Reply to Di Nunno et al. concerning objective response rates targets for recurrent glioblastoma clinical trials: Toward surrogate endpoints for phase II trials in patients with recurrent glioblastoma

Article Oncology

Objective response rate targets for recurrent glioblastoma clinical trials based on the historic association between objective response rate and median overall survival

Benjamin M. Ellingson et al.

Summary: This study reviewed past trials in recurrent glioblastoma and identified target objective response rates (ORRs) for different treatments. The study found that ORRs varied depending on the type of therapy, and ORR was significantly correlated with median overall survival (mOS) for chemotherapy, biologic, and immunotherapy trials. Based on this analysis, the study recommends a target ORR >25% and a sample size of >=40 patients for future studies in recurrent glioblastoma.

NEURO-ONCOLOGY (2023)

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Review Oncology

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021

Sundeep Agrawal et al.

Summary: Single-arm trials have been used to expedite access to transformative therapies, but there are challenges in using them for drug approval. A large number of approvals have been based on single-arm trials, with response rate as the most common endpoint. However, there are limitations and careful considerations required.

JAMA ONCOLOGY (2023)

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Article Oncology

Hypothetical generalized framework for a new imaging endpoint of therapeutic activity in early phase clinical trials in brain tumors

Benjamin M. Ellingson et al.

Summary: Imaging response assessment plays a crucial role in patient care and drug development in oncology, but the current methods are insufficient in evaluating treatment effects comprehensively. Proposed modifications to the existing framework aim to improve the accuracy in measuring treatment effects and provide a reliable basis for selecting candidate therapies and identifying effective treatments.

NEURO-ONCOLOGY (2022)

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Article Medicine, General & Internal

An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate

Emerson Y. Chen et al.

JAMA INTERNAL MEDICINE (2019)

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Review Oncology

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics A Review

Julia A. Beaver et al.

JAMA ONCOLOGY (2018)

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Editorial Material Oncology

Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies

Gideon M. Blumenthal et al.

ONCOLOGIST (2017)

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Article Oncology

A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse

WKA Yung et al.

BRITISH JOURNAL OF CANCER (2000)

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Reply to Di Nunno et al. concerning objective response rates targets for recurrent glioblastoma clinical trials: Toward surrogate endpoints for phase II trials in patients with recurrent glioblastoma

Related references

Objective response rate targets for recurrent glioblastoma clinical trials based on the historic association between objective response rate and median overall survival

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021

Hypothetical generalized framework for a new imaging endpoint of therapeutic activity in early phase clinical trials in brain tumors

An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics A Review

Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies

A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse

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