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Physicians’ Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

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Year in Review™: Reflecting on Recent Evidence with an Eye to the Future of Lung Cancer Management PER Pulse&trade Recap

PER Pulse Recap

PER Pulse™ Recap



1 of 3
PER Pulse Recap

Advances in Targeted Agents and Liquid Biopsies

Year in Review™: Reflecting on Recent Evidence with an Eye to the Future of Lung Cancer Management highlighted key clinical data in lung cancer that emerged in 2016. The program chair, Benjamin P. Levy, MD, and faculty—Alexander Drilon, MD, and Sarah B. Goldberg, MD, MPH— discussed therapeutic advances for patients with oncogene-addicted non–small-cell lung cancer (NSCLC), new biopsy techniques, and treatment paradigm shifts resulting from the approval of immune checkpoint inhibitors in multiple lines of therapy.

This first of 3 PER Pulse™ Recaps from this Year in Review™ focuses on targeted agents for patients with NSCLC driven by molecular aberrations in the epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes.

  • The use of third-generation, T790M-targeting EGFR tyrosine kinase inhibitors (TKIs) is being explored in the first-line setting. Early data from 60 patients with EGFR mutation-positive NSCLC treated with osimertinib revealed a response rate of 77% and a median progression-free survival (PFS) time of 19.3 months. Randomized data from the phase III FLAURA trial of osimertinib versus gefitinib or erlotinib as first-line therapy are awaited.
  • In the context of acquired resistance to a first-line EGFR TKI, liquid biopsies may be an attractive initial method to test for the T790M resistance mutation, especially if tissue is difficult to obtain. A positive T790M result by plasma may obviate the need for a tissue biopsy, although a negative result would need to be confirmed by tissue-based testing.
  • The use of next-generation TKIs is also being investigated in patients with ALK-rearranged NSCLC. The J-ALEX trial, carried out in Japan, showed superior PFS with alectinib compared with the standard treatment of crizotinib, with a hazard ratio of 0.34 (P < .0001). Results from the global ALEX trial, which included patients from Western populations, are highly anticipated.

To view the videos and expert commentary for this edition of Year in Review™, please visit www.gotoper.com.



2 of 3
PER Pulse™ Recap

New Therapeutic Targets in Lung Cancer

Year in Review™: Reflecting on Recent Evidence with an Eye to the Future of Lung Cancer Management highlighted key clinical data in lung cancer that emerged in 2016. The program chair, Benjamin P. Levy, MD, and faculty—Alexander Drilon, MD, and Sarah B. Goldberg, MD, MPH—discussed therapeutic advances for patients with oncogene-addicted non–small-cell lung cancer (NSCLC), new biopsy techniques, and treatment paradigm shifts resulting from the approval of immune checkpoint inhibitors in multiple lines of therapy.

This second of 3 PER Pulse™ Recaps from this Year in Review™ focuses on targeting recently identified oncogenic drivers and the development of a targeted agent in small cell lung cancer (SCLC).

  • Genetic aberrations in exon 14 of the MET gene have led to impaired turnover and accumulation of MET protein, resulting in malignant cellular behavior. In patients with NSCLC, these exon 14 mutations occur in 3%-4% of patients, although in patients with sarcomatoid lung cancer, the incidence can be as high as 30%. Crizotinib, which was initially developed as a MET inhibitor, has been investigated in this setting; in a cohort of 18 patients, a partial response was demonstrated in 8 patients (44%).
  • In patients with melanoma, targeting the BRAF-V600E mutation with the combination of dabrafenib/trametinib has been shown to be a highly active approach, and this regimen was investigated in patients with NSCLC. In 57 patients, an overall response rate (ORR) of 63% was demonstrated, along with a median progression-free survival time of 9.7 months.
  • The development of new agents has been difficult in SCLC, which may be due partially to a lack of selective biomarkers. The Delta-like protein 3 (DLL3), expressed on the surface of SCLC cells, is the target of the antibody-drug conjugate rovalpituzumab tesirine (Rova-T). In an early-phase study enrolling patients with recurrent SCLC, Rova-T yielded an ORR of 16% by central review; however, in patients with a DLL3 expression level of ≥50%, the ORR was 31%.

To view the videos and expert commentary for this edition of Year in Review™, please visit www.gotoper.com.


3 of 3
PER Pulse™ Recap

The Rapid Expansion of Immunotherapy in Lung Cancer

Year in Review™: Reflecting on Recent Evidence with an Eye to the Future of Lung Cancer Management highlighted key clinical data in lung cancer that emerged in 2016. The program chair, Benjamin P. Levy, MD, and faculty—Alexander Drilon, MD, and Sarah B. Goldberg, MD, MPH—discussed therapeutic advances for patients with oncogene-addicted non–small-cell lung cancer (NSCLC), new biopsy techniques, and treatment paradigm shifts resulting from the approval of immune checkpoint inhibitors in multiple lines of therapy.

This third of 3 PER Pulse™ Recaps from this Year in Review™ focuses on the impact of immunotherapies on the standard of care for patients with NSCLC.

  • The phase III KEYNOTE-024 trial demonstrated superiority of pembrolizumab over standard platinum-based chemotherapy in patients with newly diagnosed NSCLC and a PD-L1 expression level of ≥50%, which led to the October 2016 approval of pembrolizumab in this setting. The study included both squamous and nonsquamous histologies, but patients with known molecular aberrations in the epidermal growth factor receptor or anaplastic lymphoma kinase genes were excluded. Nevertheless, both progression-free survival and overall survival were superior with pembrolizumab, creating a new frontline standard of care for a subset of PD-L1-positive patients and making PD-L1 testing at diagnosis essential.
  • KEYNOTE-021 was a randomized phase II trial evaluating carboplatin/pemetrexed with or without pembrolizumab in patients with newly diagnosed NSCLC and adenocarcinoma histology; PD-L1 expression was not an entry requirement. This phase II trial had overall response rate (ORR) as the primary endpoint, but nevertheless the ORR of 55% with the combination has led to filing of this regimen with regulatory authorities; a decision in the United States is expected by May 10, 2017.
  • Combination PD-L1 and CTLA-4 blockade has been explored in the phase I CheckMate 012 trial. Patients with chemotherapy-naïve NSCLC received nivolumab along with ipilimumab, the latter of which was given every 12 weeks or every 6 weeks. Among all patients, the ORRs were approximately 40%-50%, and were as high as 92% in patients with a PD-L1 expression level of ≥50%.
  • In the platinum-pretreated setting, the phase III OAK trial demonstrated superior overall survival (OS) with the anti-PD-L1 antibody atezolizumab compared with docetaxel. The OS was 13.8 months with atezolizumab and 9.6 months with docetaxel (P = .0003), and an OS benefit was observed regardless of PD-L1 expression level. These data led to the approval of atezolizumab in October 2016.

To view the videos and expert commentary for this edition of Year in Review™, please visit www.gotoper.com.





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