Opinion ID: 6322310
Heading Depth: 2
Heading Rank: 1

Heading: Opdivo and the Clinical Trial

Text: In 2009, Bristol-Myers acquired a pharmaceutical company developing a drug called “nivolumab,” subsequently marketed as Opdivo. Opdivo is a type of immuno-oncology treatment referred to as a PD-1 checkpoint inhibitor, which treats various types of cancer by allowing the patient’s immune system to fight the cancer directly. Some cancer cells have PD-L1 proteins that bind with PD-1 proteins present on immune-system T-cells, preventing the immune system from combatting the tumor. PD-1 checkpoint inhibitors block this interaction. Research on PD-1 checkpoint inhibitors shows that the level of PD-L1 present in a patient’s cancer cells, referred to as “expression” and rendered as a percentage, 8 is positively correlated with the efficacy of PD-1 checkpoint inhibitors as a cancer treatment. The higher a patient’s PD-L1 expression, the more effective a checkpoint inhibitor should be in treating the cancer. After acquiring Opdivo, Bristol-Myers explored the drug’s efficacy in treating several cancers, including non-small cell lung cancer (“NSCLC”), the most common form of lung cancer in the United States. The drug’s use as a treatment for NSCLC was widely considered the most profitable potential use for PD-1 checkpoint inhibitors. A clinical study, announced on January 19, 2014, was commissioned to test Opdivo’s efficacy as a first-line treatment of NSCLC. Bristol-Myers’s announcement, published on ClinicalTrials.gov, stated that the Opdivo trial would focus on results among patients “strongly” expressing PDL1. 2 Over the course of the study, Bristol-Myers regularly updated the ClinicalTrials.gov description without specifying the percentage of expression. 2 The putative class period begins on January 27, 2015, when Bristol-Myers updated the trial data on ClinicalTrials.gov without adjusting the description of the primary patient population as those strongly expressing PD-L1, and ends on October 9, 2016, when Bristol-Myers shared full data from the trial for the first time. 9 On August 5, 2016, Bristol-Myers announced that the Opdivo trial failed to meet its primary goal--i.e., the drug did not show better results than chemotherapy in those “strongly” expressing PD-L1. The same announcement disclosed that the company defined “strong” expression in the Opdivo trial as 5% or greater PD-L1 expression. Over the following months, Bristol-Myers and investment analysts attributed the study’s failure to the selection of 5% as the threshold for strong PD-L1 expression.