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DRUG:

Qarziba (dinutuximab beta)

i
Other names: APN 311, ch14.18/CHO
Company:
Apeiron Biologics, BeiGene, Jazz, Recordati
Drug class:
GD2 ganglioside inhibitor
21d
New P3 trial
|
carboplatin • docetaxel • temozolomide • doxorubicin hydrochloride • irinotecan • Qarziba (dinutuximab beta)
1m
Trial completion date • Combination therapy
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
1m
NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Sep 2025
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL6 (Interleukin 6) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
|
MYCN amplification • IL6 expression
|
cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
1m
DiTuSarc: Treatment with Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients with Leiomyosarcoma (clinicaltrials.gov)
P2, N=10, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Jan 2025
Enrollment closed • Trial completion date • Metastases
|
zoledronic acid • Qarziba (dinutuximab beta)
5ms
DBPilot: Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma (clinicaltrials.gov)
P1, N=38, Not yet recruiting, Princess Maxima Center for Pediatric Oncology
New P1 trial
|
Qarziba (dinutuximab beta)
6ms
BEACON: Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children (clinicaltrials.gov)
P2, N=225, Active, not recruiting, University of Birmingham | Phase classification: P2b --> P2 | Trial completion date: Dec 2026 --> Feb 2026
Phase classification • Trial completion date
|
Avastin (bevacizumab) • temozolomide • cyclophosphamide • irinotecan • topotecan • Qarziba (dinutuximab beta)
6ms
Transition to a mesenchymal state in neuroblastoma may be characterized by a high expression of GD2 and by the acquisition of immune escape from NK cells. (PubMed, Front Immunol)
Concerning 691 and 717, they show high levels of GD2 and resistance to NK cell-mediated killing that can be overcome by the administration of dinutuximab beta, the anti-GD2 monoclonal antibody applied in the clinic. NB is a heterogeneous tumor representing a further hurdle in NB immunotherapy. However, different from what was reported with NB commercial cells and independent of their MES/ADRN phenotype, the expression of GD2 and its displayed sensitivity to anti-GD2 mAb ADCC indicated the possible effectiveness of anti-GD2 immunotherapy.
Journal • IO biomarker
|
WWTR1 (WW Domain Containing Transcription Regulator 1) • ENG (Endoglin)
|
Qarziba (dinutuximab beta)
7ms
Enrollment open • Surgery
|
ALK (Anaplastic lymphoma kinase) • TERT (Telomerase Reverse Transcriptase) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
cisplatin • carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • irinotecan • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • dexrazoxane
7ms
Enrollment closed
|
magrolimab (ONO-7913) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
7ms
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
|
Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
7ms
Inbraced: Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma (clinicaltrials.gov)
P1, N=44, Recruiting, University Hospital Southampton NHS Foundation Trust | Trial completion date: Nov 2023 --> Jul 2025 | Trial primary completion date: Nov 2023 --> Sep 2024
Trial completion date • Trial primary completion date
|
PD-L1 expression
|
Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
7ms
NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Sep 2024
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL6 (Interleukin 6) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
|
MYCN amplification • IL6 expression
|
cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
9ms
Trial completion date
|
lenalidomide • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
9ms
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov)
P2, N=95, Active, not recruiting, Children's Oncology Group | Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Mar 2025
Trial completion date • Trial primary completion date
|
IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CD276 (CD276 Molecule) • TNFA (Tumor Necrosis Factor-Alpha)
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
9ms
DNB: Dinutuximab Beta at the HUS and the Toulouse Oncopole (clinicaltrials.gov)
P=N/A, N=40, Recruiting, University Hospital, Strasbourg, France
New trial • HEOR
|
Qarziba (dinutuximab beta)
10ms
Trial completion
|
Qarziba (dinutuximab beta)
10ms
Targeted therapies in retinoblastoma: GD2-directed immunotherapy following autologous stem cell transplantation and evaluation of alternative target B7-H3. (PubMed, Cancer Immunol Immunother)
Anti-GD2-directed immunotherapy represents an additional therapeutic option in high-risk metastasized RB. Moreover, CD276 is another target of interest.
