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Our faculty interpret key data from the congress, complimented by an expert panel discussing what has been presented. Close

Immunotherapy-based combinations for advanced/metastatic renal cell carcinoma: What have we learned from ASCO GU 2023?

  • Downloads including slides are available for this activity in the Toolkit
Learning Objectives

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

  • Evaluate the latest efficacy and safety data for immune checkpoint inhibitor-based combinations in the treatment of advanced or metastatic RCC
  • Summarize the latest data on the use of biomarkers to predict response to immune checkpoint inhibitor-based combinations
  • Explain how the latest data on the use of immune checkpoint inhibitor-based combinations for the treatment of advanced or metastatic RCC may be implemented in clinical practice
Overview

In this activity, a renal cell carcinoma (RCC) expert reviews key data on immune checkpoint inhibitor (ICI)-based regimens for RCC from the ASCO GU 2023 Congress and discusses with two additional leading experts how these data may apply in clinical practice.

This activity was filmed following the ASCO GU 2023 Congress (San Francisco, CA, USA, 16–18 February 2023).

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, oncology surgeons and radiologists involved in the management of patients with RCC.

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 financial relationships are listed below. All individuals not listed have no relevant financial relationships.

Faculty 

Prof. Brian I Rini discloses: Advisory board or panel fees from Alkermes, Aravive, Arrowhead Pharmaceuticals, Athenex Pharmaceuticals, Aveo Oncology, Bristol Myers Squibb, Corvus Pharmaceuticals, Debiopharm, Eisai, EUSA Pharma, Genentech, HiberCell, Merck, Nikang Therapeutics, Pfizer, Surface Oncology and Synthorx. Consultancy fees from Alkermes, Aravive, Arrowhead Pharmaceuticals, Athenex Pharmaceuticals, Aveo Oncology, Bristol Myers Squibb, Corvus Pharmaceuticals, Debiopharm, Eisai, EUSA Pharma, Genentech, HiberCell, Merck, Nikang Therapeutics, Pfizer, Surface Oncology and Synthorx. Grants/research support from ADC Therapeutics, Adela, Aravive, Arcus Biosciences, Arrowhead Pharmaceuticals, AstraZeneca, Aveo Oncology, Bristol Myers Squibb, Daiichi Sankyo, Dracen Pharmaceuticals, Dragonfly Therapeutics, Exelixis, Genentech, Gilead, HiberCell, Incyte, Janssen, Merck, Pfizer, Pionyr Immunotherapeutics, POINT Biopharma, Strata Oncology, Surface Oncology, Tempus and VasGene Therapeutics. Stock/shareholder (self-managed) PTC Therapeutics.

Prof. Elizabeth Plimack discloses: Advisory board or panel fees from Astellas, AstraZeneca, Aveo, Calithera, EMD Serono, Exelixis, Genentech, IMV, Janssen, MEI Pharma, Merck, Pfizer, Regeneron, Seagen and Signatera. Consultancy fees from AstraZeneca and Infinity Pharmaceuticals. Grants/research support from Astellas, Bristol Myers Squibb, Genentech and Merck.

Prof. Thomas Powles discloses: Consultancy fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Pfizer, Roche and Seagen. Grants/research support from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Open Health, Pfizer, Roche and Seagen.

Content reviewer

Claude Bassil, MD, FACP, FASN has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Director

Sadaf Kazi and Sola Neunie have 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 1.0 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu).

Advanced Practice Providers

Physician Assistants may claim a maximum of 1.0 Category 1 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: 24 April 2023. Date credits expire: 24 April 2024.

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

This activity is CE/CME accredited

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

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Course Modules

  • Downloads including slides are available for this activity in the Toolkit

Topics covered in this activity

Renal Cancer / Genitourinary Cancer / Immunotherapy
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Immunotherapy-based combinations for advanced/metastatic renal cell carcinoma: What have we learned from ASCO GU 2023?
1.0 CE/CME credit

Question 1/4
Based on the recent subset analysis of the COSMIC-313 clinical trial, which patients with untreated advanced or metastatic RCC achieved the longest progression-free survival with the triplet therapy cabozantinib + nivolumab + ipilimumab?

IMDC, International Metastatic RCC Database Consortium; RCC, renal cell carcinoma; VEGF, vascular endothelial growth factor.

