Gynaecological Oncology CE/CME ACCREDITED Watch Time: 42 mins

touchEXPERT OPINIONS The evolving clinical landscape of biologic therapy for patients with recurrent/metastatic cervical cancer

Watch leading experts review the latest clinical data and guideline recommendations supporting the use of biologic therapies in recurrent/metastatic cervical cancer.

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Prof. Christian Marth
Innsbruck Medical University, Innsbruck, Austria
Cervical cancer: Where are we now?

Prof. Marth summarizes available and emerging therapies for recurrent/metastatic cervical cancer and provides a practical example of implementing guideline recommendations into clinical practice.

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Interview Questions

In this interview, Prof. Marth answers the following questions:

  • What do current European and US guidelines advise for the treatment of recurrent/metastatic cervical cancer?
  • What is the rationale for adding bevacizumab to chemotherapy in the treatment of recurrent/metastatic cervical cancer?
  • What is the rationale for using pembrolizumab in recurrent/metastatic cervical cancer?
  • What clinical challenges remain in the treatment of recurrent/metastatic cervical cancer?
  • What new immunotherapy approaches are being explored in recurrent/metastatic cervical cancer?
About Prof. Christian Marth

Prof. Marth has been Head and Professor of the Department of Obstetrics and Gynecology at Innsbruck Medical University in Austria since 1998. He has been President of Arbeitsgemeinschaft für Gynäkologische Onkologie (AGO) Austria, Chair of the Ovarian Committee of Gynecological Cancer InterGroup (GCIG), Council Member of the European Society of Gynaecological Oncology (ESGO), President of Oesterreichische Gesellschaft fur Gynakologie und Geburtshilfe (OEGGG), and Chair of the European Network for Gynaecological Oncological Trial (ENGOT) group. read more

He is President of the AGO Austria Study Center and Vice President of the Austrian Breast and Colorectal Study Group. Prof. Marth has been the author of more than 430 peer-reviewed articles, has received 13 national and international awards and has a h-index of 76.

Prof. Christian Marth discloses: Advisory board fees from AstraZeneca, GlaxoSmithKline, MSD, Roche and Seagen; speakers bureau fees from Novartis.

 
Prof. Susana Campos
Dana-Farber Cancer Institute, Boston, MA, USA
Biologics for cervical cancer: A deep dive into the evidence

Prof. Campos reviews the latest efficacy data for current and emerging biologic treatments in the field of recurrent/metastatic cervical cancer and considers their implications for future clinical practice.

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Interview Questions

In this interview, Prof. Campos answers the following questions:

  • What is the evidence base for the use of anti-vascular endothelial growth factor (VEGF) agents in recurrent/metastatic cervical cancer?
  • What are the data supporting the use of pembrolizumab in recurrent/metastatic cervical cancer?
  • What trials are evaluating the future role of immune checkpoint inhibitors in recurrent/metastatic cervical cancer?
  • What activity has been demonstrated in studies with antibody-drug conjugates (ADCs) in the setting of recurrent/metastatic cervical cancer?
  • What are the clinical implications of these data for the future management of recurrent/metastatic cervical cancer?
About Prof. Susana Campos

Prof. Campos is Assistant Professor of Medicine at Harvard Medical School and Medical Oncologist at the Dana-Farber Cancer Institute, where she manages patients with gynaecological malignancies. Her research focuses on the clinical application of novel therapies in cervical, ovarian and endometrial cancer, and she has served as principal investigator on multiple clinical trials in these areas.read more

Prof. Campos serves on committees for numerous professional organizations, including the American Society of Clinical Oncology (ASCO), the Gynecological Oncology Group (GOG) and the National Comprehensive Cancer Network (NCCN). She is also an editorial consultant for the ASCO International Multidisciplinary Curriculum and the American College of Physicians (ACP) ovarian cancer publications.

Prof. Susana Campos discloses: Advisory board fees from Astrazeneca, Boston Biomedical Inc., Eisai Co., Ltd. and Merck; education activity fees from Eisai Co., Ltd. and Merck.

 
Prof. Ignace Vergote
Catholic University of Leuven, Belgium
Clinical strategies for optimal response to biologic therapy: Making sense of the data

Prof. Vergote describes the factors to be accounted for when selecting patients for biologic therapies in recurrent/metastatic cervical cancer and shares strategies for managing adverse events associated with new and emerging biologic treatments.

