1879P - Effectiveness of intravenous fosnetupitant & palonosetron for cinv prophylaxis in patients receiving highly emetogenic chemotherapy regimens: Subgroup analysis from a phase IV Indian study

Background

In the absence of antiemetic prophylaxis, highly emetogenic chemotherapy (HEC) regimens can lead to acute emesis (occurring <24 hours of chemotherapy) in over 90% of individuals with delayed emesis reported in more than 50% patients and significant long-delayed (>120hr post-chemotherapy) nausea in 31% of patients receiving HEC regimen. Here, we present subgroup analysis from a phase IV study with IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA) in preventing nausea/vomiting in acute, delayed and extended delayed phases among patients receiving HEC regimens.

Methods

A phase IV, multi-centric, open label, single arm prospective study was conducted at six centres following Ethics Committee approvals. Complete response (CR) (no vomiting and no rescue medication), complete protection (CP) [CR + no significant nausea (<25mm) on visual analogue scale], complete control (CC) [CR + no nausea (<5mm)] were evaluated during acute (0-24hrs), delayed (>24-120hrs) and extended delayed (>120-240hrs) phases. Safety was evaluated up to 240hrs.

Results

Out of total 178 patients, 90 (50.56%) patients received HEC regimen with Cisplatin-Paclitaxel (19.10%), being the most common regimen. CR in acute, delayed and extended delayed phases were 74.44%, 90.00% and 94.44%, respectively. Furthermore, CP and CC were 73.33% and 47.78%, 87.78% and 71.11% and 94.44% and 84.44% in acute, delayed and extended delayed phases respectively (Table). Overall, the intravenous administration of NEPA was generally well tolerated, with only 17 (9.55%) patients experiencing adverse effects, headache (4, 2.25%) injection site reactions in (3, 1.68%) being most common. Table: 1879P

CINV efficacy assessment in patients receiving HEC regimen

Conclusions

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.

Clinical trial identification

CTRI/2023/04/051951.

Editorial acknowledgement

Legal entity responsible for the study

Glenmark Pharmaceticals Ltd.

Funding

Glenmark Pharmaceuticals Ltd.

Disclosure

All authors have declared no conflicts of interest.