FDA Approves New Test for Identifying PD-L1 Expression in Non-Small Cell Lung Cancer

Strategic Insights -

Agilent's Dako subsidiary, a worldwide provider of cancer diagnostics, has announced that the U.S. Food and Drug Administration (FDA) has approved a new test for identifying PD-L1 expression levels on the surface of non-small cell lung cancer tumor cells. The test, known as PD-L1 IHC 28-8 pharmDx, was developed in collaboration with Bristol-Myers Squibb, the maker of the immunotherapy treatment OPDIVO. This approval comes after the successful use of the diagnostic in the Phase 3 CheckMate 057 trial, where OPDIVO demonstrated superior overall survival in patients with previously treated metastatic non-squamous NSCLC compared to chemotherapy.

Key Takeaways:

  • The FDA has approved a new test, PD-L1 IHC 28-8 pharmDx, developed by Dako, which can identify PD-L1 expression levels on non-small cell lung cancer tumor cells and provide information on the survival benefit with OPDIVO.
  • The test was used to assess PD-L1 expression in the Phase 3 CheckMate 057 trial, where OPDIVO demonstrated superior overall survival in patients with previously treated non-squamous NSCLC.
  • The FDA has expanded the indication for OPDIVO to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication.
  • Dako developed the diagnostic through a collaboration with Bristol-Myers Squibb, the maker of OPDIVO.
  • Lung cancer is the leading cause of cancer-related deaths worldwide, with a one-year overall survival in the second-line treatment of NSCLC at about 26 percent.
  • Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group, expressed excitement about Agilent's involvement in advancements in immuno-oncology and the potential of the PD-L1 IHC 28-8 pharmDx in helping provide information to oncologists.
  • Michael Giordano, senior vice president and head of Development, Oncology at Bristol-Myers Squibb, mentioned the leadership in cancer innovation and commitment to advancing research evaluating the potential role of PD-L1 in multiple tumor types.

Statistics:

  • The one-year overall survival in the second-line treatment of NSCLC has been about 26 percent historically.
  • 203 patients with previously treated non-squamous NSCLC were enrolled in the Phase 3 CheckMate 057 trial.
  • 91 percent of patients in the OPDIVO arm and 74 percent in the chemotherapy arm remained alive at 10 months.
  • OPDIVO is approved by the FDA for the treatment of all patients with previously treated NSCLC.

Sources:

  • "Dako Announces FDA Approval of New Diagnostic Test for Non-Small Cell Lung Cancer." Dako, 2022.
  • "Bristol-Myers Squibb and Agilent's Dako Announce FDA Approval of Opdivo for the Treatment of Non-Small Cell Lung Cancer." Bristol-Myers Squibb, 2022.
  • "OPDIVO (nivolumab).") Dako, 2022.
  • "PD-L1 IHC 28-8 pharmDx." Dako, 2022.