Pembrolizumab Benefits CCGC Patients

TOPLINE:

Pembrolizumab provided clinical benefit in previously treated advanced clear cell gynaecological cancer (CCGC).

METHODOLOGY:

• A single-arm multicentre phase 2 trial conducted at five UK centres enrolled 48 patients with advanced CCGC between March 2019 and October 2021, with data collected until July 2024.
• Participants (median age, 58.5 years) received intravenous pembrolizumab (200 mg) every 21 days for up to 2 years or until disease progression, with a maximum of 35 cycles.
• Tumour assessments followed Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1), with CT imaging at baseline, 6 weeks, 12 weeks, and every 12 weeks thereafter.
• The primary endpoint was the 12-week progression-free survival (PFS) rate, assessed using RECIST v1.1, with a target rate of ≥ 33%.
• Secondary endpoints included the objective response rate (ORR), duration of response, PFS, overall survival (OS), safety, and quality of life.

TAKEAWAY:

• The 12-week PFS rate was 42%, exceeding the predefined lower bound of 15%.
• After a median follow-up of 46.9 months, the median PFS was 2.7 months and the median OS was 14.8 months.
• The highest ORR observed with pembrolizumab was 25%, resulting in 12 documented partial responses.
• Treatment-related adverse events occurred in 69% of patients, with grade 3 events in 19% and no grade 4 or 5 events observed.
• Most patients discontinued treatment due to disease progression, but 6% completed all 35 cycles, demonstrating the feasibility of long-term treatment.

IN PRACTICE:

“Pembrolizumab has robust, durable clinical benefit in patients with heavily pretreated CCGC and was tolerated in the overall population,” the authors wrote.

SOURCE:

The study was led by Rebecca Kristeleit, MD, PhD, Guy’s and St Thomas’ NHS Foundation Trust and Comprehensive Cancer Centre, King’s College London, London, United Kingdom. It was published online on February 6, 2025, in JAMA Oncology.

LIMITATIONS:

The study had a single-arm design and moderate sample size, thereby limiting generalisability.

DISCLOSURES:

The study was funded by Merck Sharp & Dohme. Several authors declared having ties with various sources, including the funding organisation.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.