Less than two weeks after BeiGene won approval in China for tislelizumab in esophageal cancer, its Western partner, Novartis, is announcing data that it hopes will lead to endorsements for the PD-1 checkpoint inhibitor in the U.S. and Europe.
A phase 3 study of 649 patients comparing tislelizumab plus chemotherapy to chemotherapy alone showed that the immuno-oncology med met its primary objective, “significantly” improving the chance for survival in those with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.
Novartis didn’t quantify the survival benefit but said that it would submit the data to regulatory authorities and along with BeiGene will report the results more thoroughly at an “upcoming medical meeting.”
A five-year survival rate of 5% for metastatic cases underscores “the urgency for more immunotherapy options,” Jeff Legos, Novartis’ EVP, Global Head of Oncology & Hematology Development, said in a release.
ESCC is the most common type of esophageal cancer, which is the sixth-leading cause of cancer deaths, claiming an estimated 544,000 worldwide in 2020. The annual toll in the U.S. is roughly 20,000 new cases and 16,000 deaths, the company said.
The FDA and European Medicines Agency are already reviewing tislelizumab for advanced or metastatic ESCC as a second-line treatment following chemo. The target date for approval in the U.S. is July 12.
In addition, the EMA is considering tislelizumab in advanced or metastatic non-small cell lung cancer after prior chemotherapy and also for those who have not been previously treated in combination with chemo.
Novartis is evaluating tislelizumab in 14 trials across an array of solid tumor types. The trials involve 8,800 patients enrolled in 35 countries.
After coming up short with its own PD-1 cancer candidate, spartalizumab, Novartis paid BeiGene $650 million up front and committed $1.55 billion in potential milestone payments to get in on tislelizumab.
Earlier this month, China approved the drug as a second-line treatment for ESCC. It was the eighth approval BeiGene has won for tislelizumab in its home country, including several for NSCLC. Its first came in 2019 for Hodgkin lymphoma, followed by a nod in bladder cancer.