Oncaspar liquid (pegaspargase) / Servier - LARVOL DELTA

A MULTI-CENTER, PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF PD-1 ANTIBODY SINTILIMAB IN COMBINATION WITH PEGASPARGASE AND ANLOTINIB IN STAGE IV NKTCL PATIENTS (ICML 2025) - "The LEAP regimen demonstrates robust clinical efficacy (CR rate 72.9%) and favorable tolerability in high-risk stage IV NKTCL patients ineligible for intensive induction chemotherapy. However, the high post-remission relapse rate (60%) in non-consolidated patients underscores the necessity for effective maintenance strategies. Our findings suggest consolidative auto-HSCT significantly improves disease free survival, potentially bridging the gap between immunotherapy and durable remission in this challenging patient population."

Clinical • Combination therapy • Metastases • Lymphoma • Natural Killer/T-cell Lymphoma

DDGP-based chemoradiotherapy versus radiotherapy alone in newly diagnosed early-stage extranodal NK/T-cell lymphoma: A single-center retrospective analysis. (PubMed, Leuk Res) - "To determine the optimal treatment for early-stage extranodal NK/T-cell lymphoma (ENKTL), the efficacy differences between chemoradiotherapy (CRT) and radiotherapy (RT) alone, and between sequential DDGP (dexamethasone, cisplatin, gemcitabine, and pegaspargase) followed by RT (DDGP+RT) versus RT followed by DDGP (RT+DDGP) were investigated. CRT sequencing did not significantly affect survival outcomes. These findings demonstrate CRT's superiority over RT alone and suggest β2-MG may guide optimal treatment sequencing in early-stage ENKTL."

Journal • Retrospective data • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • B2M

Pharmacokinetics of Pegaspargase with a Limited Sampling Strategy for Asparaginase Activity Monitoring in Children with Acute Lymphoblastic Leukemia. (PubMed, Pharmaceutics) - "This model predicts the AUC with 6% average error and 35% maximum error compared to the AUC estimated with all available measures. Our study demonstrates the feasibility of a direct estimation of PK parameters in a real-life situation with limited and variable blood sampling schedules and also offers a simplified method and formulae easily applicable in clinical practice while maintaining a reliable pharmacokinetic monitoring."

Journal • PK/PD data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) (clinicaltrials.gov) - P2/3 | N=1708 | Not yet recruiting | Sponsor: Children's Oncology Group

New P2/3 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

AALL1821: A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov) - P2 | N=461 | Recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Recruiting | N=300 ➔ 461

Enrollment change • Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Developmental Disorders • Genetic Disorders • Hematological Malignancies • Leukemia • Oncology • CD19

An overview of randomized phase III clinical trials of cancer nanomedicines. (PubMed, Cancer Pathog Ther) - "Studies showed that PEGylated l-asparaginase achieved a similar therapeutic effect to that of l-asparaginase, with fewer applications due to its longer half-life. Paclitaxel bound to albumin improved therapeutic efficacy as well as reduced infusion time and solvent-related toxicity of the conventional paclitaxel formulation. PEGylated liposomal doxorubicin showed better pharmacokinetics, reduced cardiotoxicity, and improved quality of life in cancer patients compared to that of free doxorubicin. This study reinforces the scientific evidence of the added value of nanomedicines to improve therapeutic efficacy and reduce toxicity in patients under chemotherapy."

Clinical • Journal • P3 data • Review • Cardiovascular • Oncology

"Selinexor+Pegaspargase+Dexamethasone"in Ⅰ/Ⅱ NKTCL (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Mingzhi Zhang | Initiation date: Sep 2022 ➔ Sep 2024

Trial initiation date • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: CStone Pharmaceuticals | Trial completion date: Nov 2028 ➔ Jun 2029 | Trial primary completion date: Nov 2027 ➔ Jun 2028

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

CAMRELIZUMAB PLUS LOW-DOSE APATINIB AND PEGASPARGASE FOLLOWED BY RADIOTHERAPY FOR NEWLY DIAGNOSED STAGE I/II NATURAL KILLER/T-CELL LYMPHOMA: A MULTICENTER PHASE II STudy (ICML 2025) - "The combination of camrelizumab, low-dose apatinib, and pegaspargase followed by radiotherapy demonstrated significant efficacy and manageable toxicity in newly diagnosed stage I/II NK/TCL. The promising CR rates and favorable safety profile suggest that this regimen could serve as a viable alternative to conventional chemoradiotherapy for this patient population."

