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M. Smith
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-078 - Pembrolizumab vs Platinum-Based Chemotherapy for PD-L1-Strong-Positive NSCLC (ID 2959)
09:30 - 09:30 | Author(s): M. Smith
- Abstract
Background:
Platinum-doublet chemotherapy with or without maintenance therapy is the standard-of-care first-line therapy for patients with NSCLC that do not harbor EGFR sensitizing mutations or ALK translocations. Most patients experience disease progression despite treatment with chemotherapy, with median overall survival <12 months. Pembrolizumab (MK-3475), a humanized monoclonal antibody against PD-1, has demonstrated a manageable safety profile and robust antitumor activity as first-line therapy in patients with advanced NSCLC enrolled in the phase 1b KEYNOTE-001 study. Improved efficacy was observed in patients whose tumors strongly expressed PD-L1 (ie, showed membranous staining in ≥50% of tumor cells). The international, open-label, phase 3 KEYNOTE-024 trial (ClinicalTrials.gov identifier NCT02142738) is designed to assess the efficacy and safety of pembrolizumab with those of standard-of-care platinum-doublet chemotherapy in patients with treatment-naive metastatic NSCLC and PD-L1 expression in ≥50% of tumor cells.
Methods:
Patients aged ≥18 years with previously untreated advanced NSCLC without EGFR sensitizing mutations or ALK translocations, membranous PD-L1 expression in ≥50% of tumor cells, Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1, no active autoimmune disease, or history of interstitial lung disease are eligible. PD-L1 expression is determined by immunohistochemistry in newly collected tumor samples at a central laboratory. Patients are randomly assigned in a 1:1 ratio to receive a 200-mg fixed dose of intravenous pembrolizumab every 3 weeks (Q3W) or investigator’s choice of up to 6 cycles of gemcitabine 1250 mg/m[2] plus cisplatin 75 mg/m[2], gemcitabine 1250 mg/m[2] plus carboplatin AUC 5 or 6, pemetrexed 500 mg/m[2] plus carboplatin AUC 5 or 6, pemetrexed 500 mg/m[2] plus cisplatin 75 mg/m[2], or paclitaxel 200 mg/m[2] plus carboplatin AUC 5 or 6; patients with nonsquamous histology may receive pemetrexed 500 mg/m[2] Q3W maintenance therapy. Randomization is stratified by ECOG PS (0 vs 1), histology (squamous vs nonsquamous), and region (East Asia vs non-East Asia). Pembrolizumab will be given for up to 35 cycles or until disease progression, intolerable toxicity, or patient withdrawal. Eligible patients may remain on pembrolizumab therapy after initial radiographic disease progression. Patients who complete 35 cycles of pembrolizumab or who stop treatment after achieving complete response may be eligible for 1 year of pembrolizumab retreatment. Crossover to pembrolizumab is permitted for patients who progress on chemotherapy. Tumor imaging is performed every 9 weeks; response is assessed per RECIST v1.1 by independent central review and by modified RECIST by investigator review. Adverse events will be collected throughout the study and for 30 days (90 days for serious adverse events) thereafter; all toxicities will be graded according to NCI CTCAE v4.0. The primary end point is progression-free survival per RECIST 1.1 by central review; secondary end points are overall response rate per RECIST 1.1, overall survival, and safety. Enrollment is ongoing and will continue until approximately 300 patients are assigned to treatment.
Results:
Not applicable.
Conclusion:
Not applicable.
