Single Dose Palonosetron Prevents Emesis Induced by Chemotherapy in Non Hodgkin’s Lymphoma Patients

BERLIN, Germany - Single Dose Palonosetron is Effective and Safe in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients With Aggressive Non-Hodgkin’s Lymphomas who Undergo Moderately Emetogenic Chemotherapy

- Data Presented Today at the European Haematology Association Congress in Berlin, Germany

New data presented today at the EHA (European Haematology Association) Congress in Berlin show that a single dose of palonosetron, a second generation 5-HT3 receptor antagonist, is effective and safe in preventing chemotherapy-induced nausea and vomiting (CINV) in patients with aggressive non Hodgkin’s lymphoma (NHL), treated with cytotoxic agents.

The result comes from a study conducted in Italy on behalf of the Italian Group of Study on Lymphomas (GISL) by a multicentric team coordinated by Dr. Nicola Di Renzo of the Vito Fazzi Hospital of Lecce. “The standard approach in the antiemetic therapy in NHL is represented by antiserotoninergic drugs. Palonosetron is a selective and potent serotonin antagonist that associated to the chemotherapy of solid tumours has demonstrated improved efficacy compared to older 5-HT3 receptor antagonists. The objective of our study was to evaluate the efficacy and safety of a single dose of palonosetron in preventing CINV induced by moderately emetogenic chemotherapy (MEC) agents used for the treatment of aggressive NHL”, explained Dr. Di Renzo.

“Palonosetron, given as antiemetic treatment, is effective and safe in preventing CINV in patients with aggressive NHL”, he concluded. The GISL study was an open-label, multicenter phase II study assessing the efficacy of a single dose of palonosetron (0.25 mg) prior to the administration of chemotherapy in the first day of treatment, in ten Italian hospitals. The study included 86 patients, affected by aggressive NHL. The primary endpoint was the overall rate of patients achieving a complete response (CR - defined as no emetic episode and no use of rescue medication) during the whole study period (0-120 h). Relevant secondary endpoints included: CR in the acute (0-24h) and delayed (24-120) phases, no emesis and no nausea rates.

The primary endpoint was achieved with a CR rate of 86%. The CR in the acute and delayed phases was 90.7% and 88.4% respectively. No emesis rates were 91.9% (0-24h), 89.5% (24-120h) and 88.4% (0-120h). Importantly, nausea, that is still considered an unmet need despite the anti emetic treatments, was very well controlled by a single palonosetron dose with no nausea rates of 84.9%, 75.6% and 74.4% in the acute, delayed and overall periods respectively. No serious drug related adverse events were reported. “These results are of special interest for both physicians and patients”, pointed out Prof. Mauro Bianchi, Medical Development Director at Helsinn, the Swiss pharmaceutical group developer and worldwide licensor of palonosetron. “Generally, NHL patients undergoing moderately emetogenic chemotherapy based on CHOP or CHOP-R protocols, including daily dose of 100 mg of prednisone orally from day 1 to day 5 - show CINV rates around 40-50%. In this study, palonosetron reduced this percentage to 14%”, he concluded.

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 Palonosetron (Aloxi(R), Onicit(R), Paloxi(R))

Palonosetron (palonosetron hydrochloride) is a selective 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 is a second generation 5-HT3 receptor antagonist, and demonstrates, in clinical trials and clinical practice, a unique long-lasting action in the prevention of CINV. Since its availability in USA in September 2003, and since then in more than 40 countries world-wide, there have been over 10 million administrations of palonosetron. The product has shown to be effective in preventing both acute and delayed CINV in patients receiving moderately emetogenic chemotherapies. A single intravenous dose of palonosetron (0.25 mg) provides better protection from CINV than first-generation 5-HT3 receptor antagonists throughout a 5-day post-chemotherapy period*. This means that a single administration of palonosetron also grants protection during the delayed phase of CINV*. Palonosetron 0.075 mg IV is also approved by FDA as a single intravenous dose administered immediately before the induction of anaesthesia for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions (incidence more than or equal to 2 percent) in CINV trials with palonosetron were headache (9 percent) and constipation (5 percent), and they were similar to the comparators. In PONV trials, the most commonly reported adverse reactions were QT prolongation (5 percent), bradycardia (4 percent), headache (3 percent), and constipation (2 percent), similar to placebo. Palonosetron has been developed by Helsinn Group of Switzerland and today it is marketed as Aloxi(R), Onicit(R), and Paloxi(R). Palonosetron, marketed as Aloxi(R), 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

About Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and subsidiaries in Ireland and USA. Helsinn is the worldwide licensor of palonosetron. Helsinn’s unique business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early 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 sold directly, through the Group subsidiaries, or eventually 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: www.helsinn.com

*These sentences refer to Moderately Emetogenic Chemotherapy (MEC) setting

Contact person at Helsinn Healthcare SA: Paolo Ferrari Head of International Marketing Tel: +41-91-985-21-21 E-Mail: info-hhc@helsinn.com

Source: Helsinn Healthcare SA

Contact person at Helsinn Healthcare SA: Paolo Ferrari, Head of International Marketing, Tel: +41-91-985-21-21, E-Mail: info-hhc at helsinn.com