Accreditation/Credit Designation

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

Physicians' Education Resource®, LLC, designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physicians' Education Resource®, LLC, is approved by the California Board of Registered Nursing, Provider #16669, for 1.5 Contact Hours.

Acknowledgment of Commercial Support

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Merck KGaA, Darmstadt, Germany, and Sanofi Genzyme.

Community Practice Connections™: 3rd Annual European Congress on Immunotherapies in Cancer™

Release Date: December 21, 2018
Expiration Date: December 21, 2019
Media: Internet - based

Activity Overview

This activity focuses on immunotherapies for cancers of the bladder, lung, and skin. It consists of a series of brief video interviews with leading experts and short summaries of clinical data related to issues discussed in the interviews. The content and videos are based on presentations given at the 3rd Annual European Congress on Immunotherapies in Cancer™, held September 21-22, 2018, in Barcelona, Spain. This program provides expert perspectives on current standards of care and emerging concepts in cancer immunotherapy, as well as practical guidance on how to integrate these therapeutics into your practice.

Acknowledgment of Commercial Support

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Merck KGaA, Darmstadt, Germany, and Sanofi Genzyme.

Instructions for This Activity and Receiving Credit

  • You will need to login to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review videos/content until you finish the presentation.
  • At the end of the activity, “educational content/video files” will be available for your reference.
  • In order to receive a CME certificate, participants must complete the activity.
  • Complete the posttest and pass with a score of 70% or higher, complete the evaluation and then click on request for credit. Participants may immediately download a CME certificate upon completion of these steps.

Target Audience

This educational activity is intended for medical oncologists and other healthcare professionals (eg, physicians, physicians-in-training, oncology nurses, pharmacists, physician assistants). Participants will primarily be those whose practice requires mastery and a critical understanding of the fundamental principles, pivotal published studies, and emerging information on immunotherapies and their evolving roles in the treatment of cancer.

Learning Objectives

At the conclusion of this activity, you should be better prepared to:

  1. Evaluate the clinical applicability of data from clinical trials of immunotherapy strategies
  2. Discuss methods to individualize the use of immunotherapy strategies, including the use of biomarkers
  3. Describe how to proactively mitigate and manage adverse events associated with the use of treatment strategies used in the care of patients with cancer
  4. Identify unmet clinical needs in cancer treatment and highly anticipated clinical trials evaluating novel immunotherapeutic approaches

Faculty, Staff, and Planners' Disclosures

Faculty

Joaquim Bellmunt
Joaquim Bellmunt, MD, PhD
Associate Professor of Medicine, Harvard Medical School
GU Oncology Research Coordinator PSMAR
Director, IMIM-Hospital del Mar Medical Research Institute
Barcelona, Spain

Disclosures: Grant/Research Support: Sanofi-Aventis, Novartis, Takeda, Pfizer; Consultant/Advisory Board: Genentech, Merck Sharp & Dohme, Pfizer, GlaxoSmithKline, Bristol-Myers Squibb, Pierre Fabre, Sanofi-Aventis, Astellas, OncoGenex, Janssen

Roman Perez-Soler
Roman Perez-Soler, MD
Chairman, Department of Oncology
Montefiore Medical Center
Professor of Medicine
Chief, Division of Medical Oncology, Department of Medicine
Deputy Director, Albert Einstein Cancer Center
Bronx, NY, USA

Disclosures: Grant/Research Support: National Cancer institute; Consultant/Advisory Board: GlaxoSmithKline, AstraZeneca, Clovis, Roche/Genentech, Boehringer Ingelheim, Lilly, Adgero; Shareholder: Adgero, Stelexis

Antoni Ribas
Antoni Ribas, MD, PhD
Professor of Medicine
Professor of Surgery
Professor of Molecular & Medical Pharmacology
David Geffen School of Medicine
Director, Tumor Immunology Program
Jonsson Comprehensive Cancer Center
University of California, Los Angeles
Chair, Melanoma Committee at SWOG
Los Angeles, CA, USA

