Merck's PD-1 Inhibitor Keytruda® Expands First-Line Indication for Head and Neck Squamous Cell Carcinoma in China

Shanghai, China,2025Year1Month13Day——MSD (the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, USA) announced that its PD-1 inhibitor Pembrolizumab (trade name: Keytruda)^®) has been approved by the China National Medical Products Administration (NMPA) as a monotherapy for the first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck whose tumors express PD-L1 (Combined Positive Score (CPS) ≥1) as assessed by a fully validated test. Previously, in December 2020, the NMPA approved pembrolizumab as a monotherapy for the first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck whose tumors express PD-L1 (Combined Positive Score (CPS) ≥20) as assessed by a fully validated test.

       "Over the past four years, pembrolizumab, as the only PD-1 inhibitor approved in China for first-line treatment of squamous cell carcinoma of the head and neck, has significantly impacted the treatment landscape for this malignant tumor."Anna Tian, Senior Vice President of MSD Global and President of MSD China"This approval expands the requirements for patients' PD-L1 expression status, which is expected to allow more patients with squamous cell carcinoma of the head and neck to benefit from innovative treatment options. This not only demonstrates MSD's continuous efforts in innovative research but also highlights our firm commitment to every patient."

       Head and neck tumors are one of the common malignant tumors in China, including a series of tumors occurring in the oral cavity, pharynx, larynx, salivary glands, nasal cavity, and paranasal sinuses.^[1],[2]The cancer disease burden data released by the National Cancer Center shows that in 2022, there were approximately 94,600 new cases of oral and laryngeal cancer in China, with a total of about 52,100 deaths.^[3]In head and neck malignant tumors, head and neck squamous cell carcinoma (HNSCC) is the most common pathological type, accounting for about 90%. At initial diagnosis, 70%-80% of patients with head and neck squamous cell carcinoma are already in locally advanced stages (Stage III or IV).^[4]The 5-year survival rate for recurrent or metastatic squamous cell carcinoma of the head and neck is less than 10%.^[4],[5]。

       "Since 2020, PD-1 inhibitors have brought significant breakthroughs in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck."Professor Guo Ye from Oriental Hospital Affiliated to Tongji University"We are very pleased to see that the indication for pembrolizumab has been expanded to include patients with PD-L1 CPS≥1, which is expected to bring new options to more patients and further advance the precise diagnosis and treatment of recurrent or metastatic squamous cell carcinoma of the head and neck."

       "Pembrolizumab provides a treatment option for Chinese patients suffering from head and neck squamous cell carcinoma with limited therapeutic choices."Dr. Zhengqing Li, Senior Vice President of MSD Global and President of MSD China R&D Center"We are very pleased to see that pembrolizumab has expanded its indications in the field of head and neck squamous cell carcinoma this time, highlighting MSD's outstanding achievements in cancer treatment research. We will continue to commit ourselves to promoting cutting-edge scientific research work and bringing innovative treatment options to more patients."

About MSD

       At MSD (the corporate name of Merck & Co., Inc. in the United States, based in Rahway, New Jersey), we work together to pursue a common goal: harnessing the power of cutting-edge science to save lives and improve health worldwide. For over 130 years, we have brought hope to humanity by developing vital medicines and vaccines. We are committed to being a leading research-intensive biopharmaceutical company — today, we stand at the forefront of innovation, delivering groundbreaking solutions to advance the prevention and treatment of diseases in humans and animals. We have built a diverse and inclusive global workforce, conducting business responsibly every day to ensure a safe, sustainable, and healthy future for all people and communities. For more information, visit www.msd.com and follow us on X (formerly Twitter), LinkedIn, and YouTube.

About MSD China

       China is a crucial part of MSD's global growth strategy. MSD’s China headquarters is located in Shanghai, with a research and development center in Beijing and manufacturing plants in Hangzhou, Ningbo, and Tianjin, integrating R&D, manufacturing, and commercial operations. With full dedication, we provide high-quality innovative medicines, vaccines, and services to the people of China, benefiting Chinese society. For more information, please visit MSD China's official website or follow MSD China's official social media account on WeChat.

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[1]Guo Ye, Zhang Chenping. Expert Consensus on Immune Checkpoint Inhibitor Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (2024 Edition)［J］. China Oncology, 2024, 34 (4): 425-438.

[2] Freddie Bray , Mathieu Laversanne , Hyuna Sung，et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin. 2024 May-Jun;74(3):229-263.

[3]Zheng Rongshou, Chen Ru, Han Bingfeng, et al. Analysis of the prevalence of malignant tumors in China in 2022[J]. Chinese Medical Journal, 2024, 46(3): 221-231.

[4]Editorial Board of Head and Neck Surgery Group, Chinese Journal of Otorhinolaryngology-Head and Neck Surgery; Head and Neck Surgery Group, Branch of Otorhinolaryngology-Head and Neck Surgery, Chinese Medical Association. Expert Consensus on Immune Checkpoint Inhibitor Treatment for Squamous Cell Carcinoma of the Head and Neck [J]. Chinese Journal of Otorhinolaryngology-Head and Neck Surgery, 2023, 58(11): 1061-1076.

[5] Guo Y, Luo Y, Zhang Q, et al. First‑line treatment with chemotherapy plus cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety results of the randomised, phase III CHANGE‑2 trial[J]. Eur J Cancer, 2021, 156: 35‑45.