Opdivo monotherapy for first-line lung cancer unable to meet primary endpoint of progression-free survival.
After the shocking clinical trial results reporting Opdivo’s failure to slow the progression of advanced lung cancer, Bristol-Myers Squibb commented on their popular selling drug.
In a press release, the company spoke of their developmental program in lung cancer designed to address the unmet needs of all lung cancer patients, making their scientific approach a “bold one.”
The CheckMate-026 trial was designed to examine the benefit of Opdivo monotherapy in a broad patient population. However, the trial was unable to meet its primary endpoint of progression-free survival in patients whose tumors expressed PD-L1 at ≥ 5%.
The first-line strategy also consists of the ongoing trial CheckMate-227, which explores the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.
“We believe that combination therapy may provide an important opportunity to address the needs of every patient with first-line lung cancer,” the company wrote in the press release. “Everyone at Bristol-Myers Squibb is relentless in our pursuit to defeat cancer and bring transformational medicines to patients who are waiting.”
In response to reports last week that Opdivo was not any better than standard chemotherapy as a first-line therapy in enhancing progression-free survival, the market shifted, with Bristol Myers stock dropping 16% by the end of the day.
Although the study did not produce the results the company had hoped for, CEO Giovanni Caforio told Forbes that despite the risk, the company took the high road in their Opdivo studies.
“Our strategy in lung cancer from the very beginning has been to answer a number of questions in order to really understand how to treat every patient with lung cancer regardless of histology or PD-1 expression or line of therapy,” Caforio said in the report. “… And the trial tells us that the role of monotherapy is likely to be limited to a very small subset of patients that express PD-L1 at very high levels, which is what we believe we know from a previous study that was reported not a long time ago.”