Express first-line treatment of esophageal cancer, two immune combination therapies of BMS are expected to add additional indications

▎ WuXi AppTec content team editor September 27, 2021, Bristol Myers Squibb (Bristol Myers Squibb) announced that based on the positive results of phase 3 clinical trials, the US FDA has accepted its PD-1 inhibitor nivolumab, Dual immunotherapy with CTLA-4 inhibitor ipilimumab; and supplementary biological product license application (sBLA) for the combination therapy of nivolumab combined with fluorouracil and platinum-containing chemotherapy for the first-line treatment of advanced unresectable Recurrent, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
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Nivolumab (Nivolumab, the English trade name is Opdivo) targets PD-1, which can help the body restore the anti-tumor immune response
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Ipilimumab (ipilimumab, Yervoy in English) targets CTLA-4
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CTLA-4 antibody enhances tumor killing ability by enhancing T cell activity
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This product is the world's first CTLA-4 antibody drug approved for marketing
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This application is based on the results of a pivotal Phase 3 clinical trial.
The primary endpoint is the patient's overall survival (OS) and progression-free survival (PFS)
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The trial showed that in patients with advanced unresectable/metastatic ESCC with tumor cell PD-L1 expression ≥1% and all randomized populations, compared with the chemotherapy control group, nivolumab plus ipilimumab, or sodium Wuliyuumab plus chemotherapy both showed statistically significant and clinically significant overall survival (OS) benefits
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The press release states that the nivolumab/ipilimumab combination is the first dual immunotherapy combination in this patient group that has demonstrated superior survival benefits over chemotherapy
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In addition, the safety profile of the combination therapy is consistent with the safety profile of the single agent
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Esophageal cancer is the eighth most common cancer and the sixth leading cause of cancer deaths in the world.
There will be approximately 600,000 new cases and more than 540,000 deaths in 2020
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The most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively
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"Thousands of patients die from this very aggressive disease, so other treatment options are urgently needed to improve patient outcomes
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" said Dr.
Ian M.
Waxman, head of gastrointestinal cancer development at Bristol-Myers Squibb.
"We believe that, Combinations based on immunotherapy can provide further clinical benefits and address this critical need
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"Reference: [1] US Food and Drug Administration Accepts Bristol Myers Squibb's Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma.
Retrieved September 27, 2021, from https:// Progress in medical and health research
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This article is not a treatment recommendation
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