Verzenio (abemaciclib)

There was no significant difference in efficacy between abemaciclib and palbociclib and both had good safety profiles. We demonstrated that ALC and NLR might predict the outcomes of CDK4/6i treatment in patients with ER + HER2 - ABC.

Meanwhile, in vivo experiments showed that Lys-PDA@AF NCs had excellent antitumor effects and safety. Overall, it was anticipated that the created Lys-PDA@AF NCs would be a potential method for treating cancer.

In the time-dependent Cox proportional hazard model, the effect of abemaciclib was consistent at the full dose compared to being reduced to a lower dose (IDFS hazard ratio: 0.905; 95% confidence interval: 0.727, 1.125; DRFS hazard ratio: 0.942; 95% confidence interval: 0.742, 1.195). These analyses showed that the efficacy of adjuvant abemaciclib was not compromised by protocol mandated dose reductions for patients with node positive, hormone receptor positive, human epidermal growth factor 2-negative, high-risk early breast cancer.

In 2L, 12 of the 21 (57.1%) patients received CDK4/6i + ET, of which 58.3% received abemaciclib. The two-year overall survival (95% CI) was 97.4% (92.4, 100.0), and the median (range) follow-up was 28.7 (3.4-67.6) months. Despite the limitations inherent in real-world studies and a limited number of patients, these AI-extracted data complement previous studies, demonstrating the effectiveness of CDK4/6i + ET in the Canadian real-world 1L, with most patients receiving palbociclib as CDK4/6i in 1L.

Still, clinicians should be aware that online tools cannot replace the technical datasheet of the drug as well as a comprehensive clinical assessment for each patient. Here we critically review the main pharmacological features of ABE, then focusing on its potential interactions with drugs, food, and alternative medicine, in order to provide a guide for its optimal use in the treatment of HR+/HER2- breast cancer patients.

Clinical Trial Registration Number: NCT04293393

P3, N=500, Not yet recruiting, AstraZeneca

Although the AEs of palbociclib and abemaciclib affected the treatment considerably, the treatment duration and RDI were similar. CDK4/6 inhibitors should be selected based on the tolerability and manageability of each AE.

We summarized the ctDNA and cancer tissue mutational landscape, including overall neoplastic burden and PIK3CA and ESR1 hotspot mutations in abemaciclib-treated patients with HR+/HER2- MBC. The data provide insights that could help optimize treatment strategies in this population.

Despite the significant gains of abemaciclib as adjuvant treatment in terms of progression-free survival, this treatment is not cost-effective for the Spanish National Health System at published prices. It may be cost-effective with an appropriate discount on the official price.

P2, N=37, Recruiting, University of Washington | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025

P1, N=215, Active, not recruiting, Eli Lilly and Company | Trial completion date: Mar 2024 --> Jul 2024

P1, N=10, Active, not recruiting, Eli Lilly and Company | Recruiting --> Active, not recruiting | N=50 --> 10 | Trial completion date: Nov 2025 --> Jul 2026 | Trial primary completion date: Dec 2024 --> Feb 2024

P3, N=900, Active, not recruiting, Eli Lilly and Company | Trial primary completion date: Oct 2025 --> Feb 2024

P2, N=550, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

P2, N=76, Not yet recruiting, Dana-Farber Cancer Institute

This review provides key background information on the CDK4/6 inhibitors, palbociclib, ribociclib, and abemaciclib. Additionally, special consideration should be given to populations at higher risk for polypharmacy, such as older patients with greater comorbidities. These interactions and patient characteristics should be considered when developing individual treatment plans with CDK4/6 inhibitors.

A treatment with the VPS34 inhibitor wortmannin (WM) suppressed Abe-/Vac-facilitated autophagic flux and the degradation of GFP-tagged aggregate-prone TDP-43. Collectively, these results suggest that Abe and Vac degrade aggregate-prone TDP-43 by accelerating autophagosome formation and autophagosome-lysosome fusion through the formation of PI(3)P.

