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KEYTRUDA® (pembrolizumab) plus chemotherapy in metastatic squamous NSCLC

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

Discover the 3-year follow-up data from KEYNOTE-407*

KEYNOTE-407 study design1
The original analysis1

A randomised, multicentre, double-blind, placebo-controlled, phase 3 trial in patients (n=559) with previously untreated metastatic squamous NSCLC.1

559 patients were randomly assigned (in a 1:1 ratio) to receive 200 mg of pembrolizumab plus chemotherapy (carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]– paclitaxel) or saline placebo plus chemotherapy (carboplatin and either paclitaxel or nabpaclitaxel) on day 1 for up to 35 cycles.1

Overall Survival (OS) and Progression-Free Survival (PFS) were primary endpoints. Secondary endpoints consisted of Overall Response Rate (ORR), Duration of Response (DOR), and Safety.1

The results of this phase 3 trial were first published with a median follow-up of 7.8 months.1
The latest follow-up was published with a median follow-up of 40.1 months.2

KEYTRUDA plus carboplatin-paclitaxel/nab-paclitaxel provides superior survival vs. plat-pac/nabpac for the first-line treatment of metastatic squamous NSCLC in adults:1

  • Superior Overall Survival (OS) with a 36% reduction in the risk of death (HR 0.64, p<0.001)
  • Superior Progression-Free Survival (PFS) with a 44% reduction in the risk of progression or death (HR 0.56, p<0.001)
  • The overall survival benefit was consistent regardless of the level of PD-L1 expression*
  • Superior Overall Response Rate (ORR) (57.9% vs. 38.4%) and improved Duration of Response (DOR)
  • A generally manageable tolerability profile that is comparable to carb-pac/nabpac1

*Exploratory endpoints – no statistical conclusions can be drawn from them.

At a median follow-up of 40.1 months, KEYTRUDA plus chemotherapy (carboplatin-paclitaxel/nab-paclitaxel) continued to provide long-term survival benefit vs. carb-pac/nabpac for the first-line treatment of metastatic squamous NSCLC in adults.2

3-year OS rate of
29.7% vs. 18.2%
for chemotherapy alone

(HR 0.71, p not tested)

Median OS of
17.2 months vs. 11.6 months
with chemotherapy alone

(p not tested)

Survival benefit observed in each of the PD-L1 TPS subgroups, including the PD-L1 TPS <1% expressers:†2
3-year OS rate of
22.1% vs. 16.4%
for chemotherapy alone

(HR 0.78, p not tested)

Overall response rate of
62.6% vs. 38.8%
for chemotherapy alone and improved DOR

(p not tested)

Exploratory endpoints – no statistical conclusions can be drawn from them.

A generally manageable tolerability profile that is comparable to carb-pac/nabpac.1–3 The frequency of adverse events for combination was comparable to previous studies.

Explore our related resources

NICE guidance
SMC guidance
Licensed indication

Pembrolizumab with carboplatin and paclitaxel is recommended as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, if their tumours express PD-L1 with a tumour proportion score less than 50%, their tumours express PD-L1 with a tumour proportion score of 50% or more and they need urgent clinical intervention, and it is stopped at 2 years of uninterrupted treatment or earlier if their disease progresses.4

Pembrolizumab is accepted for restricted use within NHS Scotland in combination with carboplatin and either paclitaxel or nabpaclitaxel, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults 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. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.5

KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.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 intravenous chemotherapy.3

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

Find out more about KEYTRUDA in mNSCLC

KEYTRUDA KEYNOTE-189

KEYTRUDA KEYNOTE-024

Patient management

References

  1. Paz-Ares L et al. N Engl J Med 2018; 379: 2040-2051.
  2. Robinson AG et al. Presented at the European Lung Cancer Virtual Congress (ELCC) 2021, 25–27 March 2021.
  3. KEYTRUDA Summary of Product Characteristics.
  4. National Institute for Health and Care Excellence (2022). Final appraisal determination: Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer (CDF Review TA600) ID1683. Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta10537/documents. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the user of its content in this document to confirm that it accurately reflects the NICE publication from which it is taken.
  5. Scottish Medicines Consortium (2019). Appraisal determination: Pembrolizumab 25mg/mL concentrate for solution for infusion and 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2187/.

Supporting documentation

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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GB-PDO-01921 | Date of Preparation: January 2022