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11th Annual New York Lung Cancer Symposium®

11th Annual New York Lung Cancer Symposium®


PER Pulse™ Recap

Resources

Community Practice Connections™: 11th Annual New York Lung Cancer Symposium®
Earn up to 2.0 AMA PRA Category 1 Credits™
Community Practice Connections™: 11th Annual New York Lung Cancer Symposium® is an online continuing medical education (CME)‒certified activity.

PER Pulse™ Recap
PER Pulse™ Recaps for Community Practice Connections™: 11th Annual New York Lung Cancer Symposium®


PER Pulse™ Recap

PER Pulse™ Recap



1 of 3
PER Pulse Recap

Recent Developments in First-line ALK Inhibition

The 11th Annual New York Lung Cancer Symposium®, November 12, 2016, was held to communicate state-of-the-art approaches in the management of patients with lung cancers, as well as emerging therapeutic paradigms. This first of 3 PER Pulse Recaps from the symposium focuses on new agents in development for first-line treatment of patients with ALK-rearranged non–small cell lung cancers (NSCLCs).

The first-line standard of care for patients with ALK-rearranged NSCLCs has been crizotinib, although next-generation agents are being investigated in this setting. Two such agents, alectinib and crizotinib, are currently approved for patients with crizotinib-pretreated disease.

The phase 3 J-ALEX trial, conducted in Japan, randomized 207 patients who had not previously received an ALK inhibitor to receive alectinib or crizotinib. The primary endpoint of the study, progression-free survival (PFS), was superior with alectinib. The median PFS with alectinib was not reached at the time of reporting, but the lower value of the 95% confidence interval was 20.3 months versus 10.2 months with crizotinib (hazard ratio [HR], 0.34; P <.0001). The overall rate of grade 3/4 adverse events (AEs) was lower with alectinib compared with crizotinib (26% vs 52%). A global version of this trial, ALEX, is currently ongoing.

Another phase 3 trial, ASCEND-4, evaluated ceritinib, the next-generation ALK inhibitor, in the first-line setting, although the comparator was platinum-based chemotherapy rather than crizotinib. This trial, which randomized 376 patients, also met its primary endpoint of PFS, which was 16.6 months with ceritinib compared with 8.1 months with chemotherapy (HR, 0.55; P <.00001). Grade 3/4 AEs varied by treatment arm, with more hematologic toxicity seen in the chemotherapy arm and more liver enzyme elevation and diarrhea occurring in the ceritinib arm.

For additional commentary about these topics and others, visit www.gotoper.com to access more resources from the 11th Annual New York Lung Cancer Symposium®, including downloadable slides from the meeting.



2 of 3
PER Pulse™ Recap

Managing Acquired Resistance to EGFR Inhibition

The 11th Annual New York Lung Cancer Symposium®, November 12, 2016, was held to communicate state-of-the-art approaches in the management of patients with lung cancers, as well as emerging therapeutic paradigms. This second of 3 PER Pulse Recaps from the symposium focuses on recent data on managing patients with non–small cell lung cancers and acquired resistance to EGFR tyrosine kinase inhibitors (TKIs).

With the availability of EGFR-T790M–targeting agents, molecular testing in the setting of acquired resistance to a first-line EGFR TKI has become a standard approach. However, acquiring a tissue biopsy may not always be feasible. Plasma-based biopsy, which is less invasive, has emerged as an alternative to tissue biopsies. The results of one study showed a turnaround time of 3 business days with plasma-based testing compared with 27 business days for tissue-based testing. Because the sensitivity of plasma-based tests can depend on factors such as the number of sites of metastases, a negative EGFR-T790M result should be confirmed with tissue-based testing.

For patients with EGFR-T790M–positive resistance, osimertinib, the third-generation EGFR TKI, received accelerated approval in 2015 based on response data. Results of the phase 3 AURA3 trial subsequently demonstrated a benefit, in terms of progression-free survival, with osimertinib compared with standard platinum-based chemotherapy in patients with EGFR-T790M resistance (10.1 months vs 4.4 months; hazard ratio [HR], 0.30; P <.001). Overall survival (OS) data were not yet available at the time of reporting.

Finally, when all available EGFR TKIs have been exhausted and the switch to chemotherapy is required, OS data from the phase 3 IMPRESS trial indicate that EGFR TKIs should not be given in combination with chemotherapy. In this trial, patients who continued a TKI while undergoing chemotherapy had a median OS of 13.4 months, which was significantly less than that of patients who discontinued a TKI and received chemotherapy alone (19.5 months; HR, 1.44; P = .016). For patients who switch to chemotherapy, the treatment-free interval should be minimal in order to prevent the occurrence of tumor flare.

For additional commentary about these topics and others, visit www.gotoper.com to access more resources from the 11th Annual New York Lung Cancer Symposium®, including downloadable slides from the meeting.

 


3 of 3
PER Pulse™ Recap

Continuing Immunotherapeutic Advances in Lung Cancers

The 11th Annual New York Lung Cancer Symposium®, November 12, 2016, was held to communicate state-of-the-art approaches in the management of patients with lung cancers, as well as emerging therapeutic paradigms. This third of 3 PER Pulse Recaps from the symposium focuses on recent developments with immunotherapy in non–small cell lung cancers (NSCLCs).

In 2016, a major development in the treatment of patients with NSCLCs was the demonstration of superior outcomes with immunotherapy compared with standard first-line chemotherapy in patients with PD-L1–positive disease. This led the FDA to approve pembrolizumab in October 2016. In the phase 3 KEYNOTE-024 trial, pembrolizumab yielded superior progression-free survival (PFS) compared with platinum-based chemotherapy (10.3 months vs 6.0 months; hazard ratio [HR], 0.50; P <.001); overall survival (OS) was also longer in the pembrolizumab arm. The trial required a PD-L1 expression level ≥50% and excluded patients with EGFR or ALK molecular aberrations, however, further underscoring the need for molecular testing of patients at diagnosis.

The results of immunotherapy-based combination regimens were also presented from 2 trials. In the phase 2 KEYNOTE-021 trial, first-line platinum-based chemotherapy was compared with the combination of pembrolizumab and chemotherapy. The primary endpoint of response was significantly higher with the addition of pembrolizumab to chemotherapy (55% vs 29%; P = .0016), as was median PFS. This combination is currently under review by the FDA, with a decision expected by May 10, 2017. The phase 1 CheckMate 012 study investigated the combination of nivolumab plus ipilimumab as first-line therapy. Response rates of approximately 40% to 50% were observed. The ongoing phase 3 CheckMate 227 trial is investigating nivolumab/ipilimumab in the frontline setting.

In patients with previously treated NSCLCs, 2 anti–PD-1 antibodies, nivolumab and pembrolizumab, were approved in 2015. Atezolizumab, another anti–PD-L1 antibody, received approval in 2016 based on randomized comparisons to docetaxel. The phase 3 OAK trial demonstrated superior OS for atezolizumab compared with docetaxel in platinum-pretreated patients (13.8 months vs 9.6 months; HR, 0.73; P = .0003). Benefit was observed even in patients without detectable PD-L1 expression, and the current indication of atezolizumab has no PD-L1 biomarker requirement.

For additional commentary about these topics and others, visit www.gotoper.com to access more resources from the 11th Annual New York Lung Cancer Symposium®, including downloadable slides from the meeting.







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