Magazin
2008-12-09
Beerse, Belgium (ots/PRNewswire) -
- Preliminary Phase II Re-treatment Results and two new AnalysesFrom Phase III VISTA Presented at ASH Annual Meeting
Janssen-Cilag today announced preliminary results from aprospective, international, multicenter, open-label, phase II studyshowing re-treatment with VELCADE(R) (bortezomib) is an effective andwell-tolerated treatment option for patients with relapsed multiplemyeloma (MM) who had previously responded to VELCADE-based treatment.The patient response after re-treatment was similar when VELCADE wasused alone or in combination with dexamethasone. These data werepresented in San Francisco, CA at the 50th American Society ofHematology (ASH) Annual Meeting & Exposition.
The data demonstrate how VELCADE can play a role throughout thetreatment sequence, which is especially important since relapsed MMpatients often build a resistance to therapy. After a treatment-freeinterval, response to VELCADE is shown to be high and follows anestablished safety profile.
The primary objective of the study was to determine the bestresponse to VELCADE re-treatment in patients with relapsed MM. Amongthe study patients, the best response to previous VELCADE treatmentwas complete response (CR) in 34 patients (27 percent) and partialresponse (PR) in 94 patients (73 percent). Re-treatment with VELCADEalone or in combination with dexamethasone resulted in 60 percentoverall response rate (ORR) including 34 percent CR by single besturine M-protein analysis. The safety profile of VELCADE duringre-treatment was consistent with that seen in phase II and IIIstudies in patients with relapsed MM.(i),(ii),(iii)
In addition, results from two new follow-up analyses of the VISTA(VELCADE as Initial Standard Therapy in Multiple Myeloma: Assessmentwith Melphalan and Prednisone) Phase III clinical trial werepresented at the ASH meeting. An analysis of the three-year survivalrate (median follow up of 25.9 months) reinforces the statisticallysignificant survival benefit for the VELCADE arm, which had been seenin earlier analyses. The VELCADE melphalan-prednisone (VMP) arm had athree-year survival rate of 72 percent versus 59 percent in themelphalan-prednisone (MP) arm. The other analysis demonstratesVELCADE efficacy in patients with renal impairment showing a reversalof renal impairment in a significant number of patients.
About VELCADE(R)
VELCADE is the first proteasome inhibitor to receive worldwideregulatory approval for the treatment of multiple myeloma (MM). In2005, VELCADE was approved in the European Union for MM after firstrelapse and has now received a positive opinion from the CHMPrecommending approval for VELCADE in combination with melphalan andprednisone for the treatment of patients with previously untreated MMwho are not eligible for high-dose chemotherapy with bone marrowtransplant.
Clinical trials are underway to investigate the potential ofVELCADE in additional settings and in combination with otheranti-cancer drugs to enhance treatment effects or reverse resistance.
VELCADE has a predictable safety profile and a favourablebenefit-risk ratio. The most common side effects reported withVELCADE include fatigue, gastrointestinal adverse events, transientthrombocytopenia and neuropathy, which is reversible in the majorityof patients.
VELCADE is the market leader in treating relapsed multiplemyeloma with over 100,000 patients treated worldwide. VELCADE isbeing co-developed by Johnson & Johnson Pharmaceutical Research &Development, L.L.C. (J&JPRD) and Millennium: The Takeda OncologyCompany. Millennium is responsible for commercialisation of VELCADEin the U.S. Janssen-Cilag companies are responsible forcommercialisation in Europe and the rest of the world. JanssenPharmaceutical K.K. is responsible for commercialisation in Japan.
The Janssen-Cilag companies have a long and successful trackrecord in developing and marketing treatments for a wide variety ofconditions such as cancer, HIV, pain management, multiple myeloma,gastroenterological disorders, epilepsy, Alzheimer's disease,schizophrenia, acute bipolar mania, behavioural psychologicalsymptoms of dementia, disruptive behaviour disorders and autism. Moreinformation can be found at http://www.janssen-cilag.com.
Notes to Editors: - ASH Abstract Numbers: 3690, 650 and 1727. - Multiple myeloma (MM) is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths(iv). - In 2002, there were approximately 85,700 cases of MM worldwide(v). - Only 30 percent of MM patients survive longer than five years(vi), with more than 18,000 people in the European Union dying each year from the disease(vii). --------------------------------- (i) Richardson PG, et al. N Eng J Med 2005;352:2487-2498. (ii) Richardson PG, et al. N Eng J Med 2003;348:2609-2617. (iii) Jagannath S, et al. Br J Haematol 2004;127:165-172. (iv) http://www.multiplemyeloma.org. (v) GLOBOCAN 2002, www-dep.iarc.fr. (vi) Brenner H. Lancet 2002; 360:1131-1135. (vii) GLOBOCAN 2002, www-dep.iarc.fr. the high proportion of this patient population had advanced disease and poor prognostic factors, achieving
ots Originaltext: Janssen-CilagIm Internet recherchierbar: http://www.presseportal.de
Contact:For more information, please contact: Jennifer Tear, Director, Internal Medicine & Bio Pharmaceutical Communications EMEA, Tel: +32-14-60-26-38, Email: JTear1@its.jnj.com
VELCADE(R) (bortezomib) Findings Reinforce Efficacy and Survival Across Multiple Patient Populations
- Preliminary Phase II Re-treatment Results and two new AnalysesFrom Phase III VISTA Presented at ASH Annual Meeting
Janssen-Cilag today announced preliminary results from aprospective, international, multicenter, open-label, phase II studyshowing re-treatment with VELCADE(R) (bortezomib) is an effective andwell-tolerated treatment option for patients with relapsed multiplemyeloma (MM) who had previously responded to VELCADE-based treatment.The patient response after re-treatment was similar when VELCADE wasused alone or in combination with dexamethasone. These data werepresented in San Francisco, CA at the 50th American Society ofHematology (ASH) Annual Meeting & Exposition.
