Earlier research has shown "robust responses" when the drug, a monoclonal antibody with high binding affinity to the PD-1 receptor, is added to platinum-based chemotherapy in patients with advanced lung cancer, Dr. Jie Wang of the Chinese Academy of Medical Sciences and Peking Union Medical College, in Beijing, and colleagues note in JAMA Oncology.
Tislelizumab is approved in China for certain patients with non-small-cell lung cancer, classical Hodgkin's lymphoma and metastatic urothelial carcinoma.
The researchers conducted an open-label, randomized phase-3 clinical trial involving 355 patients with a median age of 62 years. All were treatment-naive and had histologically confirmed stage IIIB/IV disease.
They were randomized to one of three regimens intravenously every three weeks: tislelizumab plus paclitaxel and carboplatin or tislelizumab plus nab-paclitaxel and carboplatin or paclitaxel and carboplatin. Randomization was stratified by disease stages and level of tumor cell PD-L1 expression.
Follow-up was for a median of 8.6 months and the primary endpoint was progression-free survival (PFS) assessed by an independent review committee (IRC). IRC-assessed PFS was significantly improved with tislelizumab plus chemotherapy, at 7.6 months in both of the tislelizumab groups compared to 5.5 months in those who received chemotherapy alone (P<0.001).
An IRC-assessed objective response rate (ORR) of more than 70% was seen in the triple-therapy groups and the duration of response was greater than eight months. The corresponding values for chemotherapy alone were 50% and just over four months. No association was observed between PD-L1 expression and IRC-assessed PFS or ORR.
Treatment-emergent adverse events occurred in nearly all patients and those leading to death were similar across all three arms. None were solely attributed to tislelizumab.
The results, say the researchers, "suggest that tislelizumab in combination with chemotherapy is an appropriate first-line treatment option in patients with advanced squamous non-small-cell lung cancer."
Dr. Raymond U. Osarogiagbon of the Baptist Cancer Center, in Memphis, Tennessee, author of an accompanying editorial, told Reuters Health by email, "Tislelizumab, in combination with standard platinum doublet chemotherapy, significantly delayed the worsening of advanced squamous cell lung cancer in this well-conducted randomized clinical trial in a Chinese population, suggesting that the results will likely be reproducible in non-Asian populations. Clinical trials in non-Asian populations are already afoot."
"Entry of a new, effective immune-checkpoint inhibitor into the lung-cancer-treatment arena can only help expand global access to these life-saving drugs, which remain beyond the reach of the worldwide mass of lung-cancer patients, especially those who live in low- and middle-income countries," Dr. Osarogiagbon added.
Dr. Ravi Salgia, chair of medical oncology at City of Hope, in Duarte, California, said, "This an important study in squamous-cell carcinoma of the lung. The combination of tislelizumab with chemotherapy had a better progression-free survival as compared to chemotherapy alone."
"As we go forward, it would be important to define a better biomarker so the right patient population can be selected," Dr. Salgia, who was not involved in the study, told Reuters Health by email. "As well, it would be good to have overall survival. However, this study is impactful, and hopefully, will be utilized in our clinical practice in the future."
The study was funded by BeiGene Ltd., which is developing the drug. Novartis announced in February that it will co-develop tislelizumab with BeiGene and expand access to patients in North America, Europe and Japan.
Dr. Wang did not respond to requests for comments.
By David Douglas
SOURCE: https://bit.ly/31PYcQz and https://bit.ly/2RcH9WT JAMA Oncology, online April 1, 2021.
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