Join us on Tuesday, July 27^th for this CME/MOC-accredited webinar
5:00 PM – 6:00 PM ET

Not an official event of the 2021 ASCO Annual Meeting. Not sponsored, endorsed, or accredited by ASCO^®, CancerLinQ^®, or Conquer Cancer^® the ASCO Foundation.

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc and Turning Point Therapeutics Inc.

Key Data Guiding the Management of Localized and Metastatic Non-Small Cell Lung Cancer (NSCLC) with EGFR Mutation

• Expanding role of biomarker testing in newly diagnosed and progressive NSCLC; effects, if any, of patient characteristics (eg, age, race, smoking status) on treatment decision-making and real-world outcomes
• Mechanisms of action of and resistance to first-, second- and third-generation EGFR tyrosine kinase inhibitors (TKIs) in patients with NSCLC; biomarkers of resistance and response
• Design, eligibility criteria and primary and secondary endpoints of the Phase III ADAURA trial of adjuvant osimertinib after complete tumor resection for early-stage NSCLC with EGFR mutation
• Available efficacy and safety results from ADAURA; implications for biomarker testing and clinical care
• Overall and progression-free survival benefit observed with first-line osimertinib after long-term follow-up in the Phase III FLAURA study; CNS activity of osimertinib
• Optimal treatment for patients who have experienced disease progression on first-line osimertinib; research evaluating ways to overcome resistance to osimertinib (eg, the ORCHARD trial)
• Clinical factors in the choice of first-line EGFR TKI therapy (eg, erlotinib monotherapy, erlotinib/ramucirumab, osimertinib) for patients with NSCLC harboring EGFR mutations
• Spectrum, frequency and severity of side effects associated with EGFR inhibitors; optimal prevention and management strategies
• Ongoing Phase III trials of osimertinib alone or in combination with chemotherapy or targeted therapies for patients with NSCLC with EGFR mutations (eg, FLAURA2, LAURA, NeoADAURA, COMPEL, EA5182)
• Available data and development plans with novel agents and strategies targeting EGFR exon 20 mutations (eg, mobocertinib, amivantamab, high-dose osimertinib); FDA priority review for new drug application for mobocertinib and breakthrough therapy designation for amivantamab
• Mechanism of action of lazertinib; design, eligibility criteria and key endpoints of the ongoing Phase III MARIPOSA trial comparing the combination of amivantamab and lazertinib to osimertinib or lazertinib monotherapy as first-line therapy for patients with locally advanced or metastatic NSCLC with EGFR mutations
• Ongoing and planned clinical trials evaluating novel strategies (eg, atezolizumab with chemotherapy and bevacizumab) for patients with advanced NSCLC harboring EGFR mutations or other targetable alterations who experience disease progression after receiving targeted therapies

Research Advances Shaping the Current and Future Treatment of NSCLC with ALK and ROS1 Rearrangements

• Current roles of ctDNA (circulating tumor DNA) sequencing, next-generation sequencing, FISH (fluorescence in situ hybridization) and immunohistochemistry testing platforms in the detection of actionable driver mutations and prediction of response to treatment
• Design, entry criteria and key efficacy and safety findings from the Phase III CROWN trial leading to the recent FDA approval of lorlatinib as first-line therapy for patients with advanced NSCLC with ALK rearrangements; integration into clinical management
• Similarities and differences in efficacy and safety outcomes among first-line alectinib, brigatinib, ceritinib and lorlatinib for patients with metastatic NSCLC with ALK rearrangements; optimal up-front regimen
• Assessment, frequency and spectrum of documented resistance mutations in patients with disease progression on a first-line ALK inhibitor; role of repeat testing and implications for subsequent therapeutic decision-making
• Pooled efficacy and safety findings supporting the FDA approval of entrectinib for metastatic NSCLC with a ROS1 rearrangement; intracranial response rates for patients with CNS involvement
• Optimal approach to the management of adverse events (eg, cardiac, CNS and ocular) associated with entrectinib
• Current approach to the sequencing of available agents and regimens for patients with NSCLC with ALK or ROS1 rearrangements
• Mechanism of action of repotrectinib and preliminary results for the cohort of patients with advanced NSCLC in the ongoing Phase I/II TRIDENT-1 trial evaluating repotrectinib for patients with advanced solid tumors harboring ALK, ROS1 or NTRK rearrangements; potential clinical role
• Comparison of the mechanisms of action of repotrectinib and other approved or promising investigational TKIs targeting ALK and/or ROS1 in the management of NSCLC
• Rationale for the ongoing Phase I/II trial of ceritinib in combination with trametinib for patients with advanced ALK-positive NSCLC
• Ongoing and planned clinical trials investigating novel strategies for patients with advanced NSCLC harboring ALK rearrangements or ROS1 fusions after the failure of a first-line TKI (eg, ALBATROS)

