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4435 BV-CHP in Previously Untreated Patients with CD30-Positive Adult T-Cell Leukemia-Lymphoma: A Multicenter Real-World Retrospective Study

Program: Oral and Poster Abstracts
Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Research, Antibody Therapy, Clinical Research, Diseases, Real-world evidence, Treatment Considerations, Biological therapies, Lymphoid Malignancies
Monday, December 9, 2024, 6:00 PM-8:00 PM

Junya Makiyama, MD, PhD1, Masahito Tokunaga, MD, PhD2*, Motoaki Shiratsuchi, MD, PhD3, Takanori Toyama, MD4*, Satoshi Oka, MD, PhD5*, Ilseung Choi, MD, PhD6, Takahiro Yoshida, PhD7*, Kiyoshi Okazuka, MD, PhD7* and Atae Utsunomiya, MD, PhD2

1Department of Hematology, Sasebo City General Hospital, Sasebo, Japan
2Department of Hematology, Imamura General Hospital, Kagoshima, Japan
3Department of Hematology, Iizuka Hospital, Iizuka, Japan
4Department of Internal Medicine, Miyazaki Prefectural Nobeoka Hospital, Nobeoka, Japan
5Department of Hematology and Blood Transfusion, Kochi Health Sciences Center, Kochi, Japan
6Department of Hematology and Cell therapy, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan
7Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, Tokyo, Japan

Background:

Adult T-cell leukemia-lymphoma (ATL) is defined as peripheral T-cell lymphoma (PTCL) caused by the human T-cell leukemia virus type I and is endemic in Japan. ATL has high unmet medical needs due to its poor prognosis and limited treatment options. BV-CHP (brentuximab vedotin [BV], cyclophosphamide, doxorubicin, and prednisolone) was approved for previously untreated patients with CD30-positive PTCL in Japan in December 2019, but clinical data for patients with ATL are limited. This multicenter retrospective study aims to evaluate the efficacy and safety of BV-CHP for previously untreated patients with CD30-positive ATL.

Methods:

We retrospectively collected clinical data from the medical records of patients from 6 sites in Japan between April 2020 and January 2024. Patients aged ≥18 years with previously untreated CD30-positive ATL treated with BV-CHP were enrolled. CD30 positivity was determined by immunohistochemistry or flow cytometry at each institution. The primary endpoint was the overall response rate (ORR) for BV-CHP. Adverse events (AEs) were collected from the initiation of BV-CHP to 4 weeks after the last administration of BV-CHP. This study was conducted in accordance with Ethical Guidelines for Medical and Biological Research Involving Human Subjects.

Results:

A total of 46 patients were enrolled in this study. Of these, 36 patients who met the eligibility criteria and did not receive BV-CHP in a clinical trial were analyzed. The median age at diagnosis was 71 years (range, 53–92), and 24 were female. Nineteen patients were classified as acute-type and 17 as lymphoma-type. Thirty-two patients were at advanced stage (9 at Stage III and 23 at Stage IV). For the simplified ATL prognostic index, 11, 19, and 6 patients were categorized as low-, intermediate-, and high-risk, respectively. The median cycle of BV-CHP was 3 (range, 1–6) and the relative dose intensity of BV was 86.9% (range, 57.8–123.5). The median follow-up time was 372.5 days (range, 74–1253). The ORR was 86.1% (95% confidence interval [CI], 70.5–95.3), including 10 (27.8%) complete responses (CR), 12 (33.3%) CR unconfirmed, and 9 (25.0%) partial responses (PR). The median progression-free survival (PFS) was 205 days (95% CI, 166–279), and the time to treatment failure was 166 days (95% CI, 91–205). The median overall survival was 535 days (95% CI, 343–not reached). Grade 3 or higher toxicities were observed in 32 patients. The most common grade 3 or higher AEs, occurring in >10% of patients, were neutropenia (77.8%), febrile neutropenia (38.9%), infection (25.0%), and decreased platelet count (11.1%). Among all 36 patients, 7 discontinued BV, and 1 had their dosage of BV changed due to AEs. Peripheral neuropathy (PN) events were identified in 4 patients (3 with grade 2 and 1 with grade 1), and 1 of these 4 patients had their treatment dosage of BV changed due to PN. All AEs were resolved or improved, and there were no treatment-related deaths.

Of the 36 patients, 11 received allogenic stem cell transplantation (10 cord blood and 1 peripheral blood). The disease status before transplantation was 2 CR, 8 PR, and 1 stable disease following a median of 3 cycles of BV-CHP (range, 1–6). Acute graft-versus-host disease was observed in 2 of 11 patients, including grade 1 in 1 patient and grade 4 in 1 patient. The median PFS after initiation of BV-CHP was 234 (95% CI, 168–343) and 180 (95% CI, 96–279) days in transplanted and non-transplanted patients, respectively.

Conclusion:

In this multicenter retrospective study, BV-CHP demonstrated a favorable ORR with acceptable tolerability. All AEs were manageable, and no new safety signals were observed. These data support BV-CHP as a potential standard first-line therapy for ATL.

Disclosures: Makiyama: Takeda Pharmaceutical: Honoraria; AbbVie GK: Speakers Bureau; Bristol-Myers Squibb: Speakers Bureau; Chugai Pharmaceutical: Speakers Bureau; Daiichi Sankyo: Speakers Bureau; Takeda Pharmaceutical: Speakers Bureau; Meiji Seika Pharma: Speakers Bureau; Kyowa Kirin: Speakers Bureau; Janssen Pharmaceutical: Speakers Bureau; Nippon Shinyaku: Speakers Bureau; Otsuka Pharmaceutical: Speakers Bureau; Sanofi: Speakers Bureau; SymBio Pharmaceutical: Speakers Bureau. Tokunaga: Takeda Pharmaceutical: Honoraria. Oka: Pfizer: Honoraria; Bristol-Myers Squibb: Honoraria; Takeda Pharmaceutical: Honoraria; Meiji Seika Pharma: Honoraria; Nippon Shinyaku: Honoraria; AbbVie: Honoraria; Janssen Pharma: Honoraria. Yoshida: Takeda Pharmaceutical: Current Employment. Okazuka: Takeda pharmaceuticalP: Current Employment. Utsunomiya: Daiichi Sankyo: Honoraria; Takeda Pharmaceutical: Honoraria; Kyowa Kirin: Honoraria; Bristol-Meyers: Honoraria; JIMRO: Consultancy; HUYA Japan: Consultancy; Meiji Seika Pharma: Consultancy, Honoraria.

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