Merck Showcases Long-Term Survival Data for Early and Advanced NSCLC Patients Treated with Pembrolizumab at ESMO 2025

Rowe, New Jersey, USA2025Year10Month20Day——MSD (the trade name of Merck & Co., Inc., located in Rahway, New Jersey, USA) announced its PD-1 inhibitor Pembrolizumab^[1]Latest Long-term Research Data on the Treatment of Non-Small Cell Lung Cancer (NSCLC).

      This result is derived from the long-term analysis data of multiple studies, including the five-year exploratory follow-up analysis of the KEYNOTE-671 study, which evaluates the use of pembrolizumab as a neoadjuvant treatment combined with chemotherapy followed by adjuvant therapy (perioperative treatment regimen) in patients with resectable NSCLC; as well as the eight-year analyses of KEYNOTE-024 and KEYNOTE-042, and the ten-year analyses of KEYNOTE-001 and KEYNOTE-010, assessing the long-term efficacy of pembrolizumab monotherapy in certain locally advanced or metastatic NSCLC patients.

Senior Vice President of Merck Sharp & Dohme AG Laboratories, Head of Global Clinical Development for OncologyMarjorie GreenPh.D."These long-term data represent a new milestone for patients and their families, further confirming the transformative progress we have achieved in the field of non-small cell lung cancer. We look forward to continuing to advance the exploration and breakthroughs of pembrolizumab in the field of cancer treatment."

      KEYNOTE-671Principal Investigator, Expert in Thoracic Medical Oncology, Professor of Medicine at Stanford University School of MedicineHeather WakeleePh.D."The series of results from the five-year follow-up data of the KEYNOTE-671 study are significant, demonstrating the crucial value of intervention in the early stages of non-small cell lung cancer."

      KEYNOTE-001Principal Investigator, UCLADavid GeffenProfessor of Medicine, Medical SchoolEdward B. GaronPh.D.Said: "In the past, the prognosis for patients with advanced non-small cell lung cancer was generally poor, and long-term survival was almost considered impossible. These four long-term studies provide important evidence for deepening our understanding of the potential treatment options for some patients with advanced NSCLC."

      The latest five-year follow-up data from the KEYNOTE-671 study was presented as a late-breaking abstract in the oral mini-report session at the 2025 European Society for Medical Oncology (ESMO) Congress (Abstract ID: LBA67).

      The eight-year data of KEYNOTE-024 and KEYNOTE-042, as well as the ten-year data of KEYNOTE-001 and KEYNOTE-010, were presented during the poster session at the ESMO Congress (Abstract ID: 3208P).

AboutKEYNOTE-671Research

      KEYNOTE-671 is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial (ClinicalTrials.gov Identifier: NCT03425643), designed to evaluate the efficacy of pembrolizumab combined with neoadjuvant chemotherapy followed by adjuvant monotherapy in patients with resectable stage II, IIIA, or IIIB (T3-4N2, according to the 8th edition of the AJCC Cancer Staging Manual) non-small cell lung cancer (NSCLC), compared with placebo combined with neoadjuvant chemotherapy followed by placebo alone as adjuvant treatment.

      The study has two primary endpoints: Event-Free Survival (EFS) and Overall Survival (OS); key secondary endpoints include Pathological Complete Response Rate (pCR) and Major Pathological Response Rate (mPR).

      This study enrolled a total of 797 patients, who were randomly assigned in a 1:1 ratio to one of the following two groups:

AboutKEYNOTE-001Research

      KEYNOTE-001 is a Phase Ib study (ClinicalTrials.gov Identifier: NCT01295827) evaluating the 10-year follow-up results of pembrolizumab in treatment-naive or previously treated patients with advanced NSCLC. A total of 550 patients were enrolled and received pembrolizumab at 2 mg/kg (intravenous infusion every 3 weeks) or 10 mg/kg (intravenous infusion every 2 or 3 weeks). The primary endpoint was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS).

AboutKEYNOTE-010Research

      KEYNOTE-010 is a Phase II/III study (ClinicalTrials.gov Identifier: NCT01905657) evaluating the 10-year follow-up results of pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) whose tumor PD-L1 expression TPS is ≥1%. Patients enrolled had disease progression after prior platinum-based chemotherapy; for patients with EGFR or ALK genetic abnormalities, they must have received corresponding targeted therapy before enrollment. The study enrolled 1,033 patients, who were randomly assigned 1:1:1 to receive either pembrolizumab 2 mg/kg or 10 mg/kg (intravenously every 3 weeks), or docetaxel (chemotherapy every 3 weeks). The primary endpoints were OS and PFS, with secondary endpoints including objective response rate (ORR) and duration of response (DOR).

AboutKEYNOTE-024Research

      KEYNOTE-024 is a Phase III study (ClinicalTrials.gov Identifier: NCT02142738) evaluating the 8-year follow-up results of patients with metastatic NSCLC who were PD-L1 high expressers (TPS ≥ 50%), had no EGFR or ALK genomic aberrations, and had not received prior systemic therapy. A total of 305 patients were enrolled and randomly assigned in a 1:1 ratio to receive either pembrolizumab 200 mg (administered intravenously every 3 weeks) or platinum-based chemotherapy. The primary endpoint was PFS, with secondary endpoints including OS and ORR. In this study, 10.3% (n=209) of patients subsequently transitioned to the KEYNOTE-587 study.

AboutKEYNOTE-042Research

      KEYNOTE-042 is a Phase III study (ClinicalTrials.gov Identifier: NCT02220894) that evaluated patients with Stage III NSCLC who were not candidates for surgery or chemoradiotherapy, or those with metastatic NSCLC, whose tumors expressed PD-L1 with a TPS ≥1% and who had not received prior systemic treatment. The study enrolled 1,251 patients, randomly assigned 1:1 to receive either pembrolizumab 200mg (administered intravenously every 3 weeks) or platinum-based chemotherapy. The primary endpoints were OS in patients with TPS ≥50%, ≥20%, and ≥1%. Secondary endpoints included PFS and ORR assessed by blinded independent central review (BICR) per RECIST v1.1. In this study, 4.4% (n=50) of patients subsequently transitioned into the KEYNOTE-587 study.

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[1]As of now, the National Medical Products Administration (NMPA) has approved the following indications for pembrolizumab, other indications have not been approved yet: