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Immunotherapy and EGFR, ALK Inhibitors Deliver Precision Medicine in NSCLC

Gina Columbus @ginacolumbusonc
Published: Thursday, Dec 21, 2017

Edward S. Kim, MD
Edward S. Kim, MD
It has been a year of therapeutic advancements in the field of non–small cell lung cancer (NSCLC), most notably with 2 targeted agents that significantly improved progression-free survival (PFS) outcomes in differing subgroups of patients.

First, the long-awaited findings of the double-blind, phase III FLAURA trial demonstrated that frontline treatment with the third-generation irreversible EGFR inhibitor osimertinib (Tagrisso) was associated with a 54% reduction in the risk of progression or death compared with standard therapy—a first-generation agent, gefitinib (Iressa) or erlotinib (Tarceva)—in patients with EGFR-mutant disease.

In October, the FDA granted a breakthrough therapy designation to osimertinib for the first-line treatment of patients with metastatic EGFR mutation–positive NSCLC based on these results.1

In November, the FDA approved alectinib (Alecensa) for the frontline treatment of patients with ALK-positive metastatic NSCLC, primarily based on findings from the phase III ALEX study. Here, alectinib improved PFS versus standard crizotinib (Xalkori) by 47% (HR, 0.53; 95% CI, 0.38-0.73; P <.0001).2 Immunotherapy has not gone unnoticed either, with the May 2017 approval of pembrolizumab (Keytruda) in combination with carboplatin/pemetrexed for the frontline treatment of patients with metastatic or advanced nonsquamous NSCLC regardless of PD-L1 expression. “It is great that lung cancer has actually become the face of precision medicine, because we have so many patients that we touch with lung cancer,” said Edward S. Kim, MD. “Even a 1% or 2% marker touches thousands of patients, so its impact is huge. It has been fun to watch the evolution of this occur over the last 2 decades.” 

In an interview during the 2017 OncLive® State of the Science SummitTM on Advanced Non–Small Cell Lung Cancer, Kim, chair, Solid Tumor Oncology and Investigational Therapeutics, Donald S. Kim Distinguished Chair for Cancer Research, Levine Cancer Institute, Carolinas HealthCare System, spoke to the advancements in lung cancer in 2017, specifically in EGFR- and ALK-positive patients and those with PD-L1 expression.

OncLive: You chaired this State of the Science SummitTM. Can you share some of the overall advancements we have witnessed in this field?

Kim: The landscape in lung cancer has changed so much in the last 6 months to 1 year—you can really put any time stamp on it over the last 5 years. We had a lot of interest [at the meeting] because people need to catch up. There seems to [constantly] be emails coming from the FDA or ASCO [with updates on] a new drug, new biomarker, or another indication. That is exciting for patients; this has happened with tyrosine kinase inhibitors (TKIs), biomarkers, and immunotherapy.

It confuses a lot of clinicians out there because they thought they knew how to use a drug and in what setting, and then they see you can use it in a different setting. Or, perhaps you shouldn’t use that drug anymore or there is [news about] a different or better drug. Perhaps you have to test a certain marker. We had a nice summary of these topics. 

Let's dive in to some of the updates as of late. Can you comment on osimertinib and how the FLAURA findings have impacted practice for EGFR-mutated NSCLC?

When one sees a patient with lung cancer, we don’t want a diagnosis anymore. We want tissue. We will get a diagnosis if we have enough tissue but, more importantly, we’ll get the requisite markers that we need. We absolutely must have them in order to make informed decisions to stage the patient and pick the right drug. You’ll have situations where you’ll get a diagnosis and it will be based on cytology or brushings—we don’t care. We don’t want to [just] know that its NSCLC or adenocarcinoma.

You absolutely have to [test] these biomarkers—EGFR mutation, ALK translocation, ROS1, BRAF, and PD-L1—because any one of these markers could be present and almost 50% of patients with NSCLC may have one of them. That means you don’t use chemotherapy. When we see a patient with breast cancer, do we start treating without knowing the hormone receptor status or the HER2 status? Absolutely not. Some might say that’s unethical. I am trying to implore people that this is just as important in lung cancer.

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Year in Review™: Reflecting on Recent Evidence With an Eye to the Future of Lung Cancer ManagementMar 30, 20191.5
Online Medical Crossfire®: 5th Annual Miami Lung Cancer ConferenceMay 30, 20196.5
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