Optimal Therapeutic Approaches for Patients with Genomic Aberrations Beyond EGFR, ALK and ROS1

• Design, eligibility criteria and key findings from the Phase II VISION trial leading to the recent FDA approval of tepotinib for patients with metastatic NSCLC harboring MET exon 14 skipping alterations
• Rationale for the design of the ongoing Phase II NAUTIKA1 neoadjuvant and adjuvant study of alectinib, entrectinib, vemurafenib/cobimetinib or pralsetinib for patients with resectable Stage II or Stage III NSCLC harboring ALK, ROS1, NTRK, BRAF V600 or RET molecular alterations
• Key efficacy and safety outcomes from the Phase II GEOMETRY mono-1 trial supporting the FDA approval of capmatinib for patients with metastatic NSCLC with MET exon 14 mutations
• Practical integration and optimal sequencing of capmatinib and tepotinib in the clinical care of patients with advanced NSCLC harboring MET exon 14 skipping alterations
• Available safety and efficacy results from the LIBRETTO-001 and ARROW trials leading to the FDA approvals of selpercatinib and pralsetinib for patients with RET fusion-driven NSCLC; optimal integration of these agents into clinical practice
• Design, eligibility and key endpoints of the Phase III LIBRETTO-431 and AcceleRET Lung studies comparing selpercatinib and pralsetinib, respectively, to first-line chemotherapy with or without pembrolizumab for treatment-naïve advanced NSCLC with RET fusion
• Frequency and clinical impact of HER2 overexpression or mutations in NSCLC; key efficacy and safety findings from the Phase II DESTINY-Lung01 study evaluating trastuzumab deruxtecan for patients with NSCLC with HER2 overexpression or mutations
• FDA breakthrough therapy designation and potential nonresearch role of trastuzumab deruxtecan in therapy for HER2-positive metastatic NSCLC
• Clinical impact of HER3 upregulation as a mechanism of resistance to EGFR TKIs; early efficacy and safety findings with patritumab deruxtecan in a Phase I trial for patients with previously treated unresectable or metastatic NSCLC with EGFR mutations
• Ongoing Phase II HERTHENA-Lung01 trial of patritumab deruxtecan for patients with locally advanced or metastatic NSCLC with EGFR mutations who have received prior treatment with osimertinib and at least 1 platinum-based chemotherapy regimen
• Design, eligibility criteria and key endpoints of the ongoing Phase III GEOMETRY-E trial evaluating capmatinib/osimertinib versus chemotherapy as second-line therapy after disease progression on a first or second EGFR TKI or osimertinib for patients with locally advanced or metastatic NSCLC harboring non-T790M EGFR activating mutations and MET amplification
• Mechanism of action of sotorasib and available efficacy and safety data from the Phase II CodeBreaK 100 trial evaluating it for patients with previously treated NSCLC with KRAS G12C mutations; FDA priority review status of sotorasib for KRAS G12C-mutated advanced NSCLC
• Other ongoing and planned clinical trials investigating novel agents and strategies for patients with advanced NSCLC harboring targetable gene alterations (eg, ECOG-ACRIN Lung-MAP)

Target Audience
This program is intended for medical oncologists, hematology-oncology fellows and other allied healthcare professionals involved in the treatment of lung cancer.

