Methods for treating neuroblastoma with combination therapy

A technology for neuroblastoma and chemotherapeutic agents, applied in the field of combined therapy for neuroblastoma, can solve the problems such as the inability to significantly improve the response rate

Pending Publication Date: 2021-06-01
MEMORIAL SLOAN KETTERING CANCER CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these combination therapies did not significantly improve response rates

Method used

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  • Methods for treating neuroblastoma with combination therapy
  • Methods for treating neuroblastoma with combination therapy
  • Methods for treating neuroblastoma with combination therapy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0135] Example 1: Chemoimmunotherapy for High Risk Neuroblastoma Using Hu3F8, Irinotecan / Temozolomide and Sargragrastim Combination Therapy

[0136]This study investigated the safety and efficacy of the Hu3F8 antibody called "HITS" in combination with irinotecan and temozolomide (IT) and sargragrastim (GM-CSF) in patients with drug-resistant neuroblastoma, The above-mentioned Hu3F8 antibody includes: a heavy chain variable region including the amino acid sequence shown in SEQ ID NO:11 and a light chain variable region including the amino acid sequence shown in SEQ ID NO:5. This study also evaluated the tumor response to HITS in patients with neuroblastoma, evaluating the pharmacokinetics of hu3F8. Patients received treatment according to the protocol outlined below for each cycle.

[0137] Table 1: Treatment options

[0138]

[0139] Patients were monitored weekly for toxicity, after the first two cycles for reactivity, and then every three subsequent cycles for reactivit...

Embodiment 2

[0250] Example 2: Hu3F8-Based Chemoimmunotherapy for Drug-Resistant High-Risk Neuroblastoma: Preliminary Results of the HITS Pilot / Phase II Multicenter Study

[0251] Chemotherapy resistance and recurrent disease are major barriers to cure in high-risk neuroblastoma (HR-NB). Anti-GD2 monoclonal antibody (MoAb) can effectively prevent relapse after remission. However, responses in recurrent or progressive disease (PD) may be rare. This example studies the combination of a humanized anti-GD2 MoAb Hu3F8 antibody (which comprises a heavy chain according to Sequence ID NO.11 and a light chain according to Sequence ID No.5), irinotecan, temozolomide and sargragrastim (HITS ) for the treatment of HR-NB. Sagragrastim is recombinant human GM-CSF. The pilot HITS protocol for drug-resistant HR-NB has now been extended to a phase II multicenter study (NCT03189706).

[0252] Notable eligibility criteria included having evaluable or measurable chemotherapy-resistant disease. Prior anti...

Embodiment 3

[0255] Example 3: Hu3F8-Based Chemoimmunotherapy in Drug-Resistant High-Risk Neuroblastoma: Preliminary Results from the "HITS" Pilot / Phase II Study

[0256] Chemotherapy resistance and recurrent disease are major barriers to cure in high-risk neuroblastoma (HR-NB). Anti-GD2 monoclonal antibody (MoAb) is effective in preventing relapse after remission, but responses are rare in relapsing or progressive disease (PD). We investigated the combination of a humanized anti-GD2MoAb Hu3F8 antibody (which comprises a heavy chain according to Sequence ID No. 11 and a light chain according to Sequence ID No. 5), irinotecan, temozolomide and sargragrastim (GM-CSF): The pilot "HITS" protocol for drug-resistant HR-NB has now been extended to a phase II study (NCT03189706).

[0257] Notable eligibility criteria included having evaluable or measurable chemotherapy-resistant disease. Prior anti-GD2 MoAb and / or irinotecan / temozolomide (I / T) therapy was allowed. Each cycle includes irinotecan...

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Abstract

The present disclosure provides methods of treating neuroblastoma using an anti-GD2 antibody, at least one chemotherapeutic agent, and at least one hematopoietic growth factor. The present disclosure also provides compositions for treating neuroblastoma.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Application No. 62 / 721,433, filed August 22, 2018, which is hereby incorporated by reference in its entirety. [0003] sequence listing [0004] This application contains a Sequence Listing submitted via EFS-Web, the entire contents of which are hereby incorporated by reference. Said ASCII copy was generated on August 22, 2019, named 072734.093l_ST25, and was 35,310 bytes in size. [0005] introduction [0006] The present disclosure provides methods for treating neuroblastoma (e.g., refractory and relapsed neuroblastoma) by administering an anti-ganglioside D2 (anti-GD2) antibody in combination with at least one chemotherapeutic agent and at least one hematopoietic growth factor method. The present disclosure also provides pharmaceutical compositions for treating neuroblastoma. Background technique [0007] Neuroblastoma is a common extracranial solid tumor in ch...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/203A61K31/485A61K38/00
CPCA61K31/4745A61K31/485A61K38/193A61K39/39558A61P35/00C07K16/3084A61K2300/00A61K31/437A61K31/53A61K2039/505
Inventor S·莫达克
Owner MEMORIAL SLOAN KETTERING CANCER CENT
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