COSMIC-313 is an ongoing trial assessing the efficacy and safety of the C+N+I triplet therapy in patients who are defined by the IMDC as intermediate- or poor-risk RCC.1 While C+N+I significantly improved PFS in the overall population vs placebo (P+N+I),2 subgroup analyses suggested that the treatment benefit was primarily restricted to the intermediate-risk group (C+N+I vs P+N+I, 17.9 [95% CI, 14.1–NE] vs 11.3 [8.4–15.3] months; poor-risk group, 9.5 [8.3–15.8] vs 11.2 [6.0–14.2] months).3

Abbreviations

C, cabozantinib; CI, confidence interval; I, ipilimumab; IMDC, International Metastatic RCC Database Consortium; N, nivolumab; NE, not evaluable; P, placebo; PFS, progression-free survival; RCC, renal cell carcinoma.

References

  1. ClinicalTrials.gov. NCT03937219. Available at: clinicaltrials.gov/ct2/show/NCT03937219 (accessed April 2023).
  2. Choueiri TK, et al. Presented at: ESMO Congress 2022, Paris, France. 9–13 September 2022. Abstr LBA8.
  3. Powles T, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 605.
Question 2/4
You are treating a patient with nivolumab and wish to analyse liquid biopsies to predict their likelihood of response. Based on the I-RENE trial, which of the following might suggest a potential clinical benefit from nivolumab?

IL, interleukin; MDSC, myeloid-derived suppressor cell; miRNA, microRNA.

Preliminary data from liquid biopsies analysed using multiparametric flow cytometry in the I-RENE trial indicate that clinical benefit of N seems to cluster with a boost in effector T cells and Ki67. Levels of monocytic MDSCs remain stable, while miRNA induction is associated with non-response. IL-8 levels do not associate with any response.

Abbreviations

IL, interleukin; MDSC, myeloid-derived suppressor cell; miRNA, microRNA; N, nivolumab.

Reference

Verzoni E, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 712.

Question 3/4
The histology report for a new patient indicates that they have advanced chromophobe RCC. Taking into consideration recent data presented at ASCO GU 2023, and the latest understanding of the disease, what should you do next?

ASCO GU, American Society of Clinical Oncology Genitourinary Cancers Symposium; ccRCC, clear cell RCC; IO, immuno-oncology; PD-L1, programmed cell death ligand 1; RCC, renal cell carcinoma.

A retrospective analysis of real-world data from the International Metastatic RCC Database Consortium of patients with advanced ChRCC or ccRCC who received IO-based therapies (dual IO or IO+VEGF-targeted therapy) in the first-line setting reported that OS and TTF was shorter in patients with ChRCC vs patients with ccRCC (median OS: 24.7 vs 50.5 months; p<0.001) and TTF (median TTF: 4.5 vs 11.0 months; p<0.001).1

Patients’ and oncologists’ preferences for advanced RCC treatment are determined mainly by the efficacy (survival gain) but also by the HRQoL provided.2 With no clear evidence for improved survival for IO-based therapy in patients with ChRCC,1 the primary consideration to discuss with patients is impact on HRQoL.2

Abbreviations

ccRCC, clear cell RCC; ChRCC, chromophobe RCC; HRQoL, health-related quality of life; IO, immuno-oncology; OS, overall survival; RCC, renal cell carcinoma; TTF, time to treatment failure; VEGF, vascular endothelial growth factor.

References

  1. Labaki C, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 654.
  2. Fernández O, et al. Front Oncol. 2022;11:773366.
Question 4/4
You have been treating a patient with advanced RCC with nivolumab + ipilimumab for the last 8 months. Based on data presented at ASCO GU 2023, and assuming toxicities are manageable, when would you consider initiating a treatment-free period?

ASCO GU, American Society of Clinical Oncology Genitourinary Cancers Symposium; CR, complete response; PR, partial response; RCC, renal cell carcinoma; VEGF, vascular endothelial growth factor.

Prescribing information for nivolumab indicates treatment up to 2 years or until disease progression or unacceptable toxicities.1 However, three studies from ASCO GU 2023, considering the impact of earlier initiation of treatment-free periods on patients with RCC, concluded that reductions in treatment time with IO-based therapies do not materially impact patients’ overall survival.2–4 A recently published retrospective study of patients with mRCC discontinuing nivolumab for reasons other than disease progression further concluded that patients whose initial treatment duration was <12 months or who did not achieve PR/CR had a greater risk of progression.5

Abbreviations

ASCO GU, American Society of Clinical Oncology Genitourinary Cancers Symposium; CR, complete response; IO, immuno-oncology; mRCC, metastatic RCC; PR, partial response; RCC, renal cell carcinoma.

References

  1. FDA. Nivolumab PI. Available at:  www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s112lbl.pdf (accessed April 2023).
  2. Atkins MB, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 604.
  3. Yoo JH, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 625.
  4. George L, et al. Presented at: ASCO GU 2023, San Francisco, CA, USA. 16–18 February 2023. Abstr 672.
  5. Bimbatti D, et al. Front Oncol. 2022;12:960751.
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