OSLO, NORWAY--(Marketwired - Jul 17, 2013) - Algeta ASA (
"The publication of the ALSYMPCA data in the New England Journal ofMedicine is important, as it will provide physicians withcomprehensive data on this recently approved treatment that hasdemonstrated overall survival in men with castration-resistant prostatecancer, symptomatic bone metastases and no known visceral metastaticdisease," explained Oliver Sartor, MD, North American PrincipalInvestigator for the ALSYMPCA trial and medical director of the TulaneCancer Center.
"We are very pleased to see the publication of the data from ourpivotal ALSYMPCA phase III study of Xofigo in this prestigious medicaljournal" added Gillies O'Bryan-Tear, Algeta's Chief Medical Officer.
The ALSYMPCA Trial and the Results
The ALSYMPCA trial was a phase III, randomized, double-blind,placebo-controlled international study of Xofigo plus best standard ofcare vs. placebo plus best standard of care in patients with CRPC,symptomatic bone metastases and no known visceral metastatic disease. Thetrial enrolled 921 patients in more than 100 centers in 19 countries.Patients were stratified based on their baseline alkaline phosphatase(ALP) level, current bisphosphonate use and whether or not they hadreceived docetaxel prior to study enrollment. The study treatmentconsisted of up to six intravenous injections of Xofigo or placeboeach separated by an interval of four weeks.
The primary endpoint of the study was overall survival (OS). A keysecondary endpoint was time to first symptomatic skeletal event (SSE). SSEwas defined as first use of external beam radiation therapy torelieve skeletal pain, new symptomatic pathologic bone fracture,occurrence of spinal cord compression or tumor-related orthopedicsurgical intervention. There were no scheduled radiographicassessments performed on study.
Xofigo significantly improved OS in the overall study population at thepre-specified interim analysis (HR=0.695, (95% CI 0.552-0.875),p=0.00185); median OS was 14.0 months with Xofigo plus best standard ofcare (95% CI: 12.1-15.8) vs. 11.2 months with placebo plus best standardof care (95% CI: 9.0-13.2). These findings were supported by theexploratory analysis performed before patient crossover with anadditional 214 events in which Xofigo showed improvement in OS(HR=0.695, (95% CI 0.581-0.832); median OS was 14.9 months in the Xofigoarm (95% CI: 13.9-16.1) vs 11.3 months in the placebo arm (95% CI:10.4-12.8).
In the ALSYMPCA trial the most common adverse drug reactions (greaterthan or equal to 10 percent) in patients receiving Xofigo vs placebo,respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%),vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and4 treatment-emergent adverse events were reported among 57 percent ofpatients treated with Xofigo and 63 percent of placebo-treated patients.The most common hematologic laboratory abnormalities (greater than orequal to 10 percent) in patients receiving Xofigo vs placebo,respectively, were anemia (93% vs 88%), lymphopenia (72% vs 53%),leukopenia (35% vs. 10%), thrombocytopenia (31% vs 22%), and neutropenia(18% vs 5%).
About Xofigo(®) (radium Ra 223 dichloride)
Xofigo is approved in the United States and is indicated for thetreatment of patients with castration-resistant prostate cancer,symptomatic bone metastases and no known visceral metastatic disease.
Radium Ra 223 dichloride (radium 223) is currently not approved by theEuropean Medicines Agency (EMA) or other authorities outside the US.Bayer submitted a Marketing Authorisation Application to the EMA for radium223 in December 2012.
Xofigo is an alpha particle-emitting radioactive therapeutic agent with ananti-tumor effect on bone metastases. The active ingredient in Xofigo isthe alpha particle-emitting isotope radium-223, which mimics calcium andforms complexes with the bone mineral hydroxyapatite at areas of increasedbone turnover, such as bone metastases. The high linear energy transfer ofradium-223 may cause double-strand DNA breaks in adjacent cells, resultingin an anti-tumor effect on bone metastases. The alpha particle range fromradium-223 is less than 100 micrometers which may limit the damage to thesurrounding normal tissue[i].
In September 2009, Algeta signed an agreement with Bayer for thedevelopment and commercialization of Xofigo. Under the terms of theagreement, Bayer will develop, apply for health authority approvalsworldwide and commercialize Xofigo globally. Algeta US, LLC is co-promotingXofigo with Bayer in the US.
Important Safety Information for Xofigo (radium Ra 223 dichloride)
Xofigo is contraindicated in women who are or may become pregnant.Xofigo can cause fetal harm when administered to a pregnant woman.
