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Long-term follow-up data from Brentuximab Vedotin pivotal clinical trials in relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma


Survival data from two Brentuximab vedotin ( Adcetris ) pivotal Phase 2 clinical trials in relapsed / refractory Hodgkin lymphoma ( R/R HL ) and relapsed / refractory systemic anaplastic large cell lymphoma ( R/R sALCL ) were presented at 55th American Society of Hematology (ASH) Annual Meeting and Exposition .
Brentuximab vedotin is an antibody-drug conjugate ( ADC ) directed to CD30. Median overall survival of 40.5 months was reported in R/R HL, and was not yet reached in R/R sALCL.

Three-year follow-up data and characterization of long-term remissions from an ongoing phase 2 study of Brentuximab Vedotin in patients with relapsed or refractory Hodgkin lymphoma

A pivotal, single-arm trial was conducted in 102 R/R HL patients after autologous stem cell transplant ( ASCT ) to assess the efficacy and safety of single-agent Brentuximab vedotin. In addition, the trial was designed to determine duration of response, progression-free survival ( PFS ) and overall survival.
Enrolled patients had received a median of more than three prior chemotherapy regimens.
Patients received 1.8 mg/kg of Brentuximab vedotin administered through a 30-minute intravenous ( IV ) infusion every three weeks for up to 16 cycles for patients who achieved stable disease or better.
After a median observation time of 32.7 months from the first dose of Brentuximab vedotin, the estimated median overall survival was 40.5 months ( range, 1.8 to 48.3 mos ).
Of the 34 patients who had a complete remission, the median overall survival had not yet been reached. The estimated three year survival rate was 54%.
Of the 102 patients, 14 remained in remission per independent assessment and 18 per investigator assessment, and are still being followed on study.
Overall, patients received a median of nine cycles of therapy with Brentuximab vedotin; patients who achieved an objective response ( OR ) received more cycles of therapy.
The most common adverse events of any grade were peripheral sensory neuropathy ( 47% ), fatigue ( 46% ), nausea ( 42% ), upper respiratory tract infection ( 37% ) and diarrhea ( 36% ).
The most common grade 3 or 4 AEs occurring in at least five percent of patients were neutropenia ( 20% ), peripheral sensory neuropathy ( 9% ), thrombocytopenia ( 8% ) and anemia ( 6% ).

Three-year survival results from an ongoing phase 2 study of Brentuximab Vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma

A pivotal, single-arm clinical trial was conducted in 58 R/R sALCL patients to assess the efficacy and safety of single-agent Brentuximab vedotin. In addition, the trial was designed to determine duration of response, progression-free survival and overall survival.
Enrolled patients had received a median of two prior chemotherapy regimens.
Patients received 1.8 mg/kg of Brentuximab vedotin administered through a 30-minute IV infusion every three weeks for up to 16 cycles for patients who achieved stable disease or better.
After a median observation time of 33.4 months from the first dose of Brentuximab vedotin, the median overall survival had not yet been reached. The estimated survival rate of patients at three years from initiation of Brentuximab vedotin treatment was 63%.
The median progression-free survival was 14.6 months.
Of the 34 patients who achieved a complete remission on study, 16 ( 47% ) remained in continued complete remission at the time of last follow-up.
Overall, patients received a median of seven cycles of therapy with Brentuximab vedotin; patients who achieved an objective response received more cycles of therapy. The most common adverse reactions of any grade were peripheral neuropathy ( 57% ), nausea ( 40% ), fatigue ( 38% ), pyrexia ( 34% ) and diarrhea ( 29% ).
The most common grade 3 or 4 adverse reactions occurring in at least 5% of patients included neutropenia ( 21% ), peripheral neuropathy ( 17% ), thrombocytopenia ( 14% ), anemia ( 7% ) and fatigue ( 5% ).

Adcetris for intravenous injection received accelerated approval from the U.S. Food and Drug Administration ( FDA ) and approval with conditions from Health Canada for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant ( ASCT ) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.
The indications for Adcetris are based on response rate.
There are no data available demonstrating improvement in patient-reported outcomes or survival with Adcetris.

Adcetris was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive HL following autologous stem cell transplant ( ASCT ), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ( Xagena )

Source: Seattle Genetics, 2013

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