In a phase 2 trial, camrelizumab plus apatinib demonstrated promising antitumor activity and manageable safety in patients with advanced or recurrent endometrial cancer that did not respond to first-line therapy. The findings of this trial were presented at the 2022 ASCO Annual Meeting.

“For advanced or recurrent endometrial cancer, therapeutic options remain scarce. Immune or antiangiogenic monotherapy has shown moderate efficacy in [endometrial cancer]. Preclinical and clinical data showed that camrelizumab (an anti-PD-1 antibody) plus apatinib (a selective VEGFR2 inhibitor) markedly enhanced anti-tumor efficacy in multiple solid tumors,” explained Huaying Wang, MD, Fudan University Shanghai Cancer Center, China, and colleagues.

This open-label, single-arm, phase 2 trial aimed to assess the efficacy and safety of camrelizumab and apatinib for advanced or recurrent endometrial cancer in the second-line setting or beyond. Patients received camrelizumab 200 mg, intravenously, every 2 weeks plus apatinib 250 mg, orally, daily.

The primary end point of the trial was objective response rate (ORR). Secondary end points included time to objective response (TTR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF) and safety.

A total of 21 patients were enrolled between January 20, 2020, and July 8, 2021. As of November 9, 2021, the median follow-up time was 13.5 months.

The confirmed ORR was 47.6% (95% confidence interval [CI], 25.7% to 70.2%) with a complete response in 1 patient (4.8%) and a partial response in 9 patients (42.9%). There were 8 patients with stable disease evaluable for a DCR of 85.7% (95% CI, 63.7% to 97.0%). Median PFS was 11.8 months (95% CI, 5.2 to 14.4).

Any grade treatment–related adverse events (AEs) were reported in 100% of patients. Grade ≥3 treatment-related AEs were reported in 10 (47.6%) patients. The most common grade ≥3 AEs included increased gamma-glutamyltransferase (6 [28.6%]), increased direct bilirubin (4 [19%]), increased alanine aminotransferase (3 [14.3%]), increased aspartate aminotransferase (3 [14.3%]) and hyperglycaemia (3[14.3%]).

In addition, 4 (19%) patients experienced grade 1 to 2 reactive cutaneous capillary endothelial proliferation. Researchers reported no treatment-related deaths.

“Camrelizumab plus apatinib demonstrated promising antitumor activity and a manageable safety profile in patients with advanced or recurrent [endometrial cancer] after failure of at least first-line therapy,” concluded Dr Wang and colleagues.

Source:

Wang H, Tian W, Ren Y, Jing C, Shan B. Camrelizumab plus apatinib in patients with advanced or recurrent endometrial cancer after failure of at least first-line therapy: Interim results of a single-arm phase II trial. Presented at: ASCO Annual Meeting; June 3-7, 2022. Chicago, IL, and virtual. Abstract 5591.