Akynzeo IV (fosnetupitant/palonosetron) / Helsinn, Knight Therap - LARVOL DELTA

Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC) (clinicaltrials.gov) - P2 | N=95 | Not yet recruiting | Sponsor: Helsinn Healthcare SA

New P2 trial • Chemotherapy-Induced Nausea and Vomiting • Oncology • Pediatrics

Knight Therapeutics Reports Fourth Quarter and Year-End 2024 Results (GlobeNewswire) - "For the quarter ended December 31, 2024...Revenues from our key promoted products increased by $5,781 or 42% on a constant currency basis driven by the growth of Lenvima, Akynzeo, Trelstar and the launch of Minjuvi in Brazil...For the year ended December 31, 2024, the oncology/hematology portfolio increased by $26,211 or 23% of which $11,336 is due to the Hyperinflation Impact1. Excluding IAS 29, the oncology/hematology portfolio increased by $14,875 or 12%. Our key promoted brands grew by $23,831 or 49% on a constant currency2 basis driven by the growth of Lenvima, Akynzeo, Trelstar and the launch of Minjuvi in Brazil."

Commercial • Breast Cancer • Diffuse Large B Cell Lymphoma • Endocrine Cancer • Endometrial Cancer • Hepatocellular Cancer • Prostate Cancer • Renal Cell Carcinoma • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • Uterine Leiomyoma

A prospective observational study to compare the antiemetic efficacy of fosnetupitant + palonosetron vs oral aprepitant + palonosetron (ESMO Asia 2024) - "Conclusions Patients receiving FP had statistically significant lesser number of events compared to AP. With increasing access to FP, the combination must be the preferred anti-emetic regimen in HEC and MEC regimens."

Clinical • Observational data • Oncology

Evaluation of Health System IV FosnetupitantPalonosetron and IV Aprepitant Use (ASHP 2024) - No abstract available

Effectiveness of intravenous fosnetupitant & palonosetron for cinv prophylaxis in patients receiving highly emetogenic chemotherapy regimens: Subgroup analysis from a phase IV Indian study (ESMO 2024) - "Safety was evaluated up to 240hrs. Out of total 178 patients, 90 (50.56%) patients received HEC regimen with Cisplatin-Paclitaxel (19.10%), being the most common regimen. IV NEPA demonstrated high effectiveness and excellent tolerability in a real world Indian setting, exhibiting complete response rates of ≥90% in both delayed and extended delayed phases in patients receiving HEC regimens."

CINV • Clinical • P4 data • Chemotherapy-Induced Nausea and Vomiting • Oncology

Report on a follow-up study after prophylactic administration of fosnetupitant to patients undergoing dose-dense EC therapy at our hospital (JBCS 2024) - "On the other hand, EC therapy (epirubicin + cyclophosphamide), which is positioned as a high emetogenic risk regimen (Japan Society of Clinical Oncology Antiemetic Appropriate Use Guidelines, October 2023, revised 3rd edition), like cisplatin regimens, has only been verified in a study (CONSOLE-BC study) with safety as the primary endpoint, and its efficacy has not been clarified...Method We investigated the occurrence of nausea and vomiting associated with the initial treatment in patients who received fosnetupitant under palonosetron and dose-dense EC therapy from April 2022 to October 2023... Eight patients were surveyed, with a median age of 50.5 years at the time of treatment. Two patients were treated preoperatively and six were treated postoperatively. One patient (12.5%) experienced vomiting throughout the entire period, and its onset was in the very delayed phase."

Clinical

Our experience with trastuzumab deruxtecan (JBCS 2024) - "Introduction Trastuzumab deruxtecan was approved in Japan in March 2020 for HER2-positive breast cancer, and in March 2023, its indication was expanded to include HER2-low expressing breast cancer. The median age was 66 (51-78). There were four recurrences and three stage 4 cases. Five cases were hormone receptor positive and two were negative."