Disclosures: Consultant/Advisory Board: Amgen, Bristol-Myers Squibb, Chugai, Genentech, Merck, Novartis, Roche; Shareholder: Advaxis, Arcus, BiOncotech, Compugen, CytomX, Five Prime, FLX-Bio, ImaginAb, IsoPlexis, Rgenix, Lutris, PACT, Tango, Kite Pharma

Caroline Robert
Caroline Robert, MD, PhD
Head of the Dermatology Unit
Department of Medicine
Gustave Roussy and Paris-Sud University
Villejuif Grand - Paris, France

Disclosures: Consultant/Advisory Board: Bristol-Myers Squibb, Novartis, Roche, Amgen, Merck, Pierre Fabre

The staff of Physicians' Education Resource®, LLC, (PER®) have no relevant financial relationships with commercial interests to disclose.

Disclosure Policy and Resolution of Conflicts of Interest (COI)

As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.

Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.

Off-Label Disclosure and Disclaimer

This CME activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME activity is for continuing medical education purposes only, and is not meant to substitute for the independent clinical judgment of a physician relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER®.

PER Pulse™ Recaps

1 of 3
Insight from Joaquim Bellmunt, MD, PhD – PER Pulse Recap:
Community Practice Connections: 3rd Annual European Congress on Immunotherapies in Cancer

The live continuing medical education (CME) activity, Community Practice Connections: 3rd Annual European Congress on Immunotherapies in Cancer, was held on 21-22 September 2018, in Barcelona, Spain. Co-Chairs Antoni Ribas, MD, PhD, and Caroline Robert, MD, PhD, were joined by expert faculty to discuss recent practice-changing data and state-of-the-art approaches toward use of immunotherapy for a variety of solid tumors and hematologic malignancies.

This first of 3 PER Pulse Recaps summarizing the online program focuses on an interview with Dr. Joaquim Bellmunt about advances in the use of immunotherapy for urothelial carcinoma (UC). With use of single-agent immune checkpoint inhibitors (ICPis) firmly entrenched in the first-line and post-platinum settings for metastatic UC, ongoing studies are evaluating whether use of ICPis in combination regimens can improve outcomes in the metastatic setting. Additionally, clinical trials are being conducted to assess use of ICPis in earlier stages of the disease (Table).1 To that end, results from phase II studies of single-agent ICPis for muscle-invasive bladder cancer (MIBC) were reported this year.


PURE-01 Trial
The PURE trial2 (NCT02736266) is an open-label, single-arm, phase II study of neoadjuvant pembrolizumab (3 cycles, 200 mg every 3 weeks) before cystectomy for patients with MIBC. The study enrolled 50 patients (54%, cT3 tumor; 42%, cT2 tumor; 4%, cT2-3N1 tumor). All patients underwent radical cystectomy, and 42% achieved the primary endpoint of pathologic complete response (pCR; pT0) after receiving neoadjuvant pembrolizumab. Few immune-related adverse events (irAEs) were reported, which did not delay the surgical plan. Postsurgical complications were consistent with those reported in published studies of open or robot-assisted procedures. Use of neoadjuvant ICPis was not associated with fewer lymph nodes being removed during surgery. Delayed irAEs (pyrexia, 6%; pruritus, 6%; xerostomia, 4%) occurred within 2 months postcystectomy, for which 3 patients required corticosteroid treatment. This indicates a need for close multidisciplinary monitoring during follow-up.

