These findings may provide useful insights for distinguishing abemaciclib-induced liver injury from other etiologies.

Nine compounds significantly activated Wnt signaling, including antivirals (imidocarb, proflavine, aminoacridine), anticancer agents (entinostat, enzastaurin, abemaciclib), and GSK-3β inhibitors (BIO, CP21R7). In mice, aminoacridine-especially combined with minoxidil-showed the strongest hair regrowth, while proflavine and imidocarb enhanced nail elongation. These results reveal new therapeutic candidates for hair and nail regeneration.

P2, N=16, Enrolling by invitation, Fudan University

Eligible subjects were enrolled in NSCLC or melanoma tumor-specific cohorts and treated with abemaciclib 200 mg twice daily (BID) monotherapy or 150 mg BID for NSCLC patients on concurrent pemetrexed or gemcitabine. Although abemaciclib can achieve therapeutic concentrations in brain metastases tissue, this study did not meet its primary endpoint. The limited clinical activity in this study suggests that further clinical trials should focus on the use of abemaciclib combination therapy.

P1, N=1, Active, not recruiting, National Cancer Institute (NCI) | N=17 --> 1 | Trial primary completion date: Jan 2027 --> Oct 2025 | Recruiting --> Active, not recruiting

P=N/A, N=3883, Completed, Brigham and Women's Hospital | Active, not recruiting --> Completed

Key 2025 findings (50 clinical trials) include: (1) confirmation of overall survival benefit with adjuvant CDK4/6 inhibitors in HR+/HER2- early breast cancer (monarchE: HR = 0.842, p = 0.0273); (2) establishment of trastuzumab deruxtecan (T-DXd) as a new standard in high-risk HER2+ early disease (DESTINY-Breast05: IDFS HR = 0.47) and first-line metastatic settings (DESTINY-Breast09: PFS HR = 0.58); (3) validation of TROP2-directed ADCs as first-line therapy for metastatic triple-negative breast cancer (ASCENT-03: PFS HR = 0.62; BEGONIA: ORR 79%); (4) paradigm shift to proactive, liquid biopsy-guided therapy switching (SERENA-6: PFS HR = 0.44); (5) updated efficacy and safety of the oral SERD imlunestrant from the EMBER-3 trial, supporting its role in ESR1-mutated advanced breast cancer and in combination with abemaciclib; (6) confirmation of long-term survival benefit for neoadjuvant carboplatin in early TNBC and new positive adjuvant data; (7) pivotal advances in HER2+ metastatic disease sequencing with tucatinib and T-DXd; (8) evidence supporting optimized adjuvant endocrine therapy in HER2+/HR+ early disease; and (9) emergence of novel agents with improved therapeutic indices, including PROTAC degraders, oral SERDs, and mutant-selective PI3K inhibitors. Unifying themes include biomarker-driven personalization, strategic treatment sequencing, management of unique toxicities, and emphasis on patient-reported outcomes. Future challenges include optimizing treatment integration, managing financial toxicity, and ensuring equitable global access.

A total of 100 patients were evaluable 53 treated with palbociclib, 44 with ribociclib and 3 with abemaciclib. Pretreatment sTILs levels were associated with outcome in patients treated with palbociclib. Given the lack of interaction between treatment and sTILs our findings warrant validation in larger, independent cohorts and if confirmed propose sTILs as a simple and reproducible biomarker to aid patient selection for palbociclib.

P1/2, N=564, Recruiting, AstraZeneca | Trial completion date: Aug 2026 --> Aug 2027 | Trial primary completion date: Aug 2026 --> Aug 2027