BRAIN CANCER

Using a measure known as the growth modulation index, patients with TRK fusion–positive cancers who were treated with larotrectinib had a clinically meaningful improvement in progression-free survival compared with the time to progression on their prior treatment, an analysis of patients enrolled in 1 of 3 clinical trials has found.

Three clinical trials presented at the 2019 ESMO Congress show that the tropomyosin receptor kinase inhibitor larotrectinib continues to show anti-tumor activity, including long-lasting objective responses and low toxicity, according to results from an integrated analysis.

The addition of nivolumab to the standard of care temozolomide and radiation therapy was not additive in terms of progression-free survival compared with standard of care alone in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated, according to results released from the phase III CheckMate 548 trial.

Several presentations at the 2019&nbsp;American Society of Clinical Oncology Annual Meeting highlighted a hopeful new direction in the treatment of gliomas, demonstrating the relevance of <em>IDH1/2</em> mutational status and its feasibility as a target of therapy.

General Cancer

The FDA has approved Zirabev, a biosimilar to bevacizumab for 5 indications.&nbsp;Zirabev has been approved for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non&ndash;small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

The American Cancer Society, Dana-Farber Cancer Institute, Baptist Cancer Center, and the Mayo Clinic report&nbsp;that treatment patterns varied markedly by cancer type and care facility setting for patients with de novo metastatic disease who died within 1 month after diagnosis, based on an analysis of data from 100,848 patients collected from the National Cancer Database, a hospital-based cancer registry that captures 70% of patients in the United States with a new diagnosis.

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials. The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age.

A cohort of cancer centers was selected to serve as models for identifying key strategies for racial and ethnic minority group engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population &ge;10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation.

In a case-based-style discussion, Tanios S. Bekaii-Saab, MD, and Wells Messersmith, MD, reviewed the treatment of patients with colorectal cancer whose tumors express rare gene mutations or molecular signatures, such as <em>NTRK</em> fusions.

Larotrectinib demonstrated efficacy across analyses for both pediatric patients and those with brain metastases or primary central nervous system tumors, whether pediatric or adult, with TRK fusions.

Final results from the phase III CheckMate 498 trial demonstrated that nivolumab in combination with radiation failed to demonstrate a significant improvement in overall survival compared with temozolomide and radiation in patients with newly diagnosed <em>MGMT</em>-unmethylated glioblastoma multiforme.