Precision Medicine in Oncology®

Novel strategies to modulate the microbiota are now an area of robust investigation

Jun Zhang, MD, PhD, discusses key clinical trials utilizing immunotherapy in non–small cell lung cancer, the continued importance of biomarker testing to help inform treatment decisions, and targeted therapies for EGFR, MET, and ALK mutations.

Kelvin P. Lee, MD, discusses the importance of sequencing in precision medicine.

Lynette M. Sholl, MD, discusses why cancer pathologists still want better tissue samples.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization to capmatinib for use as a single agent in select adult patients with advanced non–small cell lung cancer harboring a METex14 skipping alteration.

State of Science Summit- Precision Medicine - Lung Cancer: Chaired by Karen L. Reckamp, MD, MS

The safety, tolerability, and preliminary efficacy of the irreversible, small molecule pan-FGFR inhibitor KIN-3248 is under investigation in adult patients with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations, as part of the phase 1 KN-4802 trial.

Christopher A. Fausel, PharmD, MHA, BCOP, discusses how genetic sequencing has played a growing role in cancer care.

Marcia S. Brose, MD, PhD, FASCO, and a panel of thyroid cancer experts share their insights into the evolving treatment landscape, including the use of VEGF receptor inhibitors and some of the precision medicine treatments now identified for molecularly selected subsets of patients with differentiated thyroid cancer, such as BRAF, RET, and TRK inhibitors.

Widespread germline testing in the United States could prevent cancer in hundreds of thousands of people. However, despite known benefits, uptake for genetic testing has been slow: only 1 in 5 individuals use recommended genetic services even when there is a significant family history of colorectal, breast, or ovarian cancer.

Selpercatinib continued to provide clinically meaningful benefit to patients with metastatic RET fusion–positive non–small cell lung cancer.

The FDA has approved the BRACAnalysis CDx assay for use as a companion diagnostic to select patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who may derive clinical benefit from treatment with olaparib.

Kelvin P. Lee, MD, discusses the nuances of an effective molecular tumor board, explains the practical application of precision oncology genomics, and highlights the pathways that have the potential to change the treatment landscape for precision oncology.

A marketing authorization application has been submitted to the European Medicines Agency for 2 indications of ivosidenib: in combination with azacitidine in the frontline treatment of patients with IDH1-mutated acute myeloid leukemia who are not candidates for intensive chemotherapy and in previously treated patients with locally advanced or metastatic IDH1-mutated cholangiocarcinoma.

Leveraging the advances made with liquid biopsies in pantumor assays and specific hematologic cancers has laid the groundwork for the shift in care by using single, or multifaceted approaches for identifying, predicting, and monitoring disease progression.

Early data have demonstrated poor outcomes for patients with NRG1 fusions, and limited efficacy with available treatments represents a need for the development of novel therapeutic agents.

Improving patient outcomes is top of mind for investigators at John Theurer Cancer Center in Hackensack, New Jersey.

Upal Basu Roy, PhD, MPH, discusses the challenges of interpreting molecular testing results in lung cancer.

Maurie Markman, MD, explains the concerns surrounding liquid biopsies in cancer screening, and why regulatory agencies should be cautious and not approve any proposed molecularly based cancer diagnostic screening strategy until the tool is shown to effect cancer-specific survival compared with a control population not undergoing such testing.

Primary and metastatic brain tumors present a significant therapeutic challenge, in large part because they are protected by the blood-brain barrier, a highly restrictive interface between the bloodstream and the brain that prevents most drugs from accessing the brain parenchyma.

The European Commission has granted a marketing authorization for lorlatinib for use as a single agent in the treatment of adult patients with ALK-positive advanced non–small cell lung cancer who did not receive a prior ALK inhibitor.

The recent approval of sotorasib for the treatment of patients with advanced KRAS G12C–mutant non–small cell lung cancer marks a milestone for cancer therapy.

High expression of activated leukocyte cell adhesion molecule, also known as CD166, occurs in approximately 50% of patients with triple-negative breast cancer and up to 80% of patients with estrogen receptor– positive, HER2-negative breast cancer.

Molecular testing is an established and essential precursor to treatment for patients with non–small cell lung cancer based on the volume of actionable targets, such as EGFR and KRAS G12C mutations, as well as PD-L1 status.

Bintrafusp Alfa, a novel fusion protein designed to target the transforming growth factor beta pathway, racked up 3 clinical trial disappointments in less than a year, leaving the future of its development in question.

The FDA has approved FoundationOne CDx for use as a companion diagnostic for 2 groups of current a future regulatory-approved treatments in melanoma, including single-agent BRAF inhibitors targeting BRAF V600E mutations and BRAF/MEK combination regimens targeting BRAF V600E or V600K mutations.

The use of a routine blood test to assess and monitor patients with cancer, especially in a longitudinal manner, has long been the holy grail of cancer research.

Investigators identified potentially actionable germline variants in 10% of unselected women with newly diagnosed endometrial cancer, supporting the use of upfront multigene panel testing for all in the population.

Shridar Ganesan, MD, PhD, discusses improvements in precision medicine and the need to enroll patients with different molecular subtypes into specifically designed clinical trials.