Reason for request

Extension of indication

Substantial clinical benefit in combination with chemotherapy with carboplatin and either paclitaxel or nab-paclitaxel, as a first-line treatment for adult patients (ECOG performance status of 0 or 1) with metastatic squamous non-small cell lung carcinoma (NSCLC) and moderate clinical added value compared to this same chemotherapy.

  • KEYTRUDA has a marketing authorisation in combination with carboplatin and either paclitaxel or nab-paclitaxel as a first-line treatment for adult patients with metastatic squamous non-small cell lung carcinoma (NSCLC).
  • The superiority of KEYTRUDA in combination with carboplatin + paclitaxel/nab-paclitaxel compared to carboplatin + paclitaxel/nab-paclitaxel was demonstrated in terms of progression-free survival (increase of + 1.6 months) and overall survival (increase of + 4.6 months) in an interim analysis with a median follow-up of 8.3 months in the pembrolizumab group and 7.4 months in the placebo group.
  • The transposability of the data to the French population is limited given that 40% of patients received the nab-paclitaxel + carboplatin combination, not cited in French national recommendations.
  • No robust quality of life data are available.

Clinical Benefit

Substantial

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Clinical Added Value

moderate

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