About the AKYNZEO (netupitant/palonosetron) Pivotal Clinical TrialsThe efficacy of AKYNZEO was established in a pivotal, Phase 2, randomized, double blind, dose ranging study in 694 patients undergoing cisplatin based chemotherapy for a variety of tumor types. The efficacy of AKYNZEO was assessed in 135 chemotherapy naive patients who received AKYNZEO (netupitant 300 mg/palonosetron 0.5 mg), and 136 patients who received oral palonosetron 0.5 mg. For the key efficacy endpoints of complete response (CR), defined as no emetic episode and no use of rescue medication, for the delayed phase (25 120 hour interval), the acute phase (0 24 hour interval), and the overall phase (0 120 hours) after the start of chemotherapy administration, AKYNZEO showed significantly higher complete response rates compared with oral palonosetron in all phases (90.4% versus 80.1%; P=0.032; 98.5% versus 89.7%; P=0.002; 89.6% versus 76.5%; P=0.003, respectively)..
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