Journal
|
CD276 (CD276 Molecule)
|
Qarziba (dinutuximab beta)
11ms
Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (clinicaltrials.gov)
P1, N=82, Suspended, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Dec 2032 | Trial primary completion date: Jun 2026 --> Dec 2032
Trial completion date • Trial primary completion date
|
magrolimab (ONO-7913) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
11ms
GM-CSF, G-CSF or no cytokine therapy with anti-GD2 immunotherapy for high-risk neuroblastoma. (PubMed, Int J Cancer)
This comprehensive review summarizes clinical data regarding efficacy and safety of GM-CSF, recombinant human granulocyte colony-stimulating factor (G-CSF) or no cytokine in combination with anti-GD2 monoclonal antibodies (ie, dinutuximab, dinutuximab beta or naxitamab) for immunotherapy of patients with high-risk neuroblastoma...Suboptimal efficacy outcomes with G-CSF raise concerns about its suitability as an alternative to GM-CSF as an adjuvant in immunotherapy for patients with high-risk neuroblastoma. While programs exist to facilitate obtaining GM-CSF and anti-GD2 monoclonal antibodies in regions where they are not commercially available, continued work is needed to ensure equitable therapeutic options are available globally.
Review • Journal
|
CSF2 (Colony stimulating factor 2)
|
Qarziba (dinutuximab beta) • Danyelza (naxitamab-gqgk) • Leukine (sargramostim)
11ms
New P3 trial
|
ALK (Anaplastic lymphoma kinase) • TERT (Telomerase Reverse Transcriptase) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
cisplatin • carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • irinotecan • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • dexrazoxane
1year
Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma (clinicaltrials.gov)
P2, N=41, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
Trial completion • Combination therapy
|
Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
1year
ANTI-GD2 SYNERGIZES WITH HYPOXIA PATHWAY TARGETING TO BLOCK OSTEOSARCOMA CELL PROLIFERATION AND MIGRATION. (CTOS 2023)
Thereafter, we evaluate efficacy of rapamycin, irinotecan and dinutuximab beta in single drug approach in each model and proceed to combination assessments to understand their impact on OTS cell proliferation and migration and enable the selection the potential therapeutic combo to use. Clearly, we were able to show in patient biopsies, as well as in our patient-derived models that the 3 targets were largely expressed and might be efficiently inhibited to prevent OTS cell proliferation and migration.
IO biomarker
|
HIF1A (Hypoxia inducible factor 1, alpha subunit)
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HIF1A expression
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irinotecan • sirolimus • Qarziba (dinutuximab beta)
1year
Multimodal Therapy with Consolidating Haploidentical Stem Cell Transplantation and Dinutuximab Beta for Patients with High-Risk Neuroblastoma and Central Nervous System Relapse. (PubMed, J Clin Med)
Estimated 5-year event-free and overall survival rates were 55.5% and 65.27%, respectively. Dinutuximab beta ± scIL-2 following haplo-SCT is a promising treatment option with a generally well-tolerated safety profile for patients with HRNB and CNS relapse.
Journal
|
IL2 (Interleukin 2)
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Qarziba (dinutuximab beta)
1year
Exploring dual effects of dinutuximab beta on cell death and proliferation of insulinoma. (PubMed, Chem Biol Drug Des)
DB holds promise for the treatment of insulinoma. The study should be supported by in vivo studies.
