Astrazeneca's lung cancer blockbuster looks set for another boost

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Having already shifted standard of care in metastatic, EGFR-positive lung cancer, Tagrisso looks set to do the same in earlier settings. The Adaura study testing Astrazeneca’s kinase inhibitor as an adjuvant therapy in post-surgical patients has been stopped for “overwhelming efficacy”, years before its intended completion date. Analysts at Wolfe Research believe that the hazard ratio for the primary endpoint, which measures disease-free survival, is likely to be “impressively low”; patients will continue to be tracked to assess overall survival, and given the early stop there is a good chance of this hugely important endpoint also hitting. The adjuvant opportunity can be measured in billions of dollars of extra sales, according to Wolfe; over at SVB Leerink, analysts promptly doubled their peak adjuvant sales estimate, to $1.5bn. The news helped add around £6bn ($7.4bn) to Astra’s market cap today. Current sellside consensus for Tagrisso 2024 revenues sits at $6.4bn, according to EvaluatePharma, and this figure will surely rise in the coming months. Attention now turns to other ongoing studies in earlier settings and those examining the mechanisms through which tumours develop resistance, and hopes are high for similarly impressive findings.

Building a blockbuster: key Tagrisso studies
Study  Description  Details  Trial ID
Pending trials 
Laura Post chemoradiation in stage III unresectable EGFR+ NSCLC Data due 2022* NCT03521154
Flaura2 +/- chemo in 1st-line, locally advanced or metastatic EGFR+ NSCLC Data due 2023* NCT04035486
Savannah (phase II)
+ savolitinib in EGFR+ and Met+ patients who progressed on prior Tagrisso
Data due 2021*
NCT03778229
Orchard (phase II)
+ various agents in advanced NSCLC patients who progressed on 1st-Line Tagrisso
Data due 2022*
NCT03944772
Reported trials
Adaura Tagrisso +/- chemo as adjuvant in post-surgical patients with stage IB-IIIA NSCLC Stopped early for efficacy on primary endpoint, DFS; trial continuing to measure OS NCT02511106
Flaura Vs EGFR TKI in 1st-line locally advanced or metastatic NSCLC 54% reduction in risk of progression (p<0.0001); mPFS 18.9mth vs 10.2mth NCT02296125
Aura3 Vs chemo in 2nd-line locally advanced or metastatic NSCLC 70% reduction in risk of progression (p<0.001); mPFS 10.1mth vs 4.4mth NCT02151981
*Per primary completion date on clinicaltrials.gov; mPFS=median progression-free survival; OS=overall survival; DFS=disease-free survival. Source: clinical trial records & company materials.

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