Dr. Jänne on Biomarker Results From a Study of AZD9291

Pasi A. Jänne, MD, PhD, director, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, discusses biomarker results from the AURA study of AZD9291.

In this trial, patients were biopsied at baseline and then at Day 15. Interestingly, Jänne says, in many patients, there was not a sufficient amount of tumor cells remaining to analyze. The protocol was amended to allow for biopsies earlier than Day 15, but even then, many patients did not have evaluable tissue. The response rate was higher in those patients who could not have their tissue analyzed compared with those who could, Jänne says. This creates a possible hypothesis that residual tumor cells at a certain time point could indicate a less durable benefit.

In a subset of patients where analyses were possible, there was a biomarker modulation — phospho-EGFR went down, downstream signaling went down, PD-L1 expression went down and there was a corresponding increase in immune cell infiltrates. These findings matched what was predicted following preclinical models.

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