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This activity is supported by educational grants from Boehringer Ingelheim Pharmaceuticals, Inc., Celgene Corporation, Clovis Oncology, Genentech, Lilly, Merck & Co., Inc., and Novartis Pharmaceuticals Corporation.

For further information concerning Lilly grant funding visit www.lillygrantoffice.com.
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15th Annual International Lung Cancer Congress®

15th Annual International Lung Cancer Congress®


Resources

15th Annual International Lung Cancer Congress®: Meeting-in-a-Box
The Meeting-in-a-Box components are designed for you to share the information with colleagues, fellows, and other health care professionals.

PER Pulse™ Recap
Three PER Pulse™ Recaps presenting key topics from the 15th Annual International Lung Cancer Congress®, which was held on July 31 - August 2, 2014.



PER Meeting in a Box


Presentation Title Faculty Discussion Questions
Keynote: New USPSTF Recommendations on Screening for Lung Cancer James L. Mulshine, MD Which patients should undergo screening for lung cancer? What are the recommendations of the USPSTF and NCCN? In terms of healthcare system economics, what is the value of lung cancer screening?
Role of Pulmonologists in Optimizing Diagnosis, Staging, and Treatment Choice Ken Y. Yoneda, MD What are the contributions of a pulmonologist to a multidisciplinary thoracic oncology team?
Integrated Approach to Staging and Restaging Stephen G. Swisher, MD, FACS Besides its role in determining therapy, why is accurate staging important in lung cancer? What staging modalities are available and when should they be applied?
Current Status of Adjuvant Therapy for NSCLC Karen Kelly, MD Do EGFR TKIs have a role in the adjuvant setting? What are the current data on predictive biomarkers for adjuvant chemotherapy?
Debate: Optimal Approach for High-Risk Patients    
Harvey I. Pass, MD What are the risks of mortality with surgery in high-risk patients? What tools are available for risk assessment? How does extent of resection correlate with patient outcome?
Roy Decker, MD, PhD Are there differences in outcomes with SBRT versus surgery? What effect does SBRT have on pulmonary function and quality of life? How do patients with central tumors, larger tumors, or poor pulmonary function fare with SBRT?
Approach to Preoperative Window-of-Opportunity Studies of Novel Therapeutics Anne Tsao, MD What are the advantages and disadvantages of “window-of-opportunity” trials in lung cancer? What are appropriate endpoints for such trials?
Keynote: Potential for "Curing" Metastatic NSCLC Paul Bunn, Jr., MD Should we still carry out large phase III trials in unselected patients? What curative potential do molecular-targeted TKIs have? What are the current data with immune checkpoint inhibitors?
State of the Art for Multimodality Therapy in Stage III NSCLC Everett E. Vokes, MD Can we optimize systemic therapy in stage III NSCLC? What studies are being carried out to identify predictive factors?
Surgery in Stage III NSCLC Harvey I. Pass, MD Who are the ideal candidates for resection after induction chemotherapy? How do I determine if my patient with stage IIIA-N2 NSCLC is a good candidate for resection? What are current data with trimodality therapy in resectable stage IIIA NSCLC?
Optimizing Systemic Regimens and Integrating Targeted Agents Into Combined Modality Therapy Corey J. Langer, MD, FACP Do phase III data demonstrate a survival advantage with the addition of EGFR antibodies to chemoradiation therapy? Was the 74 Gy radiation dose superior to 60 Gy in the RTOG 0617 trial?
Update on the Treatment of Brain Metastases Laurie Gaspar, MD What is the role of prophylactic cranial irradiation in extensive-stage SCLC? When should I consider stereotactic radiosurgery or whole-brain radiation therapy? Which systemic agents play a role in the management of brain metastases?
Biology of the Immune System in Lung Cancer Roy S. Herbst, MD, PhD What are the roles of PD-1 and PD-L1 in the immune response, and which agents are targeting these molecules? What is the adverse-event profile of PD-(L)1 antibodies? What are potential biomarkers for efficacy of these agents? What trials investigating immune checkpoint inhibitors are currently being carried out?
Response Kinetics and Modified RECIST With Immune Therapies Vassiliki Papadimitrakopoulou, MD How do response kinetics with immune therapies differ from those of other agents, such as cytotoxic chemotherapy? Can apparent disease progression occur even when the patient benefits from these agents? How do immune-related response criteria differ from conventional criteria?
Managing AEs Associated With Immune Blockade Emily Duffield, APRN Which organs may exhibit toxicity following administration of immune checkpoint inhibitors? Are there specialists who should be consulted in the management of these adverse events?
Current Status of Antiangiogenic Therapy Roy S. Herbst, MD, PhD Based on the results of a randomized Japanese trial, what were the effects on efficacy and toxicity of adding bevacizumab to erlotinib in patients with EGFR-mutant NSCLC? In the phase III REVEL trial, what impact did adding ramucirumab to second-line docetaxel have on OS and adverse events? How did patients with different histologies fare?
Next-Generation EGFR Inhibitors Fred R. Hirsch, MD, PhD In a combined analysis of phase III trials comparing afatinib to first-line chemotherapy, did the OS benefit observed for afatinib apply to all EGFR mutation subgroups? What is the response rate and toxicity profile of T790M-targeting TKIs such as CO-1686 and AZD9291? In the phase III SQUIRE trial, what was the effect of adding necitumumab to chemotherapy in patients with squamous NSCLC?
Acquired Drug Resistance for Oncogene-Driven Cancers Karen Kelly, MD How do tumor heterogeneity and adaptive responses contribute to resistance, and how do they differ? What are the roles of sequential and combination regimens? What agents and approaches are available or under investigation for managing acquired resistance?
Maintenance Therapy: Current Status Heather A. Wakelee, MD Are newer targeted therapies being used with a maintenance approach?
Approaches to Mesothelioma Paul Baas, MD, PhD What is the status of mesothelioma diagnosis using measurement of exhaled volatile organic compounds? Which molecular targets are being explored in mesothelioma?
A Roadmap for Molecular Testing in 2014: Implications for Therapy Giorgio V. Scagliotti, MD, PhD Since molecular information can come from several sources, including next-generation sequencing, which markers should I use in the clinic today? How do tobacco-related molecular aberrations differ from those found in never-smokers?
Biomarkers for Personalized Lung Cancer Therapy Fred R. Hirsch, MD, PhD What role, if any, does KRAS mutation status have for selecting therapy in patients with NSCLC? What are the current issues with potential assays to predict benefit from immune checkpoint inhibitors?
Incorporating Next-Generation Sequencing Into Clinical Application Philip C. Mack, PhD What are the potential advantages and challenges with single-cell genomics?
Master Protocol Designs for Implementing Personalized Medicine Vassiliki Papadimitrakopoulou, MD In the S1400 Lung Master Protocol, which molecular targets will be studied, and what is the rationale for each? What proportion of patients with squamous NSCLC are expected to have a qualifying molecular marker?
Optimizing Care for Special Populations in Lung Cancer Paul Baas, MD, PhD Should age be used as a criterion for selection of treatment? What are the issues in determining whether or not my patient has a poor performance status (eg, PS2)? What is the role of factors, such as polypharmacy, in assessing a patient’s functional reserve?



