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Poll

When do you test for HER2 alterations in your patients with advanced NSCLC?

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Before initiating 1st line treatment
   
After progression on 1st line treatment
   
Only when no other treatment option is available
   
Other/Do not currently test
   

Tutorial

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Poll

How confident are you in the management of trastuzumab deruxtecan side effects?

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Not confident
   
A little confident
   
Moderately confident
   
Extremely confident
   

Tutorial

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Poll

What HER2 alterations are you currently testing for in your clinical practice?

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Amplification, overexpression and mutation
   
Mutation and overexpression
   
A different combination
   
None
   
 
Activating HER2 alterations in NSCLC
Testing for HER2 alterations in NSCLC
Evaluating HER2-targeted treatments in NSCLC
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Lung Cancer CE/CME accredited

touchIN CONVERSATION
A relaxed discussion between two faculty focussed on real world clinical issues. Useful tips below will show how to navigate the activity. Join the conversation. Close

Decoding HER2 in NSCLC: Advances in biomarker testing and targeted therapies

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Learning Objectives

After watching this activity, participants should be better able to:

  • Describe the specific types of HER2 alterations and HER2 testing requirements in NSCLC
  • Discuss optimal approaches for testing HER2 alterations in NSCLC and implications for their implementation into routine clinical practice
  • Recall whether HER2 status determines treatment response and outcomes in patients with NSCLC receiving HER2-targeted therapies in NSCLC
Overview

In this activity, a medical oncologist and a pathologist specializing in lung cancer respond to questions from physicians managing patients with NSCLC on the different types of HER2 alterations in NSCLC and how these impact prognosis and treatment, approaches to testing patients for HER2 alterations, and the latest clinical trial data for approved and emerging HER2-targeted therapies.

This activity is jointly provided by USF Health and touchIME. read more

Target Audience

This activity has been designed to meet the educational needs of oncologists, pulmonologists and pathologists involved in the management of patients with NSCLC.

USF Accreditation

Disclosures

USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

Faculty

Prof. Enriqueta Felip discloses: Advisory board or panel fees from Abbvie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, F. Hoffmann-La Roche, Genmab, Gilead, GSK, Janssen, Johnson & Johnson, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Pfizer, Regeneron and Sanofi. Other financial or material support fromĀ AstraZeneca, Janssen and Roche. Speakerā€™s bureau fees from Amgen, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, F. Hoffmann-La Roche, Janssen, Merck Serono, Merck Sharp & Dohme, Pfizer, Regeneron, Sanofi, Seagen and Takeda.

Prof. Keith Kerr discloses: Advisory board or panel fees from AbbVie, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and Ventana (all relationships terminated). Speakerā€™s bureau fees from AstraZeneca, Amgen, Bristol Myers Squibb, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sanofi and Ventana (all relationships terminated).

Content reviewer

Danielle Walker, DNP, APRN, AGNP-C has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Contributors

Hannah Fisher has no financial interests/relationships or affiliations in relation to this activity.

USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

If you have questions regarding credit please contact cpdsupport@usf.edu

Accreditations

Physicians

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

USF Health designates this enduring material for a maximum of 0.75Ā AMA PRA Category 1 CreditTM.Ā  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Advanced Practice Providers

Physician Assistants may claim a maximum of 0.75Ā Category 1Ā credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

Date of original release: 25 July 2024. Date credits expire: 25 July 2025.

If you have any questions regarding credit, please contact cpdsupport@usf.edu

EBACĀ® Accreditation

touchIME is an EBACĀ® accredited provider since 2023.

This programme is accredited by the European Board for Accreditation of Continuing Education for Health Professionals (EBACĀ®) for 0.75 hour of effective education time.

The Accreditation Council for Continuing Medical Education (ACCMEĀ®), and the Royal College of Physicians and Surgeons of Canada hold an agreement on mutual recognition on substantive equivalency of accreditation systems with EBACĀ®.

