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Abstract Introduction Non‐inferiority of NEPA (fixed combination of NK1 receptor antagonist (RA), netupitant, and 5‐HT3RA, palonosetron) versus an aprepitant regimen was previously shown in a pragmatic study in patients receiving anthracycline cyclophosphamide (AC) and non‐AC moderately emetogenic chemotherapy (MEC). In the MEC group a numerically higher complete response (CR: no emesis, no rescue) rate was seen for NEPA during the overall 0–120 h phase (NEPA 76.1% vs. 63.1% aprepitant). As NEPA exhibits long‐lasting efficacy, this study evaluated a prolonged period up to 144 h, beyond the traditional 120 h post‐chemotherapy. In this post‐hoc analysis we explore the comparative efficacy of NEPA versus the aprepitant regimen in the MEC group up to 144 h, while also assessing the impact of risk factors on CINV prevention. Methods This was a pragmatic, multicenter, randomized, prospective study. Oral NEPA was administered as a single dose on day 1, while aprepitant was given on days 1–3 + ondansetron on day 1; all patients were to receive dexamethasone on days 1–4. Patients were chemotherapy‐naïve and receiving MEC, with a subset evaluation of those with a risk factor for developing CINV (i.e., female, male

Introduction: Non‐inferiority of NEPA (fixed combination of NK1 receptor antagonist (RA), netupitant, and 5‐HT3RA, palonosetron) versus an aprepitant regimen was previously shown in a pragmatic study in patients receiving anthracycline cyclophosphamide (AC) and non‐AC moderately emetogenic chemotherapy (MEC). In the MEC group a numerically higher complete response (CR: no emesis, no rescue) rate was seen for NEPA during the overall 0–120 h phase (NEPA 76.1% vs. 63.1% aprepitant). As NEPA exhibits long‐lasting efficacy, this study evaluated a prolonged period up to 144 h, beyond the traditional 120 h post‐chemotherapy. In this post‐hoc analysis we explore the comparative efficacy of NEPA versus the aprepitant regimen in the MEC group up to 144 h, while also assessing the impact of risk factors on CINV prevention. Methods: This was a pragmatic, multicenter, randomized, prospective study. Oral NEPA was administered as a single dose on day 1, while aprepitant was given on days 1–3 + ondansetron on day 1; all patients were to receive dexamethasone on days 1–4. Patients were chemotherapy‐naïve and receiving MEC, with a subset evaluation of those with a risk factor for developing CINV (i.e., female, male <60 years, male ≥60 years who received carboplatin, or male ≥60 years with anxiety). CR rates were compared during the extended overall (0–144 h) phase. Results: The MEC group included 211 patients; of these 181 were in the risk factor subset. Significantly higher CR rates were seen for NEPA than aprepitant during the extended overall phase for the total MEC group (NEPA 77.1%, aprepitant 57.8%, p = 0.003) and also in the subset of patients with CINV risk factors (NEPA 73.9%, aprepitant 56.2%, p = 0.012). Conclusion: A single dose of NEPA, administered on day 1 only, was more effective than a 3‐day aprepitant regimen in preventing CINV for an extended duration in patients receiving MEC and in those with emetic risk factors. [ABSTRACT FROM AUTHOR]

AimTo assess the efficacy of oral NEPA (netupitant-palonosetron 300/0.50 mg) over multiple chemotherapy cycles.MethodsTwo randomized phase III studies evaluated a single dose of oral NEPA given on day 1 in chemotherapy-naive patients receiving anthracycline-cyclophosphamide (AC)-based (Study 1) or highly (HEC)/moderately (MEC) emetogenic chemotherapy (safety Study 2). Oral NEPA was compared with oral palonosetron 0.50 mg (Study 1) or oral aprepitant 125 mg day 1, 80 mg days 2-3/palonosetron 0.50 mg (Study 2; no formal statistical comparisons). Oral dexamethasone was administered in all treatment groups. Complete response (CR; no emesis/no rescue medication), no emesis, and no significant nausea (NSN) rates during acute (0-24 h) and delayed (>24-120 h) phases of chemotherapy cycles 1-4 in each study were evaluated.ResultsIn Study 1, 1450 patients received 5969 chemotherapy cycles; in Study 2, 412 patients received 1961 chemotherapy cycles. In each study, ≥75% of patients completed 4 or more cycles. In Study 1, oral NEPA was superior to palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases of cycle 1, with higher rates of CR (all P

