Abstract 1210P
Background
Neoadjuvant pembro + chemo followed by adjuvant pembro significantly improved event-free survival (EFS) and OS vs neoadjuvant chemo alone in patients (pts) with resectable NSCLC in the phase III KEYNOTE-671 study. At interim analysis 2 (IA2), HRs (95% CI) were 0.59 (0.48–0.72) for EFS and 0.72 (0.56–0.93) for OS. We present EFS and OS results for key pt subgroups based on IA2.
Methods
Eligible pts with resectable stage II, IIIA, or IIIB (N2) NSCLC per AJCC 8 were randomized 1:1 to 4 cycles of pembro 200 mg or pbo + cisplatin-based chemo followed by surgery and adjuvant pembro or pbo for up to 13 additional cycles. Dual primary endpoints were EFS by investigator assessment per RECIST v1.1 and OS. Randomization was stratified by disease stage (II vs III), PD-L1 TPS (<50% vs ≥50%), histology (squamous vs nonsquamous), and region (East Asia vs non–East Asia). Exploratory analyses of EFS and OS were done using a Cox regression model with treatment as a covariate for preplanned subgroups based on PD-L1 TPS, disease stage, nodal involvement, and histology at baseline. Landmark analyses of EFS and OS from time of initiation of adjuvant therapy were also done.
Results
797 pts were randomized to the pembro arm (N = 397) or the pbo arm (N = 400). Median study follow-up at IA2 (data cutoff, July 10, 2023) was 36.6 mo (range, 18.8–62.0). HRs for EFS and OS favored the pembro arm across all subgroups evaluated (Table). Among pts who started adjuvant therapy, HRs (95% CI) for EFS and OS from the start of adjuvant therapy were 0.55 (0.42–0.72; N = 548) and 0.71 (0.49–1.03; N = 557), respectively. Table: 1210P
| N | EFS HR (95% CI) | OS HR (95% CI) | |
| Stage II at baseline | 239 | 0.59 (0.40–0.88) | 0.67 (0.41–1.10) |
| Stage III at baseline | 558 | 0.58 (0.46–0.72) | 0.74 (0.55–0.98) |
| Squamous histology | 344 | 0.51 (0.38–0.69) | 0.71 (0.51–0.99) |
| Nonsquamous histology | 453 | 0.66 (0.51–0.86) | 0.73 (0.50–1.06) |
| PD-L1 TPS ≥50% | 266 | 0.48 (0.33–0.71) | 0.55 (0.33–0.92) |
| PD-L1 TPS 1%–49% | 242 | 0.52 (0.36–0.73) | 0.69 (0.44–1.07) |
| PD-L1 TPS ≥1% | 508 | 0.51 (0.39–0.66) | 0.62 (0.45–0.87) |
PD-L1 TPS ConclusionsPerioperative pembro provided a clinically meaningful improvement in EFS and OS across subgroups vs neoadjuvant chemo alone in pts with resectable stage II, IIIA, or IIIB NSCLC. Results from the landmark analyses from time of adjuvant therapy start suggest adjuvant therapy adds clinical benefit in this setting. Clinical trial identificationNCT03425643; EudraCT 2017-001832-21. Editorial acknowledgementMedical writing assistance was provided by Christabel Wilson, MSc, of ICON plc (Blue Bell, PA, USA). This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Legal entity responsible for the studyMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. FundingMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. DisclosureM.C. Garassino: Financial Interests, Personal, Advisory Board: Eli Lilly, SeaGen International GmbH, Eli Lilly, Incyte, GSK, Bayer Healthcare Pharmaceuticals, Blueprint Medicines, AstraZeneca UK, AstraZeneca and Daiichi Sankyo Oncology Teams, Roche, Daiichi Sankyo, Mirati Therapeutics, Inc, Daiichi Sankyo/AstraZeneca, AstraZeneca Poland, Daiichi Sankyo, Inc., MSD, Eli Lilly, Pfizer, AstraZeneca/MedImmune, Sanofi Genzyme corporation, Sanofi / Prex, Regeneron Pharmaceuticals, Eli Lilly, Mirati Therapeutics, Inc.; Financial Interests, Personal, Invited Speaker: WebMD, WebMD Oncology/Takeda, MSD Italia, Srl, GrupoPacifico-Secretaria Técnica ICAPEM/AstraZeneca, S.O.S S.r.l, Medscape, ecancer, Ideology; Financial Interests, Personal, Invited Speaker, Global Experts Meeting: AstraZeneca; Financial Interests, Personal, Other, AstraZeneca SPAIN: Invitation to a lung cancer investigator meeting: AstraZeneca; Financial Interests, Personal, Advisory Board, Advisory Boards: Takeda, Daiichi Sankyo, BeiGene; 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All other authors have declared no conflicts of interest. Resources from the same session1211P - IMpower010: ctDNA status and 5y DFS follow up in patients (pts) with resected NSCLC who received adjuvant chemotherapy (chemo) followed by atezolizumab (atezo) or best supportive care (BSC)Presenter: Heather Wakelee Session: Poster session 04 1212P - IMpower010: Characterisation of patients (pts) with stage II-IIIA PD-L1 TC≥50% NSCLC who were disease-free at 5 years (5yDF) in a phase III study of atezolizumab (atezo) vs best supportive care (BSC) after resection and adjuvant (adj) chemotherapy (chemo)Presenter: Enriqueta Felip Session: Poster session 04 1213P - Neoadjuvant tislelizumab (TIS) plus chemotherapy (CT) with adjuvant TIS vs. neoadjuvant placebo (PBO) plus CT with adjuvant PBO in resectable non-small cell lung cancer (NSCLC): patient-reported outcomes (PRO) in the RATIONALE-315 trialPresenter: Federico Cappuzzo Session: Poster session 04 1214P - Imaging AI prognosis of early stage lung cancer using CT radiomicsPresenter: Ann Valter Session: Poster session 04 1215P - United Kingdom (UK) real world study of adjuvant osimertinib in resected EGFR mutated lung cancerPresenter: Raghad Elghadi Session: Poster session 04 1216P - Adjuvant pembrolizumab therapy for completely resected stage I NSCLC with micropapillary or solid histological subtypePresenter: Se-Hoon Lee Session: Poster session 04 1217P - B cell infiltration and memory TOX+ CD8+ T cells in stage I-II non-small cell lung cancer (NSCLC) predict response to neoadjuvant pembrolizumab: A phase I studyPresenter: Jair Bar Session: Poster session 04 1218P - FALCONS, a non-interventional retrospective study in resected NSCLC patients using the EPITHOR database, first analysisPresenter: Marie Wislez Session: Poster session 04 1219P - Integrating artificial intelligence (AI)-based lymphocytic infiltration assessment in early stage NSCLC: A sub-study of the TNM-I trialPresenter: Falah Jabar Session: Poster session 04 1220P - A phase III randomized trial investigating preventive effects of perioperative landiolol, a selective beta1 blocker, on the reduction of recurrence of completely resected NSCLCPresenter: Yasuhiro Hida Session: Poster session 04 This site uses cookies. 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