Microsoft word - 2011-07-01f.doc

Palonosetron Better Prevents Nausea and Vomiting Linked to
High Emetogenic Chemotherapy Lung Cancer Patients
New data presented at the 14th World Conference on Lung Cancer in
Amsterdam, The Netherlands, show the efficacy of the 2nd generation 5-HT3
receptor antagonist alone and in combination with aprepitant

Amsterdam, The Netherlands, July 7th 2011 – 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 Schwartzberg, 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, “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- “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 Palonosetron (Aloxi®, Onicit®, Paloxi®)
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: www.aloxi.com *This sentence refers to Moderately Emetogenic Chemotherapy (MEC) setting About Chemotherapy-induced nausea and vomiting (CINV)
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 website: For further information please contact: Helsinn Healthcare SA
Paola Bonvicini
Head of Communication & Press Office

Source: http://www.helsinn.net/public/download/2011-07-07.pdf