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Merck's (KEYTRUDA in combination with ALIMTA and Pt CT) Receives EU Approval for 1L mNonsq NSCLC with no EGFR or ALK Genomic Tumour

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Merck's (KEYTRUDA in combination with ALIMTA and Pt CT) Receives EU Approval for 1L mNonsq NSCLC with no EGFR or ALK Genomic Tumour

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  • The approval is based on KEYNOTE-189 P-III study- assessing (KEYTRUDA + pemetrexed ALIMTA and Pt CT vs CT alone) administering KEYTRUDA 200 mg- cisplatin/carboplatin- and pemetrexed q3w IV for four cycles followed by KEYTRUDA 200 mg for up to 24 mos and pemetrexed q3w or (PBO + cisplatin/carboplatin and pemetrexed) q3w IV for four cycles followed by pemetrexed q3w
  • P-III KEYNOTE-189 study demonstrated: reducing risk of death by 51%; 48% reduction in the risk of progression/death; ORR (48% vs 19%); DOR (11.2 vs 7.8mos)
  • EU approval allows marketing of Keytruda (200mg q3w) + combination in Iceland- Lichtenstein- Norway and in 28 EU member states

/ article | Ref: Merck | Image: Merck

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