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  "documentTitle": "Bristol-Myers Squibb Company (BMY)",
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  "presentationDate": "2019-03-18 00:00:00",
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      "text": "The level of PD-L1 expression would be a key focus when analyzing CHECKMATE-026",
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      "text": "Immuno-oncology, or cancer therapies that harness the body's immune system to attack cancer cells, was considered the next significant opportunity in the pharmaceutical industry, with the potential to replace chemotherapy as the standard of care.",
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      "text": "~25% of cancer patients have cancerous cells that exhibited a level of 50% PD-L1 expression.",
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      "text": "However, only a certain subset of cancer patients express any PD-L1.",
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      "text": "While Bristol-Myers took an early lead in the race to bring PD-1 inhibitors to market with its 2014 approval of OPDIVO in Japan for the treatment of melanoma (skin cancer), the lead was short-lived, as Merck received an earlier than expected first US FDA approval of KEYTRUDA for the treatment of melanoma later in 2014.",
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      "text": "A 50% PD-L1 expression level was widely considered to be \"strong\" and increased the likelihood that the cancer patient would react positively to PD-1 inhibitors.",
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      "text": "PD-1 checkpoint inhibitors, like OPDIVO and Merck's KEYTRUDA, block the interaction between PD-1 and PD-L1.",
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      "text": "One immune system checkpoint involves the interaction between two proteins: PD-1 and PD-L1.",
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      "text": "Conversely, research suggested that mere PD-L1 positivity (e.g. 5% PD-L1 expression) alone was insufficiently predictive of a successful reaction to PD-1 inhibitors.",
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      "text": "One of the most promising IO treatments revolves around PD-1 \"checkpoint inhibitors\". Essentially, the body's immune system has a braking mechanism, referred to as a \"checkpoint\", to prevent immune system responses to self-markers. Without this checkpoint, autoimmune disease could flourish.",
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      "text": "Bristol-Myers was considered the leader in immuno-oncology heading into CHECKMATE-026.",
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      "kind": "source-note",
      "text": "Source: Public company filings, Wall Street research, Jennifer Tung, et al. v. Bristol-Myers Squibb Company, et al. lawsuit, Bloomberg.",
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      "text": "Where Did CHECKMATE-026 Go Wrong?",
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