PER Pulse™ Recap PER Pulse™ Recap
Medical Writer: David Lee, PhD


1 of 3
PER Pulse™ Recap
15th Annual International Lung Cancer Congress®
Treatment of Advanced NSCLC: State of the Art

The 15th Annual International Lung Cancer Congress®, which was held July 31-August 2, 2014, was convened to provide current, practical information on the management of lung cancer, as well as look at the novel agents and strategies that will shape the future of lung cancer care. This first of 3 PER Pulse™ Recaps from the International Lung Cancer Congress® focuses on the state-of-the-art treatment for advanced lung cancer.

Dr. Roy Herbst discussed new data with antiangiogenic agents in patients with advanced non-small-cell lung cancer (NSCLC). The vascular endothelial growth factor (VEGF) antibody bevacizumab, first approved in 2006 for patients with nonsquamous NSCLC, was recently investigated in patients with activating mutations in the epidermal growth factor receptor (EGFR) gene. In a phase II Japanese trial, patients with EGFR-mutant NSCLC received erlotinib alone or with bevacizumab. Patients receiving the combination achieved a median progression-free survival (PFS) of 16.0 months compared with 9.7 months with erlotinib alone (P = .0015). Grade ≥3 hypertension was also higher with the combination (60% vs 10%). A phase III trial studied the VEGF receptor-2 (VEGFR-2) antibody ramucirumab in combination with second-line docetaxel in patients with all NSCLC histologies. There was a statistically significant improvement in the primary endpoint of overall survival (OS) with ramucirumab plus docetaxel compared with docetaxel plus placebo (10.5 months vs 9.1 months; P = .0235). Dr. Herbst closed his discussion with a reminder that a truly predictive biomarker still needs to be identified to advance antiangiogenic therapy in cancer.

