Phase 4 N=414 Randomized Supportive Care

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)

Chemotherapy-induced Nausea and Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT04817189 ↗

Enrolled (actual)

414

Serious AEs

11.2%

Results posted

Oct 2025

Primary outcome: Primary: The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration — 0.810; 0.718 Probability of complete response — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: NEPA (300mg netupitant/0.5mg palonosetron) (Drug); Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV) (Drug); Dexamethasone, 8 mg (oral) or equivalent IV dose (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Helsinn Healthcare SA
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration	0.810; 0.718	<0.05 sig
SECONDARY Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy	0.983; 0.951; 0.966; 0.881; 0.981; 0.938	—
SECONDARY Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy	77; 97; 71; 90; 65; 86	0.412
SECONDARY Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE)	150; 150; 37; 38; 6; 11	—
SECONDARY Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events	76.5; 73.2; 18.9; 18.5; 3.1; 5.4	—
SECONDARY Number of Participants With Discontinuations Due to Adverse Events	5; 7	—
SECONDARY Percentage of Participants With Discontinuations Due to Adverse Events	2.6; 3.4	—
SECONDARY Number of Participants With Death Due to Adverse Events	2; 2	—
SECONDARY Percentage of Participants With Death Due to Adverse Events	1.0; 1.0	—
SECONDARY Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy	115.14; 111.10; 115.78; 112.10; 114.74; 111.24	<0.05 sig
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV	0.5; 0.5; 0.4; 0.6; 0.5; 0.5	—
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV	16.3; 46.3; 13.7; 19.9; 24.7; 17.5	—
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags	0; 0; 0; 0; 0; 0	—
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations	0; 0.1; 0; 0; 0; 0	—
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits	0; 0; 0; 0; 0; 0	—
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test	0; 0.1; 0; 0; 0; 0	—
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV	1; 0; 1; 1; 0; 0	—
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV	0; 2; 0; 3	—
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - the Average Length of Delay of Chemotherapy Administration Due to CINV	0; 7; 0; 7.7	—
SECONDARY Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work	3; 5.7; 1; 4.3; 2.4; 7.0	—
SECONDARY Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy	0.04; 0.09; 0.04; 0.10; 0.05; 0.11	<0.05 sig

Summary

MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study. Antiemetic guidelines recommendations are based on the emetogenic potential of the chemotherapy. Chemotherapy (CT) agents are divided in Highly, Moderately, Low and Minimally Emetogenic potential. In addition to type of chemotherapy, several patient-related risk factors can increase the risk of CINV (chemotherapy-induced nausea and vomiting). Currently, there is limited consensus surrounding the most relevant patient risk factors that may predict the risk of CINV. Based on a recent study by Dranitsaris et al. (Dranitsaris et al. Ann Oncol. 2017 Jun 1; 28(6):1260-1267.), eight (8) predictive factors have been identified and an algorithm has been developed to incorporate these factors into the optimal selection of prophylactic antiemetics: 1. nausea and/or vomiting in the prior cycle of chemotherapy 2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy 3. platinum or anthracycline-based chemotherapy 4. age < 60 years 5. expectations for (anticipating) nausea and/or vomiting 6. <7 h of sleep the night before chemotherapy 7. history of morning sickness during previous pregnancy 8. cycle of chemotherapy (A negative association between risk and number of cycles was identified where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from cycle 3 onward). The clinical application of this prediction tool has the potential to be an important resource for clinicians and may help to enhance patient care by optimizing the use of the antiemetics in a proactive manner.

Eligibility Criteria

Inclusion Criteria

Adult patients aged ≥18 years
Patients with a risk score of ≥ 13 as calculated by the algorithm - see 3.6.3.1. Baseline/screening: VISIT 0
Signed Informed consent
Both sexes
Patients with diagnosis of any cancer scheduled and intended to be treated for three consecutive cycles with a single dose of any IV MEC regimen, per cycle, including adjuvant or neo-adjuvant chemotherapy
Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Use of Standard of Care defined as a 5-HT3 RA + Dexamethasone (or equivalent corticosteroid) based-regimen on day 1 of chemotherapy for CINV prevention
Naïve and non- naïve to chemotherapy
The enrolled women should be a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test done by health care team within 1-24 hours before dosing the antiemetic treatment in both arms and outcome recorded in the medical records
Able to comply with study requirements

Exclusion Criteria

Patients receiving highly emetogenic chemotherapy (including anthracycline+cyclophosphamide-based chemotherapy)
Patients receiving oral moderately emetogenic chemotherapy drugs
Patients receiving opioids within 2 weeks prior to trial enrollment (longer use allowed)
Use of olanzapine as prophylaxis of CINV
Patients scheduled to receive radiotherapy concurrently with chemotherapy
Any illness or condition that, in the opinion of the physician, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient.
Patients with mechanical risk factors for nausea (i.e. intestinal obstruction)
Patients with liver disease (as nausea is a common presenting symptom)
Patients with metabolic risk factors for nausea (i.e. electrolyte imbalances causing nausea/vomiting)
Chronic treatment with steroids (with the exception of inhaled or topical steroids)
Pregnancy and/or breast-feeding women
Women of childbearing potential refusing to use effective contraception during the whole study treatment and up to one month after study treatment with Akynzeo®
Use of Standard of Care including an NK-1 RA-based regimen to prevent CINV

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04817189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.