Editor’s Note : Nasopharyngeal carcinoma (NPC) is a malignancy with high prevalence in Southern China and other Southeast Asian countries, imposing a significant disease burden. Treatment options for recurrent/metastatic NPC (R/M NPC) remain limited. In recent years, immune checkpoint inhibitors (ICIs) have brought new hope to this patient population, and domestically developed ICIs in China have demonstrated promising efficacy.At the 2025 ASCO Annual Meeting, Professor Haiqiang Mai from Sun Yat-sen University Cancer Center presented encouraging results from a Phase III study evaluating Tagitinlimab (a PD-L1 inhibitor developed in China) in combination with gemcitabine and cisplatin (GP) for first-line treatment of R/M NPC. In an interview with Oncology Frontier, Prof. Mai discussed the key findings and clinical implications of the study.
Oncology Frontier: Could you give us an overview of the current treatment landscape for recurrent/metastatic NPC (R/M NPC)? What role have immune checkpoint inhibitors played in this space?
Prof. Haiqiang Mai, Sun Yat-sen University Cancer Center: NPC is a malignancy with distinctive regional characteristics, often referred to as having “Chinese features.” Globally, there are over 130,000 new cases of NPC each year, with more than 70% occurring in East Asia, Southeast Asia, and North Africa—over half of which are in China, particularly Southern China.
NPC is generally sensitive to radiotherapy and chemotherapy, making chemoradiotherapy (CRT) the cornerstone of treatment. However, approximately 10%–30% of patients still experience local recurrence or distant metastasis due to radioresistance, chemoresistance, or other factors.
For R/M NPC, the standard first-line regimen remains gemcitabine plus cisplatin (GP). Yet, clinical outcomes are modest, with a median progression-free survival (PFS) of only 7.0 months and median overall survival (OS) of 1 to 2 years. This underscores the urgent need for new therapies to better control disease and improve survival outcomes.
NPC is often associated with chronic EBV infection, leading to a tumor microenvironment rich in lymphocyte infiltration and elevated PD-L1 expression—suggesting potential sensitivity to immunotherapy.
In recent years, PD-1/PD-L1 inhibitors have shown breakthrough progress in R/M NPC, with several Phase III trials exploring their use in both first-line and later-line settings. These advances have led to inclusion in domestic and international clinical guidelines.
Developing Chinese-origin immunotherapies with high efficacy, favorable safety profiles, and better accessibility could offer more options for R/M NPC patients and address unmet clinical needs.
Oncology Frontier: Tagitinlimab is a domestically developed PD-L1 monoclonal antibody now approved in China for the treatment of R/M NPC. At this year’s ASCO, results from a randomized trial (Abstract #6004) evaluating Tagitinlimab plus GP were presented. Could you walk us through the major findings—particularly regarding efficacy and safety?
Prof. Haiqiang Mai: Tagitinlimab is a PD-L1 immune checkpoint inhibitor developed in China. It was engineered using site-directed mutagenesis to optimize the Fc domain, eliminating ADCC and CDC effects. The drug offers high stability and low immune escape, making it a promising therapeutic option.
A prior Phase II study published in The Lancet Regional Health – Western Pacific demonstrated that in heavily pretreated R/M NPC patients with high tumor burden (43.9% with liver metastases; 31.8% had ≥3 prior lines of therapy), Tagitinlimab monotherapy achieved an objective response rate (ORR) of 26.5%. Median PFS and OS were 2.8 and 16.2 months, respectively, with good safety.
Building on this, we conducted a Phase III trial to evaluate the efficacy and safety of Tagitinlimab in combination with GP as a first-line therapy in R/M NPC.
At ASCO, we presented the interim results:
- The trial met its primary endpoint. Compared with chemotherapy alone, the Tagitinlimab + GP group showed significantly prolonged PFS (not reached vs. 7.9 months), with a 53% reduction in the risk of progression or death (HR 0.47; 95% CI: 0.33–0.66; one-sided P < 0.0001).
- Subgroup analyses showed consistent benefit across different patient populations.
Regarding tumor response:
- The ORR in the combination group was higher than that of chemotherapy alone (81.7% vs. 74.5%).
