Palonosetron Better Prevents Nausea and Vomiting Linked to High Emetogenic Chemotherapy Lung Cancer Patients

By Helsinn Healthcare Sa, PRNE
Wednesday, July 6, 2011

AMSTERDAM, The Netherlands, July 7, 2011 -


New data presented at the 14th World
Conference on Lung Cancer in Amsterda
he Netherlands, show the efficacy of
the 2nd generation
alone and in combination with

New data on the 2nd generation 5-HT3
receptor antagonist palonosetron, in the prevention of chemotherapy
induced nausea and vomiting (CINV) in the lung cancer setting,
presented at the 14th World Conference on Lung Cancer in
Amsterdam, today.

The study by Dr. Flavia Longo, oncologist at the Policlinico
Umberto I in Rome, Italy, showed, for the first time, that the
antiemetic efficacy of the triple combination palonosetron plus
aprepitant and dexamethasone can be sustained for up to six cycles
of cisplatin-based highly emetogenic chemotherapy (HEC).

A pooled analysis of 4 phase III studies performed by Dr. Lee
, Medical Director, The West Clinic, Memphis, USA -
demonstrated that palonosetron and dexamethasone improved CINV
prevention in patients affected with lung cancer with comparable
safety profile compared to 1st generation drugs such as
ondansetron, dolasetron, and granisetron.

“With repeated courses of chemotherapy, CINV is progressively
more difficult to control,” said Dr. Longo. “In our study we
included 158 chemotherapy-naïve patients with lung cancer,
receiving cisplatin-based HEC. We treated them with palonosetron,
aprepitant and dexamethasone 1-hour before chemotherapy, and again
with aprepitant and dexamethasone on the second and the third day.
The aim of our study was to evaluate, for the first time ever,
whether the antiemetic efficacy of the triple combination could be
sustained for up to six cycles in these patients. We verified and
in addition, we also confirmed that the adequate control in the
first cycle is more likely to be associated with control of CINV in
the subsequent ones,” she added.

The primary endpoint of the study was complete response (i.e. no
vomiting and no use of rescue medication), over five days following
HEC in up to six cycles. The study showed increasing complete
response rates over the 6 examined cycles: 74% (cycle 1), 77.2%,
80%, 79.2%, 81.8%, and 83.2% (cycle 6).

“Lung cancer is the leading cause of cancer-related death for
both men and women worldwide, being CINV a common side effect of
the treatment, often reported by patients as the most distressing
aspects of chemotherapy, associated with a significant
deterioration in the quality of life,” said Dr. Schwartzberg.
“5-HT3 receptor antagonists are the antiemetic treatment
most commonly associated with chemotherapy. The aim of our analysis
 was to assess the comparative safety and efficacy profiles of
the most used 5-HT3 RAs, palonosetron, ondansetron,
dolasetron, and granisetron in the prevention of CINV in patients
with lung cancer,” he explained.

The pooled analysis included 783 patients with lung cancer. In
the acute phase (0-24h), observed complete response rates were
78.3% for palonosetron and 76.3% for the 1st generation
5HT3-RAs Significantly higher were the complete response
rates observed for palonosetron when compared to 1st
generation 5HT3-RAs in both the delayed phase (24-120
hours; 53.5% vs. 41.8%) and the overall phase (51.2% vs. 39.8%).
The adverse event profile of palonosetron was similar to
1st generation 5HT3-RA.

“In our analysis, palonosetron statistically demonstrated
improved CINV prevention and a comparable safety profile relative
to old generation 5HT3-RAs in patients with lung
cancer,” concluded Dr. Schwartzberg.

About href="">Palonosetron(Aloxi
, Onicit®,

Palonosetron (palonosetron hydrochloride) is a second generation
5-HT3 Receptor Antagonist, developed for the prevention
of chemotherapy-induced nausea and vomiting (CINV) in patients with
cancer, with a long half-life of 40 hours and at least 30 times
higher receptor binding affinity than currently available
compounds. Palonosetron demonstrates, in clinical trials and
clinical practice, a unique long-lasting action in the prevention
of CINV. The product has shown to be effective in preventing both
acute and delayed CINV in patients receiving moderately emetogenic
chemotherapy (MEC). A single intravenous dose of palonosetron
provides better protection from CINV than first-generation
5-HT3 receptor antagonists throughout a 5-day
post-chemotherapy period*. Palonosetron is contraindicated in
patients known to have hypersensitivity to the drug or any of its
components. The most commonly reported adverse reactions in CINV
trials with palonosetron were headache (9 percent) and constipation
(5 percent), and they were similar to the comparators. Palonosetron
has been developed by the Helsinn Group in Switzerland and today it
is marketed as Aloxi®, Onicit®, and Paloxi® in more than 50
countries world-wide. Palonosetron, marketed as Aloxi®, is the
leading brand in the USA within the CINV Day of Chemo segment, and
it is steadily growing in the European markets.

For more information about palonosetron, please visit the
website: href="">

*This sentence refers to Moderately Emetogenic Chemotherapy
(MEC) setting

About Chemotherapy-induced nausea and vomiting

Chemotherapy-induced nausea and vomiting is among the most
dreaded side effects following therapy in patients with cancer.
Despite prophylaxis, on the day of chemotherapy, up to 30-45
percent of patients experience nausea or vomiting or require rescue
therapy following administration of certain types of emetogenic
chemotherapy. The 5-HT3 receptor plays a pivotal role in
the process of emesis, and agents that antagonise these receptor
subtypes are the basis for control of this effect. Following the
development of the first generation 5-HT3 receptor
antagonists, such as ondansetron and granisetron, in the late ’80s
and early ’90s, in recent years new compounds have been made
available for preventing CINV, including palonosetron.

About Helsinn Group

Helsinn is a privately owned pharmaceutical group with
headquarters in Lugano, Switzerland, and operating subsidiaries in
Ireland and USA. Helsinn’s business model is focused on the
licensing of pharmaceuticals and medical devices in therapeutic
niche areas. The Group in-licenses early to late stage new chemical
entities, completes their development from the performance of
pre-clinical/clinical studies and Chemistry, Manufacturing and
Control (CMC), development to the filing for and attainment of
their market approval worldwide. Helsinn’s products are
out-licensed to its network of local marketing and commercial
partners, selected for their deep in-market knowledge and know-how,
and assisted and supported with a full range of product and
scientific management services, including commercial, regulatory,
financial, legal and medical marketing advice. The active
pharmaceutical ingredients and the finished dosage forms are
manufactured at Helsinn’s cGMP facilities in Switzerland and
Ireland, and supplied worldwide to its customers.

For more information about Helsinn Group, please visit the

Helsinn Healthcare SA
Paola Bonvicini
Head of Communication & Press Office
Helsinn Healthcare SA
Ph: +41-91-985-21-21


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