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The following is a summary of “Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT,” published in the December 2024 issue of Oncology by Zhou et al.
HR20013 is a fixed-dose combination of fosrolapitant and palonosetron (PALO) designed to prevent chemotherapy-induced nausea and vomiting (CINV) in people receiving highly emetogenic chemotherapy (HEC), specifically cisplatin.
Researchers conducted a prospective study to evaluate the efficacy and safety of HR20013 + dexamethasone (DEX) compared to fosaprepitant (FAPR) + PALO with DEX for preventing CINV.
They assigned 750 individuals to receive HR20013 + DEX (days 1-4) or FAPR + PALO plus DEX (days 1-4) before cisplatin-based chemotherapy cycles (2 cycles total). The primary endpoint was the overall complete response (CR) rate (0-120 hours) in cycle 1.
The results showed that the overall CR rate in cycle 1 was 77.7% for HR20013 + DEX and 78.2% for FAPR + PALO + DEX (difference = –0.9% [95% CI, –6.7 to 5.0], 1-sided P<.01), demonstrating noninferiority. In cycle 2, HR20013 + DEX showed higher proportions of people with no impact on daily life during the delayed (24-120 hours) and beyond the delayed phases. Treatment-related AEs were 35.7% in cycle 1 and 42.1% for the entire study for HR20013 + DEX, compared to 38.2% and 44.0% for FAPR + PALO + DEX.
They concluded that HR20013 + DEX was noninferior to FAPR + PALO + DEX in preventing CINV and was well tolerated.
Source: ascopubs.org/doi/10.1200/JCO-24-01308