Journal
|
AKT2 (V-akt murine thymoma viral oncogene homolog 2) • PTHLH (Parathyroid Hormone Like Hormone) • ATF2 (Activating Transcription Factor 2) • CA 19-9 (Cancer antigen 19-9) • ELK1 (ETS Transcription Factor ELK1) • HSP90AA1 (Heat Shock Protein 90 Alpha Family Class A Member 1Heat Shock Protein 90 Alpha Family Class A Member 1) • KCNN4 (Potassium Calcium-Activated Channel Subfamily N Member 4)
|
Qarziba (dinutuximab beta)
1year
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
P3, N=724, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting
Enrollment closed
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
cisplatin • carboplatin • Lorbrena (lorlatinib) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • thiotepa • Qarziba (dinutuximab beta) • busulfan • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • dexrazoxane
1year
Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
P2, N=34, Active, not recruiting, Children's Oncology Group | Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Jun 2023
Trial completion date • Trial primary completion date • Combination therapy
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
1year
Dinutuximab Beta Maintenance Therapy in Patients with High-Risk Neuroblastoma in First-Line and Refractory/Relapsed Settings-Real-World Data. (PubMed, J Clin Med)
Treatment was generally well tolerated, including in patients with co-morbidities and those who had experienced toxicities with previous therapies. These findings demonstrate that the use of dinutuximab beta is feasible and beneficial as a first-line or R/R treatment in routine clinical practice in Poland.
Journal • Real-world evidence • Real-world
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Qarziba (dinutuximab beta)
over1year
Exploring the feasibility of using the ICER Evidence Rating Matrix for Comparative Clinical Effectiveness in assessing treatment benefit and certainty in the clinical evidence on orphan therapies for paediatric indications. (PubMed, Orphanet J Rare Dis)
Using the ICER Matrix to grade orphan therapies according to their treatment benefit and certainty is feasible. However, the assessment involves subjective judgements based on heterogenous evidence. Tools such as the ICER Matrix might aid decision makers to evaluate treatment benefit and its certainty when comparing therapies across indications.
Journal
|
Kymriah (tisagenlecleucel-T) • Qarziba (dinutuximab beta)
over1year
Effect and Tolerance of N5 and N6 Chemotherapy Cycles in Combination with Dinutuximab Beta in Relapsed High-Risk Neuroblastoma Patients Who Failed at Least One Second-Line Therapy. (PubMed, Cancers (Basel))
We conducted a retrospective clinical chart review of 25 patients with relapsed/refractory neuroblastoma who had failed ≥1 second-line therapy and received compassionate use treatment with dinutuximab beta long-term infusion combined with the induction chemotherapy regimens N5 (cisplatin, etoposide, vindesine) and N6 (vincristine, dacarbazine, ifosfamide, doxorubicin) recommended by the German Pediatric Oncology and Hematology Group [GPOH] guidelines. At 1 year, the estimated event-free survival was 27% (95% confidence interval [CI] 8-47) and overall survival was 44% (95% CI 24-65). Combining long-term infusion of dinutuximab beta with N5 and N6 chemotherapy demonstrated an acceptable safety profile and encouraging objective response rates in heavily pretreated patients with high-risk neuroblastoma, warranting further evaluation in clinical trials.
Journal • Combination therapy
|
cisplatin • doxorubicin hydrochloride • ifosfamide • etoposide IV • vincristine • dacarbazine • Qarziba (dinutuximab beta) • vindesine
over1year
Combined Blockade of TIGIT and PD-L1 Enhances Anti-Neuroblastoma Efficacy of GD2-Directed Immunotherapy with Dinutuximab Beta. (PubMed, Cancers (Basel))
An analysis of tumor tissue revealed both TIGIT and TIGIT ligand expression on myeloid-derived suppressor cells (MDSCs), suggesting additional mechanisms of protumoral effects in NB. Our data show that the targeting of TIGIT and PD-L1 significantly improves the antitumor efficacy of anti-GD2 immunotherapy, with DB presenting a new effective combinatorial treatment strategy against high-risk tumors.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
|
PD-L1 expression
|
Qarziba (dinutuximab beta)
over1year
Short-wave infrared imaging enables high-contrast fluorescence-guided surgery in neuroblastoma. (PubMed, Cancer Res)
Here, two NIR-I dyes (IRDye800CW and IR12), with long tails emitting in the SWIR range, were conjugated with a clinical-grade anti-GD2 monoclonal antibody (dinutuximab-beta) to compare NIR-I and SWIR imaging for neuroblastoma surgery...Crucially, the system enabled higher TBR at SWIR wavelengths than at NIR-I wavelengths, verifying SWIR imaging enables high-contrast delineation of tumor margins. This work demonstrates that by combining the high-specificity of anti-GD2 antibodies with the availability and translatability of existing NIR-I dyes, along with the advantages of SWIR in terms of depth and tumor signal-to-background ratio, GD2-targeted NIR-I/SWIR-guided surgery could improve the treatment of neuroblastoma patients, warranting investigation in future clinical trials.