Dr. Fred Hirsch provided a summary of recent clinical data with next-generation EGFR inhibitors. Data from two phase III trials of the irreversible inhibitor afatinib were combined, showing an OS benefit with afatinib versus standard first-line chemotherapy (27.3 months vs 24.3 months; P = .0374). Among patients with the most common EGFR mutations, the OS benefit appeared to be restricted to patients with exon 19 deletions.

Resistance to first- and second-generation EGFR TKIs is most commonly associated with the T790M resistance mutation, and Dr. Hirsch next discussed third-generation EGFR TKIs designed for activity in the context of EGFR-T790M. These include CO-1686 and AZD9291, both of which have received Breakthrough Therapy designation. Responses were observed in 58% of patients treated with CO-1686, with an estimated median PFS >12 months; therapy with AZD9291 at the 80-mg dosage level yielded responses in 68% of patients.

Dr. Hirsch also related that necitumumab, a fully human antibody to EGFR, has been investigated with first-line cisplatin/gemcitabine in a phase III trial enrolling patients with advanced, squamous NSCLC. The combination of necitumumab and chemotherapy met the primary endpoint of OS compared with chemotherapy alone (11.5 months vs 9.9 months; P = .012).

Dr. Ignatius Ou presented data on next-generation inhibitors of the anaplastic lymphoma kinase (ALK). Approval for ceritinib was granted in 2014 for patients with intolerance to or disease progression while being treated with crizotinib. This approval was based on data from a phase I trial showing an overall response rate (ORR) of 55% in patients with ALK inhibitor-pretreated patients. Dr. Ou also mentioned that activity against central nervous system (CNS) metastases has been observed, with an intracranial response rate of 50% (7 of 14 patients) observed in ceritinib. Another ALK TKI, alectinib, has reported an ORR of 52% (11 of 21 patients) in patients with CNS metastases at baseline in a phase I/II study. Finally, AP26113, an inhibitor of EGFR and ALK, showed regression of brain metastases in 9 of 13 patients (69%) in a phase I/II trial.

For additional commentary about these topics and others, visit www.gotoper.com to access archived video of the 15th Annual International Lung Cancer Congress®, as well as downloadable slides summarizing results from the meeting.


2 of 3
PER Pulse™ Recap
15th Annual International Lung Cancer Congress®
Harnessing the Immune System in Lung Cancer

The 15th Annual International Lung Cancer Congress®, which was held July 31-August 2, 2014, was convened to provide current, practical information on the management of lung cancer, as well as look at the novel agents and strategies that will shape the future of lung cancer care. This second of 3 PER Pulse™ Recaps from the International Lung Cancer Congress® focuses on the biology and clinical data, kinetics of response, and management of adverse events with immune checkpoint inhibitors in lung cancer, presented by Drs. Roy Herbst and Vassiliki Papadimitrakopoulou, and Emily Duffield, APRN.

As the honoree for the 2014 Addario Foundation Keynote Lecture, Dr. Herbst focused on the biology of and clinical data with immune checkpoint inhibitors. The genetic mutations accumulated by tumor cells can cause differences in the resulting proteins that mark the cells as “nonself” to the immune system. Expression by the tumor of molecules such as PD-L1, however, can inhibit the immune system and lead to tolerance of the cancer. Several antibodies have been developed with specificity to PD-L1 and its receptor PD-1, the latter of which is expressed on immune cells. Early-phase clinical trials of these antibodies have focused on patients with pretreated non-small-cell lung cancer (NSCLC). Activity has been observed across multiple subsets, including squamous NSCLC, and several phase III trials are in progress. Encouraging activity has been observed even in the absence of a predictive marker. Nevertheless, to maximize the value of immune checkpoint inhibitors, identification of a suitable biomarker for patient selection will be important to ensure that only potentially responding patients will receive these agents.

Dr. Papadimitrakopoulou discussed the distinct kinetics of response with immune checkpoint inhibitors. Many of the principles of response, stable disease, and tumor progression derived from the experience with chemotherapy may not adequately inform treatment decisions with immune therapies. Therefore, a new paradigm is being created to assess activity with immune checkpoint inhibitors, including the development of immune-related response criteria (irRC). While approaches to assessing response with this new class of agents will continue to be refined, certain differences have emerged, including the slower kinetics of response compared with chemotherapy. Additionally, prolonged disease stabilization may indicate anticancer activity. Finally, responses to immune checkpoint inhibitors may occur after apparent progressive disease, and the appearance of new small lesions alone may not be an indication to discontinue therapy.