- Median duration of response (DoR) was nearly doubled (11.7 vs. 5.8 months; HR 0.48; 95% CI: 0.32–0.70).
While OS data are still maturing, the current analysis suggests a trend toward benefit, with a 38% reduction in mortality risk (HR 0.62; 95% CI: 0.32–1.22). Safety was consistent with previous studies, and treatment was well tolerated.
Oncology Frontier: Given these results, how do you see Tagitinlimab influencing clinical practice for NPC? Are there future directions worth exploring?
Prof. Haiqiang Mai: Based on the Phase II study, Tagitinlimab was approved by the National Medical Products Administration (NMPA) of China in December 2024 for the treatment of R/M NPC patients who failed at least two prior lines of chemotherapy. This marked the world’s first regulatory approval of a PD-L1 monoclonal antibody for NPC.
In January 2025, following the results of this Phase III study, the NMPA further approved Tagitinlimab in combination with cisplatin and gemcitabine as first-line treatment for R/M NPC.
This approval completes a full treatment pathway for R/M NPC—from first-line combination therapy to later-line monotherapy—positioning Tagitinlimab as a key player in the clinical management of NPC in China. It holds great promise for improving patient outcomes.
There are still several research avenues worth pursuing. For example, in prior PD-1 inhibitor studies, high PD-L1 expression was considered a predictive biomarker. Interestingly, in our current study, Tagitinlimab combined with chemotherapy demonstrated consistent PFS benefits regardless of PD-L1 expression level. The underlying mechanisms deserve further investigation.
This study also revealed that early clearance of EBV DNA after one cycle of therapy correlated with better PFS (12.2 vs. 6.9 months; HR 0.46), suggesting a potential biomarker for immunotherapy response.
It will also be valuable to explore whether other biomarkers—such as TILs, TMB, and dMMR/MSI-H—hold predictive value for Tagitinlimab in NPC. We look forward to more exploratory analyses and translational research in this area.
Lastly, there’s growing interest in combining Tagitinlimab with radiotherapy or antibody-drug conjugates (ADCs). Whether these combinations can further improve outcomes is another important direction for future investigation.
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Professor (Second-Tier Professor), Chief Physician (First-Class), Doctoral Supervisor Assistant Director, Sun Yat-sen University Cancer Center Director, Department of Nasopharyngeal Carcinoma Vice President, Gansu Hospital, Sun Yat-sen University Cancer Center
National Recognition and Awards:
- Recipient, National Science Fund for Distinguished Young Scholars
- Leading Talent in Scientific and Technological Innovation, National Ten-Thousand Talents Program
- Leading Talent in Scientific and Technological Innovation, Ministry of Science and Technology
- Outstanding Young Talent, Ministry of Education “New Century” Program
- Leading Talent in Science and Technology Innovation, Guangdong Province
- Leading Talent in Medical Science, Guangdong Province
Academic and Professional Roles:
- Chair, Committee on Integrated Rehabilitation of Nasopharyngeal Carcinoma, Chinese Anti-Cancer Association
- Deputy Chair, Expert Committee on Quality Control of Nasopharyngeal Carcinoma, National Cancer Center of China
- Academic Committee Member, Proton Therapy Center, MD Anderson Cancer Center (USA)
- Executive Member, Youth Council, Chinese Anti-Cancer Association
- Standing Member, Expert Committee on Nasopharyngeal Carcinoma, Chinese Society of Clinical Oncology (CSCO)
- Chair, Committee on Precision Therapy for Nasopharyngeal Carcinoma, Guangdong Clinical Medicine Society
- Chair-elect, Committee on Precision Oncology, Guangdong Medical Association
- Standing Member, Professional Committee on Nasopharyngeal Carcinoma, Chinese Anti-Cancer Association
- Member, Nasopharyngeal Carcinoma Group, Chinese Medical Association – Radiation Oncology Branch
- Standing Member, Committee on Precision Radiotherapy Technology, Chinese Society of Biomedical Engineering
- Standing Member, Committee on Ion Radiation Therapy, Chinese Society for Medical Equipment
