The emergence of immuno-oncology companion products

• Published in: Personalized medicine Vol. 12; no. 5; pp. 435 - 438
• Main Author: Miller, Iain D
• Format: Journal Article
• Language: English
• Published: England Future Medicine Ltd 01.09.2015
• Subjects: antigen; Antigens; biomarker; Biomarkers; Bladder cancer; Cancer; Cancer immunotherapy; checkpoint; companion; FDA approval; Health aspects; Immunohistochemistry; Immunology; immunophenotyping; Immunotherapy; Ligands; Melanoma; Metastases; Mutation; Oncology; Patients; PD-1 protein; PD-L1 protein; Precision medicine; sequencing; Tumors; Vaccines; United Kingdom; United States > US; checkpoint; companion; immunophenotyping; antigen; biomarker; oncology; sequencing
• ISSN: 1741-0541; 1744-828X
• DOI: 10.2217/pme.15.27

[...]various authors have described long-term survival plateauing at an impressive (and unprecedented) 20% or more in patients with advanced melanoma, and extending for up to 10 years, an observation also commonly reported at the American Association for Cancer Research annual meeting in April 2015 (3). [...]Roche recently noted that higher levels of PD-L1 expression were associated with a greater response to its developmental checkpoint drug atezolimumab in the advanced or metastatic bladder cancer setting, perhaps pointing the way to the first future companion test approval in the checkpoint class (8). While we may indeed see a number of near-term PD-1/L1 immunohistochemistry-based companion test approvals for some of the four to eight most advanced checkpoint agents in clinical development, it is likely that such tests will have variable performance and utility (7) when used across the drug class. The next generation of tests: emerging immuno-oncology companion product paradigm As noted, PD-1/L1 testing in the marketplace is unlikely to yield a consistent level of high clinical utility, especially when tests are not matched with their developmental counterparts and testing does not reflect the dynamics of tumor evolution.