The data demonstrate how VELCADE can play a role throughout thetreatment sequence, which is especially important since relapsed MMpatients often build a resistance to therapy. After a treatment-freeinterval, response to VELCADE is shown to be high and follows anestablished safety profile.
The primary objective of the study was to determine the bestresponse to VELCADE re-treatment in patients with relapsed MM. Amongthe study patients, the best response to previous VELCADE treatmentwas complete response (CR) in 34 patients (27 percent) and partialresponse (PR) in 94 patients (73 percent). Re-treatment with VELCADEalone or in combination with dexamethasone resulted in 60 percentoverall response rate (ORR) including 34 percent CR by single besturine M-protein analysis. The safety profile of VELCADE duringre-treatment was consistent with that seen in phase II and IIIstudies in patients with relapsed MM.(i),(ii),(iii)
In addition, results from two new follow-up analyses of the VISTA(VELCADE as Initial Standard Therapy in Multiple Myeloma: Assessmentwith Melphalan and Prednisone) Phase III clinical trial werepresented at the ASH meeting. An analysis of the three-year survivalrate (median follow up of 25.9 months) reinforces the statisticallysignificant survival benefit for the VELCADE arm, which had been seenin earlier analyses. The VELCADE melphalan-prednisone (VMP) arm had athree-year survival rate of 72 percent versus 59 percent in themelphalan-prednisone (MP) arm. The other analysis demonstratesVELCADE efficacy in patients with renal impairment showing a reversalof renal impairment in a significant number of patients.
About VELCADE(R)
VELCADE is the first proteasome inhibitor to receive worldwideregulatory approval for the treatment of multiple myeloma (MM). In2005, VELCADE was approved in the European Union for MM after firstrelapse and has now received a positive opinion from the CHMPrecommending approval for VELCADE in combination with melphalan andprednisone for the treatment of patients with previously untreated MMwho are not eligible for high-dose chemotherapy with bone marrowtransplant.
Clinical trials are underway to investigate the potential ofVELCADE in additional settings and in combination with otheranti-cancer drugs to enhance treatment effects or reverse resistance.
VELCADE has a predictable safety profile and a favourablebenefit-risk ratio. The most common side effects reported withVELCADE include fatigue, gastrointestinal adverse events, transientthrombocytopenia and neuropathy, which is reversible in the majorityof patients.
VELCADE is the market leader in treating relapsed multiplemyeloma with over 100,000 patients treated worldwide. VELCADE isbeing co-developed by Johnson & Johnson Pharmaceutical Research &Development, L.L.C. (J&JPRD) and Millennium: The Takeda OncologyCompany. Millennium is responsible for commercialisation of VELCADEin the U.S. Janssen-Cilag companies are responsible forcommercialisation in Europe and the rest of the world. JanssenPharmaceutical K.K. is responsible for commercialisation in Japan.
The Janssen-Cilag companies have a long and successful trackrecord in developing and marketing treatments for a wide variety ofconditions such as cancer, HIV, pain management, multiple myeloma,gastroenterological disorders, epilepsy, Alzheimer's disease,schizophrenia, acute bipolar mania, behavioural psychologicalsymptoms of dementia, disruptive behaviour disorders and autism. Moreinformation can be found at http://www.janssen-cilag.com.
Notes to Editors: - ASH Abstract Numbers: 3690, 650 and 1727. - Multiple myeloma (MM) is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths(iv). - In 2002, there were approximately 85,700 cases of MM worldwide(v). - Only 30 percent of MM patients survive longer than five years(vi), with more than 18,000 people in the European Union dying each year from the disease(vii). --------------------------------- (i) Richardson PG, et al. N Eng J Med 2005;352:2487-2498. (ii) Richardson PG, et al. N Eng J Med 2003;348:2609-2617. (iii) Jagannath S, et al. Br J Haematol 2004;127:165-172. (iv) http://www.multiplemyeloma.org. (v) GLOBOCAN 2002, www-dep.iarc.fr. (vi) Brenner H. Lancet 2002; 360:1131-1135. (vii) GLOBOCAN 2002, www-dep.iarc.fr. the high proportion of this patient population had advanced disease and poor prognostic factors, achieving
ots Originaltext: Janssen-CilagIm Internet recherchierbar: http://www.presseportal.de
Contact:For more information, please contact: Jennifer Tear, Director, Internal Medicine & Bio Pharmaceutical Communications EMEA, Tel: +32-14-60-26-38, Email: JTear1@its.jnj.com
Janssen-Cilag
