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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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8th Annual New York Lung Cancer Symposium®

8th Annual New York Lung Cancer Symposium®


Resources

8th Annual New York Lung Cancer Symposium®: 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 8th Annual New York Lung Cancer Symposium®, which was held on November 9, 2013. 




PER Meeting in a Box

Presentation Title Faculty Discussion Questions

Overcoming Resistance to EGFR TKIs

Balazs Halmos, MD

What are the different mechanisms by which acquired resistance to EGFR TKIs develops? Which have been observed most often? Do different resistance mechanisms arise at different disease sites? What is your approach to assessing and managing resistance? What agents are being developed for patients with NSCLC that becomes resistant to EGFR TKIs?

ALK Inhibitors: State of the Art

Alice T. Shaw, MD, PhD

What are the mechanisms of resistance to ALK TKIs? What are the similarities and differences compared with resistance to EGFR TKIs? What is the frequency of relapses in the CNS during treatment with crizotinib? What properties do the next-generation ALK TKIs have that differ from those of crizotinib? What are the data regarding activity of ALK TKIs against the related oncogene ROS1?

Molecular Targeted Agents for Stage III NSCLC

 

Bilal Piperdi, MD

Regarding stage III NSCLC, what are the current therapeutic approaches for this setting? When radiation therapy (RT) is used, what is the optimal dosage? How do surgery and RT fit into the treatment paradigm? Why have trials of targeted agents failed in this setting? What targeted agents and approaches are currently under investigation for stage III NSCLC?

New Horizons for Small-Cell Lung Cancers

Charles M. Rudin, MD, PhD

What mutations and oncogenic drivers have been identified in SCLC? What is the potential for targeting these molecules, and are there clinical trials investigating new molecular approaches?

New Treatments for Squamous Cell Lung Cancer

Roman Perez-Soler, MD

Are there any cytotoxic or targeted agents that have demonstrated efficacy in squamous cell NSCLC? What are the most promising targeted agents being investigated in this setting?

Current Approaches to Supportive Care

Richard J. Gralla, MD

What is the current attitude of patients towards supportive care and adverse events? What supportive care approaches are recommended by guidelines (eg, MASCC)? Regarding control of emesis, how many different classes of antiemetic agents should be used? Do antiemetic agents need to be administered with each cycle?

Adjuvant Therapy

Mark G. Kris, MD

Who should receive adjuvant chemotherapy? Which chemotherapy regimens would you recommend? Is EGFR a relevant target in the adjuvant setting? What data exist regarding neoadjuvant therapy in lung cancer? Which investigational agents have the most potential in early-stage NSCLC?

Debate: Is Bevacizumab-Based Therapy the SOC in Frontline Stage IV Nonsquamous NSCLC?

 

 

Bryan J. Schneider, MD

What are the data regarding efficacy and safety of bevacizumab in NSCLC? Are there regimens with a potentially superior efficacy/toxicity ratio compared with bevacizumab/chemotherapy?

Benjamin P. Levy, MD

What are the costs of adding bevacizumab to chemotherapy compared with other targeted approaches? Do we have biomarkers to select which patients would most benefit from bevacizumab?

How I Approach Maintenance Therapy

Mark G. Kris, MD

What approaches do you take to determine whether or not to continue a maintenance therapy regimen? Do you prefer to use a switch or continuation approach to maintenance therapy? Should TKIs be approached any differently than chemotherapy in the maintenance setting?

Debate: Is There an Optimal TKI in EGFR-Mutant Lung Cancers?

 

 

Gregory J. Riely, MD, PhD

Do any currently approved EGFR TKIs stand out due to a favorable adverse-event profile? Are any of these TKIs able to demonstrate activity against resistance mechanisms such as the T790M mutation? How do next-generation EGFR TKIs differ from the approved agents and from each other in terms of efficacy and adverse-event profile?

Natasha B. Leighl, MD, MMSc, FRCPC

What is the difference in cost between the approved EGFR TKIs?

PD-(L)1 Inhibition: What Does the Future Hold?

