Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Glenmark, Mundipharma, Fosun Pharma, Knight Therap, Immedica - LARVOL DELTA

A Retrospective Study on the Efficacy and Safety of Oral NEPA Capsules in Preventing Nausea and Vomiting in Nasopharyngeal Carcinoma Patients after Cisplatin Chemotherapy (ChiCTR) - P=N/A | N=246 | Completed | Sponsor: Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University

New trial • Chemotherapy-Induced Nausea and Vomiting • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Helsinn Group submits a new formulation of AKYNZEO to the European Medicines Agency (EMA) (GlobeNewswire) - "Helsinn Group....today announced the submission of a new formulation for AKYNZEO to the European Medicines Agency (EMA)....The new AKYNZEO formulation is expected to be launched in H1 2026."

EMA approval • Launch Europe • Chemotherapy-Induced Nausea and Vomiting

A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 Mg and Metabolites in Healthy Volunteers (clinicaltrials.gov) - P1 | N=50 | Terminated | Sponsor: Helsinn Healthcare SA

New P1 trial

Helsinn Group and ESTEVE sign a partnership agreement renewal to commercialize AKYNZEO and ALOXI in Germany (GlobeNewswire) - "Helsinn Group...and ESTEVE...announced the signing of the Distribution and Licence Agreement renewal in Germany for AKYNZEO (combination of netupitant-palonosetron) and ALOXI (palonosetron) for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adult patients."

Licensing / partnership • Chemotherapy-Induced Nausea and Vomiting

NOEME: Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer (clinicaltrials.gov) - P4 | N=84 | Recruiting | Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

New P4 trial • Endometrial Cancer • Oncology • Solid Tumor

AKY15-HK-301_NEPA Study (clinicaltrials.gov) - P2 | N=55 | Active, not recruiting | Sponsor: Chinese University of Hong Kong | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

Comparison of efficacy of single agent netupitant plus palonosetron (NEPA) vs fosaprepitant in prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving high dose chemotherapy for auto-SCT In a tertiary care center from South India (ESMO Asia 2024) - "As part of conditioning regimen, high dose melphalan and BEAM regimen were used in 31 and 9 patients respectively...The overall complete response (CR-O) was also higher in NEPA arm (77.8 % vs 60%). Conclusions Single agent oral NEPA is more effective in preventing CINV in acute, delayed, overall phases in patients receiving high dose chemotherapy as conditioning regimen for Auto-SCT."

CINV • Clinical • Chemotherapy-Induced Nausea and Vomiting • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (clinicaltrials.gov) - P4 | N=414 | Completed | Sponsor: Helsinn Healthcare SA | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024

Trial completion • Trial completion date • Chemotherapy-Induced Nausea and Vomiting

Exploratory study on a single-day low-dose dexamethasone combined with a single or double standard dose of netupitant palonosetron capsules for preventing nausea and vomiting in patients undergoing moderately to highly emetogenic chemotherapy (LD-NEPA1/2 study) (ChiCTR) - P=N/A | N=164 | Not yet recruiting | Sponsor: Zhongshan Hospital Affiliated to Xiamen University; Zhongshan Hospital Affiliated to Xiamen University

New trial • Chemotherapy-Induced Nausea and Vomiting

Clinical effect of different doses of olanzapine combined with triple antiemetic therapy on the prevention of nausea and vomiting caused by high emetogenic chemotherapy for malignant tumors (ChiCTR) - P=N/A | N=400 | Not yet recruiting | Sponsor: Zhoukou Center Hospital; Zhoukou Center Hospital

New trial • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

Knight Therapeutics Reports Second Quarter 2024 (GlobeNewswire) - "Oncology/Hematology: The oncology/hematology portfolio grew by $7,690 due to the continued growth of key promoted products including Lenvima, Akynzeo, Trelstar and the launch of Minjuvi in Brazil."

Sales • Diffuse Large B Cell Lymphoma • Endometrial Cancer • Hematological Malignancies • Hepatocellular Cancer • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

An Indian real-world experience of intravenous fosnetupitant-palonosetron (IV NEPA) in preventing delayed and extended delayed CINV. (ASCO 2024) - "Cisplatin-Paclitaxel (19.10%) and Carboplatin-Paclitaxel (35.39%) were the most common HEC and MEC regimens respectively... IV NEPA demonstrated high efficacy and good tolerability in a real world Indian setting, exhibiting response rates of >92% in both delayed and extended delayed phases in patients receiving HEC/MEC regimens."

CINV • Clinical • Real-world • Real-world evidence • Chemotherapy-Induced Nausea and Vomiting • Pain

Efficacy of intravenous FosNEtupitant-PAlonosetron (IV NEPA) in preventing chemotherapy-induced nausea (CIN): A first real-world experience from India (MASCC-AFSOS-ISOO 2024) - "Cisplatin-Paclitaxel (19.10%) and Carboplatin-Paclitaxel(35.39%) were the most common HEC and MEC regimens respectively...One serious adverse event was reported but was unrelated to the study medication. Conclusions In the real-world Indian scenario, IV NEPA was found to be effective and well tolerated in preventing nausea with >95% of all patients reporting NN/NSN."

