Abstract:

CONTEXT: Palonosetron (PALO) is one of the two active components of NEPA, the fixed-combination antiemetic comprising netupitant (oral)/fosnetupitant (IV) and PALO. To increase the convenience of NEPA administration, especially for patients with swallowing difficulties, an IV NEPA formulation has been developed, where PALO is administered as a 30-minute infusion instead of the approved 30-second bolus.

OBJECTIVES: To determine the efficacy and safety of the PALO component used in IV NEPA.

METHODS: Noninferiority, double-blind, randomized phase 3 trial in chemotherapy-naive adult cancer patients requiring highly emetogenic chemotherapy (HEC). Patients were randomized to receive a single dose of PALO 0.25 mg administered IV either as a 30-minute infusion or as a 30-second bolus before HEC. The primary objective was to demonstrate noninferiority of the 30-minute infusion versus 30-second bolus in terms of complete response (CR; no emesis, no rescue medication) in the acute phase. Secondary efficacy endpoints were CR in the delayed and overall phases, and no emesis and no rescue medication in all phases. Safety was a secondary endpoint.

RESULTS: Overall, 440 patients received study treatment. In the infusion group, 186 (82.7%) patients reported CR in the acute phase versus 186 (86.5%) in the bolus group, demonstrating the noninferiority of PALO infusion versus bolus (P<0.001). Secondary endpoints showed similar results between the two treatment groups.

CONCLUSION: PALO 0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase. These results support the use of PALO 0.25 mg as a component of IV NEPA.

Reference:

Karthaus, M., Voisin, D., Rizzi, G. and Ciuleanu, T. (2020) Phase 3 study of palonosetron intravenous (IV) infusion versus IV bolus for chemotherapy-induced nausea and vomiting prophylaxis following highly emetogenic chemotherapy. Journal of Pain and Symptom Management. April 7th. doi: 10.1016/j.jpainsymman.2020.03.034. [Epub ahead of print].