A randomised, multicentre, double-blind, active-controlled, phase 3 trial in patients (n=616) with previously untreated metastatic non-squamous NSCLC with no EGFR or ALK positive mutations.¹

616 patients were randomly assigned (in a 2:1 ratio) to receive pemetrexed and a platinum based drug plus either 200 mg of pembrolizumab (n=410) or placebo every 3 weeks for 4 cycles (n=210), followed by placebo or pembrolizumab for up to a total of 35 cycles plus pemetrexed maintenance therapy.¹

Overall Survival and Progression-Free Survival were primary endpoints. Secondary endpoints consisted of Overall Response Rate, Duration of Response, and Safety.¹

The results of this phase 3 trial were first published with a median follow-up of 10.5 months.¹
The latest follow-up was published with a median follow up of 46.3 months.²

KEYTRUDA plus chemotherapy (pemetrexed and platinum) provides superior survival vs. plat-pem for the first-line treatment of metastatic non-squamous NSCLC in adults with no EGFR/ALK positive mutations:¹

• Superior OS with a 51% reduction in the risk of death (HR 0.49, p<0.001)
• Superior PFS with a 48% reduction in the risk of progression or death (HR 0.52, p<0.001)
• Survival benefit observed in each of the PD-L1 subgroups including the <1% and 1-49% expressers*
• Superior ORR (47.6% vs 18.9%, p<0.001) and improved DOR
• A generally manageable tolerability profile. The frequency of adverse events for the combination was observed to be higher than for each agent alone, reflecting the contributions of each agent^1,3

Pembrolizumab, with pemetrexed and platinum chemotherapy, is recommended as an option for untreated, metastatic, non-squamous non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)- positive mutations, only if pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier if the disease progresses, and the company provides pembrolizumab according to the commercial arrangement.⁴

Pembrolizumab is accepted for restricted use within NHS Scotland in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous non-small-cell lung carcinoma (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations and whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS.⁵

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.³

The recommended dose of KEYTRUDA as part of combination therapy is 200 mg Q3W administered intravenously over 30 minutes. KEYTRUDA should be administered first when given in combination with chemotherapy.³

Q3W = Every three weeks; Q6W = Every six weeks.