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Interview Questions

In this interview, Prof. Vergote answers the following questions:

  • What biomarkers can help with patient selection for biologic therapies in recurrent/metastatic cervical cancer?
  • What clinical factors can help determine patient eligibility for biologic therapies in recurrent/metastatic cervical cancer?
  • What are the side effects associated with bevacizumab and pembrolizumab, and how can they be managed?
  • What adverse events have been observed with emerging biologic therapies and what are the potential implications for clinical practice?
  • Does histological subtype impact treatment decision–making in recurrent/metastatic cervical cancer?
  • What are the future directions for treatment of recurrent/metastatic cervical cancer, in light of new emerging biologic therapies?
About Prof. Ignace Vergote

Prof. Em. Vergote served as Head of the Department of Obstetrics and Gynecology and Gynecologic Oncology at the Catholic University of Leuven, Belgium from 2003 until 2020.

Prof. Vergote was the co-founder and first chairman of the European Network of Gynaecologic Oncology Trial (ENGOT) groups from 2007 until 2012 and is currently Chair of the Belgian and Luxembourg Gynaecological Oncology Group (BGOG).read more

He was Chair of the European Organisation for Research and Treatment of Cancer–Gynaecological Cancer Group (EORTC–GCG) for 6 years and President of the European Society of Gynaecological Oncology (ESGO) from 2003 to 2005. From 2006 to 2008, Prof. Vergote was the president of the International Gynecologic Cancer Society (IGCS).

In 2019, Prof. Vergote received the Lifetime Achievement Award from ESGO, the University of Navarra, Spain and Nord Ostdeutsche Gesellschaft für Gynäkologische Onkologie (NOGGO). He received the Ernst Wertheim Prize from AGO in Austria, and the COBRA Prize for surgical expertise in the Netherlands.

Prof. Vergote’s main areas of clinical and translational research focus on gynaecological cancer. He has authored more than 950 original papers in peer-reviewed journals, has been cited more than 64,000 times (as of March 2021), has a h-index of 123 and has been a promoter of 30 medical PhDs. He is currently Editor of the European Journal of Cancer.

Prof. Ignace Vergote discloses: Consulting fees from Amgen Europe GmbH, AstraZeneca, Carrick Therapeutics, Clovis Oncology, Deciphera Pharmaceuticals, Inc., Elevar Therapeutics, Genmab, GlaxoSmithKline, ImmunoGen, Inc., Jazz Pharmaceuticals, Mersana Therapeutics, Millennium Pharmaceuticals, Inc., MSD, Novocure, OCTIMET Oncology NV, Oncoinvent AS, Roche, SOTIO a.s, Verastem Oncology and Zentalis Pharmaceuticals; research support from Amgen, Genmab, Oncoinvent AS and Roche; expenses from Amgen, AstraZeneca, MSD, Roche and Tesaro.

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Overview & Learning Objectives
Overview

In this activity, three experts explore the evolving landscape of biologic therapies in recurrent/metastatic cervical cancer and share strategies for patient selection and adverse event management.

This activity has been jointly provided by Oakstone and touchIME ONCOLOGY. Oakstone Publishing is accredited by the ACCME to provide continuing medical education to physicians. read more

Target Audience

This activity has been designed to meet the educational needs of oncologists, including gynaecological oncologists, involved in the management of recurrent/metastatic cervical cancer worldwide.

Disclosures

Oakstone Publishing has assessed conflict of interest with its faculty, authors, editors, and any individuals who were in a position to control the content of this CME activity. Any identified relevant conflicts of interest were resolved for fair balance and scientific objectivity of studies utilized in this activity. Oakstone Publishing’s planners, content reviewers, and editorial staff disclose no relevant commercial interests.

Faculty

Prof. Christian Marth discloses: Advisory board fees from AstraZeneca, GlaxoSmithKline, MSD, Roche and Seagen; speakers bureau fees from Novartis.

Prof. Susana Campos discloses: Advisory board fees from Astrazeneca, Boston Biomedical Inc., Eisai Co., Ltd. and Merck; education activity fees from Eisai Co., Ltd. and Merck.

Prof. Ignace Vergote discloses: Consulting fees from Amgen Europe GmbH, AstraZeneca, Carrick Therapeutics, Clovis Oncology, Deciphera Pharmaceuticals, Inc., Elevar Therapeutics, Genmab, GlaxoSmithKline, ImmunoGen, Inc., Jazz Pharmaceuticals, Mersana Therapeutics, Millennium Pharmaceuticals, Inc., MSD, Novocure, OCTIMET Oncology NV, Oncoinvent AS, Roche, SOTIO a.s, Verastem Oncology and Zentalis Pharmaceuticals; research support from Amgen, Genmab, Oncoinvent AS and Roche; expenses from Amgen, AstraZeneca, MSD, Roche and Tesaro.

