Finerenone Benefits Hold in Patients With a History of Cancer

Patients with cardio-kidney-metabolic (CKM) conditions and a history of cancer got the same relative benefit from finerenone (Kerendia; Bayer) as patients without cancer, according to a post hoc analysis of the FINE-HEART pooled program published in the European Heart Journal. Cancer history was independently linked to higher risks of death and hospitalization, but it did not blunt the treatment effect of the nonsteroidal mineralocorticoid receptor antagonist.¹

For pharmacists, the findings support using finerenone in this population, along with careful potassium, kidney, and drug interaction monitoring.¹

A Common, High-Risk Comorbidity

FINE-HEART pooled participant-level data from 3 trials: FIDELIO-DKD (NCT02540993), FIGARO-DKD (NCT02545049), and FINEARTS-HF (NCT04435626). The trials enrolled patients with chronic kidney disease and type 2 diabetes or heart failure (HF) with a left ventricular ejection fraction of 40% or higher. Of 18,991 participants, 1389 (7.3%) had a history of cancer. The most common types were gastrointestinal, male reproductive, renal and urinary tract, hematologic, and breast cancers. Another 915 participants without prior cancer (5.2%) developed cancer over a median follow-up of 2.9 years, so 12.1% had active or prior cancer during the study. All 3 trials were funded by Bayer.^1,2

Participants with a cancer history were older (mean age, 72.2 vs 66.6 years), had lower kidney function, and more often had advanced CKM stages. After adjustment, cancer history was associated with higher risks of all-cause death (hazard ratio [HR], 1.31; 95% CI, 1.13-1.52) and all-cause hospitalization (HR, 1.26; 95% CI, 1.17-1.36). It was not associated with higher risks of cardiovascular (CV) death, HF hospitalization, the composite kidney outcome, major adverse CV events (MACE), or new-onset atrial fibrillation.¹

Consistent Treatment Effects

Finerenone's effects were consistent regardless of cancer history (P values for interaction, .31 to .97). This held for CV death, all-cause death, HF hospitalization, all-cause hospitalization, the composite kidney outcome, MACE, and new-onset atrial fibrillation. The drug did not reduce incident cancer (HR, 0.95; 95% CI, 0.83-1.08) or cancer-related death (HR, 0.81; 95% CI, 0.63-1.03).¹

Safety Signals Worth Watching

Serious adverse events, adverse events leading to treatment discontinuation, and acute kidney injury were reported more often in participants with a cancer history in both the finerenone and placebo arms. Potassium above 5.5 mmol/L occurred in 15.9% of finerenone recipients with a cancer history vs 4.8% of placebo recipients, compared with 16.5% vs 7.9% among those without cancer. Systolic blood pressure below 100 mm Hg occurred in 15.4% vs 7.6% of those with a cancer history and in 10.8% vs 6.9% of those without. Rates of treatment discontinuation due to hyperkalemia were similar with or without a cancer history, and there were no hyperkalemia-related deaths.¹

"Risk may differ by cancer site, type, stage, and treatment—details unavailable in our analysis but important to assess in clinical practice," Mihály Ruppert, MD, PhD, of Brigham and Women's Hospital and Semmelweis University in Budapest, Hungary, and first author of the analysis, told Pharmacy Times. "For example, patients with hematologic malignancies, the fourth most common cancer category in our cohort, may be susceptible to treatment-related tumor lysis syndrome and hyperkalemia, whereas patients with carcinoid syndrome may experience severe hypotension.

"Monitoring of serum potassium, kidney function, and blood pressure after finerenone initiation should therefore be tailored to the individual patient and their cancer treatment," Ruppert said.

Interaction Screening at Initiation

Finerenone is primarily metabolized by CYP3A4. Strong CYP3A4 inhibitors are contraindicated with finerenone. Strong or moderate CYP3A4 inducers should be avoided because they reduce finerenone exposure. FINE-HEART did not capture anticancer medications, and the authors called for dedicated study of potential interactions.^1,3

"When initiating finerenone in a patient with a history of cancer, pharmacists should review current anticancer and supportive medications, as well as serum potassium and kidney function," Ruppert said. "Relevant anticancer examples include ribociclib, a dose-dependent CYP3A4 inhibitor, and enzalutamide and apalutamide, which are strong CYP3A4 inducers. Nephrotoxic therapies, including cisplatin, ifosfamide, high-dose methotrexate, pemetrexed, and immune checkpoint inhibitors, may compound finerenone-associated hyperkalemia if kidney function declines."

Limitations and Takeaways

The analysis was post hoc and relied on medical history records rather than systematic oncologic assessment, so it lacked data on tumor stage and cancer treatment. Only about 7% of participants had a cancer history, which limited power for interaction analyses. Patients with a life expectancy of less than 12 months were excluded, and the authors described the findings as exploratory and hypothesis-generating. Still, they concluded that a history of cancer should not deter use of therapies that improve CKM health in patients whose life expectancy is not considered to be less than 12 months.¹

REFERENCES

1. Ruppert M, Vaduganathan M, Claggett BL, et al. Finerenone benefits in patients with cardio-kidney-metabolic syndrome with or without history of cancer: the FINE-HEART pooled analysis. Eur Heart J. Published online August 18, 2026. doi:10.1093/eurheartj/ehag522

2. Vaduganathan M, Filippatos G, Claggett BL, et al. Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes. Nat Med. 2024;30:3758-3764. doi:10.1038/s41591-024-03264-4

3. Kerendia (finerenone) tablets. Prescribing information. Bayer HealthCare Pharmaceuticals Inc; revised September 2026. Accessed September 30, 2026. https://labeling.bayerhealthcare.com/html/products/pi/Kerendia_PI.pdf