A phase 2 study of inotuzumab ozogamicin in patients with indolent B-cell non-Hodgkin lymphoma refractory to rituximab alone, rituximab and chemotherapy, or radioimmunotherapy.
This phase 2 study evaluated the efficacy and safety of inotuzumab ozogamicin (InO) in patients with indolent B-cell non-Hodgkin lymphoma (NHL) refractory to rituximab alone, rituximab plus chemotherapy or anti-CD20 radioimmunotherapy. Patients received InO 1·8 mg/m(2) intravenously on a 28-d cycle for a planned 4-8 cycles. The initial InO dose and schedule could be adjusted for tolerability and patients were allowed to receive 2 additional cycles (up to 8 total) after achieving a complete response (CR). The primary endpoint was overall response. Eighty-one patients were enrolled, among whom 48 (59%) received ≥3 InO cycles and 13 (16%) completed the treatment phase. The overall response rate was 67% (CR, 31%). Median (95% confidence interval) progression-free survival was 12·7 (8·9-26·9) months; median overall survival was not reached. Haematological adverse events (AEs) were common, particularly thrombocytopenia (74%) and neutropenia (56%). These were also the most common AEs leading to treatment discontinuation (37% and 11%, respectively); 58% of patients reported AEs leading to treatment discontinuation. InO demonstrated robust activity in these heavily pretreated patients, although treatment duration was limited by haematological toxicities. Additional studies may determine dosing regimens that allow for reduced toxicity.
John Theurer Cancer Center, HUMC, Hackensack, NJ, USA.
Andre
A
Goy
University of Alabama at Birmingham, Birmingham, AL, USA.
Andres
A
Forero
Washington University School of Medicine, St. Louis, MO, USA.
Nina
N
Wagner-Johnston
Penn State Hershey Cancer Institute, Hershey, PA, USA.
W
W
Christopher Ehmann
Minnesota Oncology, Minneapolis, MN, USA.
Michaela
M
Tsai
Cancer Institute Hospital, Tokyo, Japan.
Kiyohiko
K
Hatake
Inventiv Health, Cambridge, MA, USA.
Revathi
R
Ananthakrishnan
Pfizer Inc, New York, NY, USA.
Angela
A
Volkert
Pfizer Inc, Cambridge, MA, USA.
Erik
E
Vandendries
Nagoya Daini Red Cross Hospital, Nagoya, Japan.|Tokai Central Hospital, Kakamigahara, Gifu, Japan.
Michinori
M
Ogura
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000080045:Inotuzumab Ozogamicin; D016393:Lymphoma, B-Cell / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000209:etiology; D016499:Radioimmunotherapy / Q000009:adverse effects; D012074:Remission Induction; D016879:Salvage Therapy / Q000009:adverse effects / Q000379:methods*; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced / Q000209:etiology; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D000080045:Inotuzumab Ozogamicin
chemotherapy; inotuzumab ozogamicin; non-Hodgkin lymphoma; radioimmunotherapy; rituximab