Anemia • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Infectious Disease • Interstitial Lung Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • HER-2

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

Helsinn announces publication of data evaluating impact of AKYNZEO (fosnetupitant/palonosetron) on treatment outcomes and healthcare costs (GlobeNewswire) - "Helsinn Group...announces the publication of real-world evidence of AKYNZEO® (fosnetupitant with palonosetron) injection/for injection in the journal Advances in Therapy. The article, 'Real-world Treatment Outcomes, Healthcare Resource Use, and Costs Associated with Antiemetics Among Cancer Patients on Cisplatin-based Chemotherapy', evaluates the effect of AKYNZEO® on rates of chemotherapy-induced nausea and vomiting (CINV) events, inpatient and outpatient visits, as well as treatment costs...The dataset provides insight to nearly 80% of the US healthcare system, with patient-level data from all provider types...The study findings suggest that the downstream resource use and cost impact of AKYNZEO® and APPA is not equivalent. As clinicians are making therapeutic decisions on CINV prevention, the use of real-world data can contribute to thoughtful selection of therapy to result in better resource use and cost outcomes."

Real-world evidence • US reimbursement • Chemotherapy-Induced Nausea and Vomiting • Oncology

Real-World Treatment Outcomes, Healthcare Resource Use, and Costs Associated with Antiemetics Among Cancer Patients on Cisplatin-Based Chemotherapy. (PubMed, Adv Ther) - "In this retrospective study based on claims data, NEPA was associated with lower rates of nausea and vomiting and lower CINV-related HCRU and costs compared to APPA following cisplatin-based chemotherapy. These results complement clinical trial data and published economic models supporting the use of NEPA as a safe, effective, and cost-saving antiemetic for patients undergoing chemotherapy."

HEOR • Journal • Real-world • Real-world evidence • Chemotherapy-Induced Nausea and Vomiting • Oncology

Fosnetupitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Short Review and Clinical Perspective. (PubMed, Adv Ther) - "Fosnetupitant is one of the standard treatments for the prevention of CINV in patients who are receiving highly (any treatment where CINV occurs in more than 90% of patients) or moderately (where CINV occurs in 30-90% of patients) emetogenic chemotherapies. The aim of this commentary is to describe the mechanism of action, tolerability, and antiemetic efficacy of single-agent fosnetupitant in the prevention of CINV, and to discuss its clinical application, in order to aid optimal use."

CINV • Journal • Review • Chemotherapy-Induced Nausea and Vomiting

Efficacy of intravenous (IV) NEPA, a fixed NK1/5-HT3 receptor antagonist (RA) combination, for prevention of CINV following cisplatin- and anthracycline cyclophosphamide (AC)-based chemotherapy (CT) (ESMO 2019) - P3b; "An IV formulation of NEPA (fixed combination of the NK 1 RA, fosnetupitant and 5-HT 3 RA, palonosetron) was recently approved in the US and is under review in Europe...Data was also reviewed from 9 phase III cisplatin and AC studies with other NK 1 RA (aprepitant [APR], fosaprepitant [FOS], rolapitant [ROL]) regimens... Both IV and oral formulations of NEPA along with DEX represent highly effective guideline-compliant single-dose antiemetics. Clinical trial identification: NCT03403712. Legal entity responsible for the study: Helsinn Healthcare."

CINV • Clinical • Oncology • Solid Tumor

Antiemetic use and chemotherapy induced nausea and vomiting related hospitalization costs after highly or moderately emetogenic chemotherapy. (PubMed, Future Oncol) - "Materials & PrecisionQ analyzed its database to evaluate CINV related hospitalizations and costs following antiemetics use including netupitant/fosnetupitant with palonosetron (NEPA), aprepitant/fosaprepitant with ondansetron (APON) or aprepitant/fosaprepitant with palonosetron (APPA) in patients receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy. Database analysis identified 15,583 patient records (807 NEPA, 2023 APON, 12,753 APPA) and mean CINV related hospitalization costs were lower across all patients receiving NEPA (US$301) compared with patients receiving APON ($1006, p < 0.0001) or APPA ($321, p < 0.0001). NEPA is associated with lower CINV related hospitalization costs compared with APON and APPA among patients receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy."

