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• W2247758429 abstract "8526 Background: CD30 expression by Reed-Sternberg cells is a defining feature of Hodgkin lymphoma (HL). The ADC SGN-35 comprises an anti-CD30 antibody conjugated to monomethyl auristatin E (MMAE). SGN-35 mechanism of action involves binding to CD30 on the tumor cell surface, ADC internalization, MMAE release and binding to tubulin, prompting cell cycle arrest and apoptosis. Methods: A multicenter phase I dose escalation study was conducted in patients with refractory or recurrent CD30-positive hematologic malignancies. Twenty-nine patients (pts) were enrolled; 26 with HL, 3 with other CD30+ malignancies. Median age was 32 (range 22–87) and pts received a median of 5 prior therapies; 76% previously received an autologous stem cell transplant. Most (89%) pts had an ECOG performance status of 0/1. SGN-35 dose levels were 0.1, 0.2, 0.4, 0.6, 0.8, 1.2, 1.8 and 2.7 mg/kg (2-hr outpatient IV infusion, premedications not required) every 3 weeks (wks). Pts with stable disease or better after 2 doses were eligible to receive additional doses of SGN-35. Results: All pts were evaluable for safety, 28 pts were evaluable for response. Dose-limiting toxicity was not defined and 1 infusion-related reaction was observed. One pt (0.1 mg/kg) experienced G3 hypercalcemia and 1 pt (1.8 mg/kg) had G4 thrombocytopenia (both reversible and possibly related). One pt (0.4 mg/kg) experienced a possibly related myocardial infarction that resolved without sequalae. The most common related adverse events were G1/2 fatigue, diarrhea and cough. Pharmacokinetic data indicate exposure (AUC) to SGN-35 increased relative to dose level, with no accumulation after repeated dosing. Best response: partial remission (n=9), stable disease (n=11), and progressive disease (n=8). At dose levels of ≥1.2 mg/kg, 7 of 13 pts (54%) achieved PR and remain on therapy at 11+ to 25+ wks; tumor reductions occurred in 11 of 13 pts. Enrollment continues at 2.7 mg/kg. Conclusions: SGN-35, a novel ADC targeting CD30, was generally well tolerated at doses up to 2.7 mg/kg, and induced multiple objective responses in heavily pretreated pts. These encouraging results indicate SGN-35 should be further evaluated in phase II studies for pts with HL. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Seattle Genetics, Inc Seattle Genetics, Inc Seattle Genetics, Inc" @default.
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• W2247758429 date "2008-05-20" @default.
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• W2247758429 title "Objective responses in a phase I dose-escalation study of SGN-35, a novel antibody-drug conjugate (ADC) targeting CD30, in patients with relapsed or refractory Hodgkin lymphoma" @default.
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