KEYTRUDA – Tested in 3 phase III studies in the 1st line1,2,3

* pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab or placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy
**200 mg of pembrolizumab or saline placebo for up to 35 cycles, along with carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]–paclitaxel for the first 4 cycles

KEYTRUDA in Combination Therapy


Study Design

Randomized, multi-center, double-blind, placebo-controlled Phase III study in non-pre-treated patients with mNSCLC without squamous cell histology, including patients without PD – L1 expression2
• Primary efficacy endpoints: OS and PFS
• Secondary efficacy endpoints: ORR and DOR
• Stratification after PD – L1 expression (TPS <1%, TPS ≥ 1%), cisplatin or carboplatin and smoking history
• Because of an increased risk of pneumonitis, patients were also excluded if they had received more than 30 Gy of radiotherapy to the lung in the previous 6 months.


Increasing the median overall survivala,4

Overall survival in Non Squamous mNSCLC EGFR & ALK – , KEYNOTE-1894,a (ITT Group)

aFor the data cut, the median follow-up was 23.1 months.4 Graphic modified according to Gadgeel S, et al., J Clin Oncol 38: 1505-1517

Safety Data

Summary of Adverse Events in the Total Population5,a

Data are presented as n (%), unless otherwise noted.
†Additional adverse events leading to death since the prior analysis were spinal fracture and general physical health deterioration in the pembrolizumab combination arm; and respiratory failure and bronchitis in the placebo combination arm.
a Median (range) duration of exposure to initially allocated study treatment was 7.2 mo (0.03–30.4) in the pembrolizumab plus pemetrexed and platinum arm and 4.2 mo (0.03–25.0) in the placebo plus pemetrexed and platinum arm.


Study Design

Randomized, multicentre, double-blind, placebo-controlled Phase III study in 559 previously untreated patients with mNSCLC Squamous cell histology, independent of the PD-L1 expression status of the tumor3
• Primary efficacy endpoints: OS and PFS
• Secondary efficacy endpoints: ORR and DOR
• Patients were stratified according to tumor PD-L1 status (TPS <1%; TPS ≥ 1%), choice of taxane, (paclitaxel or Nabpaclitaxel) and the geographic region of enrollment.3

a Administration of KEYTRUDA® was allowed beyond the disease progression defined by RECIST when the patient was was clinically stable and considered by the investigator to be a clinical benefit.3
b Patients in the group of chemotherapy alone, in whom the disease progression is verified by BICR according to RECIST v1.1 could switch to KEYTRUDA® monotherapy (crossover).


Increasing the median overall survival3

Overall survival in the Squamous mNSCLC, KEYNOTE-4073 (ITT Group)

KEYTRUDA in Monotherapy


Study Design

Randomized, open-label, Controlled, multicentre Phase-III-Study:1
• Primary Endpoint: PFSb
• Secondary Endpoint: OS, ORRb
• Explorative Endpoint: DOR, PFS

a The investigators determined chemotherapies included Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, Gemcitabine + Carboplatin or paclitaxel + carboplatin. Chemotherapy regimens with pemetrexed were only in tumors without squamous histology allowed. Pemetrexed could be used as maintenance therapy for tumors without squamous histology.
b Rated using BICR according to RECIST v1.1


Continuous and long-term use6

Overall survival in KEYNOTE-024 – 5 Year OS Update6,a
(secondary endpoint, ITT collective)

a Median Follow-up was 59.9 Months

Safety Data

Updated analysis AE summary6,a

Median follow up: 59.9 months

a During treatment with the initially assigned therapy.
b 7 additional patients in the pembrolizumab arm and no additional patients in the chemotherapy arm had treatment -related grade 3–5 AEs since the initial publication of KEYNOTE-024 (Reck M, et al. N Engl J Med. 2016;375:1823–1833). There was no change since the updated analysis at 25.2 months median follow-up, irrespective of attribution to treatment by the investigator.
  1. Reck M, Rodríguez-Abreu D, Robinson AG, et al; for the KEYNOTE-024 investigators. Pembrolizumab versus
    chemotherapy for PD – L1–positive non–small-cell lung cancer. N Engl J Med. 2016; 375 (19): 1823 – 1833.
  2. Gandhi L, et al. Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer. N Engl J Med.
    2018;378:2078 – 2092.
  3. Paz-Ares L, Luft A, Vicente D, et al; for the KEYNOTE-407 investigators. Pembrolizumab plus chemotherapy for
    squamous non–small-cell lung cancer. N Engl J Med 2018; 379:2040 – 2051.
  4. Gadgeel S, et al, J Clin Oncol 38: 1505-1517.
  5. Gadgeel S, et al, J Clin Oncol 38: 1505-1517: Supplementary Appendix.
  6. Brahmer JR, et al, Keynote 024, 5 Year OS Update, First line pembrolizumab vs platinum-based chemotherapy in patients with mNSCLC and PD-L1 Tumor proportion score ≥ 50%, presented at ESMO virtual congress 2020. September 19-21 2020.