ABACUS Trial
The ABACUS trial3 (NCT02662309) is a phase II study investigating neoadjuvant atezolizumab (1200 mg, two 3-weekly cycles) for MIBC. The coprimary endpoints of the study are pCR occurring in ≥20% of patients and increased CD8 cell count. Results of an interim analysis presented at the 2018 ASCO Annual Meeting were based on 74 patients who received the study drug, 68 of whom were evaluable for the primary efficacy endpoint. The pCR rates were 20% for all evaluable patients, 40% for patients with PD-L1–positive tumors, and 16% for patients with PD-L1–negative tumors. One treatment-related death during cycle 2 was reported to have been due to dyspnea (myocardial infarction, pulmonary embolism, and pulmonary edema). Treatment was well tolerated; 10% of patients experienced a grade 3-4 surgical complication.

“It is very important for urologists to be involved more and more with the management of bladder cancer and the use of immunotherapy. Obviously, the field is moving to a multidisciplinary approach, and we need to collaborate and work together in the different phases of the disease.”
— Joaquim Bellmunt, MD, PhD

References

  1. Bellmunt J, Powles T, Vogelzang NJ, et al. A review on the evolution of PD-1/PD-L1 immunotherapy for bladder cancer: the future is now. Cancer Treat Rev. 2017;54:58-67. doi: 10.1016/j.ctrv.2017.01.007.
  2. Necchi A, Anichini A, Raggi D, et al. Pembrolizumab as neoadjuvant therapy before radical cystectomy in patients with muscle-invasive urothelial bladder carcinoma (PURE-01): an open-label, single-arm, phase II study [published online October 20, 2018]. J Clin Oncol. 2018. doi: 10.1200/JCO.18.01148.
  3. Powles T, Rodriguez-Vida A, Duran I, et al. A phase II study investigating the safety and efficacy of neoadjuvant atezolizumab in muscle invasive bladder cancer (ABACUS). Presented at the 2019 Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2018; Chicago, IL. Abstract 4506.

2 of 3
Insight from Roman Perez-Soler, MD – PER Pulse Recap:
Community Practice Connections: 3rd Annual European Congress on Immunotherapies in Cancer

The live continuing medical education (CME) activity, Community Practice Connections: 3rd Annual European Congress on Immunotherapies in Cancer, was held on 21-22 September 2018, in Barcelona, Spain. Co-Chairs Antoni Ribas, MD, PhD, and Caroline Robert, MD, PhD, were joined by expert faculty to discuss recent practice-changing data and state-of-the-art approaches toward use of immunotherapy for a variety of solid tumors and hematologic malignancies.

This second of 3 PER Pulse Recaps summarizing the online program focuses on an interview with Dr. Roman Perez-Soler about the tremendous amount of progress that has been made with use of immunotherapy for lung cancer in the past year. During the interview, Dr. Perez-Soler shared guidance for community oncologists regarding new data and how to put newly introduced regimens into practice, adverse events (AEs) to expect from new regimens and how to mitigate them, and his overall approach toward sequencing therapies for metastatic and stage III non-small cell lung cancer (NSCLC).

PACIFIC Trial
The phase III PACIFIC trial1 randomized patients with stage III, unresectable NSCLC who did not have disease progression after chemoradiation to receive durvalumab for up to 1 year. The coprimary endpoints of the study were progression-free survival (PFS) and overall survival (OS). Positive results for the OS endpoint at a median follow-up of 25.2 months were published in The New England Journal of Medicine in September 2018 (Table). An earlier analysis demonstrated that use of durvalumab significantly improved PFS.2


“Stage III is treated with chemoradiotherapy, and now have also the addition of durvalumab in the patients who get a response to the therapy, which I think is major progress for those patients.”
– Roman Perez-Soler, MD

References

  1. Antonia SJ, Villages A, Daniel D, et al; for the PACIFIC Investigators. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC [published online September 25, 2018]. N Engl J Med. 2018. doi: 10.1056/NEJMoa1809697.
  2. Antonia SJ, Villegas A, Daniel D, et al; for the PACIFIC Investigators. Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. N Engl J Med. 2017;377:1919-1929. doi: 10.1056/NEJMoa1709937.