Journal • Surgery
|
Qarziba (dinutuximab beta)
over1year
Enrollment closed • Combination therapy
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
over1year
Trial suspension • Combination therapy
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
over1year
Anti-tumor activity of vobramitamab duocarmazine (MGC018), an investigational duocarmycin-based anti-B7‑H3 antibody-drug conjugate (ADC), in preclinical neuroblastoma models (AACR 2023)
In the pseudometastatic model and in five orthotopic NB mouse models, weekly iv treatments with 1 mg/kg MGC018 for 3 weeks resulted in delayed tumor growth and increased survival rates compared to animals treated with an irrelevant (anti-CD20) duocarmycin-ADC or an anti-GD2 antibody (dinutuximab beta). A 4-week course of treatment further ameliorated MGC018 antitumor effect in both the orthotopic and resected NB models and increased the survival of NB-bearing mice co-treated with TOpotecan-TEMozolomide (TOTEM), the standard-of-care therapy for relapsed disease. MGC018 exerts relevant antitumor activity in pre-clinical NB models and may represent a potential candidate for future NB clinical translation.
Preclinical
|
CD276 (CD276 Molecule) • ANXA5 (Annexin A5)
|
CD276 expression
|
temozolomide • topotecan • vobramitamab duocarmazine (MGC018) • Qarziba (dinutuximab beta)
over1year
Anti-GD2 Antibody Dinutuximab Beta and Low-Dose Interleukin 2 After Haploidentical Stem-Cell Transplantation in Patients With Relapsed Neuroblastoma: A Multicenter, Phase I/II Trial. (PubMed, J Clin Oncol)
DB therapy after haplo-SCT in patients with rHR-NB is feasible, with low risk of inducing GvHD, and results in long-term remissions likely attributable to increased antineuroblastoma activity by donor-derived effector cells.
P1/2 data • Journal
|
IL2 (Interleukin 2)
|
Qarziba (dinutuximab beta)
almost2years
Chemotherapeutics Used for High-Risk Neuroblastoma Therapy Improve the Efficacy of Anti-GD2 Antibody Dinutuximab Beta in Preclinical Spheroid Models. (PubMed, Cancers (Basel))
Vincristine, etoposide, carboplatin, cisplatin, and cyclophosphamide, as well as DB, were used at concentrations achieved in pediatric clinical trials. The CD107a/IFN-γ assay revealed no additional activation of NK cells by the chemotherapeutics. The synergistic effect of DB with chemotherapeutics seems primarily attributed to the combined toxicity of antibody-dependent cellular cytotoxicity and chemotherapy, which supports further clinical evaluation in frontline induction therapy.
Preclinical • Journal
|
IFNG (Interferon, gamma)
|
cisplatin • carboplatin • cyclophosphamide • etoposide IV • vincristine • Qarziba (dinutuximab beta)
almost2years
Recent Evidence-Based Clinical Guide for the Use of Dinutuximab Beta in Pediatric Patients with Neuroblastoma. (PubMed, Target Oncol)
Topics such as the mode of preparation and administration, the concomitant use of interleukin-2, the recommended pediatric age and dose for its use, or the adequate management of possible toxicities are important aspects to review. The objective of this article was to update the clinical guide to management with dinutuximab beta of children with neuroblastoma based on the most recent published evidence and our own experience in clinical practice.