In the randomized trial, 2% of patients in the Xofigo arm experiencedbone marrow failure or ongoing pancytopenia, compared to no patientstreated with placebo. There were two deaths due to bone marrow failure.For 7 of 13 patients treated with Xofigo bone marrow failure was ongoingat the time of death. Among the 13 patients who experienced bonemarrow failure, 54% required blood transfusions. Four percent (4%) ofpatients in the Xofigo arm and 2% in the placebo arm permanentlydiscontinued therapy due to bone marrow suppression. In the randomizedtrial, deaths related to vascular hemorrhage in association withmyelosuppression were observed in 1% of Xofigo-treated patientscompared to 0.3% of patients treated with placebo. The incidence ofinfection-related deaths (2%), serious infections (10%), and febrileneutropenia (less than 1%) was similar for patients treated with Xofigo andplacebo. Myelosuppression -- notably thrombocytopenia, neutropenia,pancytopenia, and leukopenia -- has been reportedin patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow reserveclosely and provide supportive care measures when clinically indicated.Discontinue Xofigo in patients who experience life-threateningcomplications despite supportive care for bone marrow failure.
Monitor blood counts at baseline and prior to every dose of Xofigo.Prior to first administering Xofigo, the absolute neutrophil count(ANC) should be greater than to equal to 1.5 × 10(9)/L, the plateletcount greater than or equal to 100 × 10(9)/L, and hemoglobin greaterthan or equal to 10 g/dL. Prior to subsequent administrations, the ANCshould be greater than or equal to 1 × 10(9)/L and the plateletcount greater than or equal to 50 × 10(9)/L. DiscontinueXofigo if hematologic values do not recover within 6 to 8 weeks afterthe last administration despite receiving supportive care.
Safety and efficacy of concomitant chemotherapy with Xofigo have notbeen established. Outside of a clinical trial, concomitant use of Xofigoin patients on chemotherapy is not recommended due to thepotential for additive myelosuppression. If chemotherapy, othersystemic radioisotopes, or hemibody external radiotherapy areadministered during the treatment period, Xofigo should be discontinued.
Xofigo should be received, used, and administered only by authorizedpersons in designated clinical settings. The administration of Xofigo isassociated with potential risks to other persons from radiation orcontamination from spills of bodily fluids such as urine, feces, orvomit. Therefore, radiation protection precautions must be taken inaccordance with national and local regulations.
The most common adverse reactions (greater than or equal to 10%) in theXofigo arm vs. the placebo arm, respectively, were nausea (36% vs 35%)diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13%vs 10%). Grade 3 and 4 adverse events were reported in 57% ofXofigo-treated patients and 63% of placebo-treated patients. The mostcommon hematologic laboratory abnormalities in the Xofigo arm (greaterthan or equal to 10%) vs the placebo arm, respectively, were anemia(93% vs 88%), lymphocytopenia (72% vs.53%), leukopenia (35% vs. 10%),thrombocytopenia (31% vs. 22%), and neutropenia (18% vs. 5%).
For full prescribing information visit www.xofigo-us.com.
Xofigo® is a registered trademark of Bayer
Algeta is a company focused on developing novel targeted therapies forpatients with cancer based on its alpha-pharmaceutical platform. TheCompany is headquartered in Oslo, Norway, and has a US subsidiary, AlgetaUS, LLC, based in Cambridge, MA performing commercial marketingoperations in the US. Algeta is listed on the Oslo Stock Exchange(ALGETA.OL). For more information please visit www.algeta.com.
This news release contains certain forward-looking statements that arebased on uncertainty, as they relate to events and depend oncircumstances that will occur in the future and which, by their nature, mayhave an impact on results of operations and the financial conditionof Algeta. Such forward-looking statements reflect our current viewsand are based on the information currently available to Algeta. Algetacannot give any assurance as to whether such forward looking statementswill prove to be correct. These forward looking statements includestatements regarding our co-promotion of Xofigo in the US. There are anumber of factors that could cause actual results and developments todiffer materially from those expressed or implied by these forward-lookingstatements. These factors include, among other things, generaleconomic and business conditions, the impact of competition, the abilityto successfully commercialize Xofigo, the risk that costs associated withthe co-promotion of Xofigo may be greater than anticipated, manufacturingcapacity, risks in obtaining additional regulatory approvals for radium223 and the other risks and uncertainties described in our annualreport.
[i] XOFIGO Prescribing information. May 2013
This announcement is distributed by Thomson Reuters on behalf of ThomsonReuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Algeta ASA via Thomson Reuters ONE[HUG#1717195]
- Health Care Industry
- bone metastases
- radium 223
- Prostate CAncer
For further information, please contact:
Mike Booth / Renate Birkeli
+47 23 00 67 32
Communications & Corporate Affairs
+44 207 638 9571
Citigate Dewe Rogerson
+1 781 235 3060
MacDougall Biomedical Communications
US investor enquiries:
+1 646 378 2953
The Trout Group