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 either 200 mg Q3W or 400 mg Q6W 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.