Naiyer A. Rizvi, MD

What molecules are involved in activation or inhibition of the immune system against tumor cells? Why do lung cancers evade the immune system? Are there any biomarkers to select patients for treatment with anti-PD-(L)1 antibodies? How long should these agents be administered? What are the kinetics of response with antibodies to PD-(L)1 versus chemotherapy or anti-CTLA-4 antibodies such as ipilimumab? Are there any differences in the safety profiles between antibodies to PD-(L)1 versus CTLA-4?





PER Pulse™ Recap

PER Pulse™ Recap
Medical Writer: David Lee, PhD



1 of 3
PER Pulse™ Recap
8th Annual New York Lung Cancer Symposium®
State of the Art: EGFR and ALK Inhibitors in Molecularly Selected Patients

The live CME activity, 8th Annual New York Lung Cancer Symposium®, featured key lung cancer experts from the New York City area addressing best practices for the management of patients with lung cancer, as well as emerging therapeutic paradigms. This program featured expert updates on molecular targeted agents, best practices in adjuvant and metastatic disease, and investigational approaches for patients with squamous non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). This first of 3 PER Pulse™ Recaps focused on the 8th Annual New York Lung Cancer Symposium®, examines the current and future approaches for patients with EGFR-mutated and ALK-positive NSCLC, discussed by Drs. Gregory Riely, Natasha Leighl, Balazs Halmos, and Alice Shaw.

Regarding patients with EGFR-mutant NSCLC, gefitinib, erlotinib, and afatinib all have regulatory approval in this patient population, although gefitinib is not available in the United States. All three EGFR tyrosine kinase inhibitors (TKIs) have demonstrated superior response and progression-free survival (PFS) compared with standard chemotherapy. However, none of these TKIs can overcome resistance mechanisms that arise in patients receiving them.

There are several mechanisms of resistance to EGFR TKIs. These include the T790M mutation, activation of alternative signaling pathways, and pharmacokinetic insufficiency. The T790M resistance mutation, which inhibits binding of the TKI to the EGFR kinase domain, is the most common mechanism of resistance, occurring in approximately 50% of resistant cases. For this mutation, third-generation EGFR TKIs, such as CO-1686 and AZD9291, are being developed. In other cases, alternate signaling pathways, such as MET, AXL, and HER2, are activated, and combinations with inhibitors of these pathways are being explored.

Practical issues were also addressed, including patients with isolated sites of resistance. For these patients, local therapy such as radiation may be considered while continuing the EGFR TKI. In these patients, EGFR TKI therapy may still be beneficial in the majority of disease sites, and it was recommended not to have patients off therapy for an extended period of time due to the potential for disease flare upon discontinuation of the TKI.

For patients with ALK-rearranged NSCLC, the ALK TKI crizotinib is currently the only approved therapy. Similar to EGFR TKIs, crizotinib demonstrated superiority to standard chemotherapy; unfortunately, resistance to crizotinib also occurs.

Resistance mechanisms to ALK TKIs include mutations such as L1196M, which is similar to the T790M resistance mutation seen in EGFR. In contrast to EGFR, however, there is a wider variety of ALK resistance mutations that have been observed. Bypass signaling mechanisms, such as upregulation of EGFR signaling, have also been implicated in resistance to crizotinib. Finally, the central nervous system (CNS) is a common site of recurrence due to insufficient delivery past the blood–brain barrier.

Second-generation ALK inhibitors, such as LDK378, alectinib, and AP26113, are being investigated. All of these agents have demonstrated activity in patients with crizotinib-pretreated NSCLC, as well as those with CNS lesions.

For additional commentary about these topics and others, visit www.gotoper.com to access archived video of the 8th Annual New York Lung Cancer Symposium®


2 of 3
PER Pulse™ Recap
8th Annual New York Lung Cancer Symposium®
Emerging Targeted Approaches for Squamous Cell NSCLC and SCLC

The live CME activity, 8th Annual New York Lung Cancer Symposium®, featured key lung cancer experts from the New York City area addressing best practices for the management of patients with lung cancer, as well as emerging therapeutic paradigms. This program featured expert updates on molecular targeted agents, best practices in adjuvant and metastatic disease, and investigational approaches for patients with squamous non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). This second of 3 PER Pulse™ Recaps focuses on emerging therapeutic opportunities for patients with squamous cell NSCLC and SCLC, as presented by Drs. Roman Perez-Soler and Charles Rudin.

