2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Poster Session
Time: Sunday June 2, 8:00 AM to 11:00 AM
Location: Hall A
Brigatinib (BRG) versus crizotinib (CRZ) in Asian versus non-Asian patients (pts) in the phase III ALTA-1L trial.
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #349)
J Clin Oncol 37, 2019 (suppl; abstr 9026)
Author(s): Myung-Ju Ahn, HyeRyun Kim, James Chih-Hsin Yang, Ji-Youn Han, Jong Seok Lee, Maximilian J. Hochmair, Jacky Yu-Chung Li, Gee-Chen Chang, Ki Hyeong Lee, Cesare Gridelli, Rosario Garcia Campelo, Angelo Delmonte, Dong-Wan Kim, David Kerstein, Quanhong Ni, Pingkuan Zhang, Sanjay Popat, D. Ross Camidge; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; Yonsei University Severance Hospital, Seoul, South Korea; National Taiwan University, Taipei, Taiwan; Center for Lung Cancer, National Cancer Center, Gyeonggi-Do, South Korea; Seoul National University Bundang Hospital, Seoul, South Korea; Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Vienna, Austria; Hong Kong United Oncology Centre, Kowloon, China; Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, and Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea; A.O.S.G. Moscati, Avellino, Italy; Complejo Hospitalario Universitario A Coruña, Coruna, Spain; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy; Seoul National University Hospital, Seoul, South Korea; Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA; The Royal Marsden Hospital, London, United Kingdom; University of Colorado Cancer Center, Aurora, CO
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
|All pts, % (95% CI)||(n = 59)||(n = 49)||(n = 78)||(n = 89)|
|ORRa||80 (67–89)||84 (70–93)||73 (62–83)||67 (57–77)|
|Confirmed ORR||75 (62–85)||71 (57–83)||68 (56–78)||54 (43–65)|
|P= 0.5833b||P= 0.0753b|
|Median INV PFS, mo||NR (NR)||11.1 (9.2–NR)||NR (NR)||7.4 (5.7–9.4)|
|HR||0.49 (0.23–1.02); P= 0.0519c||0.45 (0.27–0.74); P= 0.0012c|
|With any iCNS metastases, % (95% CI)||(n = 20)||(n = 17)||(n = 23)||(n = 30)|
|iORRa||70 (46–88)||41 (18–67)||87 (66–97)||13 (4–31)|
|Confirmed iORR||60 (36–81)||35 (14–62)||74 (52–90)||7 (1–22)|
|P= 0.0180b||P< 0.0001b|
|Median iPFS, mo||NR (9.2–NR)||9.2 (3.7–11.1)||NR (7.4–NR)||5.5 (3.7–7.5)|
|1-year iPFS||75 (46–90)||NR (NR)||59 (31–79)||30 (13–48)|
|HR||0.15 (0.04–0.56); P= 0.0037c||0.29 (0.12–0.70); P= 0.0030c|
INV, investigator assessed.
a≥1 response assessment; bCochran-Mantel-Haenszel test; cLog-rank test.