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DRUG:

pegylated liposomal doxorubicin

i
Other names: Doxorubicin Hydrochloride Cytori, ATI-0918, Dox-SL, SPI 49, JNS-002, TLC177, TLC 177
Company:
Generic mfg.
Drug class:
Topoisomerase II inhibitor
Related drugs:
1d
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) (clinicaltrials.gov)
P3, N=340, Active, not recruiting, Merck Sharp & Dohme LLC | N=800 --> 340 | Trial completion date: Jul 2028 --> Mar 2025 | Trial primary completion date: Jul 2028 --> Mar 2025
Enrollment change • Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative
|
Keytruda (pembrolizumab) • paclitaxel • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin
14d
Phase classification • Combination therapy
|
pegylated liposomal doxorubicin • maplirpacept (TTI-622)
23d
Enrollment closed
|
gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • raludotatug deruxtecan (DS-6000)
25d
MIROVA: Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer (clinicaltrials.gov)
P2, N=136, Active, not recruiting, AGO Research GmbH | Recruiting --> Active, not recruiting
Enrollment closed
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • FOLR1 ( Folate receptor alpha ) • MUC16 (Mucin 16, Cell Surface Associated)
|
BRCA2 mutation • BRCA1 mutation • BRCA wild-type
|
carboplatin • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx)
28d
PEMBOV: Pembrolizumab in Combination with Bevacizumab and Pegylated Liposomal Doxorubicin in Patients with Ovarian Cancer (clinicaltrials.gov)
P1, N=47, Completed, Gustave Roussy, Cancer Campus, Grand Paris | Active, not recruiting --> Completed
Trial completion • Combination therapy
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • pegylated liposomal doxorubicin
29d
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas (clinicaltrials.gov)
P1, N=24, Recruiting, Case Comprehensive Cancer Center | Trial completion date: Nov 2024 --> Apr 2025 | Trial primary completion date: Oct 2024 --> Apr 2025
Trial completion date • Trial primary completion date
|
pegylated liposomal doxorubicin
1m
Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma (clinicaltrials.gov)
P2, N=120, Recruiting, Université de Sherbrooke | Initiation date: Sep 2024 --> Dec 2024
Trial initiation date
|
carboplatin • temozolomide • etoposide IV • pegylated liposomal doxorubicin • melphalan
1m
New P2 trial • Metastases
|
Lynparza (olaparib) • Tagrisso (osimertinib) • carboplatin • gefitinib • gemcitabine • paclitaxel • temozolomide • tamoxifen • Verzenio (abemaciclib) • pemetrexed • fulvestrant • letrozole • pegylated liposomal doxorubicin • exemestane • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
1m
SL03-OHD-105: Phase 1b Study of SL-172154 Administered with Combination Agent(s) in Subjects with Ovarian Cancers (clinicaltrials.gov)
P1, N=86, Active, not recruiting, Shattuck Labs, Inc. | Trial completion date: Apr 2025 --> Nov 2024
Trial completion date
|
FOLR1 ( Folate receptor alpha )
|
FOLR1 expression
|
pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • SL-172154
1m
New P3 trial
|
gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • rinatabart sesutecan (PRO1184)
2ms
Comparison of neoadjuvant chemotherapy response and prognosis among pegylated liposomal doxorubicin, epirubicin and pirarubicin in HR ⩽ 10%/HER2-negative breast cancer: an exploratory real-world multicentre cohort study. (PubMed, Ther Adv Med Oncol)
For patients with pCR, the differences in EFS (log-rank p = 0.47) and OS (log-rank p = 0.38) were not statistically significant among the three groups, and the EFS (log-rank p = 0.59) and OS (log-rank p = 0.14) of non-pCR patients in the PLD group were similar to those in the epirubicin and pirarubicin groups. PLD had a similar therapeutic response and prognosis compared to epirubicin or pirarubicin in NAC for patients with HR ⩽ 10%/HER2 negative breast cancer, which means that PLD represents a potential NAC option.
