Highlights of this article
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Navulizumab (nivolumab, trade name Ondivol) is a new immunotherapy drug that is a PD-1 (or programmed cell death receptor-1, programmed death-1) inhibitor that blocks PD-1 on the surface of T lymphocytes from binding to its ligand, thereby enhancing the tumor-killing effect of lymphocytes.
Navulizumab was approved in Japan for gastric cancer and is also available in China
In July 2014, Japan was the first to approve a marketing application for nabolutumab, and in December of the same year, the United States also approved its marketing. in June 2018, nabolutumab, a new immune drug, was launched in China. Although the drug is not currently approved for gastric cancer in either China or the U.S., in September 2017 Japan approved nabolutumab for the treatment of unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy. This also gives us hope that the drug could potentially be used in patients with gastric cancer in China.
Navulizumab extends survival in advanced gastric cancer after second-line treatment
Navulizumab was approved for gastric cancer in Japan based on the results of a study called ATTRACTION-2. The study, conducted in Japan, Korea, and Taiwan, enrolled patients with unresectable advanced or recurrent gastric or gastroesophageal junction cancer who were resistant or intolerant to at least two chemotherapy regimens, and nabritumomab significantly extended overall survival (OS) by more than 1 month (from 4.14 months to 5.26 months), and nabritumomab reduced the risk of death by The risk of death was reduced by 37% with 26.2% of patients still alive at 12 months.
The safety profile of nabumetumab in patients with gastric cancer is consistent with the safety profile previously demonstrated in other solid tumor studies, with moderate-to-severe treatment-related adverse events in patients treated with nabumetumab including diarrhea, malaise, decreased appetite, fever, and elevated transaminases [including elevated aspartate aminotransferase (AST) and elevated alanine aminotransferase (ALT)].
Can patients with gastric cancer in China get on nabolutumab?
Navulizumab is not currently approved for the treatment of gastric cancer in China, but clinical studies are underway. From the China Drug Clinical Trial Registration and Information Publication Platform (http://www.chinadrugtrials.org.cn/), we know that a phase III clinical trial (registration number CTR20170371) is enrolling patients with advanced or metastatic gastric cancer or gastroesophageal union cancer who are PD-L1 positive and may receive nabumetinumab in the study. Patients must be PD-L1 positive and may be treated with either nabumab in combination with Ipilimumab or chemotherapy. As the evidence accumulates, it is believed that patients with gastric cancer in China may also have access to nabritumomab.
However, it is also important to recognize that immunotherapy is not available for all patients. The PD-L1 expression test is usually required before immunotherapy is selected, but it does not cover all patients who are sensitive to immunotherapy, and researchers are exploring better metrics to screen for the right population for immunotherapy, so that the right people can get the benefits they deserve.
Summary
Navulizumab, a new immunotherapy agent, has been approved in Japan for the second-line treatment of unresectable advanced or recurrent gastric cancer and is also available in China. With the unveiling of the results of the study in our patients, it is expected that our gastric cancer patients will also have an additional treatment option.