Adding Tislelizumab to Chemotherapy Showed Improved PFS in Nasopharyngeal Cancer in Phase III Study

For immediate release
April 18, 2022


Rachel Facci

ASCO Expert Perspective 
“This study demonstrates that the addition of tislelizumab to chemotherapy extended survival for patients with recurrent or metastatic nasopharyngeal cancer and the combination provides another treatment option for patients affected by this disease.” 
Sharon Spencer, MD, ASCO Expert in Nasopharyngeal Cancer

The addition of tislelizumab to chemotherapy showed statistical and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy alone in patients with recurrent/metastatic nasopharyngeal cancer. These findings will be presented during the ASCO Plenary Series session taking place April 19, 2022, at 3:00 p.m. ET.   

Nasopharyngeal cancer is a type of head and neck cancer that originates in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. It has a higher occurrence in certain parts of Southeast Asia, the Middle East, and North Africa. The current standard treatment for recurrent or metastatic nasopharyngeal cancer is a combination of chemotherapies gemcitabine plus cisplatin. When this study began, tislelizumab had been approved in China for the treatment of other types of cancer, both alone and in combination with chemotherapy.

In the RATIONALE-309 study, 263 patients were randomized 1:1 to receive either tislelizumab in combination with standard chemotherapy or a placebo in combination with standard chemotherapy. There was an observed improvement of median PFS in the tislelizumab plus chemotherapy arm (9.6 months) compared to the placebo + chemotherapy arm (7.4 months), with a 50% lower risk of disease progression. Median PFS after next line of treatment (PFS2) and overall survival (OS) were not yet reached for the tislelizumab + chemotherapy arm. In the placebo + chemotherapy arm, PFS2 was 13.9 months and OS was 23 months.

The combination of tislelizumab with chemotherapy was generally well tolerated and had a comparable safety profile compared with placebo plus chemotherapy.  

“These findings support the use of tislelizumab in combination with chemotherapy as a potential standard-of-care as first line therapy in recurrent or metastatic nasopharyngeal cancer,” said Lead Principal Investigator 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. 

This research was funded by BeiGene, Ltd. 

Watch the session  

View the abstract 

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