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Pembrolizumab (MK-3475) versus platinum-based chemotherapy for PD-L1+ non-small cell lung cancer (NSCLC): Randomized, open-label, phase 3 KEYNOTE-042 study

Date

20 Dec 2015

Session

Poster presentation 2

Presenters

Tony Mok

Citation

Annals of Oncology (2015) 26 (suppl_9): 125-147. 10.1093/annonc/mdv532

Authors

T. Mok1, Y. Wu2, S. Sadowski3, J. Zhang4, R. Rangwala3, G. de Lima Lopes5

Author affiliations

  • 1 Clinical Oncology, Chinese University of Hong Kong, N/A - Hong Kong/HK
  • 2 Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, N/A - Guangdong/CN
  • 3 Clinical Oncology, Merck & Co., Inc., Kenilworth/US
  • 4 Bards, Merck & Co., Inc., Kenilworth/US
  • 5 Oncology, Oncoclínicas do Brasil Group and Johns Hopkins University, São Paulo/BR
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Resources

Abstract 1160

Background

Tumors use the PD-1 pathway to suppress immune responses. The anti–PD-1 monoclonal antibody pembrolizumab (pembro) showed a manageable safety profile and promising antitumor activity in patients (pts) with treatment-naive NSCLC enrolled in the phase 1b KEYNOTE-001 study. KEYNOTE-042 (NCT02220894) is a randomized, open-label, international, phase 3 study comparing the efficacy and safety of pembro with those of platinum-doublet chemotherapy, the standard therapy for treatment-naive NSCLC lacking ALK translocations or EGFR-sensitizing mutations, as first-line therapy for PD-L1+ advanced NSCLC.

Trial design

Pts with advanced NSCLC without EGFR-sensitizing mutations or ALK translocations and no prior systemic chemotherapy are eligible if they have PD-L1 expression in ≥1% of tumor cells and ECOG PS 0-1. Pts are randomized 1:1 to receive pembro 200 mg Q3W or investigator's choice of carboplatin AUC 5 or 6 + paclitaxel 200 mg/m2 Q3W or carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 Q3W. Randomization is stratified by ECOG PS (0 vs 1), histology (squamous vs nonsquamous), region (East Asia vs non-East Asia), and PD-L1 expression (staining in ≥50% of tumor cells [tumor proportion score (TPS) ≥50%] vs staining in 1%-49% of tumor cells [TPS 1%-49%] as assessed by IHC). Pembro will continue for 35 cycles or until progression, intolerable toxicity, or investigator decision; treatment may continue beyond initial radiographic disease progression in eligible pts. Discontinuation of pembro is permitted for pts who have CR confirmed ≥4 wk after initial observation. Chemotherapy will be given for a maximum of 6 cycles and may be followed by optional pemetrexed 500 mg/m2 Q3W maintenance therapy in pts with nonsquamous histology. AEs will be collected throughout the study and for 30 d (90 d for serious AEs) thereafter and graded per NCI CTCAE v4.0. Response will be assessed every 9 wk per RECIST v1.1 by central review. Pts will be followed for survival every 2 mo. Primary end point is OS in the PD-L1 TPS ≥50% stratum; secondary end points are PFS in the TPS ≥50% stratum and PFS and OS in all pts. Enrollment is ongoing and will continue until ∼1240 pts have enrolled.

Clinical trial identification

NCT02220894

Disclosure

T. Mok: speaker/honoraria: AZ, Roche/Genentech, Pfizer, Eli Lilly, BI, MSD, Amgen, Janssen, Clovis, GSK, Novartis; stock: Sanomics; Advisory board: AZ, Roche/Genentech, Pfizer, Eli Lilly, BI, Merck Serono, MSD, Janssen, Clovis, BioMarin, GSK, Novartis, SFJ. Y.-L. Wu: speaker fees: AstraZeneca, Roche, Eli Lilly, Pfizer, and Sanofi. S. Sadowski, J. Zhang, R. Rangwala: employee of Merck & Co., Inc. G. de Lima Lopes: research/honoraria: Roche, Sanofi Aventis, Eli Lilly, Merck Serono, Merck Sharp & Dohme, BMS, Pfizer, Fresenius Kabi, AstraZeneca.

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