Tagitanlimab Plus Chemotherapy Receives Chinese Approval for Recurrent/Metastatic Nasopharyngeal Cancer

The Chinese National Medical Products Administration (NMPA) has granted marketing authorization to the PD-L1–directed innovative humanized monoclonal antibody tagitanlimab (formerly KL-A167) for use in combination with cisplatin and gemcitabine for the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).1

The approval is based on data from a randomized, double-blinded, placebo-controlled, multicenter phase 3 trial (NCT05294172) in which treatment with tagitanlimab plus cisplatin and gemcitabine led to a median progression-free survival (PFS) that was not reached vs 7.9 months with placebo plus chemotherapy (HR, 0.47; 95% CI, 0.33-0.66; P < .0001). The median overall survival (OS) is not yet mature, but a trend in favor of the investigational regimen has been observed (HR, 0.62; 95% CI, 0.32-1.22).

The objective response rate (ORR) was also improved with the addition of tagitanlimab, at 81.7% vs 74.5% with placebo plus chemotherapy. The median duration of response (DOR) was also prolonged in the investigational arm, at 11.7 months vs 5.8 months with placebo plus chemotherapy (HR, 0.48; 95% CI, 0.32-0.70). The safety profile was also manageable.

“We are pleased that the second indication of our self-developed PD-L1 monoclonal antibody was successfully approved for marketing and demonstrated statistically significant and clinically meaningful improvements in PFS,” Micheal Ge, PhD, CEO of Kelun-Biotech said in a news release. “For domestic [patients with] NPC, tagitanlimab has realized a breakthrough in therapeutic coverage and innovation from the backline to the frontline, which once again strongly validates the excellent strength of Kelun-Biotech’s new drug research and development. In the future, the company will always be based on unmet clinical needs, source innovation, and explore more and more excellent clinical therapeutic solutions to benefit more patients.”

Previously, the NMPA approved the marketing application for tagitanlimab in China as monotherapy for the treatment of patients with recurrent or metastatic NPC whose disease has progressed after prior chemotherapy in the second-line setting.2 This approval was based on data from a single-arm, multicenter phase 2 trial (NCT03848286) in which treatment with single-agent tagitanlimab led to an independent review committee (IRC)–assessed ORR of 26.5% (95% CI, 19.2%-34.9%) in patients with recurrent or metastatic NPC following at least 2 prior lines of therapy (n = 132) at a median follow-up of 21.7 months (95% CI, 19.8-22.5).2,3 The median DOR was 12.4 months (95% CI, 6.8-16.5), and the median OS was 16.2 months (95% CI, 13.4-21.3).3

Notably, grade 3 immune-related adverse effects (AEs) occurred in 3.9% of patients, and no grade 4 or 5 immune-related AEs occurred.

The phase 3 trial, upon which the second indication was granted, enrolled patients between the ages of 18 and 75 years who had received a definitive histologic or cytologic diagnosis of recurrent or metastatic NPC.4 Patients had to have either distant metastasis at the time of initial diagnosis, defined as stage IVB NPC according to the 8th Edition of the staging system of the Union for International Cancer Control and American Cancer Joint Committee, or local recurrence and/or distant metastasis more than 6 months after the end of prior radical treatment. Patients could not have received prior systemic treatment for recurrent or metastatic NPC, and those with local recurrence could not suitable for local treatment or have been treated locally.

In addition to an ECOG performance status of 0 or 1, patients needed to have at least 1 measurable lesion according to RECIST 1.1 criteria, adequate organ function, and the ability to provide tissues or tissue specimens for biomarker analysis during screening.

The primary end point of the trial is IRC-assessed PFS. Secondary end points include investigator-assessed PFS, ORR, disease control rate, DOR, OS, and time to response.

References

1. Kelun-Biotech’s product tagitanlimab approved for marketing in second indication in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC. News release. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. January 23, 2025. Accessed January 23, 2025. https://www.prnewswire.com/news-releases/kelun-biotechs-product-tagitanlimab-approved-for-marketing-in-second-indication-in-combination-with-cisplatin-and-gemcitabine-for-the-first-line-treatment-of-patients-with-recurrent-or-metastatic-npc-302358194.html
2. Kelun-Biotech’s anti-PD-L1 (tagitanlimab) receives NMPA approval for marketing. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. December 31, 2024. Accessed January 23, 2025. https://www.kluspharma.com/news/kelun-biotech's-anti-pd-l1-(tagitanlimb)-receives-nmpa-approval-for-marketing
3. Shi Y, Qin X, Peng X, et al. Efficacy and safety of KL-A167 in previously treated recurrent or metastatic nasopharyngeal carcinoma: a multicenter, single-arm, phase 2 study. Lancet Reg Health West Pac. 2022;31:100617. doi:10.1016/j.lanwpc.2022.100617
4. KL-A167 injection combined with cisplatin and gemcitabine vs placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma. ClinicalTrials.gov. Updated October 23, 2023. Accessed January 23, 2025. https://clinicaltrials.gov/study/NCT05294172