LUNG CANCER

General Cancer

The FDA has granted an orphan drug designation to durvalumab (Imfinzi) for the treatment of patients with small cell lung cancer (SCLC).<br /> &nbsp;

Hussain Borghaei, DO, MS, discusses the significance of the overall survival data update from the KEYNOTE-001 trial. This trial investigated the PD-1 inhibitor pembrolizumab as a treatment for patients with advanced non&ndash;small cell lung cancer.

In an interview with&nbsp;Targeted Oncology, David Spigel, MD, discussed the updated findings from the PACIFIC trial and how these data will impact the treatment landscape for patients with stage III NSCLC, as well as those with earlier-stage disease. He also highlighted controversies that clinicians face with incorporating immunotherapy into their practice for patients.

Treatment with erlotinib significantly extended progression-free survival in patients with stage IIIA-N2&nbsp;<em>EGFR-</em>mutant non&ndash;small cell lung cancer compared with a combined chemotherapy regimen of gemcitabine plus cisplatin, according to clinical trial results published recently in the&nbsp;<em>Journal of Clinical Oncology</em>.

Biomarker expansion has enjoyed a boom since 2006, with patient incidence of positive biomarkers reaching up to 50% in non&ndash;small cell lung cancer and melanoma and 25% in acute myeloid leukemia and myelodysplastic syndromes, according&nbsp; to the <em>Global Oncology Trends 2018</em> report.

A new study shows comparability between liquid biopsy and tissue biopsy in both diagnostics and monitoring of non&ndash;small cell lung cancer (NSCLC). However, based on the results, liquid biopsies may be preferable to help oncologists make swifter decisions that help manage the disease.<br /> &nbsp;

In June 2019, the FDA approved a number of agents many fields, including diffuse large B-cell lymphoma, head and neck squamous cell carcinoma, small cell lung cancer, gastroenteropancreatic neuroendocrine tumors, and multiple myeloma. The FDA also approved the fifth biosimilar for trastuzumab and another biosimilar for&nbsp;bevacizumab across several indications.

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.

Frontline durvalumab led to a statistically significant and clinically meaningful improvement in overall survival (OS) in combination with etoposide and platinum-based chemotherapy in patients with extensive-stage small cell lung cancer, according to the results of a planned interim analysis of the phase III CASPIAN trial.

David Spigel, MD, chief scientific officer, Sarah Cannon Research Institute, director of the Lung cancer Research Program, and member of the Association of Community Cancer Centers explains to <em>Targeted Oncology, </em>the ways in which ACCC is improving the care landscape and outcomes for patients with advanced non&ndash;small cell lung cancer.

In an interview with <em>Targeted Oncology, </em>Shirish Gadgeel, MBBS, of the Department of Medicine, Hematology/Oncology Division, University of Michigan, discussed recent study updates from the phase III KEYNOTE-189 trial and potential implications for the combination on clinical practice.

During a recent&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives presentation, Mary Jo J. Fidler, MD, reviewed treatment options in the first and second line based on a case study of a patient with NSCLC who experiences rapid progression on her first-line regimen.&nbsp;

The first regulatory approval has been granted to entrectinib in Japan. The Japanese&nbsp;Ministry of Health, Labour and Welfare recently&nbsp;approved the agent for the treatment of adult and pediatric patients with&nbsp;<em>NTRK&nbsp;</em>fusion&ndash;positive, advanced recurrent solid tumors.

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.

Two abstracts presented at the 2019 ASCO Annual Meeting analyzed potential combinations with osimertinib (Tagrisso), a third-generation EGFR TKI, with additional agents to potentially overcome resistance mutations following progression in patients with <em>EGFR</em>-mutant NSCLC.

In an interview with&nbsp;<em>Targeted Oncology</em>, Kazuhiko Nakagawa, MD, PhD discussed the findings from the RELAY trial for the combination of ramucirumab plus erlotinib compared to erlotinib plus placebo. He suggested that these data could be practice-changing for the treatment of newly diagnosed patients with&nbsp;<em>EGFR</em>-positive NSCLC.<br /> &nbsp;

Kartik Konduri, MD, discussed with a group of physicians in a recent&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives presentation the diagnostic workup and treatment considerations he makes when he sees a patient with non&ndash;small cell lung cancer in the clinic. Konduri explained his treatment decision making based on the case scenario of a patient with locally advanced NSCLC.&nbsp;

An accelerated approval has been granted by the FDA to&nbsp;single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer who have disease progression on or after platinum-based chemotherapy and &ge;1 other prior line of therapy.

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.