Enhertu reduced the risk of disease recurrence or death vs. T-DM1 in high-risk HER2+ early breast cancer following neoadjuvant therapy

“Basic Experimental Studies Involving Humans” no longer classified as clinical trials at NIH in an effort to reduce administrative burden

NIH announced Jan. 29 that “Basic Experimental Studies Involving Humans,” also called BESH, will no longer be considered clinical trials and will therefore no longer be subject to the requirements under the NIH definition of a clinical trial, including registration and reporting requirements in ClinicalTrials.gov.

NCCN updates guidelines recognizing MammaPrint to guide personalized anthracycline use in HR+/HER2- early‑stage breast cancer

The NCCN added MammaPrint + BluePrint to the Clinical Practice Guidelines in Oncology for the identification of a subset of hormone receptor positive, HER2-negative early-stage breast cancer patients most likely to benefit from anthracycline-based chemotherapy.

February 06, 2026

Vol.52 No.05

Antibody halts triple-negative breast cancer in preclinical models

Triple-negative breast cancer is one of the most aggressive and treatment-resistant cancers. It grows quickly, spreads early, and lacks hormone receptors that make it treatable with targeted therapies. Even when patients initially respond to treatment, the cancer often returns and is more resistant.

January 30, 2026

Vol.52 No.04

By Hayley Kamin

Clinical Roundup

Itismeran autogene + Keytruda demonstrated improvement in recurrence-free survival in neoadjuvant melanoma

Moderna and Merck announced median five-year follow-up data from the phase IIb KEYNOTE-942/mRNA-4157-P201 study, evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with high-risk melanoma (stage 3/4) following complete resection.

January 30, 2026

Vol.52 No.04

Clinical Roundup

Oral bacterium may promote breast cancer development and spread, Hopkins study finds

Researchers at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Institute for Cancer Immunotherapy found that an oral bacterium commonly associated with periodontal disease can promote breast cancer initiation, tumor growth, and spread by inducing DNA damage and altering cancer cell behavior.

January 30, 2026

Vol.52 No.04

Drugs & Targets

Trodelvy added to NCCN guidelines as preferred regimen option for first-line metastatic TNBC

Trodelvy (sacituzumab govitecan-hziy) was added to the NCCN Guidelines as a category 1 preferred first-line treatment option for people with metastatic triple-negative breast cancer whose disease is PD-L1 negative (CPS <10) and no germline BRCA1/2 PV.

January 30, 2026

Vol.52 No.04

Enhertu reduced the risk of disease recurrence or death vs. T-DM1 in high-risk HER2+ early breast cancer following neoadjuvant therapy

YOU MAY BE INTERESTED IN

“Basic Experimental Studies Involving Humans” no longer classified as clinical trials at NIH in an effort to reduce administrative burden

NCCN updates guidelines recognizing MammaPrint to guide personalized anthracycline use in HR+/HER2- early‑stage breast cancer

Antibody halts triple-negative breast cancer in preclinical models

Itismeran autogene + Keytruda demonstrated improvement in recurrence-free survival in neoadjuvant melanoma

Oral bacterium may promote breast cancer development and spread, Hopkins study finds

Trodelvy added to NCCN guidelines as preferred regimen option for first-line metastatic TNBC

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