Verzenio (abemaciclib)

P3, N=315, Active, not recruiting, AstraZeneca | Trial completion date: Nov 2027 --> Sep 2028

While generally well tolerated, their toxicity profiles differ, with palbociclib and ribociclib more commonly associated with hematologic toxicity and abemaciclib with gastrointestinal adverse effects such as diarrhea...We report a 65-year-old woman with metastatic HR+ breast cancer who presented with a two-week history of watery diarrhea (10-12 episodes/day), abdominal cramping, and a 5-pound weight loss while receiving palbociclib, fulvestrant, and denosumab...Although biopsy later demonstrated cytomegalovirus (CMV) positivity, antiviral therapy was deferred given negative CMV PCR and complete clinical resolution. This case highlights an uncommon presentation of palbociclib-induced pancolitis and underscores the importance of careful clinical evaluation and contextual interpretation of histologic findings to avoid unnecessary treatment.

Ribociclib and abemaciclib may provide superior rwPFS and OS compared to palbociclib in HR+/HER2- mBC patients with bone metastases..

P3, N=920, Recruiting, Eli Lilly and Company | N=274 --> 920

The CDK4/6 inhibitors abemaciclib and palbociclib have demonstrated promising results in patient-derived xenograft models of PM...While some cells showed sensitivity to Bcl-xL inhibitors, neither navitoclax nor the specific Bcl-xL inhibitor A-1331852, nor other BH3 mimetics targeting Bcl-2 (venetoclax) or Mcl-1 (S63845) increased cell death when combined with palbociclib...Therefore, we employed inhibitors of these pathways, such as dasatinib, momelotinib or Torin-1, which did not synergise with palbociclib to kill the cells...The differential effects of palbociclib and cisplatin on permanent growth arrest were verified by sorting PM cells based on size and β-galactosidase activity. Our findings underscore the importance of understanding the nature of therapy-induced senescence when assessing the effectiveness of senolytics in different tumour models.

P2, N=57, Active, not recruiting, Royal Marsden NHS Foundation Trust | Recruiting --> Active, not recruiting | N=324 --> 57 | Trial completion date: Sep 2026 --> Jun 2027 | Trial primary completion date: Sep 2026 --> Jun 2027

P2, N=50, Active, not recruiting, Alliance for Clinical Trials in Oncology | Suspended --> Active, not recruiting | N=186 --> 50

P2, N=46, Active, not recruiting, Eli Lilly and Company | Trial completion date: Sep 2028 --> Dec 2026

P2, N=700, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting

P1, N=39, Recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027

P1/2, N=42, Recruiting, Icahn School of Medicine at Mount Sinai | Trial completion date: Dec 2027 --> Jun 2028 | Trial primary completion date: Dec 2026 --> Jun 2027

Indeed, the frequency and presentation of these CV toxicities vary according to the TT: arterial hypertension with VEGFR inhibitors, thromboembolic events with abemaciclib, left ventricular dysfunction with osimertinib or BRAF/MEK inhibitors, QTc prolongation with ribociclib or vandetanib, and metabolic disorders (dyslipidemia, hyperglycemia) with PI3K/AKT/mTOR pathway inhibitors. A multidisciplinary approach involving oncologists, cardiologists, primary care physicians, and patients is key. Patient education, optimization of risk factors, and individualized monitoring are the cornerstones of optimal care.