Journal • Real-world evidence • Real-world
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
pegylated liposomal doxorubicin • epirubicin • Pinorubin (pirarubicin)
2ms
ORIENTA: Organoid-based Functional Precision Therapy for Advanced Breast Cancer (clinicaltrials.gov)
P2, N=252, Recruiting, Guangdong Provincial People's Hospital | Initiation date: Jan 2024 --> Sep 2024
Trial initiation date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HR positive • HER-2 negative • ER positive + PGR positive • HER-2 negative + ER positive • HER-2 negative + HR negative
|
carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • Halaven (eribulin mesylate) • pegylated liposomal doxorubicin • vinorelbine tartrate • Trodelvy (sacituzumab govitecan-hziy) • Lipusu (liposomal paclitaxel) • utidelone IV (UTD1)
2ms
Trial completion date
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
|
BRCA2 mutation • BRCA1 mutation • BRCA mutation
|
Lynparza (olaparib) • carboplatin • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
3ms
ANITA: Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer (clinicaltrials.gov)
P3, N=417, Completed, Grupo Español de Investigación en Cáncer de Ovario | Trial completion date: Jan 2024 --> Aug 2024 | Trial primary completion date: Jan 2024 --> Aug 2024 | Active, not recruiting --> Completed
Trial completion • Trial completion date • Trial primary completion date
|
TMB (Tumor Mutational Burden) • BRCA (Breast cancer early onset)
|
Tecentriq (atezolizumab) • carboplatin • paclitaxel • Zejula (niraparib) • pegylated liposomal doxorubicin
3ms
Trial completion date • Trial primary completion date
|
FOLR1 ( Folate receptor alpha )
|
gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • luveltamab tazevibulin (STRO-002) • Neulasta (pegfilgrastim)
3ms
Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
P2, N=31, Recruiting, Haider Mahdi | Trial completion date: Dec 2027 --> Dec 2031 | Trial primary completion date: Sep 2025 --> Sep 2029
Trial completion date • Trial primary completion date • Combination therapy
|
Keytruda (pembrolizumab) • pegylated liposomal doxorubicin • evorpacept (ALX148)
3ms
NRG-GY023: Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents (clinicaltrials.gov)
P2, N=120, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2025 --> Jun 2025
Trial completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
|
Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
3ms
SL03-OHD-105: Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers (clinicaltrials.gov)
P1, N=86, Active, not recruiting, Shattuck Labs, Inc. | Trial primary completion date: Jul 2024 --> Dec 2024
Trial primary completion date
|
FOLR1 ( Folate receptor alpha )
|
pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • SL-172154
3ms
Enrollment open • Combination therapy • Metastases
|
Rituxan (rituximab) • cyclophosphamide • pegylated liposomal doxorubicin • vincristine • prednisone • bendamustine • golcadomide (CC-99282)
3ms
Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=31, Not yet recruiting, Roswell Park Cancer Institute | Trial completion date: Jun 2028 --> Sep 2028 | Initiation date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2028 --> Sep 2028
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
tamoxifen • pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
4ms
Trial completion date • Metastases
|
FOLR1 ( Folate receptor alpha )
|
paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan
4ms
Doxil/Caelyx BE Study (clinicaltrials.gov)
P1, N=36, Completed, Baxter Healthcare Corporation | Not yet recruiting --> Completed
Trial completion • Metastases
|
pegylated liposomal doxorubicin
4ms
Phase III MIRASOL trial: Updated overall survival results of mirvetuximab soravtansine (MIRV) vs. investigator's choice chemotherapy (ICC) in patients (pts) with platinum-resistant ovarian cancer (PROC) and high folate receptor-alpha (FRα) expression (ESMO 2024)
Here, we report updated nonanalytical results based on a median follow-up of 16.7 months. 453 PROC pts with high FRα expression (VENTANA FOLR1 [FOLR1-2.1] RxDx Assay) with 1-3 prior therapies were randomized 1:1 to MIRV 6 mg/kg, adjusted ideal body weight, Day 1 of a 21-day cycle or ICC: paclitaxel (PAC), pegylated liposomal doxorubicin (PLD), or topotecan (Topo). With a median follow-up of 16.7 months, MIRV demonstrated improved efficacy vs ICC in pts with PROC. The efficacy data, along with the well-characterized safety profile, supports MIRV as the standard of care for pts with FRα positive PROC. Clinical Trial Information: NCT04209855.
