Biomarker-Driven Lung Cancer

Selpercatinib will be compared with the standard of care in the first ever phase III clinical trial in patients with advanced or metastatic treatment-na&iuml;ve&nbsp;<em>RET</em>&nbsp;fusion-positive non&ndash;small cell lung cancer, according to a press release from Eli Lilly and Company.

A new drug application has been filed for accelerated approval with the FDA for lurbinectedin in patients with small cell lung cancer who have progressed after prior platinum-containing therapy, according to the manufacturer, PharmaMar.1 The filing was based on results from a phase II basket trial, presented at the 2019 ASCO Annual Meeting.

Pembrolizumab showed improvements in overall survival, progression-free survival, and objective response rate compared with pemetrexed or paclitaxel chemotherapy in patients with metastatic nonsquamous non&ndash;small cell lung cancer whose tumors are PD-L1&ndash;positive, regardless of their&nbsp;KRAS&nbsp;mutational status.

In a&nbsp;Targeted Oncology&nbsp;case-based peer perspectives live discussion, Nathan A. Pennell, MD, PhD, associate professor of the Department of Medicine at Case Western Reserve University and a medical oncologist at Taussig Cancer Center and the Cleveland Clinic Cancer Center discussed treatment options for EGFR-mutant non&ndash;small cell lung cancer, based on the case of a real patient.<br /> &nbsp;

Cancer has historically been divided between localized and metastatic disease. The underlying principle, derived from the Halsted theory of cancer progression, is that once cancer has spread to other sites, it is a systemic disease. Heroic efforts to remove or ablate all evidence of visible cancer thus would expose patients to toxicity without a chance for benefit.

The FDA granted an Investigational Device Exemption approval to the Personal Genome Diagnostics Inc. elio^TM&nbsp;tissue complete assay for use in a Merck trial evaluating pembrolizumab combinations in non&ndash;small cell lung cancer, according to a press release from PGDx, developer of the assay.

Improving Overall Survival In Extensive Stage Small Cell Lung Cancer

The FDA has approved the combination of atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy for the treatment of patients with metastatic nonsquamous non&ndash;small cell lung cancer, according to a press release from Genentech USA, Inc.<br /> &nbsp;

Andreas Rimner, MD, gives an overview of his presentation titled, &ldquo;Crossing the PACIFIC,&rdquo; which he presented at the 2019 New York Lung Cancers Symposium. He evaluates some potential next steps for durvalumab (Imfinzi) following the practice-changing results from the PACIFIC trial.

A supplemental Biologics License Application for durvalumab has been accepted by the FDA, and the drug has been granted priority review for the treatment of previously untreated extensive-stage small cell lung cancer, according to a press release from AstraZeneca.

In patients whose solid<strong> </strong>tumors harbor a mutation in <em>KRAS </em>G12C, therapy with MRTX849 has produced promising responses and acceptable toxicity across 3 tumors types, according to data presented at the 2019 American Association for Cancer Research&ndash;National Cancer Institute&ndash;European Organization for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics.

Tumor mutational burden has generated interest as a potential biomarker of response to immunotherapy and has already been examined in the context of several lung cancer trials to gauge its utility.

In an interview with Targeted Oncology, Chul Kim, MD, MPH, discussed the results from the phase I/II trial evaluating the combination of an EGFR TKI and Src inhibitor in&nbsp;<em>EGFR</em>-mutant NSCLC. He also highlighted other important advances in the treatment of lung cancer, including the evolving role of circulating tumor DNA to detect disease progression.

The FDA has accepted a Biologics License Application (BLA) for SB8, a biosimilar candidate to reference bevacizumab that was submitted by Samsung Bioepis in September 2019, according to a press release from the company.

Patients with untreated advanced EGFR-mutant non&ndash;small cell lung cancer showed an improvement in progression-free survival with the combination of gefitinib, a TKI that targets EGFR, with carboplatin plus pemetrexed compared with gefitinib alone, according to the results of the NEJ009 study.

Fred R. Hirsch, MD, PhD, discusses how genomic testing has expanded over the last few years and has impacted the lung cancer treatment paradigm.

In an interview with&nbsp;Targeted Oncology, Willemina R. Geurts-Giele, PhD, discussed the accuracy of detecting&nbsp;MET&nbsp;exon 14 skipping mutations in patients with NSCLC with DNA-based NGS panels. These findings were presented at The Association for Molecular Pathology Annual Meeting and Expo.

In a presentation describing the utility of circulating tumor DNA liquid biopsy assays at the 14th Annual New York Lung Cancers Symposium, Bob T. Li, MD, MPH, said that plasma genotyping demsonstrates practice-changing potential in non&ndash;small cell lung cancer.

Testing for driver mutations is essential before initiating therapy in patients with non&ndash;small cell lung cancer, because there is a risk that the type of upfront treatment chosen could add to the toxicity of, and spur resistance to, targeted therapy options, Suresh S. Ramalingam, MD, said at the 14th Annual New York Lung Cancers Symposium.

In an interview with Targeted Oncology during the 14th Annual New York Lung Cancers Symposium, Zofia Piotrowska, MD, MHS,&nbsp;discussed the role of osimertinib in treating patients with EGFR-mutant NSCLC and how it compares with other therapeutic options in that space.

The identification of&nbsp;<em>MET&nbsp;</em>exon 14 skipping mutations in patients with non&ndash;small cell lung cancer presents a complex diagnostic challenge that requires both DNA and RNA analysis, according to results of a University of Michigan pathology study.

Although the use of PD-1 and CTLA-4 pathway blockade in non&ndash;small cell lung cancer has had mixed results in the past, the combination of nivolumab and ipilimumab has demonstrated positive benefit in overall survival and adverse event profile compared with chemotherapy. Research suggests that anti&ndash;CTLA-4 helps induce T-cell responses and anti&ndash;PD-1 aids to restore anti-tumor T cell function.

The combination of bemcentinib, a first in class selective AXL inhibitor, and pembrolizumab is well-tolerated in patients with composite AXL-positive non&ndash;small cell lung cancer, according to updated data presented at Society for Immunotherapy of Cancer&rsquo;s 34th Annual Meeting.

According to Tina Cascone, MD, PhD, in a presentation during the 14th Annual New York Lung Cancers Symposium, neoadjuvant immunotherapy is under investigation for patients with&nbsp;non&ndash;small cell lung cancer and holds hope as a treatment for patients.

Mark G. Kris, MD, discusses treatment options for <em>MET</em>-mutant non&ndash;small cell lung cancer.