Helsinn publishes results from a secondary analysis of a Phase 3 trial in patients with CINV in The Oncologist

On 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, reported 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 (Press release, Helsinn, JAN 4, 2023, View Source [SID1234625805]).

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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."