P3 data • Clinical
|
FOLR1 ( Folate receptor alpha )
|
FOLR1 expression
|
VENTANA FOLR1 RxDx Assay
|
paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan
4ms
Comparison of the efficacy, safety and quality of life of pegylated liposomal doxorubicin-cyclophosphamide versus epirubicin-cyclophosphamide in patients with early stage HER2-negative breast cancer: A prospective, randomized, multicenter, Phase II study. (PubMed, Oncol Res Treat)
Comparable efficacy and safety between adjuvant PLD and epirubicin for stage I-II HER2-negative breast cancer was observed. There was no difference in 5-year DFS and OS rate between the two treatment arms. However, less grade 3-4 AEs and a trend of favorable QoL symptom scales were observed in the LC arm, suggesting that PLD-containing regimen could become a new standard treatment for early stage HER2-negative breast cancer patients.
P2 data • Journal • HEOR
|
HER-2 (Human epidermal growth factor receptor 2)
|
cyclophosphamide • pegylated liposomal doxorubicin • epirubicin
4ms
Trial completion
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
pegylated liposomal doxorubicin • epirubicin
4ms
Pegylated liposomal doxorubicin combined with cyclophosphamide and vincristine in pediatric patients with relapsed/refractory solid tumor: a single-arm, open-label, phase I study. (PubMed, EClinicalMedicine)
Three dose levels of PLD (Duomeisu®) were studied (30, 40, or 50 mg/m2) in combination with cyclophosphamide (1500 mg/m2), mesna (1500 mg/m2), and vincristine (1.5 mg/m2, maximum 2 mg) once every 3 weeks. 82203303], and the Basic and Applied Basic Research Foundation of Guangdong Province [No. 2021A1515110234].
P1 data • Journal
|
TP53 (Tumor protein P53)
|
cyclophosphamide • pegylated liposomal doxorubicin • vincristine • mesna • Duomeisu (pegylated liposomal doxorubicin)
4ms
Trial completion date
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
|
Lynparza (olaparib) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
4ms
Ultrasound -Induced Thermal Effect Enhances the Efficacy of Chemotherapy and Immunotherapy in Tumor Treatment. (PubMed, Int J Nanomedicine)
The distribution and accumulation of commercial pegylated liposomal doxorubicin (PLD) and PD-L1 antibody (anti-PD-L1) in the tumor were analyzed through frozen section analysis, ELISA, and in vivo fluorescence imaging...By incorporating US irradiation, the therapeutic efficacy of PLD and anti-PD-L1 was substantially boosted, leading to effective suppression of tumor growth and prolonged survival in mice. The application of US (0.8 W/cm2 for 10 min) can effectively induce vasodilation and enhance the delivery of PLD and anti-PD-L1 into tumors, thereby reshaping the immunosuppressive tumor microenvironment and optimizing therapeutic outcomes.
Journal
|
CD8 (cluster of differentiation 8)
|
pegylated liposomal doxorubicin
4ms
Accumulation of liposomes in metastatic tumor sites is not necessary for anti-cancer drug efficacy. (PubMed, J Transl Med)
These findings suggest that liposomal formulations achieve therapeutic benefits through mechanisms that extend beyond the enhanced permeability and retention effect.
Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Herceptin (trastuzumab) • pegylated liposomal doxorubicin
5ms
Reciprocal Interaction with Neutrophils Facilitates Cutaneous Accumulation of Liposomes. (PubMed, ACS Nano)
Unfortunately, PEGylated liposomal doxorubicin (sLip/DOX) exhibits serious dose-limiting cutaneous toxicities, which are closely related to the extravascular accumulation of sLip/DOX in the dermis...Furthermore, inhibition of complement activation either by CRIg-L-FH (a C3b/iC3b targeted complement inhibitor) or blocking the phosphate negative charge in mPEG-DSPE could significantly reduce liposome uptake by neutrophils and alleviate the cutaneous accumulation of liposomes. These results validated the liposome extravasation pathway mediated by neutrophils and provided potential solutions to the devastating cutaneous toxicities occurring during sLip/DOX treatment.