Through an agreement between the European Board for Accreditation of Continuing Education for Health Professionals and the American Medical Association (AMA), physicians may convert EBACĀ® CE creditsĀ to AMA PRA Category 1 CreditTM. Information on the process to convert EBACĀ® credit to AMA credit can be found on the AMA website. Other health care professionals may obtain from the AMA a certificate of having participated in an activity eligible for conversion of credit toĀ AMA PRA Category 1 CreditTM.

Faculty Disclosure Statement / Conflict of Interest Policy

In compliance with EBACĀ® guidelines, all speakers/ chairpersons participating in this programme have disclosed or indicated potential conflicts of interest which might cause a bias in the presentations. The Organizing Committee/Course Director is responsible for ensuring that all potential conflicts of interest relevant to the event have been mitigated and declared to the audience prior to the CME activities.

Faculty

Prof. Enriqueta Felip discloses: Advisory board or panel fees from Abbvie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, F. Hoffmann-La Roche, Genmab, Gilead, GSK, Janssen, Johnson & Johnson, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Pfizer, Regeneron and Sanofi. Other financial or material support fromĀ AstraZeneca, Janssen and Roche. Speakerā€™s bureau fees from Amgen, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, F. Hoffmann-La Roche, Janssen, Merck Serono, Merck Sharp & Dohme, Pfizer, Regeneron, Sanofi, Seagen and Takeda.

Prof. Keith Kerr discloses: Advisory board or panel fees from AbbVie, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and Ventana (all relationships terminated). Speakerā€™s bureau fees from AstraZeneca, Amgen, Bristol Myers Squibb, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sanofi and Ventana (all relationships terminated).

Touch Medical Contributors

Hannah Fisher has no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

Certificates of Completion may be awarded upon successful completion of the post-test and evaluation form. If you have completed one hour or more of effective education through EBACĀ® accredited CE activities, please contact us at accreditation@touchime.org to receive your EBACĀ® CE credit certificate. EBACĀ® grants 1 CE credit for every hour of education completed.

Date of original release: 25 July 2024. Date credits expire: 25 July 2025.

Time to Complete: 45 minutes

If you have any questions regarding the EBACĀ® credits, please contact accreditation@touchime.orgĀ 

This activity is CE/CME accredited

To obtain the CE/CME credit(s) from this activity, please complete this post-activity test.

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Topics covered in this activity

Lung Cancer
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touchIN CONVERSATION
Decoding HER2 in NSCLC: Advances in biomarker testing and targeted therapies
0.75 CE/CME credit

Question 1/5
What is the prevalence of HER2 overexpression in NSCLC?

HER2, human epidermal growth factor receptor 2; NSCLC, non-small cell lung cancer.

HER2 overexpression has been reported to occur in 2ā€“30% of patients with NSCLC. Other HER2 alterations observed in these tumours include HER2 mutations (1ā€“4%) and HER2 amplification (2ā€“5%).

Abbreviations

HER2, human epidermal growth factor receptor 2; NSCLC, non-small cell lung cancer.

Reference

Loeffler E, et al. Life (Basel). 2023;14:64.

 

Question 2/5
When ordering a test to assess for HER2 mutations in your patient with NSCLC, which of the following methods would you consider using as the optimal approach for analysing a tissue sample?

FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; NGS, next-generation sequencing; NSCLC, non-small cell lung cancer; RT-PCR, reverse transcription polymerase chain reaction.

While there are multiple techniques for testing for HER2 mutations, including NGS, Sanger sequencing and RT-PCR, NGS is considered the optimal and recommended technique.1ā€“3 Additionally, NGS is recommended as the preferred technique by international guidelines including ESMO, ASCO and NCCN.3ā€“5 FISH is considered the main method for assessing HER2 amplification.1,2Ā 

Abbreviations

ASCO, American Society of Clinical Oncology; ESMO, European Society for Medical Oncology; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; NCCN, National Comprehensive Cancer Network; NGS, next-generation sequencing; NSCLC, non-small cell lung cancer; RT-PCR, reverse transcription polymerase chain reaction.

