A phase 2 study of polatuzumab vedotin + bendamustine + rituximab in relapsed/refractory diffuse large B‐cell lymphoma

Autor: Yasunori Ueda, Noriko Fukuhara, Shinya Rai, Kenichi Ishizawa, Tomohisa Saito, Koji Izutsu, Yasuhito Terui, Hirohiko Shibayama, Kazuhito Yamamoto, Hideki Goto, Motoko Yamaguchi, Takayuki Ishikawa, Atsuko Kawasaki, Junya Kuroda, Youko Suehiro, Kyoya Kumagai, Ken Ohmine, Jun Takizawa, Misato Hashizume, Nobuhiro Kanemura, Koji Kato
Jazyk: angličtina
Rok vydání: 2021
Předmět:
0301 basic medicine
Bendamustine
Cancer Research
medicine.medical_specialty
Immunoconjugates
Phases of clinical research
Neutropenia
polatuzumab vedotin
Gastroenterology
Drug Administration Schedule
03 medical and health sciences
0302 clinical medicine
Autologous stem-cell transplantation
rituximab
Japan
Clinical Research
Internal medicine
Positron Emission Tomography Computed Tomography
Antineoplastic Combined Chemotherapy Protocols
Granulocyte Colony-Stimulating Factor
medicine
Bendamustine Hydrochloride
Humans
bendamustine
Aged
relapsed/refractory (R/R)
Aged
80 and over
business.industry
diffuse large B‐cell lymphoma
Antibodies
Monoclonal
General Medicine
Original Articles
Middle Aged
medicine.disease
Progression-Free Survival
Polatuzumab vedotin
030104 developmental biology
Oncology
Drug Resistance
Neoplasm
030220 oncology & carcinogenesis
Rituximab
Original Article
Lymphoma
Large B-Cell
Diffuse
business
Diffuse large B-cell lymphoma
Febrile neutropenia
medicine.drug
Zdroj: Cancer Science
ISSN: 1349-7006
1347-9032
Popis: Polatuzumab vedotin (pola) is a CD79b‐targeted antibody‐drug conjugate delivering a potent antimitotic agent (monomethyl auristatin E) to B cells. This was an open‐label, single‐arm study of pola 1.8 mg/kg, bendamustine 90 mg/m2, rituximab 375 mg/m2 (pola + BR) Q3W for up to six cycles in patients with relapsed/refractory (R/R) diffuse large B‐cell lymphoma (DLBCL) who received ≥1 prior line of therapy and were ineligible for autologous stem cell transplantation (ASCT) or experienced treatment failure with prior ASCT. Primary endpoint was complete response rate (CRR) at the end of the treatment (EOT) by positron emission tomography–computed tomography (PET‐CT) using modified Lugano Response Criteria. Secondary endpoints included efficacy, safety, and pharmacokinetics. Thirty‐five patients (median age 71 [range 46‐86] years) were enrolled. Twenty‐three (66%) patients had refractory disease, and 23 (66%) had ≥2 prior lines of therapy. At a median follow‐up of 5.4 (0.7‐11.9) months, patients received a median of five treatment cycles. CRR was 34.3% (95% confidence interval [CI] 19.1‐52.2) at EOT. Overall response rate was 42.9% at EOT, and median progression‐free survival was 5.2 months (95% CI 3.6‐not evaluable). Median overall survival was not reached. No fatal adverse events (AEs) were observed. Grade 3‐4 AEs were mainly hematological: anemia (37%), neutropenia (31%), white blood cell count decreased (23%), thrombocytopenia/platelet count decreased/neutrophil count decreased (20% each), and febrile neutropenia (11%). Grade 1‐2 peripheral neuropathy (PN; sensory and/or motor) was reported in 14% of patients; there were no ≥grade 3 PN events. This study (JapicCTI‐184048) demonstrated the efficacy and safety of pola + BR in Japanese patients with R/R DLBCL who were ineligible for ASCT.
We report the results of an open‐label, single‐arm study of polatuzumab vedotin 1.8 mg/kg, bendamustine 90 mg/m2, rituximab 375 mg/m2 in patients with transplant‐ineligible relapsed/refractory (R/R) diffuse large B‐cell lymphoma (DLBCL). A complete response rate of 34.3% at the end of the treatment and consistent safety profile with previous studies with polatuzumab vedotin were observed.
Databáze: OpenAIRE
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