Clinical • Real-world • Real-world evidence • Oncology • Pain

Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer (clinicaltrials.gov) - P3 | N=1351 | Completed | Sponsor: University of Rochester NCORP Research Base | Recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Feb 2024

Trial completion • Trial completion date • Breast Cancer • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (clinicaltrials.gov) - P4 | N=414 | Active, not recruiting | Sponsor: Helsinn Healthcare SA | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2024 ➔ Jul 2024

Enrollment closed • Trial primary completion date • Chemotherapy-Induced Nausea and Vomiting

An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India. (PubMed, Cureus) - "Adverse events were reported in 3.88% of patients. Conclusions Oral NEPA was found to be effective in the Indian real-world setting, eliciting a >90% complete response with HEC and MEC regimens across the acute, delayed, and overall phases."

CINV • Journal • Observational data • Chemotherapy-Induced Nausea and Vomiting • Oncology

NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens (clinicaltrials.gov) - P3 | N=627 | Not yet recruiting | Sponsor: Fudan University

Head-to-Head • New P3 trial • Chemotherapy-Induced Nausea and Vomiting

EFFICACY AND SAFETY OF NETUPITANT/PALONOSETRON COMBINATION (NEPA) AND LOW DOSE OF DEXAMETHASONE IN PREVENTING NAUSEA AND VOMITING IN PATIENTS UNDERGOING ALLOGENEIC STEM CELL TRANSPLANTATION (EBMT 2024) - "NEPA and low dose of dexamethasone, administered every other day, show to be very effective in preventing CINV in patients undergoing alloSCT with a good tolerability profile"

Clinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chemotherapy-Induced Nausea and Vomiting • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Non-Hodgkin’s Lymphoma • Oncology • Pain • Transplantation

EFFICACY AND SAFETY OF NETUPITANT/PALONOSETRON COMBINATION (NEPA) AND LOW DOSE OF DEXAMETHASONE IN PREVENTING NAUSEA AND VOMITING IN PATIENTS UNDERGOING ALLOGENEIC STEM CELL TRANSPLANTATION (EBMT 2024) - "NEPA and low dose of dexamethasone, administered every other day, show to be very effective in preventing CINV in patients undergoing alloSCT with a good tolerability profile"

Clinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chemotherapy-Induced Nausea and Vomiting • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Non-Hodgkin’s Lymphoma • Oncology • Pain • Transplantation

Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer (clinicaltrials.gov) - P3 | N=1600 | Recruiting | Sponsor: University of Rochester NCORP Research Base | Trial completion date: Jun 2025 ➔ Jun 2024 | Trial primary completion date: Jun 2025 ➔ Apr 2024

Trial completion date • Trial primary completion date • Breast Cancer • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

AKY15-HK-301_NEPA Study (clinicaltrials.gov) - P2 | N=55 | Active, not recruiting | Sponsor: Chinese University of Hong Kong | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor

Assessing the Benefit of NEPA (Fixed Combination of Netupitant/Palonosetron) for Preventing Chemotherapy-induced Nausea and Vomiting (CINV) in Patients at Increased Emetic Risk Receiving Moderately Emetogenic Chemotherapy (DGHO 2023) - P4 | "Background: In patients receiving moderately emetogenic chemotherapy (MEC), antiemetic guidelines lack evidence to recommend an NK 1 receptor antagonist (RA) for all patients; therefore, they endorse a 5-HT 3 RA + dexamethasone (DEX)...A generalized linear model will analyze CR over 3 cycles of MEC with logit link function, binomial distribution, and with study treatment, carboplatin use, and the country as factors...Enrollment is open; as of April 26, 2023, 287 patients have been randomized. In Germany, 96 of 100 patients have been enrolled by five study centres."

CINV • Clinical • Chemotherapy-Induced Nausea and Vomiting • Oncology

Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Simon Williamson Clinic

New P2 trial • Chemotherapy-Induced Nausea and Vomiting

Effectiveness of NEPA, an oral fixed-dose combination of netupitant and palonosetron in the prevention of chemotherapy induce nausea (CIN): A post-hoc analysis. (ASCO 2023) - "Anthracycline-Cyclophosphamide (36.16%) and FOLFOX (6.21%) were the most common HEC and MEC regimens, respectively... NEPA was found to be effective and well tolerated in preventing nausea in patients receiving HEC/MEC regimens, with almost 90% of patients reporting no significant nausea in real world Indian setting. Clinical trial information: CTRI/2020/02/023586. >"

Retrospective data • Oncology • Pain

THE IMPACT OF TIMING: DOES ANTI-EMETIC PRE-MEDICATION TIMING AFFECT CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV)? (MASCC-JASCC-ISOO 2023) - "Akynzeo® an oral 5HT-3 /NK1 receptor antagonist combination recommends a 1 hour delay prior to commencing anti-neoplastics...Conclusions This small self-reported study showed that there were no significant adverse events associated with a shorter interval between premedication administration and treatment commencement. Limitations include small sample size, extended sample time of questionnaire period due to COVID-19 and lack of control arm."

CINV • Chemotherapy-Induced Nausea and Vomiting • Infectious Disease • Novel Coronavirus Disease • Oncology