Found 1 Presentation For Request "1197P"
1197P - First-line lorlatinib versus crizotinib in ALK-positive non-small cell lung cancer: Asian subgroup analysis of CROWN
- Qing Zhou (Guangzhou, China)
Abstract
Background
Lorlatinib, a 3rd-generation ALK inhibitor, significantly prolonged progression-free survival (PFS) vs crizotinib in the CROWN trial in patients with untreated
Methods
In this ongoing phase III trial (NCT03052608), untreated patients (n = 296) with
Results
In the Asian subgroup, 120 patients were randomised (59 to lorlatinib, 61 to crizotinib [1 not treated]): 48 in Japan, 21 South Korea, 20 mainland China, 16 Taiwan, 8 Singapore and 7 Hong Kong. Baseline characteristics (median age: 61 and 55 years; female: 46% and 61% for lorlatinib and crizotinib, respectively) were similar to the overall population except for a slightly greater gender imbalance between treatments. Lorlatinib prolonged PFS and increased overall and intracranial response vs crizotinib (Table). The most common any-grade adverse events (AEs) with lorlatinib were hypertriglyceridaemia (68%), hypercholesterolaemia (68%), oedema (44%) and weight increased (42%), and with crizotinib were nausea (58%), diarrhoea (58%), vomiting (45%), vision disorder (43%) and constipation (42%). Grade 3/4 AEs were reported by 78% (lorlatinib) vs 60% (crizotinib). Fewer patients had AEs leading to permanent treatment discontinuation in the lorlatinib arm (6.8%) than the crizotinib arm (11.7%). aShaw et al.
Asian subgroup Overall populationa Lorlatinib (n = 59) Crizotinib (n = 61) Lorlatinib (n = 149) Crizotinib (n = 147) HR (95% CI) 0.44 (0.24–0.78) 0.28 (0.19–0.41) 0.002b <0.001 Event-free at 12 months, 72 (59–82) 48 (32–62) 78 (70–84) 39 (30–48) n (%) 45 (76.3) 35 (57.4) 113 (75.8) 85 (57.8) 95% CI 63.4–86.4 44.1–70.0 68.2–82.5 49.4–65.9 (n = 11) (n = 16) (n = 38) (n = 40) n (%) 8 (72.7) 4 (25.0) 25 (65.8) 8 (20.0) 95% CI 39.0–94.0 7.3–52.4 48.6–80.4 9.1–35.6
Conclusions
In the Asian subgroup, a consistent and clinically meaningful improvement in PFS was observed for lorlatinib vs crizotinib. The efficacy and safety of lorlatinib vs crizotinib in the Asian subgroup of CROWN was consistent with the overall population.
Clinical trial identification
NCT03052608.
Editorial acknowledgement
Medical writing support was provided by Annette Smith, PhD, of CMC Affinity, McCann Health Medical Communications, and was funded by Pfizer.
Legal entity responsible for the study
Pfizer Inc.
Funding
Pfizer Inc.
Disclosure
Q. Zhou: Financial Interests, Personal, Other, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria: Roche. H.R. Kim: Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: Roche/Genentech. R. Soo: Financial Interests, Personal, Other, Consulting or Advisory Role: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, Pfizer, Roche/Genentech, Taiho Pharmaceutical, Yuhan, Takeda, Amgen, Lilly, Merck; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Lilly, Novartis, Pfizer, Roche/Genentech, Takeda, Yuhan, Amgen, Bayer, Merck; Financial Interests, Personal, Other, Research Funding: AstraZeneca, Boehringer Ingelheim. C. Chiu: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharma, Lilly, Merck Sharp & Dohme, Novartis, Ono Pharmaceutical, Pfizer, Roche, Takeda; Financial Interests, Personal, Other, Consulting or Advisory Role: Lilly, Merck Sharp & Dohme, Novartis, Roche. H. Hayashi: Financial Interests, Personal, Other, Contracted/Support Research Grant: AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Chugai Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd. S. Teraoka: Financial Interests, Personal, Other, Honoraria: Chugai Pharma, Novartis, AstraZeneca, Taiho Pharmaceutical, Ono Pharmaceutical, Boehringer Ingelheim. Y. Goto: Financial Interests, Personal, Other, Grant support, Lecture Fees, Advisory Board Fees: Eli Lilly, Taiho Pharmaceutical, Pfizer, Novartis, Merck Sharp & Dohme, Ono Pharmaceutical, Kyorin Pharmaceutical, Bristol Myers Squibb; Financial Interests, Personal, Other, Lecture Fees and Advisory Board Fees: Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca; Financial Interests, Personal, Other