Verzenio (abemaciclib)

P2, N=45, Recruiting, Eli Lilly and Company | Not yet recruiting --> Recruiting

Surgery was not possible due to comorbidities, so fulvestrant(500 mg/month)+denosumab(120 mg/month)was started. Furthermore, as the tumor markers were elevated, abemaciclib(300 mg/day)was added, which resulted in a decrease in the tumor markers...During the course of treatment, the tumor markers rose again, so the dose was increased to 250 mg/day, which resulted in a decrease in the tumor markers and good tolerability. At present, 36 months after the start of treatment, long SD has continued, no adverse events of grade 3 or higher have been observed, and the drug has been well tolerated.

P1, N=28, Recruiting, Memorial Sloan Kettering Cancer Center | Not yet recruiting --> Recruiting

No abstract available

The combination of abemaciclib and fulvestrant has promising activity with durable responses in advanced or recurrent EC; a randomized trial is planned.

Her treatment was adjusted to include Faslodex (fulvestrant) and Verzenio (abemaciclib), followed by the surgical resection of the metastatic lymph node. Understanding dormancy and reactivation mechanisms is essential for guiding clinical decisions. Prioritizing individualized follow-up strategies and refining treatment protocols will be key to improving patient outcomes and maintaining quality of life.

This study confirms first-line CDK 4/6i effectiveness, with abemaciclib and ribociclib showing prolonged PFS vs. palbociclib. This study could not confirm a ranking of the three CDK 4/6i.

P1/2, N=36, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Sep 2025 | Trial primary completion date: Dec 2025 --> Sep 2025

P1/2, N=55, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2026 --> Dec 2029 | Trial primary completion date: Dec 2025 --> Dec 2028

P3, N=400, Not yet recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

P2, N=130, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | Trial completion date: Aug 2029 --> Aug 2030 | Trial primary completion date: Aug 2026 --> Aug 2027

P2, N=90, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2026 --> Jun 2025

P1, N=28, Not yet recruiting, Memorial Sloan Kettering Cancer Center

Our data demonstrate that FMD overcomes resistance and potentiates the anti-tumor effect of CDK4/6i by inhibiting mTORC1 signaling via lowering the levels of IGF1 and RAS, providing the rationale for clinical investigation of a potential FMD-CDK4/6i strategy in breast cancer.

No abstract available

Furthermore, the side effects were manageable and no dose reductions were necessary during treatment. These findings suggest that the combination of CDK4/6i and ET in the treatment of HR+/HER2-advanced breast cancer cannot be underestimated.

Patients with lower body weight are more susceptible to the adverse events of abemaciclib, increasing their risk of treatment discontinuation. In such patients, strict monitoring of adverse events and consideration of more frequent medical visits are necessary from the start of abemaciclib therapy.

These results represent the first full report of a CDK4/6 inhibitor in Chinese patients with EBC and support the positive benefit-risk profile of adjuvant abemaciclib + ET in Chinese patients. ClinicalTrials.gov identifier: NCT03155997 (first posted: May 16, 2017).

Imlunestrant, as monotherapy and combined with abemaciclib, has a manageable safety profile with preliminary evidence of antitumor activity in patients with ER+ EEC.

Our research provided compelling evidence attesting to the reliability and potential of PDX and PDXO models in the realm of precision medicine. These models are instrumental in identifying patients who are likely to respond favorably to a specific drug treatment.

P=N/A, N=319, Not yet recruiting, Erika Matos

P1/2, N=138, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

P3, N=453, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2024 --> Dec 2025

In this real-world study of patients diagnosed with brain metastases and initiating abemaciclib, most patients received radiation/local surgery to the brain before abemaciclib initiation. Although the outcomes in this real-world study are encouraging, it is unclear if the benefit was due to local therapy, abemaciclib, or the combination, and causality cannot be inferred. Further prospective clinical studies are needed to confirm the clinical benefit of this approach.

While advancements in CKS treatment offer hope, further studies on immunotherapy are warranted to broaden the therapeutic options, such as anti-bromodomain or BPTF-targeted therapy.

The findings of this paper demonstrate a significant improvement in iDFS when ET is combined with CDK4/6i, compared to ET alone. Specifically, treatments with abemaciclib and ribociclib showed notable enhancements in dRFS.

Significantly higher eligibility rates were observed in patients who underwent a mastectomy, >70 years and ≤40 years for adjuvant abemaciclib and ribociclib, and in patients >80 years for ribociclib. A higher discontinuation rate for abemaciclib was reported in patients aged ≥65 years and it can be assumed that discontinuation rates may increase in even older patients. If the results of the NataLEE trial translate into clinical practice, the number of patients potentially eligible for adjuvant CDK4/6 inhibitors may increase, especially in the elderly population.

Spontaneous improvement allowed us to resume ABM treatment. Clinicians may need to consider radiation hepatitis as a potential cause of hepatic dysfunction in patients who underwent PMRT, along with drug-induced liver injury.

In a pt subset from monarchE enriched for IDFS events, ctDNA detection was relatively infrequent (<20%); however, its detection at any time during the 24 months of study therapy was adversely prognostic. As compared to pts who had remaining ctDNA positive (+), pts who had clearance of ctDNA on therapy had lower risk of IDFS events, but the event risk still remained clinically meaningful in these pts.

Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life.

P3, N=500, Recruiting, AstraZeneca | Trial completion date: Jul 2030 --> Oct 2030

P3, N=493, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2024 --> Dec 2025

P2, N=38, Not yet recruiting, OHSU Knight Cancer Institute

P3, N=504, Not yet recruiting, Danish Breast Cancer Cooperative Group | Phase classification: P4 --> P3 | N=250 --> 504

P=N/A, N=30, Recruiting, University Hospital, Brest

Then we detected 10 repurposable drug molecules (Irinotecan, Imatinib, Telaglenastat, Olaparib, RG-4733, Sorafenib, Sitravatinib, Cabozantinib, Abemaciclib, and Dovitinib.) by molecular docking with KGs-mediated receptor proteins. Their ADME/T analysis and cross-validation with the independent receptors, also supported their potent against ccRCC. Therefore, these outputs might be useful inputs/resources to the wet-lab researchers and clinicians for considering an effective treatment strategy against ccRCC.

Our study provides the RWD with the use of CDK4/6 inhibitors in the treatment of metastatic HR+/HER2- breast cancer. To our best knowledge, there are limited RWD regarding CDK 4/6 inhibitors use in western Balkan; thus, our study provides valuable data from everyday clinical practice for this region of Europe, bridging the gap between randomized clinical trials and clinical reality in western Balkan.

While the therapeutic role(s) of abemaciclib was fairly established in a subset of patients with advanced/metastatic BC through the pivotal MONARCH trials, its attributes and clinical utility in EC are limited. Thus, based on some promising pre-clinical/translational insights and a recent phase II study, we highlight abemaciclib's properties and potential clinical usefulness in patients with EC, particularly in recurrent estrogen-receptor-positive cases.

P3, N=312, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting

P1, N=164, Completed, Eli Lilly and Company | Active, not recruiting --> Completed

P2, N=105, Recruiting, Eli Lilly and Company | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027

Healthcare providers should be aware of abemaciclib's effect on serum creatinine but should not eliminate the possibility of actual kidney injury. Alternative biomarkers for GFR assessment are recommended, although the usefulness of cystatin-C in patients receiving abemaciclib should be investigated in greater depth.