Pinatuzumab vedotin: Preliminary Phase II data

Preliminary data from 115 evaluable patients with relapsed or refractory follicular NHL or diffuse large B cell lymphoma (DLBCL) in the open-label, international Phase II ROMULUS trial showed that combinations of rituximab plus IV pinatuzumab vedotin and rituximab plus IV polatuzumab vedotin every 21 days were generally well tolerated with similar safety profiles. The most common treatment-emergent adverse events were fatigue, diarrhea, nausea, peripheral neuropathy and constipation. Serious adverse events were reported in 36% of patients and 2 of 7 deaths unrelated to NHL were attributed to treatment with pinatuzumab vedotin.

Polatuzumab vedotin plus rituximab produced an ORR of 51%, including 5 complete responses and 14 partial responses, in 37 patients with DLBCL and an ORR of 60%, including 6 complete responses and 6 partial responses, in 20 patients with follicular NHL. Pinatuzumab vedotin plus rituximab produced an ORR of 54%, including 7 complete responses and 13 partial responses, in 37 patients with DLBCL and an ORR of 67%, including 1 complete response and 13 partial responses, in 21 patients with follicular NHL. Data will be presented at the American Society of Clinical Oncology meeting in Chicago. Roche's Genentech Inc. unit said a Phase Ib/II trial is evaluating polatuzumab vedotin plus R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) to treat B cell lymphoma. The company said it is "continuing to look into development options" for pinatuzumab vedotin. ...