FDA approves pembrolizumab in combination with chemoradiotherapy for cervical cancer
Cervical cancer remains a significant global health concern, particularly affecting women in resource-limited settings. According to the World Health Organization (WHO), cervical cancer is the fourth most common cancer in women worldwide, with an estimated 604,000 new cases and 342,000 deaths in 2020.1 The standard treatment for locally advanced cervical cancer typically involves a combination of chemotherapy and radiation therapy. However, despite advancements in treatment modalities, the prognosis for patients with advanced disease remains poor.
In a landmark development, the Food and Drug Administration (FDA) announced on January 12, 2024, the approval of pembrolizumab in conjunction with chemoradiotherapy (CRT) for patients diagnosed with FIGO 2014 Stage III-IVA cervical cancer.2 This approval marks a significant milestone in the management of cervical cancer and offers a promising new treatment option for patients facing this challenging diagnosis.
The approval is based on the compelling results from the KEYNOTE-A18 trial (NCT04221945), a large-scale, multicenter, randomized, double-blind, placebo-controlled study involving over 1,000 patients across 30 countries. The trial evaluated the efficacy of pembrolizumab combined with concurrent chemoradiation and brachytherapy in patients with locally advanced high-risk cervical cancer.
Domenica Lorusso, MD, PhD, Fondazione IRCCS National Cancer Institute of Milan, Milan, Italy, commenting on the trial results presented at ESMO 2023 in Madrid, Spain, stated, “KEYNOTE-A18 was a randomized trial evaluating for the first time the combination of immunotherapy pembrolizumab with concurrent chemoradiation and brachytherapy for the treatment of locally advanced high-risk cervical cancer. The trial enrolled more than 1,000 patients across 30 countries and reported a significant reduction and clinically meaningful reduction in the risk of progression with a hazard ratio of 0.7 when pembrolizumab was combined with the chemoradiation.”
The trial demonstrated a statistically significant improvement in progression-free survival (PFS) in the overall population, with particularly noteworthy benefits observed in patients with FIGO 2014 Stage III-IVA disease. Importantly, the safety profile of pembrolizumab in combination with chemoradiotherapy was consistent with previous findings, with manageable adverse reactions observed.
The approval of pembrolizumab represents a significant advancement in the treatment landscape of cervical cancer, offering healthcare professionals a valuable therapeutic option to improve patient outcomes. As efforts continue to combat this formidable disease, this milestone underscores the importance of ongoing research and collaboration in advancing innovative treatment approaches for patients with cervical cancer.
Written by Sol Yohannes
References:
- World Health Organization. (2023, November 17). Cervical cancer. Available from: https://www.who.int/news-room/fact-sheets/detail/cervical-cancer
- Center for Drug Evaluation and Research. FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer. U.S Food and Drug Administration. FDA. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemoradiotherapy-figo-2014-stage-iii-iva-cervical-cancer
