Approval was based on P-III (FLAURA2) study of Tagrisso + CT, followed by Tagrisso with pemetrexed maintenance as a 1L treatment of patients (n=557) with locally advanced (stage IIIB-IIIC) or metastatic (stage IV) EGFRm NSCLC
Study depicted a 38% PFS with mPFS of 25.5mos. (Tagrisso + CT) vs 16.7mos. (Tagrisso alone) during investigator evaluation; similar PFS with mPFS of 29.4mos. vs 19.9mos. was found by BICR. Favorable OS trend (41% maturity) was seen during 2nd interim analysis, further evaluation is underway
PFS in China cohort during investigator evaluation was 44% with mPFS of 27.4mos. vs 22.3mos.; similar PFS with mPFS of 33.2mos. vs 22.0mos. & a favorable OS trend was seen by BICR
Ref: Astrazeneca | Image: Astrazeneca
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