Amit Jain, MD, fellow, Hematology and Oncology, The University of Tennessee Health Science Center, discusses the benefit of CDK7 inhibitors in hormone receptor (HR)–positive breast cancers.

CDK7 inhibitors are addressing an area of need for patients with HR-positive breast cancer who progress following first-line therapy, since beneficial second-line options are scarce, Jain says. Most of the options currently available in the second line, including chemotherapy, mTOR inhibitors, and PI3K inhbitors, are associated with severe toxicity and subpar efficacy, Jain explains. Although hormone therapies are well tolerated, they lack efficacy, Jain adds.

A phase 1/2 trial (NCT03363893) investigating samuraciclib, a CDK7 inhibitor, in combination with fulvestrant (Faslodex) produced positive data, Jain notes. If larger phase 3 studies can also demonstrate the benefit of CDK7 inhibitors in patients with HR-positive breast cancer, they could become the standard of care in the second line, Jain concludes.

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Amit Jain, MD, discusses the benefit of CDK7 inhibitors in hormone receptor–positive breast cancers.


Dr. Jain on the Benefit of CDK7 Inhibitors in HR+ Breast Cancers

Amit Jain, MD, a hematology oncology fellow at The University of Tennessee Health Science Center, discusses the potential role of emerging biomarkers in selecting treatment with CDK7 inhibitors in patients with metastatic hormone receptor (HR)–positive, HER2-negative breast cancer.

In a phase 1/2 trial (NCT03363893) investigating samuraciclib, a CDK7 inhibitor, in combination with fulvestrant (Faslodex) in this patient population, patients with 

 wild-type disease demonstrated the best responses when compared with patients with 

 mutations, Jain says. These data show that tumor 

 status is a possible biomarker for predicting the efficacy of CDK7 inhibitors in patients with advanced HR-positive, HER2-negative breast cancer, Jain explains.

Additionally, this study showed that the absence of liver metastases may predict samuraciclib efficacy, as patients with liver metastases had a median progression-free survival (PFS) of 11.9 weeks compared with a PFS that was not yet reached in patients without liver metastases, Jain notes. Although this was a small study, these findings provide an important basis for future investigation of CDK7 inhibitor efficacy and reliable biomarkers, Jain concludes.

Amit Jain, MD, discusses the potential role of emerging biomarkers in selecting treatment with CDK7 inhibitors in patients with metastatic hormone receptor–positive, HER2-negative breast cancer.

Amit Jain, MD

Articles

Dr. Jain on the Benefit of CDK7 Inhibitors in HR+ Breast Cancers

Dr. Jain on Potential Biomarkers in HR-Positive, HER2-Negative Breast Cancer