Pfizer has reported positive interim analysis results from the Phase III CROWN trial of Lorbrena (lorlatinib) versus Xalkori (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Data showed that treatment with Lorbrena demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS).
Lorbrena is a tyrosine kinase inhibitor (TKI), which was observed to be highly active in preclinical ALK-positive lung cancer models.
The global randomised, open-label, parallel two-arm trial enrolled 296 patients who were given Lorbrena monotherapy or Xalkori monotherapy.
The trial’s primary endpoint is PFS based on BICR, while secondary endpoints include PFS based on investigator’s assessment, overall survival (OS), objective response rate (ORR), intracranial objective response, and safety.
Interim data showed a 72% reduction in the risk of progression or death in patients treated with Lorbrena as compared to Xalkori.
Pfizer Global Product Development Oncology chief development officer Chris Boshoff said: “The prolonged progression-free survival data and intracranial responses seen in the CROWN trial highlight the potential role for Lorbrena to significantly improve outcomes for people with previously untreated ALK-positive advanced NSCLC and we are pleased that these data will be reviewed as part of the FDA’s Real-Time Oncology Review (RTOR) pilot programme.”
The confirmed ORR, a secondary endpoint, was 76% with Lorbrena versus 58% with Xalkori.
Moreover, Lorbrena demonstrated increased intracranial activity as compared to Xalkori.
The trial is progressing to evaluate OS, which was not mature when the interim analysis was conducted.
On obtaining positive results from the trial, the data will be reviewed under the US Food and Drug Administration (FDA)’s Real Time Oncology Review pilot programme.
The latest development will be conveyed to other health authorities to seek approval for an indication including previously untreated ALK-positive advanced NSCLC.