Abstract NEPA is the only fixed combination antiemetic, comprised of an NK1RA (netupitant) and a 5‐HT3RA (palonosetron). In the first head‐to‐head trial to compare NK1RA‐containing regimens, a single oral dose of NEPA was non‐inferior to a 3‐day aprepitant/granisetron (APR/GRAN) regimen for the primary endpoint of overall (0‐120 hours) complete response (no emesis/no rescue). This pre‐specified analysis evaluates the efficacy of NEPA versus APR/GRAN in the subset of Chinese patients in the study. In addition, efficacy in patients at greatest emetic risk receiving high‐dose cisplatin (≥70 mg/m2) was explored. Chemotherapy‐naïve patients with solid tumors in this randomized, double‐blind study received either a single dose of NEPA prior to cisplatin‐based chemotherapy or a 3‐day regimen of APR/GRAN, both with dexamethasone on Days 1‐4. Efficacy was evaluated through complete response, no emesis, and no significant nausea rates during the acute (0‐24 hours), delayed (25‐120 hours) and overall phases as well as individual days post‐chemotherapy, as the daily course of CINV protection is often unstudied. The Chinese subset included 667 patients; of these, 363 (54%) received high‐dose cisplatin. Baseline characteristics were comparable. While response rates were similar for NEPA and APR/GRAN during the acute, delayed and overall phases, significantly fewer NEPA patients experienced breakthrough CINV on individual Days 3‐5 in both the Chinese patients and also in those receiving high‐dose cisplatin. As a fixed oral NK1RA/5HT3RA combination given once/cycle, NEPA is a convenient highly effective prophylactic antiemetic that may offer better protection from CINV than a 3‐day APR/GRAN regimen on Days 3‐5 following highly emetogenic chemotherapy.

Abstract Aim To assess the efficacy of oral NEPA (netupitant‐palonosetron 300/0.50 mg) over multiple chemotherapy cycles. Methods Two randomized phase III studies evaluated a single dose of oral NEPA given on day 1 in chemotherapy‐naive patients receiving anthracycline‐cyclophosphamide (AC)–based (Study 1) or highly (HEC)/moderately (MEC) emetogenic chemotherapy (safety Study 2). Oral NEPA was compared with oral palonosetron 0.50 mg (Study 1) or oral aprepitant 125 mg day 1, 80 mg days 2‐3/palonosetron 0.50 mg (Study 2; no formal statistical comparisons). Oral dexamethasone was administered in all treatment groups. Complete response (CR; no emesis/no rescue medication), no emesis, and no significant nausea (NSN) rates during acute (0‐24 h) and delayed (>24‐120 h) phases of chemotherapy cycles 1‐4 in each study were evaluated. Results In Study 1, 1450 patients received 5969 chemotherapy cycles; in Study 2, 412 patients received 1961 chemotherapy cycles. In each study, ≥75% of patients completed 4 or more cycles. In Study 1, oral NEPA was superior to palonosetron in preventing chemotherapy‐induced nausea and vomiting (CINV) in the acute and delayed phases of cycle 1, with higher rates of CR (all P

NEPA is the only fixed combination antiemetic, comprised of an NK1RA (netupitant) and a 5‐HT3RA (palonosetron). In the first head‐to‐head trial to compare NK1RA‐containing regimens, a single oral dose of NEPA was non‐inferior to a 3‐day aprepitant/granisetron (APR/GRAN) regimen for the primary endpoint of overall (0‐120 hours) complete response (no emesis/no rescue). This pre‐specified analysis evaluates the efficacy of NEPA versus APR/GRAN in the subset of Chinese patients in the study. In addition, efficacy in patients at greatest emetic risk receiving high‐dose cisplatin (≥70 mg/m2) was explored. Chemotherapy‐naïve patients with solid tumors in this randomized, double‐blind study received either a single dose of NEPA prior to cisplatin‐based chemotherapy or a 3‐day regimen of APR/GRAN, both with dexamethasone on Days 1‐4. Efficacy was evaluated through complete response, no emesis, and no significant nausea rates during the acute (0‐24 hours), delayed (25‐120 hours) and overall phases as well as individual days post‐chemotherapy, as the daily course of CINV protection is often unstudied. The Chinese subset included 667 patients; of these, 363 (54%) received high‐dose cisplatin. Baseline characteristics were comparable. While response rates were similar for NEPA and APR/GRAN during the acute, delayed and overall phases, significantly fewer NEPA patients experienced breakthrough CINV on individual Days 3‐5 in both the Chinese patients and also in those receiving high‐dose cisplatin. As a fixed oral NK1RA/5HT3RA combination given once/cycle, NEPA is a convenient highly effective prophylactic antiemetic that may offer better protection from CINV than a 3‐day APR/GRAN regimen on Days 3‐5 following highly emetogenic chemotherapy. [ABSTRACT FROM AUTHOR]