Brigatinib (BRG) versus crizotinib (CRZ) in Asian versus non-Asian patients (pts) in the phase III ALTA-1L trial
In: Journal of Clinical Oncology, Jg. 37 (2019-05-20), S. 9026-9026
Online
unknown
Zugriff:
9026 Background: We report an analysis of BRG vs CRZ in Asian vs non-Asian pts with ALK inhibitor–naive, ALK+ NSCLC from ALTA-1L (NCT02737501). Methods: Pts were randomized 1:1 to BRG 180 mg QD (7-day lead-in at 90 mg) or CRZ 250 mg BID. Primary endpoint: blinded independent review committee (BIRC)-assessed PFS (RECIST v1.1). Secondary efficacy endpoints: BIRC-assessed ORR, intracranial (i) ORR, and iPFS. Results: 275 pts were randomized; 108 Asian (BRG/CRZ, n = 59/49), 167 non-Asian (n = 78/89); median age: Asian, 55/56 y; non-Asian, 60/60 y. 32/24% of Asians vs 22/28% of non-Asians received prior chemotherapy for advanced disease; 36/33% vs 24/28% had baseline CNS metastases. As of 19 Feb 2018, median follow-up was 10.1/10.0 mo (BRG/CRZ) in Asians vs 11.0/9.0 mo in non-Asians, with 12 vs 20 PFS events in Asians and 24 vs 43 in non-Asians. In Asians, median BIRC-assessed PFS (mo) was not reached (NR; 95% CI 11.2–NR) with BRG vs 11.1 (9.2–NR) with CRZ (HR 0.41 [95% CI 0.20–0.86]; log-rank P= 0.0261); in non-Asians, BRG PFS was NR (NR) vs 9.4 (7.3–NR) with CRZ (HR 0.54 [0.33–0.90]; log-rank P= 0.0132) (Table). AE profile of each drug was similar in Asians vs non-Asians. Most common any-grade AEs (≥25%) in Asians in BRG arm: diarrhea; elevated blood CPK, ALT, and AST. Discontinuation due to AE (BRG/CRZ): 8.5/6.3% in Asian pts; 14.3/10.1% in non-Asian pts. Conclusions: BRG showed comparable improvement in PFS vs CRZ both in Asians and non-Asians in ALK inhibitor–naive ALK+ NSCLC. Clinical trial information: NCT02737501. [Table: see text]
Titel: |
Brigatinib (BRG) versus crizotinib (CRZ) in Asian versus non-Asian patients (pts) in the phase III ALTA-1L trial
|
---|---|
Autor/in / Beteiligte Person: | Rosario Garcia Campelo ; Dong Wan Kim ; Popat, Sanjay ; Chang, Gee-Chen ; Han, Ji-Youn ; Ki Hyeong Lee ; Zhang, Pingkuan ; Gridelli, Cesare ; Jacky Yu-Chung Li ; James Chih-Hsin Yang ; Hye Ryun Kim ; Hochmair, Maximilian ; Ahn, Myung-Ju ; Delmonte, Angelo ; Kerstein, David ; Ni, Q. ; D. Ross Camidge ; Jong Seok Lee |
Link: | |
Zeitschrift: | Journal of Clinical Oncology, Jg. 37 (2019-05-20), S. 9026-9026 |
Veröffentlichung: | American Society of Clinical Oncology (ASCO), 2019 |
Medientyp: | unknown |
ISSN: | 1527-7755 (print) ; 0732-183X (print) |
DOI: | 10.1200/jco.2019.37.15_suppl.9026 |
Schlagwort: |
|
Sonstiges: |
|