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Jazz And PharmaMar’s Zepzelca Hits Buffers In ATLANTIS Study

Confirmatory Phase III Trial Misses Endpoint

 
• By Alexandra Shimmings

Jazz and PharmaMar need to see what further data will be needed to convert their FDA authorization into a full approval following disappointing results in the ATLANTIS Phase III trial.    

Lung Cancer
• Source: Shutterstock

Jazz Pharmaceuticals and its partner PharmaMar, S.A. look likely to need another trial to support the full US approval of their novel anticancer Zepzelca in small-cell lung cancer after the Phase III ATLANTIS study missed its overall survival (OS) primary endpoint.

Zepzelca (lurbinectedin) received an accelerated approval from the US Food and Drug Administration in June for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy on the basis of overall response rate and duration of response in an open-label monotherapy study in 105 patients. Zepzelca patients had an overall response rate of 35% and a median duration of response of 5.3 months, measured by investigator assessment

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