Study study type PathologyT1T0Patientssample sizesROB Results

mML - L2 - all population metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - all population

versus ipilimumab alone
pembrolizumab (10mg/kg)
KEYNOTE-006 (3 week), 2015
  NCT01866319
RCTmML - L2 - all populationpembrolizumab every 3 wkipilimumabhistologically confirmed, unresectable stage III or IV melanoma and had received no more than one previous systemic therapy for advanced disease277 / 278some concern
conclusif
  • demonstrated 31 % decrease in deaths (OS) (PE)
  • demonstrated 42 % decrease in progression or deaths (PFS) (PE)
  • suggested 32 % decrease in deaths (OS) (extension)
  • suggested 39 % decrease in PFS (extension)
versus Standard of Care (SoC)
pembrolizumab (10mg/kg)
KEYNOTE-002 (10 mg/kg), 2015
  NCT01704287
RCTmML - L2 - all populationpembrolizumabICC (carboplatin plus paclitaxel, dacarbazine, paclitaxel alone or oral temozolomid)18 years or older with unresectable stage III or stage IV melanoma, not amenable to local therapy; confirmed disease progression within 24 weeks of the last ipilimumab dose, previous BRAF or MEK inhibitor therapy or both,181 / 179some concern
conclusif
  • suggested 26 % decrease in deaths (OS) (PE)
  • demonstrated 50 % decrease in progression or deaths (PFS) (PE)