medwireNews: The ALESIA trial comprising treatment-naïve patients with advanced anaplastic lymphoma kinase (ALK) translocation-positive non-small-cell lung cancer (NSCLC) confirms the systemic and intracranial efficacy of alectinib over crizotinib in an Asian population.
Reporting the findings at the ESMO 2018 Congress in Munich, Germany, Caicun Zhou (Tongji University, Shanghai, China) noted that the phase III trial “met its primary objective of showing consistency with the global ALEX study” comparing the two ALK inhibitors in patients of different ethnicities.
The ALESIA investigators recruited 187 participants with stage IIIB or IV disease from 21 sites in China, South Korea, and Thailand, and randomly assigned them to receive either alectinib 600 mg twice daily (n=125) or crizotinib 250 mg twice daily (n=62).
Over a median follow-up duration of 16.2 and 15.0 months for the alectinib and crizotinib groups, respectively, the primary endpoint of investigator-assessed median progression-free survival (PFS) was unreached with alectinib and was 11.1 months with crizotinib, giving a significant hazard ratio for progression or death of 0.22.
The PFS benefit associated with alectinib was consistent across most subgroups, including by age, sex, smoking status, and central nervous system (CNS) metastases, said Zhou.
Furthermore, the overall response rate as assessed by the investigators was also higher with alectinib than crizotinib, at 91.2% versus 77.4%, and the response lasted longer, with the median unreached and 9.3 months, respectively.
Similarly, a greater proportion of alectinib-treated patients achieved a CNS response – as evaluated by an independent review committee – than their counterparts given crizotinib; this was true both for the subgroup of patients with measurable CNS lesions at baseline (94.1 vs 28.6%) and those with measurable and unmeasurable lesions (72.7 vs 21.7%).
And in a competing risks analysis also including non-CNS progression and death, the cumulative incidence of CNS progression was significantly lower in the alectinib than crizotinib group (7.3 vs 35.5%).
The safety profile of alectinib also appeared to be better than that of crizotinib, said Zhou, with grade 3–5 adverse events (AEs) occurring in a respective 28.8% and 48.8% of participants, and serious AEs in 15.2% and 25.8%.
The only AE of grade 3 or worse that was more common in the alectinib study arm was dyspnea, reported in 2.4% of patients compared with none of the crizotinib-treated patients.
Moreover, Zhou noted that the safety findings in the Asian patient population of ALESIA “were generally consistent with the known safety profile of alectinib.”
He concluded that “ALESIA further confirms alectinib as standard of care in first-line treatment for ALK+ NSCLC.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group
See also:
- ALUR, ALEX results cement alectinib as advanced ALK-positive NSCLC standard of care
- Alectinib outperforms crizotinib in Japanese patients with ALK-rearranged NSCLC
- Advanced NSCLC PFS gain with alectinib maintained with longer follow-up
- US ALK-positive metastatic NSCLC patients may receive first-line alectinib