References

  1. Ren S, et al. ESMO Open. 2022;7:100482.
  2. Bontoux C, et al. J Pers Med. 2022;12:1652.
  3. NCCN. NSCLC. V6.2024. Available at: www.nccn.org (accessed 28 June 2024).
  4. Hendriks LE, et al. Ann Oncol. 2023;34:339ā€“57.
  5. Jaiyesimi IA, et al. J Clin Oncol. 2024;42:e1ā€“22.
Question 3/5
Your patient is newly diagnosed with stage IV metastatic NSCLC. You are aware of the need to test the patient for HER2 alterations to help inform treatment decisions. When would you perform these tests for this patient?

HER2, human epidermal growth factor receptor 2; ICI, immune checkpoint inhibitor; NSCLC, non-small cell lung cancer.

The ESMO guidelines for NSCLC recommend NGS panel testing, including HER2 mutations, prior to first-line therapy in patients with stage IV metastatic NSCLC.1 NCCN guidelines also recommend molecular testing, including HER2, in patients with advanced or metastatic disease at clinical presentation.2

Abbreviations

ESMO, European Society for Medical Oncology; HER2, human epidermal growth factor receptor 2; NCCN, National Comprehensive Cancer Network; NGS, next-generation sequencing; NSCLC, non-small cell lung cancer.

References

  1. Hendriks LE, et al. Ann Oncol. 2023;34:339ā€“57.Ā 
  2. NCCN. NSCLC. V6.2024. Available at: www.nccn.org (accessed 28 June 2024).
Question 4/5
What ORR has been reported from the SOHO-01 trial investigating the HER2-targeted TKI BAY 2927088 in patients with HER2 mutation-positive NSCLC after prior systemic therapy?

HER2, human epidermal growth factor receptor 2; NSCLC, non-small cell lung cancer; ORR, objective response rate; TKI, tyrosine kinase inhibitor.

The SOHO-01 trial is a phase I/II trial investigating the TKI BAY 2927088 in patients with advanced NSCLC harbouring a HER2-activating mutation and experiencing disease progression after ā‰„1 systemic therapy, but HER2-targeted therapy naive (n=34). At the 2024 ASCO Annual Meeting, an ORR of 70% (95% CI 51.3ā€“84.4) was reported (n=33).

Abbreviations

ASCO, American Society of Clinical Oncology; CI, confidence interval; HER2, human epidermal growth factor receptor 2; NSCLC, non-small cell lung cancer; ORR, objective response rate; TKI, tyrosine kinase inhibitor.Ā 

Reference

Girard N, et al. Presented at: 2024 ASCO Annual Meeting, Chicago, IL, USA. 30 Mayā€“4 June 2024. Abstr. LBA8598.

Question 5/5
Your 73-year-old patient has advanced NSCLC, which has progressed following first-line treatment with platinum-doublet chemotherapy + ICI. Genomic testing has identified a HER2 mutation. Based on the current ESMO guidelines, which treatment would you recommend for this patient?

ESMO, European Society for Medical Oncology; HER2, human epidermal growth factor receptor 2; ICI, immune checkpoint inhibitor; NSCLC, non-small cell lung cancer.

ESMO guidelines recommend trastuzumab deruxtecan in patients who have advanced NSCLC with HER2 exon 20 mutations following prior first-line therapy. Amivantamab and larotrectinib are recommended in the second-line setting for tumours with EGFR exon 20 insertions and NTRK translocation, respectively. Trastuzumab emtansine is not included in the ESMO treatment recommendations.

Abbreviations

EGFR, epidermal growth factor receptor; ESMO, European Society for Medical Oncology; HER2, human epidermal growth factor receptor 2; NSCLC, non-small cell lung cancer; NTRK, neurotrophic tyrosine receptor kinase.

Reference

Hendriks LE, et al. Ann Oncol. 2023;34:339ā€“57.

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