NEJM: "Head-to-head" Phase III studies have confirmed the treatment of ALK-positive non-small cell lung cancer, and loratinib is significantly superior to closinib

On November 19, 2020, NEJM published the results of the Phase III CROWN study for untreated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) compared to Xalkori.
72 percent lower risk of disease progress or death than clotini, reaching the primary endpoint of progress-free survival (PFS).
CROWN study included 296 previously untreated ALC-positive advanced NSCLC patients who were randomly assigned to a single treatment in Lorbrena or Xalkori.
results showed that the Lorbrena treatment group had 78 percent of patients who survived without disease progress at 12 months, compared with 39 percent in the Xalkori group, and that Lorbrena reduced the risk of disease progress or death by 72 percent compared to Xalkori, reaching the main end of PFS.
and Lorbrena's intracranial activity improved significantly compared to Xalkori.
96 percent of patients in the Lorbrena group who did not experience progression in central nervous system disease at 12 months, compared with 60 percent in the Xalkori group.
82 percent of patients in the Xalkori group with measurable brain metastasis, compared with 23 percent in the Lorbrena group, which reached the secondary end of the study.
In terms of safety, 72 percent of patients treated with Lorbrena had level 3 or 4 adverse events (AEs), compared with 56 percent of patients treated with Xalkori, most commonly hyperglycerideemia, weight gain, hypercholesterolemia and high blood pressure.
, adverse events that led to permanent drug suspension occurred at 7% and 9%, respectively.
chris Boshoff, chief development officer of Pfizer Oncology, noted that Lorbrena was "specifically developed to inhibit tumor mutations, and crown's findings demonstrate Lorbrena's ability to extend PFS and improve intracranial response, further demonstrating Lorbrena's therapeutic potential."