The Combination of Palonosetron and Aprepitant Shows Superior Protection From Significant Nausea and Vomiting Than Daily Granisetron in Patients Receiving High Dose Chemotherapy as Conditioning Prior to Stem Cell Transplantation

LONDON, June 10, 2011 -

- New data presented at the European Hematology Association (EHA) 2011
Annual Meeting in London show better control of nausea and vomiting with the
combination palonosetron plus aprepitant when compared to granisetron in
patients receiving multiday highly emetogenic conditioning chemotherapy
regimens - Significantly higher the complete response during the acute,
delayed and overall periods

The combination of palonosetron (0.25 mg iv every 48 h) and aprepitant
(125 mg on day 1, followed by 80 mg each of the remaining days) improves
control of CINV (Chemotherapy Induced Nausea and Vomiting) compared with
daily granisetron (3 mg iv) during the conditioning period (5-6 days) of
patients prior to stem cell transplantation (HSCT).

The results come from a prospective, multicenter, randomized, stratified
by conditioning regimen, double-blind study (AMENO Study) presented at the
European Hematology Association (EHA) 2011 Annual Meeting in London by the
Spanish groups GETH (Grupo Espanol de Trasplante Hematopoyetico y Terapia
Celular) and PETHEMA (Programa de Estudio y Tratamiento de las Hemopatias
Malignas).

"Nausea and vomiting in patients receiving high-dose, multiday
conditioning regimens prior to stem cell transplantation is particularly
common and affects between 55 and 100% of the patients," Javier
Lopez-Jimenez, Hospital Ramon y Cajal, Hematology Department and the lead
investigator, said. "CINV is particularly troublesome, especially in the
delayed phase beginning 24 hours after the start of conditioning. Though
newer anti-emetics as palonosetron and aprepitant appear to significantly
reduce acute and delayed CINV, in comparison to the older 5-HT3 receptor
antagonists, few studies had prospectively evaluated the efficacy of these
drugs in this very challenging setting," he explained.

Sixty consenting patients were included in the study, received a
conditioning regimen prior to HSCT, and an anti-emetic prophylaxis (31,
palonosetron + aprepitant; 29, granisetron). Significantly more patients in
the group treated with the combination of palonosetron and aprepitant had a
complete response - defined as no emesis and no use of rescue medication -
during the acute (0-24h; 92.3% versus 67.9% in the granisetron group),
delayed (24-120h; 61.5% versus 28.6%, respectively) and overall (0-120h;
61.5% versus 28.6%, respectively) periods.

In addition, palonosetron plus aprepitant significantly reduced the
proportion of patients with emesis during the acute, delayed and overall
periods and showed a trend toward a reduction in percentage of patients with
significant nausea during the delayed period.

There were no significant differences between the groups in adverse
events or in the times of engraftment or severe infections.

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