Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma

Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refr...

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Vydané v:	Journal of clinical oncology Ročník 30; číslo 18; s. 2183
Hlavní autori:	Younes, Anas, Gopal, Ajay K, Smith, Scott E, Ansell, Stephen M, Rosenblatt, Joseph D, Savage, Kerry J, Ramchandren, Radhakrishnan, Bartlett, Nancy L, Cheson, Bruce D, de Vos, Sven, Forero-Torres, Andres, Moskowitz, Craig H, Connors, Joseph M, Engert, Andreas, Larsen, Emily K, Kennedy, Dana A, Sievers, Eric L, Chen, Robert
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States 20.06.2012
Predmet:	Adolescent Adult Aged Antineoplastic Agents - therapeutic use Disease-Free Survival Female Hodgkin Disease - drug therapy Humans Immunoconjugates - adverse effects Immunoconjugates - therapeutic use Male Middle Aged Recurrence Young Adult
ISSN:	1527-7755, 1527-7755
On-line prístup:	Zistit podrobnosti o prístupe
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Abstract	Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refractory CD30-positive lymphomas. In this multinational, open-label, phase II study, the efficacy and safety of brentuximab vedotin were evaluated in patients with relapsed or refractory Hodgkin's lymphoma (HL) after autologous stem-cell transplantation (auto-SCT). Patients had histologically documented CD30-positive HL by central pathology review. A total of 102 patients were treated with brentuximab vedotin 1.8 mg/kg by intravenous infusion every 3 weeks. In the absence of disease progression or prohibitive toxicity, patients received a maximum of 16 cycles. The primary end point was the overall objective response rate (ORR) determined by an independent radiology review facility. The ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months. After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea. The ADC brentuximab vedotin was associated with manageable toxicity and induced objective responses in 75% of patients with relapsed or refractory HL after auto-SCT. Durable CRs approaching 2 years were observed, supporting study in earlier lines of therapy.
AbstractList	Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refractory CD30-positive lymphomas. In this multinational, open-label, phase II study, the efficacy and safety of brentuximab vedotin were evaluated in patients with relapsed or refractory Hodgkin's lymphoma (HL) after autologous stem-cell transplantation (auto-SCT). Patients had histologically documented CD30-positive HL by central pathology review. A total of 102 patients were treated with brentuximab vedotin 1.8 mg/kg by intravenous infusion every 3 weeks. In the absence of disease progression or prohibitive toxicity, patients received a maximum of 16 cycles. The primary end point was the overall objective response rate (ORR) determined by an independent radiology review facility. The ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months. After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea. The ADC brentuximab vedotin was associated with manageable toxicity and induced objective responses in 75% of patients with relapsed or refractory HL after auto-SCT. Durable CRs approaching 2 years were observed, supporting study in earlier lines of therapy. Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refractory CD30-positive lymphomas.PURPOSEBrentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refractory CD30-positive lymphomas.In this multinational, open-label, phase II study, the efficacy and safety of brentuximab vedotin were evaluated in patients with relapsed or refractory Hodgkin's lymphoma (HL) after autologous stem-cell transplantation (auto-SCT). Patients had histologically documented CD30-positive HL by central pathology review. A total of 102 patients were treated with brentuximab vedotin 1.8 mg/kg by intravenous infusion every 3 weeks. In the absence of disease progression or prohibitive toxicity, patients received a maximum of 16 cycles. The primary end point was the overall objective response rate (ORR) determined by an independent radiology review facility.PATIENTS AND METHODSIn this multinational, open-label, phase II study, the efficacy and safety of brentuximab vedotin were evaluated in patients with relapsed or refractory Hodgkin's lymphoma (HL) after autologous stem-cell transplantation (auto-SCT). Patients had histologically documented CD30-positive HL by central pathology review. A total of 102 patients were treated with brentuximab vedotin 1.8 mg/kg by intravenous infusion every 3 weeks. In the absence of disease progression or prohibitive toxicity, patients received a maximum of 16 cycles. The primary end point was the overall objective response rate (ORR) determined by an independent radiology review facility.The ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months. After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea.RESULTSThe ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months. After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea.The ADC brentuximab vedotin was associated with manageable toxicity and induced objective responses in 75% of patients with relapsed or refractory HL after auto-SCT. Durable CRs approaching 2 years were observed, supporting study in earlier lines of therapy.CONCLUSIONThe ADC brentuximab vedotin was associated with manageable toxicity and induced objective responses in 75% of patients with relapsed or refractory HL after auto-SCT. Durable CRs approaching 2 years were observed, supporting study in earlier lines of therapy.
Author	Rosenblatt, Joseph D de Vos, Sven Ramchandren, Radhakrishnan Sievers, Eric L Larsen, Emily K Cheson, Bruce D Savage, Kerry J Younes, Anas Bartlett, Nancy L Ansell, Stephen M Moskowitz, Craig H Engert, Andreas Kennedy, Dana A Gopal, Ajay K Smith, Scott E Forero-Torres, Andres Connors, Joseph M Chen, Robert
Author_xml	– sequence: 1 givenname: Anas surname: Younes fullname: Younes, Anas email: ayounes@mdanderson.org organization: The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA. ayounes@mdanderson.org – sequence: 2 givenname: Ajay K surname: Gopal fullname: Gopal, Ajay K – sequence: 3 givenname: Scott E surname: Smith fullname: Smith, Scott E – sequence: 4 givenname: Stephen M surname: Ansell fullname: Ansell, Stephen M – sequence: 5 givenname: Joseph D surname: Rosenblatt fullname: Rosenblatt, Joseph D – sequence: 6 givenname: Kerry J surname: Savage fullname: Savage, Kerry J – sequence: 7 givenname: Radhakrishnan surname: Ramchandren fullname: Ramchandren, Radhakrishnan – sequence: 8 givenname: Nancy L surname: Bartlett fullname: Bartlett, Nancy L – sequence: 9 givenname: Bruce D surname: Cheson fullname: Cheson, Bruce D – sequence: 10 givenname: Sven surname: de Vos fullname: de Vos, Sven – sequence: 11 givenname: Andres surname: Forero-Torres fullname: Forero-Torres, Andres – sequence: 12 givenname: Craig H surname: Moskowitz fullname: Moskowitz, Craig H – sequence: 13 givenname: Joseph M surname: Connors fullname: Connors, Joseph M – sequence: 14 givenname: Andreas surname: Engert fullname: Engert, Andreas – sequence: 15 givenname: Emily K surname: Larsen fullname: Larsen, Emily K – sequence: 16 givenname: Dana A surname: Kennedy fullname: Kennedy, Dana A – sequence: 17 givenname: Eric L surname: Sievers fullname: Sievers, Eric L – sequence: 18 givenname: Robert surname: Chen fullname: Chen, Robert
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/22454421$$D View this record in MEDLINE/PubMed
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Snippet	Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing...
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SubjectTerms	Adolescent Adult Aged Antineoplastic Agents - therapeutic use Disease-Free Survival Female Hodgkin Disease - drug therapy Humans Immunoconjugates - adverse effects Immunoconjugates - therapeutic use Male Middle Aged Recurrence Young Adult
Title	Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma
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