Tislelizumab Approved By China NMPA for Recurrent or Metastatic Nasopharyngeal Cancer


Based on results of the phase 3 RATIONALE-309 trial, the China National Medical Products Administration has approved tislelizumab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal cancer.

The China National Medical Products Administration had approved tislelizumab plus chemotherapy for first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC), according to a press release from BeiGene.1

The approval is based on results from the phase 3 RATIONALE-309 trial (NCT03924986) that investigated tislelizumab plus chemotherapy or matched placebo.2 The primary end point of progression-free survival (PFS) was met at the planned interim analysis.

“NPC is one of the most common head and neck cancers in China and many parts of Asia. Treatment options have been limited, with chemotherapy primarily provided for front-line care. On behalf of these patients, today’s approval of tislelizumab, a potentially differentiated checkpoint inhibitor, for patients with recurrent or metastatic NPC could provide new hope,” Mark Lanasa, MD, PhD, chief medical officer of Solid Tumors at BeiGene, said in the press release. “We look forward to bringing this important immunotherapy to the underserved patient community in China.”

At the median follow-up of 15.5 months, the median PFS in the tislelizumab arm was 9.6 months vs 7.4 months in the placebo arm (HR, 0.50; 95% CI, 0.37-0.68). Neither median PFS after the next line of treatment (PFS2) nor overall survival (OS) were reached compared with 13.9 months (HR, 0.38; 95% CI, 0.25-0.58) and 23.0 months (HR, 0.60; 95% CI, 0.35-1.01), respectively, in the placebo group.

At 6 months, the OS rates in the tislelizumab and placebo groups were 95.3% (95% CI, 89.9%-97.9%) and 97.6% (95% CI, 92.9%-99.2%), respectively; at 9 months, rates were 94.5% (95% CI, 88.8%-97.3%) and 92.6% (95% CI, 86.3%-96.1%); and at 12 months, they were 89.6% (95% CI, 82.8%-93.8%) and 86.4% (95% CI, 78.8%-91.5%).

Additionally, rates of PFS 2 at 6 months were 95.3% (95% CI, 89.8%-97.9%) and 94.4% (95% CI, 88.6%-97.3%); 93.6% (95% CI, 87.7%-96.8%) and 82.4% (95% CI, 74.3%-88.2%) at 9 months; and 83.4% (95% CI, 75.4%-88.9%) and 62.6% (95% CI, 53.1%-70.8%) at 12 months in the tislelizumab and placebo groups, respectively.

“In the pivotal Phase 3 RATIONALE-309 trial, comparing 2 arms of patients receiving either tislelizumab in combination with standard chemotherapy or a placebo with standard chemotherapy, we observed statistical and clinically meaningful improvement in progression-free survival in the tislelizumab arm as assessed by both independent review committee and clinical investigators, and a positive trend in overall survival. These results were consistent with the updated survival data with a follow-up time of 15 months, and tislelizumab was generally well tolerated,” Li Zhang, MD, professor at the Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China and Sun Yat-sen University Cancer, and the principal investigator of the trial concluded.


  1. China NMPA approves tislelizumab for recurrent or metastatic nasopharyngeal cancer. News Release. BeiGene. June 10, 2022. Accessed June 13, 2022. https://bwnews.pr/3mGjkDd
  2. Zhang L, Yang Y, Pan J, et al. RATIONALE-309: updated PFS, PFS2, and OS from a phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy as first-line treatment for recurrent/metastatic nasopharyngeal cancer. American Society of Clinical Oncology Plenary Series: April 2022 Session. April 19, 2022. Accessed April 19, 2022.

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