# Pembrolizumab and lenvatinib in the treatment of recurrent ovarian carcinoma: A single institution experience

## TL;DR

This study shows that combining pembrolizumab and lenvatinib is a safe and effective treatment for platinum-resistant recurrent ovarian cancer.

## Contribution

The study provides clinical evidence that pembrolizumab-lenvatinib is effective in treating MSS/pMMR platinum-resistant ovarian cancer.

## Key findings

- 54% of evaluable patients had a partial response to pembrolizumab-lenvatinib.
- The 6-month clinical benefit rate was 69%.
- Median progression-free survival was 7.9 months.

## Abstract

•The use of single agent immune checkpoint inhibitors has not shown significant clinical benefit in ovarian cancer.•Preclinical studies have shown that lenvatinib enhances antitumor activity of anti-PD-1 antibody.•Pembrolizumab and lenvatinib are FDA approved for treatment of MSS/pMMR endometrial cancer and renal cell carcinoma.•Pembrolizumab/lenvatinib is a safe, effective option for treatment of platinum resistant ovarian cancer.•Reduced doses of lenvatinib may help mitigate toxicity while providing meaningful clinical response.

The use of single agent immune checkpoint inhibitors has not shown significant clinical benefit in ovarian cancer.

Preclinical studies have shown that lenvatinib enhances antitumor activity of anti-PD-1 antibody.

Pembrolizumab and lenvatinib are FDA approved for treatment of MSS/pMMR endometrial cancer and renal cell carcinoma.

Pembrolizumab/lenvatinib is a safe, effective option for treatment of platinum resistant ovarian cancer.

Reduced doses of lenvatinib may help mitigate toxicity while providing meaningful clinical response.

Advanced stage ovarian carcinoma has a poor prognosis with recurrence rates of over 80%, 5-year survival of 36–45%, and limited response to standard therapy. Pembrolizumab and lenvatinib are FDA approved for treatment of microsatellite stable (MSS)/mismatch repair proficient (pMMR) endometrial and renal cell cancers. Early phase II studies have shown promising results in a variety of advanced solid tumors, including ovarian cancer. We report on the clinical outcome of recurrent MSS/pMMR ovarian cancer patients treated with this therapy.

For this retrospective cohort study, patients with a diagnosis of ovarian cancer treated with pembrolizumab and lenvatinib from January 2020 to April 2024 at MD Anderson Cancer Center at Cooper were identified. Demographic data, tumor characteristics, germline/somatic genetic testing, treatment duration, and toxicity were collected. Response rate by RECIST criteria, progression free survival (PFS), and clinical benefit rate were calculated.

Sixteen patients were identified. Most had high-grade serous (n = 11, 68.75 %) or clear cell histologies (n = 4, 25 %) and FIGO stage III/IV disease (n = 15, 93.75 %). Eighty-one percent had platinum resistant recurrent disease. Three patients discontinued therapy after one cycle, unrelated to drug toxicity, and were non-evaluable for response. Of 13 patients evaluable for response, 54 % had a partial response and 31 % had stable disease. The 6-month clinical benefit rate was 69 %. The median PFS for all evaluable patients was 7.9 months. At the time of data analysis, 2 patients remained on treatment.

Pembrolizumab-lenvatinib therapy demonstrated favorable clinical benefit in recurrent, platinum resistant MSS/pMMR ovarian cancer, a group of patients in need of more therapeutic options.