3 of 3
Insight from Caroline Robert, MD, PhD – PER Pulse Recap:
Community Practice Connections: 3rd Annual European Congress on Immunotherapies in Cancer

The live continuing medical education (CME) activity, Community Practice Connections: 3rd Annual European Congress on Immunotherapies in Cancer, was held on 21-22 September 2018, in Barcelona, Spain. Co-Chairs Antoni Ribas, MD, PhD, and Caroline Robert, MD, PhD, were joined by expert faculty to discuss recent practice-changing data and state-of-the-art approaches toward use of immunotherapy for a variety of solid tumors and hematologic malignancies.

This third of 3 PER Pulse Recaps summarizing the online program focuses on an interview with Dr. Caroline Robert about recent advances in the use of immunotherapy for Merkel cell carcinoma (MCC) and cutaneous squamous cell carcinoma (cSCC). Highlights from the interview include:

  • MCC is a rare dermatologic cancer that carries a high mortality burden, particularly for patients with metastatic disease.
    • In the single-arm, phase II JAVELIN Merkel 200 trial1-3 of the PD-L1 inhibitor avelumab for the treatment of MCC that progressed after ≥1 lines of chemotherapy, approximately one-third of patients achieved a response, about two-thirds of which were durable at 2 years of follow-up.
    • Recently, avelumab has been shown to be effective as first-line therapy for metastatic MCC.4 Ongoing trials are evaluating avelumab and other therapies for MCC across multiple settings, based on a growing understanding of the pathophysiology and biology underlying this tumor type.5,6
  • cSCC is a common form of skin cancer that is difficult to treat in the unresectable/metastatic settings.
    • In a single-arm, phase II study, the PD-1 inhibitor cemiplimab induced responses in 47% of patients with metastatic cSCC; 82% of responses were ongoing at the median follow-up of 7.9 months.7
  • Additional studies of immune checkpoint inhibitors for MCC and cSCC are ongoing (Table).

“If you compare the survival curves with what we had before, we have 39 patients alive at 2 years and we had zero before without this treatment, so it is a huge step forward.”
– Caroline Robert, MD, PhD, regarding introduction of immune checkpoint inhibition for MCC


References

  1. Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016;17(10):1374-1385. doi: 10.1016/S1470-2045(16)30364-3.
  2. Kaufman HL, Russell JS, Hamid O, et al. Durable responses to avelumab (anti-PD-L1) in patients with Merkel cell carcinoma progressed after chemotherapy: 1-year efficacy update. Presented at the 2017 American Association for Cancer Research Annual Meeting; April 1-5, 2017; Washington, DC. Abstract CT079.
  3. Nghiem P, Bhatia S, Brohl AS, et al. Two-year efficacy and safety update from JAVELIN Merkel 200 part A: a registrational study of avelumab in metastatic Merkel cell carcinoma progressed on chemotherapy. Presented at the 2018 Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2018; Chicago, IL. Abstract 9507.
  4. D’Angelo SP, Russell J, Lebbe C, et al. Efficacy and safety of first-line avelumab treatment in patients with stage IV metastatic Merkel cell carcinoma: a preplanned interim analysis of a clinical trial. JAMA Oncol. 2018;4(9):e180077. doi:10.1001/jamaoncol.2018.0077.
  5. Nghiem, Bhatia S, Lipson EJ, et al; CITN-09 Trial Group. Durable tumor regression and overall survival (OS) in patients with advanced Merkel cell carcinoma (aMCC) receiving pembrolizumab as first-line therapy. Presented at the 2018 Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2018; Chicago, IL. Abstract 9506.
  6. Topalian SL, Bhatia S, Reiney R, et al. Nivolumab as neoadjuvant therapy in patients with resectable Merkel cell carcinoma. Presented at the 2018 Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2018; Chicago, IL. Abstract 9505.
  7. Migden MR, Rischin D, Schmults CD, et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous cell carcinoma. N Engl J Med. 2018;379:341-351. doi: 10.1056/NEJMoa1805131.

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