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

Real-world treatment outcomes and healthcare resource use associated with antiemetics among cancer patients on highly emetogenic platinum-based chemotherapy. (ASCO 2022) - "Study patients were age ≥18 years and administered IV 1) fosnetupitant/palonosetron (IV NEPA), 2) aprepitant/fosaprepitant + palonosetron (IV APPA) or 3) aprepitant/fosaprepitant + ondansetron (IV APON) along with HEC. The choice of antiemetics to prevent CINV among cancer patients receiving HEC may impact real-world outcomes and healthcare resource use."

Clinical • HEOR • Real-world evidence • Chemotherapy-Induced Nausea and Vomiting • Oncology

Knight Therapeutics and Helsinn Healthcare SA Enter into Exclusive License, Distribution, and Supply Agreement for Akynzeo and Aloxi (GlobeNewswire) - "Knight Therapeutics Inc....and Helsinn Healthcare SA...announced that Knight, through one of its wholly-owned subsidiaries, and Helsinn have entered into an exclusive license, distribution and supply agreement for AKYNZEO® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI® oral/IV (palonosetron) in Canada....Under the terms of the agreement, Knight shall have the exclusive right to distribute, promote, market and sell the Products in the licensed territories. Knight will begin commercial activities following a transition period from Helsinn’s current licensees."

Licensing / partnership • Oncology

Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE). (PubMed, Oncol Ther) - "In this exploratory analysis, fosnetupitant appeared to be more effective than fosaprepitant in preventing CINV associated with cisplatin-based HEC during the extended 7-day period following chemotherapy."

CINV • Clinical • Journal • P3 data • Chemotherapy-Induced Nausea and Vomiting

Helsinn announces European Commission approval of the liquid formulation of AKYNZEO (fosnetupitant/palonosetron) (GlobeNewswire) - "Helsinn Group...is pleased to announce that the European Commission (EC) has approved the liquid formulation of AKNYZEO® (fosnetupitant/palonosetron). AKYNZEO® 235 mg/0.25 mg concentrate for solution for infusion is indicated for the prevention of acute and delayed nausea and vomiting associated with both highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy."

European regulatory • Chemotherapy-Induced Nausea and Vomiting • Oncology

Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "This field of supportive cancer care is very well researched. However, new drugs or drug combinations are continuously emerging and need to be systematically researched and assessed. For people receiving HEC, synthesised evidence does not suggest one superior treatment for prevention and control of chemotherapy-induced nausea and vomiting.  For people receiving MEC, synthesised evidence does not suggest superiority for treatments including both NK₁ and 5-HT₃ inhibitors when compared to treatments including 5-HT₃ inhibitors only. Rather, the results of our NMA suggest that the choice of 5-HT₃ inhibitor may have an impact on treatment efficacy in preventing CINV.  When interpreting the results of this systematic review, it is important for the reader to understand that NMAs are no substitute for direct head-to-head comparisons, and that results of our NMA do not necessarily rule out differences that could be..."

Journal • Retrospective data • Review • Chemotherapy-Induced Nausea and Vomiting • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

Helsinn and Fosun Pharma sign exclusive license and distribution agreements for Aloxi Akynzeo oral, NEPA IV and anamorelin in Mainland China, Hong Kong SAR and Macau SAR (GlobeNewswire) - “Helsinn Group (‘Helsinn’)…announced today the signing of exclusive license and distribution agreements effective from October 1st 2021 in the territory of Mainland China for Aloxi®, Akynzeo® and anamorelin. Under the terms of the agreements, Helsinn will grant Fosun Pharmaceutical A.G. an exclusive license to distribute, promote, market, and sell the following products in the aforesaid territory…Helsinn will also grant Fosun Pharmaceutical A.G. an exclusive license for the said products in Hong Kong SAR and Macau SAR....Helsinn Pharmaceuticals Beijing Co. Ltd. (HPC) will provide Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., a subsidiary company of Fosun Pharma with certain medical, marketing and commercial services, including co-promotion services in Shanghai, China, in support to the commercialization of the products in Mainland China, Hong Kong SAR and Macau SAR.”

