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

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...