Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials

The U.S. Food and Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.

January 17, 2025

Vol.51 No.02

By Laura A. Levit, Mark J. Ratain, Julie R. Gralow, Clifford A. Hudis and Elizabeth Garrett-Mayer

In Brief

David Chung named director of clinical research at Northwell Health

Northwell Health appointed David J. Chung, a prominent oncologist-investigator, as director of clinical research at the Northwell Health Cancer Institute. In this newly created role, Chung also will serve as system chief of multiple myeloma across Northwell’s cancer centers.

January 17, 2025

Vol.51 No.02

Clinical Roundup

Trastuzumab emtansine improves OS in HER2+ breast cancer, phase III study shows

In patients with high-risk HER2-positive breast cancer, post-surgery, or adjuvant, treatment with trastuzumab emtansine, also referred to as T-DM1) reduced the long-term risk of death or invasive disease by 46% and improved survival compared to trastuzumab alone, according to the final results of the phase III KATHERINE clinical trial led by researchers from the University of Pittsburgh and UPMC Hillman Cancer Center.

January 17, 2025

Vol.51 No.02

Clinical Roundup

Nivolumab demonstrates superiority over standard of care for head-and-neck cancer in phase III trial

The Groupe d’Oncologie Radiothérapie Tête Et Cou, also known as the Head and Neck Oncology and Radiotherapy Group or GORTEC, announced that the randomized phase III CheckMate -9KW/NIVOPOSTOP GORTEC 2018-01 trial evaluating nivolumab (Opdivo) as a post-operative treatment component for resected patients with locally advanced squamous cell carcinoma of head and neck with high risk of relapse met its primary endpoint of disease-free survival across all comers.

January 17, 2025

Vol.51 No.02

Clinical Roundup

Immunotherapy for pediatric osteosarcoma with lung metastases after resection shows positive data

OS Therapies Inc. announced positive data from a phase IIb clinical trial (NCT04974008) of OST-HER2 (OST31-164)—the company’s HER2-targeted immunotherapy candidate in the rare pediatric-designated indication of prevention of recurrent, fully resected, lung metastatic osteosarcoma.

January 17, 2025

Vol.51 No.02

Clinical Roundup

Drug in clinical trials for breast cancer could also treat some blood cancers, studies show

Two new studies led by researchers at Washington University School of Medicine in St. Louis have identified a possible way to block the progression of several forms of blood cancer using a drug already in clinical trials against breast cancer.

January 17, 2025

Vol.51 No.02

Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

YOU MAY BE INTERESTED IN

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials

David Chung named director of clinical research at Northwell Health

Trastuzumab emtansine improves OS in HER2+ breast cancer, phase III study shows

Nivolumab demonstrates superiority over standard of care for head-and-neck cancer in phase III trial

Immunotherapy for pediatric osteosarcoma with lung metastases after resection shows positive data

Drug in clinical trials for breast cancer could also treat some blood cancers, studies show

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