AstraZeneca’s Tagrisso sparks expert uncertainty on potential to achieve 22-month PFS needed to become first-line EGFR NSCLC SOC
AstraZeneca’s (LON:AZN) Phase III study of Tagrisso (osimertinib) requires at least a 22-month progression-free survival (PFS) in order to be clinically viable in first-line EGFR mutant non-small-cell lung cancer (NSCLC), experts said. Although Phase III data was recently reported to be statistically significant over Roche’s (VTX:ROG) Tarceva (erlotinib) and AstraZeneca’s (AZ’s) Iressa (gefitinib), experts were not able to definitively conclude whether the results, once detailed, would also be clinically significant, with some citing a lack of data and others debating the drug’s binding characteristics.
The FLAURA trial (NCT02296125), which was announced as positive on 27 July, did not provide details on the PFS benefit, and full data is expected at an upcoming medical conference, according to a company press release. One analyst report predicts peak sales of USD 2bn for Tagrisso with no specified year.
While analyst reports have mirrored the company release, noting statistical significance and expecting Tagrisso to dominate the first-line EGFR NSCLC market, experts this news service interviewed said for clinical significance and to get established as the new standard of care (SOC), PFS does not just need to exceed Tarceva or Iressa, as has been stated by the press release. It also needs to also exceed the overall benefit of a first- or second-generation EGFR inhibitor followed by Tagrisso, they added. Should it do so, it will render all other EGFR inhibitors irrelevant in the first-line EGFR NSCLC space, said Dr Heather Wakelee, associate professor of medicine, Stanford University, California.