EGFR+ Lung Cancer

The combination of pembrolizumab and chemotherapy improved progression-free survival in patients with small cell lung cancer compared with chemotherapy alone, meeting 1 of the primary end points of the phase III KEYNOTE-604 study, according to a press release from pembrolizumab developer, Merck. Compared with a chemotherapy regimen of either etoposide plus cisplatin or cisplatin alone, the progression-free survival mprovement with pembrolizumab was significant.

The FDA granted approval to countless treatments across cancer types throughout 2019 until the end of the year, with a final approval on December 31^st for the first BRCA targeted therapy in pancreatic cancer. Following the excitement for a new year of further advances, Targeted Oncology followers on Twitter shared their thoughts on some of the most impactful FDA approvals in 2019.

Justin F. Gainor, MD, discusses the latest advancements with immune checkpoint inhibitors for the treatment of patients with non—small cell lung cancer.

In December 2019, the FDA approved a number of new treatments in lung cancer, pancreatic cancer, urothelial carcinoma, breast cancer, and prostate cancer. A tissue complete assay was also approved by the FDA for use in a clinical trial evaluating pembrolizumab.

Osimertinib demonstrated a manageable toxicity profile and encouraging activity in patients with non–small cell lung cancer who harbor an uncommon EGFR mutation, according to results from a phase II clinical trial conducted in Korea.

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 an interview with&nbsp;Targeted Oncology, Brennan J. Decker, MD, PhD, discussed a real-life scenario of a patient with lung cancer who harbored both an&nbsp;EGFR&nbsp;and&nbsp;BRAF&nbsp;mutation. He highlighted the key takeaways of this case, which he presented at the 2019 Association for Molecular Pathology Annual Meeting and Expo.

With the inevitability of resistance to first- and second-generation EGFR tyrosine kinase inhibitors in patients with EGFR-mutant non&ndash;small cell lung cancer, novel options like lazertinib, an irreversible, third-generation, mutant-selective, EGFR TKI are being explored. Lazertinib has shown promise for the treatment of this patient population, according to a phase I/II dose-escalation study published in The Lancet Oncology.

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.

Brennan J. Decker, MD, PhD, discusses the role of identifying&nbsp;<em>EGFR</em>&nbsp;mutations in patients with lung cancers. In lung adenocarcinoma, there are many different activating mutations that can lead to the development of cancer, Decker explains.

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.

New results from the FLAURA trial have shown that patients with treatment-na&iuml;ve, EGFR&nbsp;mutation&ndash;positive advanced non&ndash;small-cell lung cancer who received first-line osimertinib experienced improved overall survival compared with patients who received either gefitinib or erlotinib.

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;

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.

During a Targeted Oncology live case-based peer perspectives discussion, Matthew A. Gubens, MD, MS, reviewed with a group of physicians the localized and systemic treatment options available for the management of patients with non&ndash;small cell lung cancer.<br /> &nbsp;

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.

Dacomitinib monotherapy significantly prolonged progression-free survival in Asian patients with locally advanced or metastatic non&ndash;small cell lung cancer with epidermal growth factor receptor-activating mutations, according to results of a subgroup analysis from the phase III ARCHER 1050 study, Pfizer reported in a press release.