Tislelizumab Approved for First-Line in ESCC
The US Food and Drug Administration has approved tislelizumab (Tevimbra, BeiGene), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express programmed death ligand-1 (PD-L1; ≥ 1). The new approval is the Chinese immune checkpoint inhibitor’s third within a year. Tislelizumab was
The US Food and Drug Administration has approved tislelizumab (Tevimbra, BeiGene), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express programmed death ligand-1 (PD-L1; ≥ 1).
The new approval is the Chinese immune checkpoint inhibitor’s third within a year.
Tislelizumab was previously approved for unresectable/metastatic ESCC in the second line after chemotherapy in patients who have not had a PD-L1 inhibitor. Tislelizumab also carries a first-line gastric/gastroesophageal junction adenocarcinoma indication in combination with chemotherapy for PD-L1 positive tumors.
Two competing checkpoint inhibitors, pembrolizumab (Keytruda) and nivolumab (Opdivo), also carry first-line gastric cancer and first- and second-line unresectable/metastatic esophageal cancer indications.
The new approval is based on BeiGene’s RATIONALE-3src6 trial in 481 adults with PD-L1 positive unresectable, locally advanced recurrent, or metastatic ESCC, according to a statement from the manufacturer. Median overall survival was 16.8 months when tislelizumab was added to upfront chemotherapy vs 9.6 months, translating to a 34% reduction in the risk for death with the drug combination.
The most common adverse events with tislelizumab, occurring in 2src% or more of RATIONALE-3src6 subjects, were anemia, fatigue, decreased appetite, nausea, constipation, decreased weight, diarrhea, peripheral sensory neuropathy, vomiting, and stomatitis. Two percent or more developed pneumonia, dysphagia, diarrhea, fatigue, and esophageal stenosis.
The recommended dose is 2srcsrc mg IV once every 3 weeks. The cost is $5713.67 for 1src mL of a 1src mg/mL IV solution, according to drugs.com.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com.
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