Contributions
Abstract: PB1553
Type: Publication Only
Session title: Hodgkin lymphoma - Clinical
Background
Brentuximab vedotin (BV, ADCETRIS®) is approved for the treatment of adults with treatment‑naïve Stage III or IV classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) (Connors 2017). Nivolumab is approved for treatment of adults with relapsed/refractory cHL. Both agents have been well tolerated with promising activity when combined with multi‑agent chemotherapy. The combination of BV plus nivolumab was evaluated as a frontline treatment option for patients (pts) with cHL who are over 60 years and ineligible for or declined conventional combination chemotherapy (Yasenchak 2020). The ongoing study reported an overall response rate (ORR) of 82% in 11 pts and appears well tolerated in this population. In another trial in 93 pts in the first salvage setting, the combination produced a 67% complete response (CR) rate (Herrera 2018, Moskowitz 2019) and the majority of pts were able to undergo subsequent stem cell transplant. It is reasonable to expect that the combination of BV, nivolumab, A, and D (AN+AD) will result in high response rates and be well tolerated, with potentially less toxicity relative to A+AVD.
Aims
Part A will evaluate the efficacy and safety of A+AVD when administered with growth factor prophylaxis in pts with Stage III/IV cHL. Part B will evaluate the combination of AN+AD in pts with Stage I or II cHL with bulky mediastinal disease or Stage III or IV cHL. Part C will evaluate the efficacy and tolerability of AN+AD in pts with Stage I or II cHL without bulky disease. The primary objective of Parts B and C is to estimate the CR rate at end of treatment (EOT) in pts with treatment-naïve cHL.
Methods
SGN35-027 (EudraCT 2020-004027-17) is an open-label, multiple part, multicenter, phase 2 clinical trial. Approximately 240 pts will be enrolled in this study: approximately 40 in Part A, 50 in Part B, and 150 in Part C. Part A has completed enrollment, and Part B is fully enrolled. Pts in Parts B and C will be treated with BV 1.2 mg/kg, nivolumab 240 mg, doxorubicin 25 mg/m2, and dacarbazine 375 mg/m2, administered separately by IV infusion on Days 1 and 15 of each 28-day cycle. Pts in Part B will receive up to 6 cycles of treatment; pts in Part C will receive 4 cycles. Efficacy will be assessed by PET/CT scans at Cycle 2 and EOT; disease response and progression for Parts B and C will be assessed using the LYRIC modification of the Lugano Classification Revised Staging System for nodal non‑Hodgkin and Hodgkin lymphomas (Cheson 2016). Pts will be followed for disease progression and overall survival for 5 years. Enrollment is ongoing in the US, with plans for rest‑of‑world expansion for Part C.
Results
N/A
Conclusion
N/A
Keyword(s): Hodgkin's lymphoma
Abstract: PB1553
Type: Publication Only
Session title: Hodgkin lymphoma - Clinical
Background
Brentuximab vedotin (BV, ADCETRIS®) is approved for the treatment of adults with treatment‑naïve Stage III or IV classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) (Connors 2017). Nivolumab is approved for treatment of adults with relapsed/refractory cHL. Both agents have been well tolerated with promising activity when combined with multi‑agent chemotherapy. The combination of BV plus nivolumab was evaluated as a frontline treatment option for patients (pts) with cHL who are over 60 years and ineligible for or declined conventional combination chemotherapy (Yasenchak 2020). The ongoing study reported an overall response rate (ORR) of 82% in 11 pts and appears well tolerated in this population. In another trial in 93 pts in the first salvage setting, the combination produced a 67% complete response (CR) rate (Herrera 2018, Moskowitz 2019) and the majority of pts were able to undergo subsequent stem cell transplant. It is reasonable to expect that the combination of BV, nivolumab, A, and D (AN+AD) will result in high response rates and be well tolerated, with potentially less toxicity relative to A+AVD.
Aims
Part A will evaluate the efficacy and safety of A+AVD when administered with growth factor prophylaxis in pts with Stage III/IV cHL. Part B will evaluate the combination of AN+AD in pts with Stage I or II cHL with bulky mediastinal disease or Stage III or IV cHL. Part C will evaluate the efficacy and tolerability of AN+AD in pts with Stage I or II cHL without bulky disease. The primary objective of Parts B and C is to estimate the CR rate at end of treatment (EOT) in pts with treatment-naïve cHL.
Methods
SGN35-027 (EudraCT 2020-004027-17) is an open-label, multiple part, multicenter, phase 2 clinical trial. Approximately 240 pts will be enrolled in this study: approximately 40 in Part A, 50 in Part B, and 150 in Part C. Part A has completed enrollment, and Part B is fully enrolled. Pts in Parts B and C will be treated with BV 1.2 mg/kg, nivolumab 240 mg, doxorubicin 25 mg/m2, and dacarbazine 375 mg/m2, administered separately by IV infusion on Days 1 and 15 of each 28-day cycle. Pts in Part B will receive up to 6 cycles of treatment; pts in Part C will receive 4 cycles. Efficacy will be assessed by PET/CT scans at Cycle 2 and EOT; disease response and progression for Parts B and C will be assessed using the LYRIC modification of the Lugano Classification Revised Staging System for nodal non‑Hodgkin and Hodgkin lymphomas (Cheson 2016). Pts will be followed for disease progression and overall survival for 5 years. Enrollment is ongoing in the US, with plans for rest‑of‑world expansion for Part C.
Results
N/A
Conclusion
N/A
Keyword(s): Hodgkin's lymphoma