Learning Objectives

• Review published research data documenting the safety and efficacy of EGFR tyrosine kinase inhibitors alone or in combination with other systemic approaches for metastatic non-small cell lung cancer (NSCLC) with an EGFR tumor mutation, and appropriately apply this information in patient care.
• Acknowledge available Phase III findings supporting the use of adjuvant osimertinib for patients with early-stage NSCLC with EGFR mutations, and consider the potential effects of this information on current and future clinical practice.
• Appreciate available clinical trial findings supporting the recent FDA approval of lorlatinib for patients with metastatic NSCLC with ALK rearrangements, and discern how this agent can be optimally employed in nonresearch clinical practice.
• Assess the efficacy and safety of other commercially available ALK inhibitors for patients with metastatic NSCLC with ALK rearrangements, and apply this understanding to the selection and sequencing of these drugs as first- and later-line therapy.
• Recognize the recent FDA approval of tepotinib for patients with metastatic NSCLC harboring MET exon 14 skipping alterations, and appropriately incorporate this novel agent into treatment algorithms.
• Recall other oncogenic pathways (ie, ROS1, RET, HER2, HER3, KRAS) mediating the pathogenesis of tumors in unique patient subgroups, and employ available and recently FDA-approved agents in the care of those individuals.

CME Credit Form
CME and ABIM MOC credit form links will be emailed to each participant within 5 days of the activity.

Accreditation Statement
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit Designation Statement
Research To Practice designates this live activity for a maximum of 1 AMA PRA Category 1 Credit^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Board of Internal Medicine (ABIM) — Maintenance of Certification (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information. For those clinicians wishing to receive ABIM MOC credit for attending, you will receive an email after the event with instructions.

Disclosure Policy
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant conflicts of interest, which have been mitigated through a conflict of interest mitigation process:

Prof Peters — Advisory Committee and Consulting Agreements (All fees to institution): AbbVie Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Biocartis, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Clovis Oncology, Daiichi Sankyo Inc, Debiopharm Group, Elsevier, Foundation Medicine, Genentech, a member of the Roche Group, Illumina, Incyte Corporation, IQVIA, Janssen Biotech Inc, Lilly, Merck Serono, Merck Sharp & Dohme Corp, Merrimack Pharmaceuticals Inc, Novartis, Pfizer Inc, PharmaMar, Phosplatin Therapeutics, Regeneron Pharmaceuticals Inc, Sanofi Genzyme, Seagen Inc, Takeda Oncology; Data and Safety Monitoring Board/Committee: Lilly; Speaking Engagements (All fees to institution): AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Genentech, a member of the Roche Group, Lilly, Merck Sharp & Dohme Corp, Pfizer Inc, Sanofi Genzyme, Takeda Oncology. Dr Piotrowska — Advisory Committee: AstraZeneca Pharmaceuticals LP, Blueprint Medicines, C4 Therapeutics, Genentech, a member of the Roche Group, Incyte Corporation, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Lilly, Medtronic Inc, Takeda Oncology; Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Cullinan Oncology, Daiichi Sankyo Inc, Janssen Biotech Inc, Novartis, Spectrum Pharmaceuticals Inc, Takeda Oncology, Tesaro, A GSK Company. Dr Riely — Advisory Committee (Uncompensated): Daiichi Sankyo Inc,Mirati Therapeutics, Pfizer Inc; Contracted Research: Merck, Mirati Therapeutics, Novartis, Pfizer Inc, Roche Laboratories Inc, Takeda Oncology.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: AbbVie Inc, Adaptive Biotechnologies Corporation, ADC Therapeutics, Agios Pharmaceuticals Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Coherus BioSciences, Daiichi Sankyo Inc, Eisai Inc, Epizyme Inc, Exact Sciences Inc, Exelixis Inc, Five Prime Therapeutics Inc, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, GlaxoSmithKline, Grail Inc, Halozyme Inc, Helsinn Healthcare SA, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Novartis, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sanofi Genzyme, Seagen Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, TG Therapeutics Inc, Turning Point Therapeutics Inc and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS
Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc and Turning Point Therapeutics Inc.