Review • Journal
|
IL2 (Interleukin 2)
|
Qarziba (dinutuximab beta)
2years
The Immunocytokine FAP-IL-2v Enhances Anti-Neuroblastoma Efficacy of the Anti-GD Antibody Dinutuximab Beta. (PubMed, Cancers (Basel))
Analysis of tumor tissue revealed increased NK and cytotoxic T cell numbers and reduced Treg compared to controls. Our data show that FAP-IL-2v is a potent immunocytokine that augments the efficacy of DB against NB, providing a promising alternative to IL-2.
Journal • IO biomarker
|
IL2 (Interleukin 2) • FAP (Fibroblast activation protein, alpha)
|
FAP expression
|
Qarziba (dinutuximab beta)
3years
Immunomonitoring of Stage IV Relapsed Neuroblastoma Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation and Subsequent GD2 (ch14.18/CHO) Antibody Treatment. (PubMed, Front Immunol)
Haploidentical stem cell transplantation (haplo SCT) in Stage IV neuroblastoma relapsed patients has been proven efficacious, while immunotherapy utilizing the anti-GD2 antibody dinutuximab beta has become a standard treatment for neuroblastoma...No impact of FcGR polymorphism on event-free and overall survival was found. Collectively, this study has shown that in-patient functional immunomonitoring is feasible and valuable in contributing to the understanding of anti-cancer combinatorial treatments such as haplo SCT and antibody immunotherapy.
Clinical • Clinical Trial,Phase I • Clinical Trial,Phase II • Journal • IO biomarker
|
IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • FCGR2A (Fc fragment of IgG receptor IIa)
|
Qarziba (dinutuximab beta)
over3years
GD2-directed bispecific trifunctional antibody outperforms dinutuximab beta in a murine model for aggressive metastasized neuroblastoma. (PubMed, J Immunother Cancer)
Here we provide proof-of-concept for EKTOMUN preclinical efficacy against neuroblastoma, presenting this bispecific trAb as a promising new agent to fight neuroblastoma.
Preclinical • Journal
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
Qarziba (dinutuximab beta) • Ektomab (TRBS07)
over3years
Randomized Trial of Two Induction Therapy Regimens for High-Risk Neuroblastoma: HR-NBL1.5 International Society of Pediatric Oncology European Neuroblastoma Group Study. (PubMed, J Clin Oncol)
No difference in outcome was observed between rCOJEC and MSKCC-N5; however, acute toxicity was less with rCOJEC, and therefore rCOJEC is the preferred induction regimen for International Society of Pediatric Oncology European Neuroblastoma Group.
Clinical • Journal
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL2 (Interleukin 2)
|
MYCN amplification
|
cisplatin • carboplatin • etoposide IV • vincristine • melphalan • Qarziba (dinutuximab beta) • busulfan
almost4years
Impact of IL-2 on Treatment Tolerance in Patients With High-Risk Neuroblastoma Treated With Dinutuximab Beta-Based Immunotherapy. (PubMed, Front Pediatr)
Clinical parameters (body temperature, vital signs, Lansky performance score), laboratory values [C-reactive protein, IFN-γ, IL-6, and IL-18 (cycle 1)], and requirement of i.v. co-medication (e.g., morphine, metamizole) were systematically assessed. Patients receiving regimen B showed a shorter time to achieve normal vital parameters and required less co-medication compared to patients in regimen A that resulted in a shorter median time period to discharge and to achieve a potential outpatient status (6d regimen A and 3-5d regimen B after start of antibody infusion, respectively). This study shows that omitting IL-2 from immunotherapy with DB allows reduced co-medication and hospitalization time and therefore results in improved quality of life in patients with high-risk neuroblastoma.
Clinical • Journal
|
IFNG (Interferon, gamma) • IL6 (Interleukin 6) • IL2 (Interleukin 2) • IL18 (Interleukin 18) • CRP (C-reactive protein)
|
Qarziba (dinutuximab beta)