Dr. Perez-Soler highlighted future directions for patients with squamous cell NSCLC. He began by explaining that this group of patients has been excluded from the recent advances in NSCLC, such as bevacizumab, pemetrexed, and epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), which were generally restricted to nonsquamous NSCLC or molecularly selected patients. Current therapeutic options for squamous cell NSCLC include taxane- and gemcitabine-based platinum doublets. Cetuximab with cisplatin/vinorelbine is a category 2B NCCN recommendation based on the phase III FLEX trial. Nab-paclitaxel in combination with carboplatin is approved for NSCLC and has demonstrated a higher overall response rate (ORR) compared with standard paclitaxel in squamous cell NSCLC as part of a first-line doublet (41% vs 24%; P < 0.001), although no overall survival (OS) difference was observed.
 
Regarding new developments, Dr. Perez-Soler mentioned that the phase III SQUIRE trial, conducted exclusively in squamous cell NSCLC, met the primary endpoint of OS with the addition of the EGFR antibody necitumumab to cisplatin/gemcitabine; data are anticipated in mid-2014. He also mentioned that early-phase trials have been reported with immune checkpoint inhibitors, which reverse the immunosuppressive activities of molecules called PD-1 and PD-L1. The anti-PD-1 antibodies nivolumab and MK-3475, and the anti-PD-L1 antibody MPDL3280A have shown single-agent ORRs of up to 33% in patients with heavily pretreated, squamous cell NSCLC. All three antibodies are being compared to docetaxel in both squamous cell and nonsquamous NSCLC in ongoing phase III trials.

The MET signaling pathway is implicated in tumor proliferation and metastasis; Dr. Perez-Soler related that onartuzumab, a monovalent antibody against MET, is being investigated with platinum-doublet therapy in a phase II trial in squamous cell NSCLC. Finally, squamous cell NSCLC is a highly mutated cancer, with an average of 360 mutations per tumor. Dr. Perez-Soler mentioned that fibroblast growth factor receptor 1 (FGFR1) and discoidin domain receptor 2 (DDR2) are potential targets, and inhibitors of these molecules are under investigation in clinical trials.

Dr. Rudin discussed new directions for SCLC, a disease for which the standard of care has not changed in over 30 years, despite numerous efforts. He explained that recent analyses of molecular aberrations in SCLC have revealed potential therapeutic targets, including (sex determining region Y)-box 2 (SOX2), bromo and extra terminal (BET) domains, and poly ADP ribose polymerase 1 (PARP1). Inhibitors of SOX2 have demonstrated preclinical activity; Dr. Rudin pointed out that SOX2 itself may be difficult to target, but molecules downstream of SOX2 may prove to be therapeutic targets. The BET domains are found in proteins that can affect chromatin structure, and the BET inhibitor JQ1 has been found to downregulate the oncogene MYC. GSK525762, a derivative of JQ1, is being investigated in a phase I/II trial that includes multiple tumor types, including SCLC. Finally, Dr. Rudin described how proteomic analysis has shown that PARP1 is highly upregulated in SCLC; a randomized phase II trial is therefore investigating temozolomide with or without the PARP inhibitor veliparib in recurrent SCLC.

For additional commentary about these topics and others, visit www.gotoper.com to access archived video of the 8th Annual New York Lung Cancer Symposium®


3 of 3
PER Pulse™ Recap
8th Annual New York Lung Cancer Symposium®
Incorporating Targeted Agents into Early-Stage and Locally Advanced NSCLC

The live CME activity, 8th Annual New York Lung Cancer Symposium, featured key lung cancer experts from the New York City area addressing best practices for the management of patients with lung cancer, as well as emerging therapeutic paradigms. This program featured expert updates on molecular targeted agents, best practices in adjuvant and metastatic disease, and investigational approaches for patients with non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). This third of 3 PER Pulse™ Recaps focuses on new approaches for incorporating targeted agents into treatment regimens for stage I-III NSCLC, as presented by Drs. Mark Kris and Bilal Piperdi.
 