Clinical • P2 data • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

REAL WORLD ANALYSIS OF OUTCOMES USING A MODIFIED DFCI PROTOCOL FOR ADULTS WITH BCR-ABL NEGATIVE ACUTE LYMPHOBLASTIC LEUKEMIA – IMPACT OF MRD (EHA 2025) - "From 2020-24 pegaspargase was substituted for native E. coli asparaginase...Blinatumomab was not used for MRD negative patients, but was used for MRD+ B-ALL patients after 2019... For patients receiving a modified DFCI protocol, MRD positivity >0.1% post-induction predicts for inferior DFS and OS in patients age >35. There was no evidence of improved outcomes with SCT in MRD+ patients. MRD negativity predicts for a favorable outcome with approx."

Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Septic Shock • T Acute Lymphoblastic Leukemia • ABL1 • BCR

REAL WORLD STUDY OF EFFICACY AND SAFETY OF PD-1 ANTIBODY MONOTHERAPY AND COMBINATION THERAPY IN PEDIATRIC LYMPHOMA PATIENTS IN SOUTH CHINA (ICML 2025) - "Five ENKTL children were treated with PD-1 inhibitors in combination with gemcitabine and asparaginase-based multiagent chemotherapy, 2 patients received regimen of PGMDE (pegaspargase, gemcitabine, etoposide, and dexamethasone) and 3 patients received regimen of P-Gemox (pegaspargase, gemcitabine, and oxaliplatin)...Two cycles of sintilimab plus PGMDE regimen were given to a relapsed pediatric systemic EBV-positive T-cell lymphoma. Our findings indicate a high response rate and low toxicity associated with PD-1 antibody treatment in pediatric lymphoma patients."

Clinical • Combination therapy • Monotherapy • Real-world • Real-world evidence • B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Large B Cell Lymphoma • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A NOVEL TREATMENT REGIMEN FOR NEWLY DIAGNOSED CAEBV INDUCING A HIGH RESPONSE RATE: PD-1 INHIBITOR, L-ASPARGASE AND CHIDAMIDE (ICML 2025) - "The study aims to explore an effective and safe regimen for CAEBV: PD-1 inhibitor Sintilimab, L-asparaginase-class drug Pegaspargase, and histone deacetylase inhibitor Chidamide (P-P-Chi). The P-P-Chi regimen demonstrated significant efficacy and favorable safety in CAEBV as a first-line therapy, warranting further clinical trials and broader application."

Lymphoma

LINPERLISIB COMBINED WITH CAMRELIZUMAB AND PEGASPARGASE IN ADVANCED OR RELAPSED/REFRACTORY NK/T-CELL LYMPHOMA: ANALYSIS OF THE PHASE Ib PART (ICML 2025) - P1/2 | "The combination of linperlisib, camrelizumab, and pegaspargase proved to be well-tolerated and effective in patients with advanced or relapsed/refractory NK/T-cell Lymphoma. The efficacy and safety profiles will be further evaluated in the ongoing phase II study."

Metastases • P1 data • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • PIK3CD

UPDATED OUTCOMES OF P-GEMD IN TREATMENT-NAÏVE EARLY-STAGE NON-UPPER AERO-DIGESTIVE TRACT OR ADVANCED-STAGE EXTRANODAL NK/T CELL LYMPHOMA (ICML 2025) - P2 | "At the 2024 ASH annual meeting (Abstract 6396), preliminary efficacy and manageable safety of pegaspargase combined with gemcitabine, etoposide, mitoxantrone hydrochloride liposome (Lipo-MIT), and dexamethasone (P-GEMD) regimen in treatment- naïve early-stage NUAT or advanced-stage ENKTL were reported, with an objective response rate (ORR) of 87.5% and a complete response (CR) rate of 81.3%. P-GEMD regimen demonstrates encouraging preliminary anti-tumor efficacy with manageable toxicities as a front-line therapy for early-stage NUAT or advanced stage ENKTL."