Ms. Duffield presented an overview of immune-related adverse events (irAEs) with immune checkpoint inhibitors and recommendations for the management of irAEs. Severe AEs are rare, but several organs can be affected, resulting in colitis, nephritis, pneumonitis, dermatitis, and other inflammatory reactions. The average time to onset of irAEs is approximately 6-12 weeks after starting treatment. It is important to consult colleagues of the appropriate specialty; for example, a nephrologist should be consulted in a timely manner in the case of renal toxicity as part of a multidisciplinary approach to managing irAEs.

For additional commentary about these topics and others, visit www.gotoper.com to access archived video of the 15th Annual International Lung Cancer Congress®, as well as downloadable slides summarizing results from the meeting.


3 of 3
PER Pulse™ Recap
15th Annual International Lung Cancer Congress®
Emerging Agents and Approaches for Lung Cancer Therapy

The 15th Annual International Lung Cancer Congress®, which was held July 31-August 2, 2014, was convened to provide current, practical information on the management of lung cancer, as well as look at the novel agents and strategies that will shape the future of lung cancer care. This third of 3 PER Pulse™ Recaps from the International Lung Cancer Congress® focuses on upcoming agents and clinical studies to develop new therapies.

Dr. Paul Bunn presented an overview of fibroblast growth factor receptor 1 (FGFR1) inhibitors in lung cancer. Amplification of the FGFR1 gene has been reported in approximately 20% of cases of squamous non-small-cell lung cancer (NSCLC), and preclinical experiments showed that FGFR1-amplified cells were particularly sensitive to FGFR inhibitors. Several early-phase trials, as well as the phase II/III Lung Master Protocol, mentioned below, are investigating FGFR pathway inhibitors. The FGFR tyrosine kinase inhibitor (TKI) AZD4547 is being studied in a phase I/II trial with docetaxel, in comparison with docetaxel alone, as second-line therapy for patients with FGFR1-amplified, squamous NSCLC. Another FGFR TKI, lucitanib, is being investigated as a single agent in patients with pretreated squamous NSCLC. While most FGFR pathway inhibitors directly act on FGFR itself, GSK3052230 is a decoy receptor for the FGF ligands; this agent is being investigated with chemotherapy in FGFR1-amplified, first- and second-line NSCLC, and also in first-line mesothelioma.

Dr. Ignatius Ou discussed the state of therapy for patients with ROS1-rearranged NSCLC. The similarity between the kinase domain of ROS1 and ALK means that several TKIs that inhibit ALK are also active in patients with NSCLC and ROS1 rearrangements. A study investigating crizotinib in patients with ROS1-rearranged NSCLC demonstrated responses in 72% of patients. Two phase II trials, one in Europe and one in Asia, are further investigating crizotinib in patients with ROS1-rearranged NSCLC. Other agents under investigation for patients with NSCLC and ROS1 rearrangements include ceritinib and AP26113. Unfortunately, the similarities to ALK include the development of resistance mutations; in the case of ROS1, the G2032R mutation leads to acquired resistance of current ROS1 inhibitors. Dr. Ou pointed out that in addition to lung cancer, ROS1 rearrangements are found in several other solid tumors, including colorectal and gastric cancers, as well as glioblastoma.

Dr. Vali Papadimitrakopoulou described the S1400 Lung Master Protocol, a phase II/III biomarker-driven study to develop second-line therapies for patients with squamous NSCLC. This public-private partnership will carry out genomic screening in patients with stage IV, squamous NSCLC and a performance status of 0-2. Patient tumor biopsies will undergo genomic screening, at which time they will be assigned a treatment arm based on the screening results. Current arms are defined by aberrations involving PI3K, CDK4/6, FGFR, and HGF/MET signaling pathways. Within each arm, patients will be randomized to receive a matched targeted therapy or standard of care. Patients whose tumors do not have a molecular aberration fitting into one of the above categories will be able to enter the arm investigating an immune checkpoint inhibitor.

For additional commentary about these topics and others, visit www.gotoper.com to access archived video of the 15th Annual International Lung Cancer Congress®, as well as downloadable slides summarizing results from the meeting.



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


This activity is not approved for AMA PRA Category 1 Credit™.

Supported by educational grants from Boehringer Ingelheim Pharmaceuticals, Inc., Celgene Corporation, Clovis Oncology, Genentech, Lilly, Merck & Co., Inc., and Novartis Pharmaceuticals Corporation.

For further information concerning Lilly grant funding visit www.lillygrantoffice.com.







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