AstraZeneca’s Tagrisso Phase III data in first-line EGFR mutant NSCLC likely secures new standard of care status though trial design questions remain – oncologists

28 Sep 2017

AstraZeneca’s Tagrisso Phase III data in first-line EGFR mutant NSCLC likely secures new standard of care status though trial design questions remain – oncologists

AstraZeneca’s (LON:AZN) Tagrisso (osimertinib) Phase III data in first-line EGFR mutant non-small-cell lung cancer (NSCLC) has oncologists noting it will likely be the new standard of care (SOC) due to its similar efficacy to comparators as well as CNS metastases activity and tolerability benefits. However, some oncologists noted that some key questions on whether a greater progression-free survival (PFS) benefit could be obtained through sequencing agents have not been answered by the Phase III FLAURA trial design.

Analyst reports noted that Tagrisso is all but certain to be approved in first-line EGFR NSCLC given the benefit it demonstrated over Roche’s (VTX:ROG) Tarceva (erlotinib) and AstraZeneca’s Iressa (gefitinib) in the first-line setting, but they stated the key question remains whether the drug becomes the new SOC.

Given the PFS benefit was just shy of what would be expected with sequencing agents, and the drug showed CNS activity and tolerability advantages, Tagrisso, which is already approved for EGFR mutant NSCLC following treatment with a first- or second-generation EGFR inhibitor, should become the new SOC after approval, oncologists agreed, despite some questions remaining on the trial design. Two experts noted the trial could have been designed better by comparing Tagrisso first-line to Iressa or Tarceva, followed by Tagrisso in the second-line. Experts agreed that Tagrisso is superior to first- and second-generation EGFR inhibitors in terms of safety and tolerability with little to no rash or diarrhea.

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