Breakthrough: Pembrolizumab Approved for Advanced Cervical Cancer Treatment

Merck Sharp & Dohme (Merck’s trade name) announced that its PD-1 inhibitor pembrolizumab (trade name: Koraida®) has been approved by the China National Drug Administration (NMPA) for the treatment of patients with the International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage III-IVA cervical cancer in combination with radiotherapy.

This approval on pembrolizumab is based on data from the global Phase III clinical trial KEYNOTE-A18 study.

Anna Tian, senior vice president of Merck Sharp & Dohme Global and president of Merck Sharp & Dohme China, said that the elimination of cervical cancer is the vision of all mankind and the mission of Merck Sharp & Dohme.

Merck Sharp & Dohme will continue to work closely with its partners and stakeholders to support the World Health Organization’s and China’s shared goal of eliminating cervical cancer by 2030 so that more women can have a brighter and healthier future.

Cervical cancer is a common malignant tumour of the female reproductive system in China.

In 2022, China is estimated to have 150,700 new cases of cervical cancer and 55,700 deaths.

About 37% of cervical cancer patients are in locally advanced stages when they are diagnosed.

Although the diagnosis and treatment level of cervical cancer in China has improved substantially in recent years, due to the large size of local tumours and often accompanied by high-risk factors such as lymph node metastasis and paravaginal infiltration, distant metastases are prone to occur after treatment, and the 5-year overall survival rate is low, at only 50%-60%.

KEYNOTE-A18 study principal investigator in Asia, Professor Xiang Yang of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, said that pembrolizumab in combination with radiotherapy has been approved as a new indication for the treatment of locally advanced cervical cancer in China and that this progress will bring new treatment options for more Chinese cervical cancer patients, help to improve the prognosis and diagnosis and treatment of cervical cancer, and contribute to the goal of ‘Accelerating the Elimination of Cervical Cancer’.

This development will bring new treatment options to more Chinese cervical cancer patients, help improve the prognosis, diagnosis, and treatment of cervical cancer, and contribute to the goal of ‘accelerating the elimination of cervical cancer’.

Dr. Zhengqing Li, Senior Vice President of Merck Sharp & Dohme and President of Merck Sharp & Dohme China R&D Center, said that the KEYNOTE-A18 study is a landmark immunotherapy study in the field of cervical cancer.

The approval of pembrolizumab for a new indication in the treatment of locally advanced cervical cancer, which is the first cervical cancer indication for pembrolizumab approved within China, once again highlights our leading position in the field of oncology treatment.

DengYueMed will continue to explore the frontiers of tumour therapy and innovate treatment options to benefit more cancer patients.

References:

[1] ZHENG Rongshou, CHEN Ru, HAN Bingfeng, et al. Analysis of the prevalence of malignant tumors in China in 2022 [J]. Chinese Journal of Tumor, 2024, 46(6): 221-231.

[2] Monk BJ, Tan D, Hernández Chagüi JD, et al. Proportions and incidence of locally advanced cervical cancer: a global systematic literature review [J]. Int J Gynecol Cancer, 2022, 32(12):1531-1539.

[3] Jiang P, Liu Z, Wei Lichun, et al. Chinese expert consensus on targeted and immunologic drugs combined with simultaneous radiotherapy for locally advanced cervical cancer [J]. Chinese Journal of Radiation Oncology, 2024, 33(10):893-901.

[4] ZHOU Li, LU An-Wei. Controversies and countermeasures in the treatment of locally advanced cervical cancer [J]. Chinese Journal of Practical Gynecology and Obstetrics, 2019, 35(10):1116-1119.

[5] Domenica Lorusso , Yang Xiang , Kosei Hasegawa, et al. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomized, double-blind, phase 3 clinical trial[J]. Lancet. 2024 Apr 6;403(10434):1341-1350. doi: 10.1016/S0140-6736(24)00317-9. Epub 2024 Mar 20.

However, DengYueMed offers this information as a guide, not a substitute for professional medical advice. Consult your doctor before any treatment.