In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 18_suppl ( 2019-06-20), p. LBA9015-LBA9015
Abstract:
LBA9015 Background: Pembrolizumab (pembro) monotherapy has demonstrated durable antitumor activity in advanced PD-L1–expressing NSCLC. We present 5-y OS for patients (pts) enrolled in the phase 1b KEYNOTE-001 study (NCT01295827), the first trial evaluating pembro in advanced NSCLC. These data provide the longest efficacy/safety follow-up for NSCLC pts treated with pembro. Methods: Pts had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by IHC using the 22C3 antibody. Pts received pembro 2 mg/kg Q3W or 10 mg/kg Q2W or Q3W. The primary efficacy endpoint was ORR. OS was a secondary endpoint. Results: 550 pts were enrolled (treatment-naive, n=101; previously treated, n=449). As of November 5, 2018 (data cutoff), median (range) follow-up was 60.6 (51.8–77.9) mo; 82% (n=450/550) had died. Estimated 5-y OS rates were 23.2% for treatment-naive pts and 15.5% for previously treated pts (Table). ORR (by investigator per irRC) was 42% (95% CI, 32–52) for treatment-naive pts and 23% (95% CI, 19–27) for previously treated pts. Median (range) DOR was 16.8 (2.1+ to 55.7+) mo and 38.9 (1.0+ to 71.8+) mo, respectively. Immune-mediated AEs had occurred in 17% of pts at 5 y, similar to the incidence reported at 3-y follow-up. Additional results, including outcomes in key subgroups and detailed safety follow-up data, will be presented. Conclusions: In KEYNOTE-001, 5-y OS rate was 23.2% in treatment-naive pts and 15.5% in previously treated pts with advanced NSCLC treated with pembro, compared to a historical rate of ~5% (per SEER 2008–2014), prior to the introduction of anti–PD-1 therapy. 5-y OS rate was at least 25% in pts with PD-L1 TPS ≥50% in both pt populations in KEYNOTE-001. Clinical trial information: NCT01295827. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2019.37.18_suppl.LBA9015
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2019
detail.hit.zdb_id:
2005181-5