Abstract 1746P
Background
Information on the epidemiology of DDLPS, a subgroup of liposarcoma (LPS), in Japan is scarce and the efficacy of available treatments is limited. We used the existing MASTER KEY Registry Database to inform the epidemiology and clinical outcomes of patients (pts) with advanced/metastatic LPS treated with systemic antineoplastic therapy in Japan.
Methods
In this non-interventional/observational cohort study, pts with LPS and a history of systemic antineoplastic therapy for LPS enrolled in the MASTER KEY Project Registry Database from May 1, 2017 to Dec 31, 2022 were included. Data were collected up to May 15, 2023. We assessed pts with advanced/metastatic LPS (Cohort 1; C1) and advanced/metastatic DDLPS (Cohort 2; C2) treated with first-line (1L) pharmacotherapy with any drug, or with 1L doxorubicin (DXR) monotherapy. Here, we present real-world (rw) progression-free survival (PFS), defined as time from index date [date of 1L treatment initiation] to disease progression, end of treatment, or death, and rw overall survival (OS), defined as time from index date to death. Sensitivity analyses (prospective registry subgroup) were performed to minimize immortal time bias.
Results
Since 2017, 100 pts (C1) and 62 pts (C2) were enrolled; 50 (50.0%; C1) and 34 (54.8%; C2) were male. Response rates are shown in the table. In pts with LPS (C1), median age at diagnosis was 59.5 y and 47 pts received 1L DXR. Median rwPFS in LPS pts treated with 1L DXR was 6.9 months (95% CI: 3.1–13.8). In pts with DDLPS (C2), median age at diagnosis was 63.0 y and 34 pts received 1L DXR. Median rwPFS in DDLPS pts treated with 1L DXR was 4.4 months (95% CI: 2.5–9.0); the median rwOS of 13.9 months (3.9–NR) in the sensitivity analysis was similar to previous reports. Table: 1746P
Response rates for pts with LPS and DDLPS
LPS (Cohort 1) | DDLPS (Cohort 2) | |||
1L pharmacotherapy | Doxorubicin monotherapy (1L pharmacotherapy) | 1 L pharmacotherapy | Doxorubicin monotherapy (1L pharmacotherapy) | |
Total, n (%) | 97 | 47 | 60 | 34 |
CR | 2 (2.1) | 0 (0.0) | 1 (1.7) | 0 (0.0) |
PR | 12 (12.4) | 5 (10.6) | 7 (11.7) | 4 (11.8) |
SD | 39 (40.2) | 22 (46.8) | 23 (38.3) | 14 (41.2) |
PD | 27 (27.8) | 17 (36.2) | 22 (36.7) | 15 (44.1) |
NE | 8 (8.2) | 2 (4.3) | 5 (8.3) | 1 (2.9) |
Unknown | 8 (8.2) | 1 (2.1) | 1 (1.7) | 0 (0.0) |
Missing | 1 (1.0) | 0 (0.0) | 1 (1.7) | 0 (0.0) |
ORR, % | 14.4 | 10.6 | 13.3 | 11.8 |
DCR, % | 54.6 | 57.4 | 51.7 | 52.9 |
CR, complete response; DCR, disease control rate; NE, not evaluable; ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease
Conclusions
These first data investigating DDLPS in Japanese pts suggest they have higher unmet needs among pts with LPS due to limited efficacy of currently available treatments, with a shorter PFS observed for pts with DDLPS versus LPS.
Clinical trial identification
Editorial acknowledgement
Medical writing support for the development of this abstract, under the direction of the authors, was provided by Lorena Mejias Martinez of Ashfield MedComms, an Inizio Company, and funded by Nippon Boehringer Ingelheim.
Legal entity responsible for the study
Nippon Boehringer Ingelheim.
Funding
Nippon Boehringer Ingelheim.
