ARTICLE | Clinical News

U.S. and China clear Phase III of DB102 to treat DLBCL

October 27, 2017 9:41 PM UTC

Denovo Biopharma LLC (San Diego, Calif.) said FDA and China FDA approved an IND to begin the Phase III ENGINE trial of enzastaurin (DB102) to treat diffuse large B cell lymphoma (DLBCL).

The double-blind, placebo-controlled, international trial will evaluate DB102 plus Rituxan rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in 235 treatment-naïve, high-risk DLBCL patients. In the induction phase, patients will receive R-CHOP plus placebo or a 1,125 mg loading dose of DB102 followed by 500 mg daily DB102 for up to 6, 21-day cycles. In an unblinded maintenance phase, patients will receive 500 mg daily DB102 monotherapy for up to 2 years...