Phase III CROWN trial of Lorbrena shows continued benefit at 3-years in non-small cell lung cancer.- Pfizer

This analysis reported after a median follow-up of three years, Lorbrena continued to demonstrate meaningful improvement in progression-free survival (PFS) assessed by blinded independent central review (BICR), the primary endpoint, compared to Xalkori (HR, 0.27; 95% CI, 0.18–0.39), corresponding to a 73% reduction in the rate of progression or death.

In this analysis, 64% of people treated with Lorbrena were without disease progression after three years (95% CI, 55-71, n=149) compared to 19% for people treated with Xalkori after the same amount of time (95% CI, 12-27, n=147). As a secondary endpoint, the objective response rate (ORR) was 77% with Lorbrena (95% CI, 70-84) and 59% with Xalkori (95% CI, 50-67). Additionally, Lorbrena treatment resulted in a 92% reduction in the rate of intracranial progression (HR, 0.08; 95% CI, 0.04–0.17). The intracranial objective response rate (IC-ORR) for people with measurable brain metastases at baseline was 83% (95% CI, 59–96, n=15) with Lorbrena and 23% (95% CI, 5–54, n=3) with Xalkori, with an intracranial complete response rate of 72% and 8%, respectively. In people without brain metastases at baseline, Lorbrena demonstrated a 98% reduction in the rate of intracranial progression (HR 0.02; 95% CI, 0.002-0.136).

The safety profile observed in the three-year follow-up analysis was consistent with the established safety profiles of Lorbrena and Xalkori. In the initial 2020 analysis of the CROWN trial, the most frequent adverse events (AEs) in at least 20% of 149 patients treated with Lorbrena were edema, weight gain, peripheral neuropathy, cognitive effects, diarrhea, dyspnea, and hypertriglyceridemia. Serious AEs occurred in 34% of people treated with Lorbrena; the most frequently reported serious AEs were pneumonia, dyspnea, respiratory failure, cognitive effects, and pyrexia. Fatal AEs occurred in 3.4% of people treated with Lorbrena. Permanent discontinuation of Lorbrena due to AEs occurred in 6.7% of people. These data will be presented on April 12, 2022, at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Abstract # CT223 / 2).