Disclosure
K. Tsuchihashi: Financial Interests, Personal, Invited Speaker: Taiho Pharma. E. Baba: Financial Interests, Personal, Advisory Board: Astellas, Daiichi Sankyo, AstraZeneca, Eli Lilly, Chugai, Taiho, Ono pharma, MSD, Merck, Takeda, Bayer, Janssen; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Chugai, Eli Lilly, Taiho. I. Kinoshita: Financial Interests, Personal, Invited Speaker, Invited Speaker: MSD Pharmaceutical; Financial Interests, Personal, Invited Speaker, Invited Speaker, chairperson of lecture: Bayer; Financial Interests, Personal, Invited Speaker, Invited Speaker: Takeda Pharmaceutical, Konica Minolta Realm; Financial Interests, Personal, Other, chairperson of lecture: Chugai Pharma, Novartis Pharma, Guardant Health Japan; Financial Interests, Personal and Institutional, Local PI, local PI: Daiichi Sankyo; Financial Interests, Personal and Institutional, Research Grant, research grant: Konica Minolta Realm; Financial Interests, Personal and Institutional, Local PI, Local PI: Eisai. M. Muto: Financial Interests, Personal, Invited Speaker: Chugai, MSD, Ono pharma, Meiji Seika Pharma, Novartis, Taiho; Non-Financial Interests, Advisory Role: KBBM, PRiME-R. W. Sakamoto, Y. Hirata: Financial Interests, Personal, Full or part-time Employment: Nippon Boehringer Ingelheim Co., Ltd. K. Nakamura: Financial Interests, Personal, Invited Speaker: Chugai, Taiho, AstraZeneca, Lilly, Takeda. K. Yonemori: Financial Interests, Personal, Advisory Board: Eisai, AstraZeneca, Sanofi, Genmab, Gliad, OncXerna, Takeda, Novartis, MSD, Henlius; Financial Interests, Personal, Invited Speaker: Pfizer, Eisai, AstraZeneca, Eli Lilly, Takeda, Chugai, Fuji Film Pharma, PDR Pharma, MSD, Boehringer Ingelheim, Ono Pharma, Daiichi Sankyo, Bayer, Janssen, Asteras, Bristol Myers Squibb, Novartis, Sanofi, Merck BioPharma; Financial Interests, Institutional, Research Grant: MSD, Daiichi Sankyo, Merck BioPharma, AstraZeneca, Taiho, Pfizer, Novartis, Takeda, Chugai, Ono Pharma, Sanofi, Seattle Genetics, Eisai, Eli Lilly, Genmab, Boehringer Ingelheim, Kyowa Hakko Kirin, Nihon Kayaku, Haihe; Financial Interests, Institutional, Principal Investigator: MSD, Daiichi Sankyo, Genmab, Seagen, AstraZeneca, Taiho, Merck BioPharma, Pfizer, Novartis, Takeda, Chugai, Ono Pharma, Sanofi, Seattle Genetics, Eisai, Eli Lilly, Genmab, Boehringer Ingelheim, Kyowa Hakko Kirin, Nihon Kayaku, Haihe. All other authors have declared no conflicts of interest.
Resources from the same session
1393TiP - A phase II/III study to evaluate the optimal dose, safety, and efficacy of livmoniplimab (Livmo) in combination with budigalimab (Budi) plus chemotherapy (CT) vs pembrolizumab (Pembro) plus CT in untreated metastatic non-small cell lung cancer (mNSCLC)
Presenter: Nicolas Girard
Session: Poster session 06
1394TiP - KRYSTAL-7: A phase III study of first-line adagrasib plus pembrolizumab versus pembrolizumab alone in patients with advanced NSCLC with KRASG12C mutation
Presenter: Marina Garassino
Session: Poster session 06
1395TiP - A randomized phase III trial evaluating oral BAY 2927088, compared with standard of care, as first-line treatment of locally advanced or metastatic NSCLC harboring HER2-activating mutations (SOHO-02)
Presenter: Antonio Passaro
Session: Poster session 06
1397TiP - Phase III trial of the therapeutic cancer vaccine OSE2101 versus docetaxel in patients with metastatic non-small cell lung cancer and secondary resistance to immunotherapy
Presenter: Stephen Liu
Session: Poster session 06
Resources:
Abstract
1398TiP - Be6A Lung-01, a phase III study of sigvotatug vedotin (SV), an investigational antibody-drug conjugate (ADC) versus docetaxel in patients (pts) with previously treated non-small cell lung cancer (NSCLC)
Presenter: Solange Peters
Session: Poster session 06
1399TiP - Phase III, double-blind study of cannabis sativa extract in pain management and quality of life in patients with metastatic lung cancer: Protocol of a study (IPElife trial)
Presenter: Danielli Matias
Session: Poster session 06
1728P - Results of TNT: A phase II study using talimogene laherparepvec, nivolumab and trabectedin for advanced leiomyosarcoma and liposarcoma [NCT# 03886311]
Presenter: Sant Chawla
Session: Poster session 06
1729P - Update on SAINT: A phase II study using trabectedin (T) in combination with ipilimumab (I) and nivolumab (N) in previously treated soft tissue sarcoma
Presenter: Anmol Dia Agarwal
Session: Poster session 06