Content Reviewer

Walter Murray Yarbrough, MD, FACP has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Director

Hennah Patel, MPharm, RPh, has no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

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 the joint providership of Oakstone Publishing and touchIME. Oakstone Publishing is accredited by the ACCME to provide continuing medical education for physicians.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 Credit™ into European CME credit (ECMEC) should contact the UEMS (www.uems.eu).

Oakstone Publishing designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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

Date of original release: 19 May 2021. Date credits expire: 19 May 2022.

Learning Objectives

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

  • Describe current and emerging immunotherapy approaches for the treatment of recurrent/metastatic cervical cancer
  • Recall the latest clinical efficacy data for biologic therapies in recurrent/metastatic cervical cancer
  • Discuss selection of biologic therapies for patients with recurrent/metastatic cervical cancer, adverse event management and future directions for treatment guidelines
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Question 1/5
Based on current US and European guidelines, what would be your preferred first-line systemic therapy for a patient with recurrent/metastatic cervical cancer?
Correct

The preferred first-line systemic regimen for patients with recurrent/metastatic cervical cancer recommended by NCCN guidelines version 1.2021 (October 2020) is a combination of chemotherapy with bevacizumab. This is either with cisplatin/paclitaxel plus bevacizumab (category 1 recommendation*) or carboplatin/paclitaxel plus bevacizumab.1

The most recent ESMO guidelines (2017) recommend carboplatin/paclitaxel plus bevacizumab,2 and the latest ESGO guidelines (2018) recommend carboplatin/paclitaxel or cisplatin/paclitaxel with the addition of bevacizumab if the patient’s performance status is good.3

ESGO, European Society of Gynaecologic Oncology; ESMO, European Society for Medical Oncology; NCCN, National Comprehensive Cancer Network.

*Category 1 recommendation: based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

 

References

  1. NCCN Clinical Practice Guidelines – Cervical Cancer v.1.2021 – October 2, 2020. Available at: www.nccn.org/professionals/physician_gls/pdf/cervical.pdf (accessed 30 April 2021).
  2. Marth C, et al. Ann Oncol. 2017;28:iv72–83.
  3. Cibula D, et al. Int J Gynecol Cancer. 2018;28:641–55.
Question 2/5
Second-line pembrolizumab is included in the NCCN guidelines for patients with recurrent/metastatic cervical cancer who have progressed on first-line therapy. Which of these patients are eligible for pembrolizumab therapy?
Correct

The NCCN guidelines version 1.2021(October 2020) preferentially recommend pembrolizumab as second-line therapy for patients with PD-L1–positive (as determined by an FDA-approved test) or MSI-H/dMMR tumours.

dMMR, deficient DNA mismatch repair; FDA, US Food and Drug Administration; MSI-H; microsatellite instability-high; NCCN, National Comprehensive Cancer Network; PD-L1, programmed cell death-ligand 1.

Reference

NCCN Clinical Practice Guidelines – Cervical Cancer v.1.2021 – October 2, 2020. Available at: www.nccn.org/professionals/physician_gls/pdf/cervical.pdf (accessed 30 April 2021).

Question 3/5
Which of the following is true regarding efficacy outcomes from clinical trials investigating new biologic approaches in recurrent/metastatic cervical cancer?
Correct

The single-arm, phase II InnovaTV 204 trial (NCT03438396) evaluated tisotumab vedotin in previously treated (≤2 prior systemic regimens) patients with recurrent/metastatic cervical cancer (n=101).1,2 Tisotumab vedotin was associated with an ORR of 24% including 7 CRs and an OS of 12.1 months.

The phase I/II CheckMate-358 trial (NCT02488759) of nivolumab + ipilimumab with two different dosing schedules demonstrated durable clinical activity in recurrent/metastatic cervical cancer.3,4

The phase III ENGOT-Cx10/BEATcc trial (NCT03556839) of atezolizumab + bevacizumab + chemotherapy in patients with recurrent/metastatic cervical cancer previously untreated with systemic therapy is currently ongoing (May 2021).5

The phase III trial (NCT03257267) of cemiplimab versus chemotherapy in patients with recurrent/metastatic cervical cancer previously treated with chemotherapy was stopped early due to positive OS results.6,7

CR, complete response; ORR, overall response rate; OS, overall survival.

