Lugano, Switzerland, January 4, 2023 – Helsinn Group (“Helsinn”), a fully integrated global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases, announces results from a secondary analysis of a Phase 3 multicenter pivotal trial in patients with breakthrough chemotherapy-induced nausea and vomiting (CINV) receiving antiemetic prophylaxis (oral or IV NEPA) have been published in The Oncologist.
The objectives of this analysis were to assess the rate of complete response (CR, no nausea/vomiting or rescue medications), and to evaluate the association between the duration of CINV in the first chemotherapy cycle and the risk of CINV in subsequent cycles in patients receiving chemotherapy.
Using data from a previously reported phase 3 trial, the analysis classified patients into 3 groups based on their response during the first chemotherapy cycle: CR, short-term CINV (1-2 days), and extended CINV (3-5 days). The analysis indicated that patients who experienced CR in their first cycle had a 93% or higher CR rates in subsequent cycles. Comparing patients with short-term CINV and extended CINV in cycle 1, recurrent CINV occurred in 30.6% and 69.5% of subsequent cycles, respectively (p<0.001). With close monitoring during the first chemotherapy cycle, clinicians can use the patient’s response data to optimize antiemetic prophylaxis when extended CINV does occur.
Details of the publication:
- Title: “Duration of chemotherapy-induced nausea and vomiting (CINV) as a predictor of recurrent CINV in later cycles”
- Authors: Rudolph Navari, MD PhD; Gary Binder, MBA; Alex Molassiotis, PhD; Jørn Herrstedt, MD; Eric J Roeland, MD; Kathryn J. Ruddy, MD MPH; Thomas W LeBlanc, MD; Dwight D Kloth, PharmD; Kelsey A Klute, MD; Eros Papademetriou, MA; Luke Schmerold, BS; Lee Schwartzberg, MD
- Journal: The Oncologist
- Link: Duration of Chemotherapy-Induced Nausea and Vomiting (CINV) as a Predictor of Recurrent CINV in Later Cycles | The Oncologist | Oxford Academic (oup.com)
Dr. Rudolph Navari, MD, PhD, hematologist oncologist, commented: “From the results of this analysis we can see that the duration of CINV in the first cycle of chemotherapy predicts CINV outcomes for the remainder of the patient’s course. This may potentially have significant implications when treating patients in the future, meaning that clinicians should consider monitoring the duration of breakthrough CINV and optimizing antiemetic prophylaxis when this occurs.”
About AKYNZEO® in the USA
AKYNZEO® (netupitant 300mg/palonosetron 0.5mg) capsules was approved in October 2014 in the United States and is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
AKYNZEO® (fosnetupitant 235mg/palonosetron 0.25) for injection was approved in April 2018 and AKYNZEO® injection was approved in May 2020 in the United States. Each is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.
About Helsinn
Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and a consolidated network of partners to reach out to patients in more than 190 countries worldwide.
Established in 1976, Helsinn is a fourth-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision.
To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and x.
