Sotorasib’s Confirmatory Trial Too Troubled to Be Interpreted, Adcomm Says

Amgen’s open-label confirmatory study of its lung cancer drug Lumakras (sotorasib) had too many data integrity problems to effectively show that the drug is an improvement over the standard-of-care chemotherapy docetaxel, according to the Oncologic Drugs Advisory Committee (ODAC), which met Thursday.

Ten committee members voted no on the question: Can the trial’s primary endpoint, progression-free survival (PFS), per blinded independent central review (BICR) be reliably interpreted? Only two voted yes.

The FDA said during the meeting and in briefing documents that it doesn’t fully trust the integrity of Amgen’s confirmatory trial, and that there might not be sufficient evidence of sotorasib’s efficacy to justify full approval.

To read the whole story, click here to subscribe.

Related Topics