Dr Lan on the Efficacy of Cadonilimab Plus Lenvatinib in Advanced Endometrial Cancer

“Cadonilimab plus lenvatinib demonstrated promising antitumor activity in patients with advanced endometrial cancer who had progressed after prior platinum-based chemotherapy.”

Chunyan Lan, MD, PhD, of the Department of Gynecologic Oncology at Sun Yat-sen University Cancer Center, discussed findings from a multicenter, single-arm, phase 2 trial (NCT05824481) evaluating cadonilimab plus lenvatinib (Lenvatinib) in patients with advanced endometrial cancer.

This trial enrolled patients with histologically confirmed advanced, recurrent, or metastatic endometrial cancer who had progressed on or after prior platinum-based chemotherapy and had measurable lesions per RECIST 1.1 criteria. A 3+3 dose de-escalation design was used to determine the recommended phase 2 dose for lenvatinib. Patients in the safety run-in cohort received lenvatinib plus cadonilimab at 1 of 2 dose levels. Patients treated at dose level 1 received lenvatinib at 16 mg once daily plus cadonilimab at 10 mg/kg every 3 weeks. Patients treated at dose level 2 received lenvatinib at 12 mg once daily plus cadonilimab at 10 mg/kg every 3 weeks.

Overall response rate (ORR) served as the trial’s primary end point. Secondary end points included disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival, and safety.

Among efficacy-evaluable patients (n = 28), the ORR was 42.9% (95% CI, 24.5%-62.8%), including best responses of partial response (PR; n = 12), stable disease (SD; n = 14), and progressive disease (PD; n = 2). In the full analysis set (n = 32), the ORR was 37.5% (95% CI, 21.3%-56.3%), including best responses of PR (n = 12), SD (n = 14), and PD (n = 2); 4 patients were not evaluable for response. The DCRs in these respective populations were 92.9% (95% CI, 95% CI, 76.5%-99.1%) and 81.3% (95% CI, 63.6%-92.8%). The ORRs among efficacy-evaluable patients with mismatch repair–deficient/microsatellite instability–high disease, disease with a nonspecific molecular profile and p53 abnormalities were 33.3%, 50.0%, and 16.7%, respectively.

At a median follow-up of 7.6 months (range, 3.0-14.5), the median PFS and median DOR were both not reached.