Journal
|
ITGAM (Integrin, alpha M) • ITGB2 (Integrin Subunit Beta 2)
|
pegylated liposomal doxorubicin
5ms
Study to Assess TOPO2A as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma (clinicaltrials.gov)
P=N/A, N=24, Active, not recruiting, Fox Chase Cancer Center | Trial completion date: May 2024 --> Oct 2024
Trial completion date
|
doxorubicin hydrochloride • pegylated liposomal doxorubicin
5ms
Tumor microenvironment reprogramming improves nanomedicine-based chemo-immunotherapy in sarcomas. (PubMed, Mol Cancer Ther)
Collectively, our findings provide evidence that ketotifen-induced TME reprograming can improve the efficacy of nanomedicine-based chemoimmunotherapy in sarcomas.
Journal
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
pegylated liposomal doxorubicin
5ms
Enrollment closed • Combination therapy
|
Keytruda (pembrolizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • nemvaleukin alfa (ALKS 4230)
5ms
Trial completion
|
Keytruda (pembrolizumab) • cyclophosphamide • etoposide IV • pegylated liposomal doxorubicin • vincristine • prednisone • dacarbazine • Matulane (procarbazine hydrochloride) • bleomycin • vinblastine
5ms
Enrollment open
|
MSI (Microsatellite instability) • PD-1 (Programmed cell death 1) • WT1 (WT1 Transcription Factor)
|
Avastin (bevacizumab) • gemcitabine • paclitaxel • Jemperli (dostarlimab-gxly) • pegylated liposomal doxorubicin
5ms
Combination therapy • Enrollment change • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 IHC 22C3 pharmDx
|
pegylated liposomal doxorubicin • CDX-1140 • Mobista (CDX-301)
5ms
Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, (DURVA+ Study) (clinicaltrials.gov)
P2; Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Jun 2026
Combination therapy • Trial completion date • Trial primary completion date • Tumor mutational burden • IO biomarker • Metastases
|
TMB (Tumor Mutational Burden) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
|
TruSight Oncology 500 Assay
|
carboplatin • Imfinzi (durvalumab) • gemcitabine • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • Duomeisu (pegylated liposomal doxorubicin)
5ms
Focus on Trabectedin in Ovarian Cancer: What Do We Still Need to Know? (PubMed, Drug Des Devel Ther)
Within the ovarian cancer treatment algorithm, particularly in the emerging context of PARPi resistance, the role of trabectedin, in combination with pegylated liposomal doxorubicin (PLD) still preserves its significance. The main results of clinical trials and studies involving trabectedin/PLD, along with hints of Breast Cancer genes (BRCA)-mutated and BRCAness phenotype cases, are critically discussed. Moreover, this review provides and contextualizes potential scenarios of administering trabectedin in combination with PLD in ROC, according to established guidelines and beyond.
Review • Journal • BRCA Biomarker • PARP Biomarker
|
BRCA (Breast cancer early onset)
|
pegylated liposomal doxorubicin • Yondelis (trabectedin)
5ms
Chidamide+Decitabine Plus Anti-PD-1 Antibody in PD-1 Inhibitor Failed Patients With Classical Hodgkin Lymphoma. (clinicaltrials.gov)
P2, N=60, Recruiting, Chinese PLA General Hospital | Not yet recruiting --> Recruiting
Enrollment open • IO biomarker
|
PD-1 (Programmed cell death 1)
|
carboplatin • gemcitabine • ifosfamide • etoposide IV • decitabine • pegylated liposomal doxorubicin • Adcetris (brentuximab vedotin) • Epidaza (chidamide)
6ms
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers (clinicaltrials.gov)
P1, N=86, Active, not recruiting, Shattuck Labs, Inc. | Enrolling by invitation --> Active, not recruiting
Enrollment closed
|
FOLR1 ( Folate receptor alpha )
|
pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • SL-172154
6ms
New P2 trial • Metastases
|
tamoxifen • pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
6ms
ZN-c3-002: A Study of ZN-c3 in Patients With Ovarian Cancer (clinicaltrials.gov)
P1, N=140, Recruiting, K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc | Phase classification: P1b --> P1 | Trial completion date: Aug 2024 --> Feb 2027 | Trial primary completion date: Jan 2024 --> Dec 2024
Phase classification • Trial completion date • Trial primary completion date • Combination therapy
|
Avastin (bevacizumab) • carboplatin • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • azenosertib (ZN-c3)