Roche announced that the first data on a novel blood-based assay, co-developed with Foundation Medicine, will be presented during the European Society for Medical Oncology (ESMO) Congress from 8-12 September 2017 in Madrid, Spain. These data have been generated as part of a broad, ongoing effort to advance the personalisation of cancer immunotherapy by delivering treatment options tailored to the specific immune biology associated with a person’s tumour. In pursuit of this goal, Roche is currently developing 20 cancer immunotherapy medicines across 9 types of cancer and in more than 50 combinations with other medicines. Roche is committed to advancing the science of cancer immunotherapy and exploring multiple biomarker approaches including PD-L1 immunohistochemistry, tumour gene expression, RNA sequencing and tumour mutational burden (TMB).
New data presented at ESMO demonstrates for the first time that a blood-based TMB test (bTMB) can measure TMB with a high degree of precision and accuracy. TMB is a quantitative clinical marker that measures the number of mutations within a tumour genome. TMB has been found to be an indicator of likelihood of progression-free survival (PFS) benefit from immunotherapies when used alone (monotherapy) in patients with non-small cell lung cancer (NSCLC). Until now, TMB could only be measured using a tumour biopsy. By using this blood-based testing approach, it may be possible to extend TMB testing to more patients, including those who are unable to undergo an invasive tumour biopsy, or where tissue is unavailable or of insufficient size to evaluate.
“Pursuing next generation biomarker development is a critical component of our cancer immunotherapy strategy,” said Sandra Horning, MD, Roche’s chief medical officer and Head of Global Product Development. “Biomarkers will not only improve our understanding of immune biology but will ultimately help match our therapies and combinations to the people most likely to benefit. This blood-based TMB assay is one example of how we and our partners are advancing the science toward personalisation of cancer therapy.”
The bTMB biomarker study being presented at ESMO was conducted using 794 plasma samples from the pivotal phase II POPLAR and phase III OAK Tecentriq studies. The purpose of the analysis was to collect initial, retrospective evidence of an association between bTMB and Tecentriq activity. These early data will inform ongoing and future prospective research to better understand the role of both TMB and bTMB as it relates to treatment with cancer immunotherapy.
Two prospective studies in patients receiving first-line treatment for NSCLC are underway, which aim to clinically evaluate and prospectively validate our novel blood-based diagnostic assay and assess the efficacy and safety Tecentriq and/or Alecensa (alectinib) for patients with NSCLC.
The B-F1RST study is a single-arm study evaluating the safety and efficacy of Tecentriq in first-line NSCLC and will evaluate the association between bTMB and efficacy in biomarker-unselected patients through prospective collection of blood samples that will be retrospectively tested.
BFAST is a phase II/III global, multicentre, open-label, umbrella trial designed to evaluate the safety and efficacy of Tecentriq or Alecensa in patients with unresectable, advanced or metastatic NSCLC. Treatment selection of Tecentriq or Alecensa is based on the presence of a positive bTMB score or oncogenic somatic mutations, respectively.
Tecentriq is currently approved in the United States for certain types of lung and bladder cancers regardless of PD-L1 expression levels. Beyond cancer immunotherapy, Roche has an extensive oncology pipeline with ongoing studies in collaboration with Foundation Medicine for molecules such as the oral AKT inhibitor ipatasertib, Alecensa, and Avastin.