Metastases • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

CENTRAL NERVOUS SYSTEM INVOLVEMENT IN EXTRANODAL NATURAL KILLER/T-CELL LYMPHOMA: A RETROSPECTIVE STUDY OF A CONSECUTIVE 13-YEAR CASE SERIES (ICML 2025) - "Following confirmed CNS invasion, 16 patients received chemotherapy incorporating high-dose methotrexate and pegaspargase... CNS involvement in ENKTCL is very rare and portends a grim prognosis. Routine implementation of radiological and cytological examinations, including analysis of cerebrospinal fluid and aqueous humor, should be employed to facilitate timely detection of CNS involvement. To improve the outcomes of ENKTCL with CNS, new treatment approaches are warranted."

Retrospective data • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

IMPACT OF RELATIVE DOSE INTENSITY OF CHEMOTHERAPY IN ELDERLY PATIENTS WITH EXTRANODAL NK/T-CELL LYMPHOMA (ICML 2025) - "RDI was calculated for first-line regimens incorporating pegaspargase (PEG-Asp), platinum antineoplastic agents (included cisplatin or oxaliplatin), and gemcitabine (GEM) using a standardized approach: (1) Standard dose intensity (SDI): SDI = planned dose per cycle (mg/m2) / planned cycle duration (weeks). Optimal RDI thresholds for elderly Chinese NKTCL pts require further validation. Higher dose intensity correlates with improved survival, but toxicity management is crucial to reduce treatment interruptions."

Clinical • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

EXOSOMAL BCYRN1 IN NK/T—CELL LYMPHOMA: UNVEILING ITS ROLE IN MACROPHAGE POLARIZATION AND TUMOR PROGRESSION (ICML 2025) - "M2 macrophages induced by exosomal lnc-BCYRN1 promoted the proliferation of NKTCL tumor cells and increased their chemoresistance to drugs like pegaspargase and gemcitabine. This study clarified that exosomal lnc-BCYRN1 from NKTCL tumor cells promotes macrophage M2 polarization through the USP10/PABPC1/Wnt1 axis, activating the Wnt/β-catenin signaling pathway and ultimately promoting NKTCL tumor cell proliferation."

Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • BCYRN1 • HNRNPK • IL10 • MRC1 • PABPC1

IMPACT OF RELATIVE DOSE INTENSITY OF CHEMOTHERAPY IN ELDERLY PATIENTS WITH EXTRANODAL NK/T-CELL LYMPHOMA (EHA 2025) - "RDI was calculated for first-line regimens incorporating pegaspargase (PEG-Asp), platinum antineoplastic agents (included cisplatin or oxaliplatin), and gemcitabine (GEM) using a standardized approach: (1) Standard dose intensity (SDI): SDI = planned dose per cycle (mg/m²) / planned cycle duration (weeks). Optimal RDI thresholds in elderly NKTCL pts require multicenter validation. Higher dose intensity correlates with improved survival, but toxicity management is crucial to reduce treatment delays."

Clinical • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma

A NOVEL TREATMENT REGIMEN FOR NEWLY DIAGNOSED CAEBV INDUCING A HIGH RESPONSE RATE: PD-1 INHIBITOR, L-ASPARGASE AND CHIDAMIDE (EHA 2025) - "The P-P-Chi regimen (Sintilimab + Pegaspargase + Chidamide) demonstrated significant efficacy and favorable safety in CAEBV as a first-line therapy, warranting further clinical trials and broader application."

Anemia • Anorexia • Bone Marrow Transplantation • CNS Disorders • Epstein-Barr Virus Infections • Fatigue • Fibrosis • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Leukopenia • Liver Failure • Neutropenia • Novel Coronavirus Disease • Rare Diseases • Respiratory Diseases • Thrombocytopenia

A CAMPUS ALL RETROSPECTIVE MULTICENTER STUDY ON THE OUTCOME OF ADULT LYMPHOBLASTIC LYMPHOMA PATIENTS TREATED IN THE REAL-LIFE ACCORDING TO THE GIMEMA LAL1913 PROTOCOL (EHA 2025) - "Briefly, pegaspargase was added at cycles 1 (in addition to idarubicine, vincristine, HCD-dexamethasone); 2, 4, 6 (in addition to idarubicine, vincristine, HCD dexamethasone and cyclophosphamide) and 5 (in addition to only higher doses (HD) methotrexate). Cycles 3 and 7 were pegaspargase-free being combined with methotrexate HD and cytarabine HD... Our study shows very promising results in terms of OS, DFS and EFS (Figure 1a), especially if we take into account that it is based on a drug combination never tested before in a real-life setting. Bearing in mind the successful use of pegaspargase even in the presence of a dose-reduction, the results observed with the LAL1913-based protocol in the real-life suggest that it may be considered as a reference for the frontline treatment of adult LL-patients."

