The market for oncology companion diagnostics is poised for significant growth, according to Sagient Research Systems. Reporting from ASCO 2014, Sagient analysts highlight key presentations on companion diagnostics, provide information on oncology diagnostic market trends, and note movement in clinical trials toward more adaptive designs with smaller patient numbers and incorporation of companion diagnostics.

Companion Diagnostics To Watch:

• The KEYNOTE trials conducted by Merck will be interesting to track as the company is using proprietary PD-L1 immunohistochemistry assays to identify expression in patients in the trials. The KEYNOTE-001 trial evaluating pembrolizumab as an initial therapy for melanoma and NSCLC is expected to be completed in January 2015. Phase III KEYNOTE-040 is expected to start Q3 2014 comparing pembrolizumab with the standard of care for head and neck cancer.
• The BRACAnalysis CDx, Myriad’s flagship companion diagnostic device, is being used by 20 different pharmaceutical companies to develop companion diagnostics. Myriad, partnering with AstraZeneca, expects US FDA and EMA approval for the platinum sensitive ovarian cancer indication in calendar year 2015.
• MedImmune and Ventana Medical are collaborating to develop a custom PD-L1 assay for Medimmune’s MEDI4736 anti-PD-L1 therapy. The MEDI4736 ATLANTIC trial using the custom assay is slated for primary completion in April 2015.

Additionally, download a comprehensive list of the companion diagnostics or biomarkers that were either presented at ASCO 2014 or mentioned in press releases concurrent with the conference, including information on the companies developing them and on clinical time frames.

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