P3, N=1900, Recruiting, Fudan University | Not yet recruiting --> Recruiting

P1, N=18, Not yet recruiting, University of Washington | Initiation date: Apr 2024 --> Jul 2024

P=N/A, N=150, Recruiting, Fudan University

P3, N=2030, Not yet recruiting, Fudan University

In our dataset approximately 21% rate of high-risk HR positive early BC patients are potentially eligible for adjuvant abemaciclib treatment. Umberto Veronesi Foundation.

P1, N=50, Recruiting, Nader Sanai | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P1, N=500, Active, not recruiting, Eli Lilly and Company | Phase classification: P1a/1b --> P1

P2, N=90, Recruiting, Dana-Farber Cancer Institute | Initiation date: Feb 2024 --> Oct 2023

A 46-year-old woman with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer who had multiple LMs and bone metastases underwent seven lines of systemic therapy (paclitaxel/bevacizumab for 38 months; letrozole, nivolumab/fulvestrant, eribulin, gemcitabine/vinorelbine, high-dose toremifene/abemaciclib, and capecitabine for 21 months in total). However, owing to its adverse effects and the continued progression of the LMs, systemic therapy was switched to HAIC (40 mg/body epirubicin on day 1, 4 mg/body mitomycin C on days 1 and 15, and 500 mg/body 5-fluorouracil on days 1, 8, and 15; 28-day courses)...Our findings identify a potential window for the use of traditional chemotherapeutic agents such as anthracyclines. Novel strategies to improve drug delivery are warranted in the future.

P1, N=100, Active, not recruiting, Eli Lilly and Company | Phase classification: P1b --> P1

P1, N=198, Active, not recruiting, Eli Lilly and Company | Phase classification: P1b --> P1

P2, N=44, Recruiting, Medical College of Wisconsin | Trial completion date: Sep 2025 --> Jun 2027 | Trial primary completion date: Sep 2024 --> Jun 2026

Abemaciclib monotherapy was well tolerated and showed clinical activity in this heavily pretreated population, nearly half with visceral metastases. This study is considered preliminary proof-of-concept and designates CDK4/6 as a valid therapeutic target in prostate cancer.

P2, N=29, Recruiting, Case Comprehensive Cancer Center | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025

P2, N=60, Not yet recruiting, University of Washington | Trial completion date: Mar 2025 --> Jun 2026

P2, N=237, Completed, Eli Lilly and Company | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Nov 2023

P2, N=85, Completed, Jules Bordet Institute | Active, not recruiting --> Completed

P3, N=2450, Active, not recruiting, Eli Lilly and Company | Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2024 --> Jun 2024

In a large real-world sample, more men with eBC are at clinical high risk according to the inclusion criteria of monarchE, NATALEE and OlympiA than would be expected in women. This is most likely due to more advanced stages at initial diagnosis in men. To evaluate whether CDK4/6 and PARP inhibitors improve prognosis also in men should be the topic of future real- world analyses.

P1/2; N=204 --> 24 | Trial completion date: Nov 2024 --> Mar 2025 | Trial primary completion date: Nov 2024 --> Jun 2023

P2, N=9, Active, not recruiting, University of Alabama at Birmingham | Recruiting --> Active, not recruiting | N=30 --> 9

We aimed to assess the cost-effectiveness of dalpiciclib plus letrozole/anastrozole (non-steroidal aromatase inhibitor [NSAI]) compared with abemaciclib plus NSAI as a first-line treatment for HR+/HER2- ABC in China. At a willingness-to-pay threshold of 3 times gross domestic product per capita in China for 2023 ($37721.5/QALY), the cost-effectiveness probability of dalpiciclib plus NSAI was 77.42%. From the perspective of Chinese payers, dalpiciclib plus NSAI appears to be a cost-effective strategy compared with abemaciclib plus NSAI for the first-line treatment of patients with HR+/HER2- ABC in China.

Patient recruitment will be completed by the end of 2025 and reporting of the final study results will be done by the end of 2027. NCT05872204.

Abemaciclib was originally FDA approved for patients with ER-positive/HER2-negative breast cancer with Ki-67 expression ≥20%...The average Ki-67 difference was 4.36 for CNB vs RES, 6.95 for CNB versus ALN, and RES versus ALN (P=0.93, 0.99, and 0.94, respectively). Our study concludes that further refinement in Ki-67 scoring is advisable to reduce clinically significant variation.