Retrospective data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Genetic Disorders • Hematological Malignancies • Leukemia • Lymphoma • Obesity • Oncology • Pediatrics • CD1a

LATEST UPDATE RESULTS OF P-GEMD REGIMEN IN NEWLY DIAGNOSED EARLY NON-UPPER AERO-DIGESTIVE TRACT OR ADVANCED STAGE EXTRANODAL NK/T CELL LYMPHOMA (EHA 2025) - P2 | "At the 2024 ASH annual meeting (Abstract 6396), preliminary efficacy and manageable safety of pegaspargase combined with gemcitabine, etoposide, mitoxantrone hydrochloride liposome, and dexamethasone (P-GEMD) regimen in newly diagnosed early NUAT or advanced-stage ENKTL were reported, showing an objective response rate (ORR) of 87.5% and a complete response (CR) rate of 81.3%. P-GEMD regimen has shown encouraging preliminary anti-tumor activity with manageable toxicities as a front-line treatment for early NUAT or advanced stage ENKTL. These results support further randomized controlled trial (RCT) to confirm activity and assess efficacy in this population."

Metastases • Anemia • Cardiovascular • Endocrine Disorders • Epstein-Barr Virus Infections • Heart Failure • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Leukopenia • Lymphoma • Natural Killer/T-cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Rare Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

VENETOCLAX, TUCIDINOSTAT, PEGASPARGASE, AND DEXAMETHASONE INDUCTION REGIMEN FOR NEWLY DIAGNOSED ADULT ETP-ALL: A CHEMOTHERAPY-FREE, LOW-TOXICITY, EFFECTIVE REGIMEN (EHA 2025) - "BEAT chemofree induction regimen is a promising regimen in newly diagnosed adult ETP-ALL, with high CR/CRi and well-tolerated."

Clinical • Anemia • Bone Marrow Transplantation • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pediatrics • Respiratory Diseases • T Acute Lymphoblastic Leukemia • Thrombocytopenia • KMT2A

PEGASPARGASE ADMINISTRATION IN ACUTE LYMPHOBLASTIC LEUKEMIA PATIENTS AGED 55 YEARS OR OLDER TREATED WITH THE PEDIATRIC-INSPIRED PROGRAM LAL1913. A SUBANALYSIS OF THE CAMPUS ALL STUDY (EHA 2025) - "In this real-world setting, including 90 ALL pts aged over 55 years, fit for intensive chemotherapy and treated homogeneously with a pediatric-inspired protocol, 96% of cases received PEG-ASP in at least one of the first two chemotherapy courses. Our analysis confirms the feasibility of PEG-ASP administration in fit older ALL pts. Clinicians' expertise in dose adjustment according to pts age and comorbidities is very important to balance efficacy and toxicity."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Hepatology • Immunology • Leukemia • Obesity • Oncology • Pediatrics

Cerebral Sinovenous Thrombosis with asparaginase use in pediatric leukemia - MD Anderson experience (ISTH 2025) - "To our knowledge, there are no studies comparing CSVT in pediatric patients receiving Erwinia Asparaginase (Erwinia) versus Long-acting asparaginase formulations (LA-asparaginase) including pegaspargase and calaspargase...None of the patients receiving calaspargase developed CSVT. Table or Figure Upload"

Clinical • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Pediatrics • Thrombocytopenia • Thrombosis

Successful treatment with decompressive laparotomy for abdominal compartment syndrome induced by asparaginase-associated pancreatitis in a pediatric patient with acute lymphoblastic leukemia: a case report. (PubMed, Transl Pediatr) - "We present a case of a 2-year-old boy with ALL who developed ACS, a fatal complication of severe acute pancreatitis (SAP) following treatment with pegaspargase (PEG-ASP)...During follow-up, the child's abdominal symptoms gradually improved, and bridging therapy with blinatumomab was administered...Optimal timing of surgical intervention combined with advanced perioperative care is critical for achieving favorable outcomes. We strongly recommend conducting high-quality clinical research to establish evidence-based treatment guidelines."

Journal • Acute Lymphocytic Leukemia • Critical care • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Pancreatitis • Pediatrics