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Jazz Pharma and PharmaMar's Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

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Jazz Pharma and PharmaMar's Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

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  • The P-III ATLANTIS study involves assessing Zepzelca (lurbinectedin- 2.0mg/m2) + doxorubicin vs topotecan/ CAV in 613 adult patients in a ratio (1:1) aged ≥18yrs. with SCLC whose disease progressed following one prior Pt.-containing line
  • The study did not meet its 1EP of OS in the ITT population while there were no adverse effects on OS with the experimental arm. The safety data were consistent with the known safety profile of Zepzelca monothx. with no new safety signals observed
  • Zepzelca is an alkylating drug that binds guanine residues within DNA. The therapy received the US FDA’s accelerated approval in Jun’2020 for m-SCLC with disease progression on or after Pt.-based CT

 ­ Ref: PRNewswire | Image: WebMD

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