Biomarker-Driven Lung Cancer

H. Jack West, MD, thoracic oncologist, Swedish Cancer Institute at Swedish Medical Center, discusses how he treats patients with advanced lung cancer who do not have actionable oncogenic drivers. 

Multiple Myeloma

The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.

Regardless of smoking history, patients with cancer of the lung harboring specific genetic alterations who were treated with targeted therapies experienced longer survival than those patients who did not receive targeted treatment, according to results of a multi-institutional extension study to identify and treat oncogenic driver events.

Julie R. Brahmer, MD, interim director, Sidney Kimmel Comprehensive Cancer Center, associate professor of oncology, Johns Hopkins Medicine, reviews developments in 2017 for the treatment of lung cancer.

A supplemental new drug application (sNDA) for osimertinib (Tagrisso) has been granted a priority review by the FDA&nbsp;as a first-line treatment for patients with non&ndash;small cell lung cancer (NSCLC) whose tumors harbor <em>EGFR</em> mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).

According to findings presented at the 2017 World Conference on Lung Cancer, the&nbsp;potent and selective inhibitor of ROS1 and TRKentrectinib induced an objective response rate of 68.8% by blinded independent central review, which included 2 complete responses (6.3%), for patients with <em>ROS1</em> fusion-positive advanced non&ndash;small cell lung cancer.

AstraZeneca has submitted a&nbsp;supplemental new drug application to Japan&#39;s&nbsp;Pharmaceuticals and Medical Devices Agency for the use of the&nbsp;third-generation, irreversible EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) in the frontline treatment of patients with&nbsp;inoperable or recurrent <em>EGFR</em>-positive non&ndash;small cell lung cancer.

Suresh A. Ramalingam, MD,&nbsp;discusses some of the changes to the NCCN guidelines in NSCLC, specifically with <em>EGFR</em>-mutation&ndash;positive disease, and how the frontline recommendation of osimertinib will impact clinical practice.

George R. Blumenschein, MD,&nbsp;discusses the current treatment landscape for patients with squamous cell lung cancer.

Justin F. Gainor, MD, medical oncologist, Assistant Professor of Medicine, Massachusetts General Hospital, Harvard Medical School, discusses how the treatment paradigm for EGFR+ lung cancer will transform over the next several years.

In data presented at the 2017 ESMO Asia Congress, updated results again sustained the benefit of frontline osimertinib (Tagrisso) in patients with <em>EGFR</em>-positive advanced non&ndash;small cell lung cancer (NSCLC) and CNS metastases at baseline.

Anne Chiang, MD, PhD, professor and thoracic oncologist at Yale Cancer Center, discusses the future of treatment for oligometastatic lung cancer.

After granting a priority review to durvalumab (Imfinzi) in October for the treatment of patients&nbsp;with stage III, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation, the FDA is now reviewing results from the phase III PACIFIC trial, which have now&nbsp;been published in the print edition of the New England Journal Medicine.

In topline results announced from the phase III IMpower150 trial, atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) and chemotherapy delayed progression or death when compared with bevacizumab and chemotherapy alone for patients with advanced nonsquamous non&ndash;small cell lung cancer.

Although great advances have been made in the treatment of advanced, metastatic, and nonresectable, nonsquamous, non&ndash;small cell lung cancer (NSCLC), prognosis remains relatively poor, and recurrence is common. Howard Jack West, MD, medical director of the Thoracic Oncology Program at Swedish Cancer Institute, Seattle, Washington, explained in an abstract that &ldquo;platinum-based chemotherapy is the current standard of care for patients with newly diagnosed advanced nonsquamous NSCLC.

Experts within the lung cancer community are eagerly anticipating the phase III findings of the KEYNOTE-189 trial, and they are hopeful that the combination of pembrolizumab (Keytruda) plus carboplatin and pemetrexed (Alimta) will demonstrate an overall survival advantage in patients with nonsquamous non&ndash;small cell lung cancer.

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 80% to 85% of lung cancer cases, whereas small cell lung cancer (SCLC) comprises approximately 10% to 15% of lung cancer cases.

Nonsquamous non&#8210;small cell lung cancer (NSCLC) is a heterogeneous disease with multiple treatment options dependent upon staging, presence of metastasis, and patient factors&mdash;including presence of comorbidities&mdash;among other considerations. As such, current treatment options include surgical resection, chemotherapy, radiation, immunotherapy, and targeted therapy.

In a presentation at the&nbsp;35th annual CFS, Edward S. Kim, MD, discussed the &quot;renaissance&quot; in the&nbsp;non&ndash;small cell lung cancer landscape that has come with the rapid evolution of targeted treatment for patients with&nbsp;<em>EGFR</em>-mutation&ndash;positive disease.

Four tumor serum markers commonly used in other solid tumors could be used in monitoring therapeutic outcomes in patients with stage IV lung adenocarcinoma, according to a single-center retrospective analysis.

David R. Gandara, MD, director, Thoracic Oncology Program, professor, senior advisor to director, UC Davis Comprehensive Cancer Center, UC Davis Health System, discusses results of the ALEX clinical trial, which compared alectinib (Alecensa) versus crizotinib (Xalkori) in patients with ALK+&nbsp;non&ndash;small cell lung cancer (NSCLC).

H. Jack West, MD, a thoracic oncologist of Swedish Cancer Institute at Swedish Medical Center, discusses appropriate treatment for patients with stage IV adenocarcinoma who do not harbor oncogenic drivers.

Alectinib (Alecensa) has received FDA approval for the frontline treatment of patients with&nbsp;ALK-positive metastatic non&ndash;small cell lung cancer,&nbsp;Genentech, the manufacturer of the second-generation ALK inhibitor, announced today.