References

  1. ClinicalTrials.gov. A Trial of Tisotumab Vedotin in Cervical Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT03438396 (accessed 30 April 2021).
  2. Coleman RL, et al. Lancet Oncol. 2021;22:609–19.
  3. Naumann RW, et al. Ann Oncol. 2019;30:v851–934.
  4. ClinicalTrials.gov. An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors (CheckMate358). Available at: clinicaltrials.gov/ct2/show/NCT02488759 (accessed 30 April 2021).
  5. ClinicalTrials.gov. Platinum chemotherapy plus paclitaxel with bevacizumab and atezolizumab in metastatic carcinoma of the cervix (BEATcc). 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03556839 (accessed 30 April 2021).
  6. ClinicalTrials.gov. Study of Cemiplimab in Adults With Cervical Cancer. Available at: clinicaltrials.gov/ct2/show/NCT03257267 (accessed 30 April 2021).
  7. GOG Foundation. Press release. 2021. Available at: www.gog.org/news/phase-3-trial-of-libtayo-cemiplimab-monotherapy-in-advanced-cervical-cancer-stopped-early-for-positive-result-on-overall-survival/ (accessed 30 April 2021).
Question 4/5
Which of the following would mean your patient with recurrent/metastatic cervical cancer may not be suitable for first-line chemotherapy plus bevacizumab?
Correct

Some patients are ineligible for bevacizumab owing to its contraindications and side effect profile.1

In the phase III GOG 240 trial (NCT00803062), the following patients were excluded:2,3

  • Candidates for curative therapy by means of pelvic exenteration
  • Patients with non-healing wounds
  • Patients with active bleeding conditions
  • Patients with inadequately anticoagulated thromboembolism

Side effects associated with bevacizumab include gastrointestinal fistula, hypertension, haemorrhage and serious thromboembolic events.1–4

In clinical practice, eligibility for therapy is a dynamic process. For example, active bleeding conditions may be managed to control the bleeding and allow the patient to receive bevacizumab therapy.1

References

  1. Skelton W, et al. Clin Med Insights Oncol.2018;12:1179554918779587.
  2. ClinicalTrials.gov. Paclitaxel and cisplatin or topotecan with or without bevacizumab in treating patients with stage IVB, recurrent, or persistent cervical cancer. 2019. Available at: clinicaltrials.gov/ct2/show/NCT00803062 (accessed 30 April 2021).
  3. Tewari KS, et al. Lancet. 2017;390:1654–63.
  4. Roche. Avastin – summary of product characteristics. 2021. Available at: www.medicines.org.uk/emc/product/3885 (accessed 30 April 2021).
Question 5/5
Which statement is true about the safety profiles of emerging biologic therapies in the setting of recurrent/metastatic cervical cancer?
Correct

The single-arm, phase II InnovaTV 204 trial (NCT03438396) evaluated tisotumab vedotin in previously treated (≤2 prior systemic regimens) patients with recurrent/metastatic cervical cancer (n=101). The most common TRAEs were alopecia, epistaxis, nausea, conjunctivitis, fatigue and dry eye. 53% of patients had grade 1/2 ocular TRAEs, most of which were resolved at study follow-up.1,2

Cemiplimab versus chemotherapy in patients with recurrent/metastatic cervical cancer previously treated with chemotherapy was investigated in a phase III trial.3,4 AEs were observed in 88% of cemiplimab-treated patients (n=300) and SAEs occurred in 30%. The 5 most common AEs were anaemia, nausea, fatigue, vomiting and constipation.4

The bifunctional fusion protein bintrafusp alfa is being investigated in a phase I trial in recurrent/metastatic cervical cancer (n=25).5 Grade 3 TRAEs occurred in 24% of patients and 1 patient experienced a grade 4 TRAE.

AE, adverse event; SAE, serious adverse event; TRAE, treatment-related adverse event.

References

  1. Coleman RL, et al. Lancet Oncol. 2021;22:609–19.
  2. ClinicalTrials.gov. A Trial of Tisotumab Vedotin in Cervical Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT03438396 (accessed 30 April 2021).
  3. ClinicalTrials.gov. Study of Cemiplimab in Adults With Cervical Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT03257267 (accessed 30 April 2021).
  4. GOG Foundation. Phase 3 trial of Libtayo® (cemiplimab) monotherapy in advanced cervical cancer stopped early for positive result on overall survival. Press release. 2021. Available at: www.gog.org/news/phase-3-trial-of-libtayo-cemiplimab-monotherapy-in-advanced-cervical-cancer-stopped-early-for-positive-result-on-overall-survival/ (accessed 30 April 2021).
  5. Allan S, et al. Int J Gynecol Cancer. 2019;29:A72–73.
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