Licensing / partnership • Oncology

Efficacy of an intravenous formulation of NEPA, a fixed combination of fosnetupitant and palonosetron, compared with oral NEPA studies in the prevention of chemotherapy-induced nausea and vomiting (CINV): An analysis of 1026 patient experiences. (ASCO 2018) - P3; "NCT02517021 Background: The approval of oral NEPA, a novel fixed antiemetic combination comprised of the NK1RA netupitant (300 mg) and 5-HT3RA palonosetron (PALO, 0.50 mg), was based on demonstrating superior prevention of CINV over PALO in patients receiving highly emetogenic chemotherapy (HEC) and anthracycline/cyclophosphamide (AC)... Data is compiled from 4 pivotal registration studies in adult chemotherapy-nave patients with solid tumors undergoing predominantly cisplatin-based HEC...All patients received dexamethasone on Days 1-4... Both IV and oral formulations of NEPA represent safe, effective, and convenient single-dose prophylactic antiemetics targeting two distinct CINV pathways, offering comparable options for clinicians and patients in different settings."

CINV • Clinical • Solid Tumor

Safety of intravenous (IV) NEPA and oral NEPA for prevention of CINV in patients (pts) with breast cancer (BC) receiving anthracycline/cyclophosphamide (AC) chemotherapy (CT). (ASCO 2019) - P3b; "Background: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose...In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast, hypersensitivity reactions and anaphylaxis have been reported with IV aprepitant, fosaprepitant and rolapitant, with the highest rate (35%) for fosaprepitant in the AC setting... There were no infusion-site AEs related to IV NEPA and no anaphylaxis reported for either formulation. Consistent with the pivotal study, IV NEPA is safe and effective in pts receiving AC. As a simplified single-dose formulation, IV NEPA may be better tolerated than other NK1 RAs."

CINV • Clinical

Recent Advances in Antiemetics: New Formulations of 5-HT3 Receptor Antagonists in Adults. (PubMed, Cancer Nurs) - "Nurses play a critical role in understanding and using new antiemetic formulations and updated antiemetic guidelines in their practices.This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited."

Clinical • Journal • Chemotherapy-Induced Nausea and Vomiting

[VIRTUAL] Stability and compatibility of the combination of intravenous (IV) NEPA (fosnetupitant-palonosetron) solution and dexamethasone (DEX) for efficient IV administration of antiemetic prophylaxis (ASHP 2020) - "Overall, the solutions containing IV-NEPA and DEX showed good stability. IV-NEPA+DEX solutions lacked visible particles and were colorless for all conditions tested and were clear under most conditions. The concentration of fosnetupitant, palonosetron, and DEX active compounds did not significantly change from baseline under all storage conditions; there was no significant formation of related substances."

Efficacy of intravenous NEPA, a fixed NK/5-HT receptor antagonist combination, for the prevention of chemotherapy-induced nausea and vomiting (CINV) during cisplatin- and anthracycline cyclophosphamide (AC)-based chemotherapy: A review of phase 3 studies. (PubMed, Crit Rev Oncol Hematol) - "This paper presents an overview of the efficacy of intravenous (IV) NEPA (fixed combination of the NKRA, fosnetupitant, and 5-HTRA, palonosetron) relative to oral NEPA and also to historical data for other NKRA regimens. The overall (0-120 h) complete response (no emesis, no rescue use), no emesis, and no significant nausea rates for IV NEPA were similar to that of oral NEPA and were consistently numerically higher than historical NKRA regimens. As a single-dose prophylactic antiemetic combination given with dexamethasone, IV NEPA is a highly effective and convenient guideline-compliant antiemetic agent which may offer a safety benefit over other IV NKRA regimens due to its lack of associated hypersensitivity and injection-site reactions."

CINV • Clinical • Journal • P3 data • Review • Chemotherapy-Induced Nausea and Vomiting • Immunology • Oncology • Solid Tumor