In terms of incorporating targeted agents into the treatment of resectable NSCLC, Dr. Kris began with studies using epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in patients with resected, EGFR-mutant NSCLC. The SELECT trial, reported in 2012, showed a 2-year disease-free survival (DFS) rate of 94% with adjuvant erlotinib in 36 patients with resected, stage IA-IIIA NSCLC. Another study, carried out at the Memorial Sloan-Kettering Cancer Center, showed that DFS was superior with an adjuvant EGFR TKI versus no treatment (HR = 0.43; P = .001) in a cohort of 286 patients; a trend towards improved overall survival (OS) was observed (HR = 0.50; P = .076). Moreover, patients who developed recurrence were still sensitive to retreatment with an EGFR TKI. The proposed EURECA trial will randomize 286 patients with resected, EGFR-mutant, stage I-III NSCLC in a 2:1 ratio to 2 years of adjuvant erlotinib or observation.
 
Dr. Kris mentioned other ongoing or proposed trials of TKIs in molecularly selected patients. A phase II trial at Massachusetts General Hospital is examining 3 months or 2 years of adjuvant afatinib in patients with resected, stage I-III NSCLC and EGFR mutations. The National Cancer Institute has proposed the ALCHEMIST protocol, which will screen 6000-8000 patients with resected NSCLC. Patients with EGFR mutations will enter the Alliance A081105 trial, randomizing patients to 2 years of erlotinib or placebo; the ECOG 4517 trial will similarly randomize anaplastic lymphoma kinase (ALK)-positive patients to crizotinib or placebo.
 
Two other large trials of adjuvant therapy with targeted agents are ongoing, but do not employ molecular selection. The phase III RADIANT trial is examining erlotinib in patients with resected NSCLC. Patients are required to have EGFR protein expression, but the presence of EGFR mutations is not an entry criterion. The phase III ECOG 1505 trial is investigating the addition of bevacizumab to adjuvant chemotherapy, although no biomarker has yet been validated for bevacizumab. This trial has closed to accrual and results are expected in 2016.

Dr. Piperdi discussed targeted agents in unresectable stage III NSCLC. He initially mentioned two recently reported phase III trials that did not meet their primary endpoint. The RTOG 0617 trial investigated the addition of cetuximab to chemoradiation therapy (CRT), based on the encouraging results from the single-arm RTOG 0324 trial. No OS benefit was observed in the cetuximab-containing arm, however. The START trial randomized patients to either the MUC1-based vaccine tecemotide or placebo following CRT. Although this trial did not meet the primary endpoint of OS in the overall population, the subset of patients receiving concurrent CRT (as opposed to sequential administration) demonstrated a 10-month improvement in OS with tecemotide compared with placebo. Based on these results, a new phase III trial, START-2, will re-examine tecemotide exclusively in patients receiving concurrent CRT.
 
As with the metastatic and early-stage settings, Dr. Piperdi mentioned that targeted agents are also being investigated in molecularly selected patients with locally advanced NSCLC. The phase II RTOG 1306 trial will examine the addition of EGFR or ALK TKIs to concurrent CRT in patients with unresectable stage III NSCLC and EGFR mutations or EML4-ALK rearrangements, respectively. The phase II EVENT trial is enrolling patients with resectable or unresectable stage III NSCLC and EGFR mutations. Following 2 months of erlotinib therapy, patients will be restaged; the primary endpoints of this trial are pathologic complete response and the rate of mediastinal nodal downstaging to N0 status as measured pathologically.

For additional commentary about these topics and others, visit www.gotoper.com to access archived video of the 8th Annual New York Lung Cancer Symposium®



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 Celgene Corporation, Genentech, Lilly USA, LLC, and Novartis Pharmaceuticals Corporation.
 







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