Featured Content

Study demonstrates potential for prospective, biomarker-directed assessment to guide clinical trial enrollment

Many approved cancer therapies only benefit a subset of patients. For example, pembrolizumab treatment for patients with advanced non-small cell lung cancer (NSCLS) may fail due to differences in the tumor microenvironment. By profiling the genomic signatures unique to each patient’s cancer, treatment can be personalized to take advantage of available targeted and immune therapies.1  
The ongoing KEYNOTE-495/KeyImPaCT Phase II trial incorporates screening of validated biomarkers to prospectively evaluate the efficacy of novel pembrolizumab combination therapies for first-line treatment of advanced NSCLC.2,3,4 Patients were stratified into four subgroups representative of distinct biological properties based on T-cell-inflamed gene expression profile (TcellinfGEP) and tumor mutational burden (TMB) status, the latter of which was assessed using Personal Genome Diagnostics (PGDx) elioTM tissue complete. 

Download this info sheet to learn more about the assays used and the recently reported interim results—namely, that patient stratification based on TcellinfGEP and TMB status enabled improved responses in specific subgroups. 
Resources

Educational tools to enhance biomarker-driven drug development
Solid tissue profiling solutions

Reduce development time and costs while maximizing patient stratification and accelerating biomarker selection
References

  1. Keefer LA, White JR, Wood DE, et al. Automated next-generation profiIing of genomic aIterations in human cancers. Nat Commun. 2022;13:2830. doi:10.1038/s41467 -022 -30380-x
  2. A study of biomarker-directed, pembrolizumab (MK-3475) based combination therapy for advaneed non-small cell lung cancer (MK-3475 -495/KEYNOTE-495). C IinicalTrials.gov. Updated August 26, 2022.
  3. Accessed August 21, 2023. https://clinicaltrials.gov/study/NCT03516981
  4. Gutierrez M, Lam WS, Hellmann MD, et al. Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeylmPaCT trial interim results. Nat Med. 2023;29:1718 -1727. doi:10.1038/s41591-023 -02385-6