Cancer Summaries and Commentaries™: Report From Chicago on Advances in Genitourinary Cancers

Release Date: July 31, 2019
Expiration Date: July 31, 2020
Media: Internet - based

Activity Overview

This online activity is designed to update physicians on data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held in June in Chicago, IL. Cancer Summaries and Commentaries™: Report From Chicago on Advances in Genitourinary Cancers online continuing medical education (CME) activity facilitates critical assessment and clinical integration of new evidence, when appropriate. The activity reviews 5 abstracts with some of the most compelling and clinically relevant genitourinary (GU) cancer presentations from the meeting. For each abstract, a short summary of key clinical data is accompanied by expert perspectives that provide insight into how clinicians can apply these findings to their clinical practice to improve patient care.

Benefits of Participating

• Become informed about recent clinical trials in the field of GU malignancies and their impact on clinical practice decisions
• Identify emerging treatments for the management of GU malignancies
• Explore future directions for the treatment and management of GU malignancies

Acknowledgement of Commercial Support

This activity is supported by educational grants from Bayer and Sanofi Genzyme.

Target Audience

This educational activity is directed toward medical oncologists and fellows who treat patients with GU cancers. Surgical oncologists, radiation oncologists, nurse practitioners, nurses, physician assistants, pharmacists, researchers, and other healthcare professionals interested in the treatment of GU cancers are also invited to participate.

Learning Objectives

Upon successful completion of this educational activity, you should be better prepared to:

• Understand designs and endpoints from recently completed and ongoing clinical trials evaluating novel strategies for the management of patients with GU malignancies
• Interpret key findings from recent practice-changing clinical trials that evaluated novel strategies for the treatment of GU malignancies
• Integrate emerging evidence into clinical context concerning novel agents and approaches for the management of GU malignancies

Faculty, Staff, and Planners’ Disclosures

Faculty

Daniel P. Petrylak, MD
Professor of Medicine (Medical Oncology) and Urology
Director, Prostate and GU Medical Oncology
Director, Prostate Cancer Translational Research Group
Yale Cancer Center
New Haven, CT

Disclosures: Grant/Research Support: Agensys, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Clovis, Dendreon, Endocyte, Genentech, Innocrin, Johnson & Johnson, Lilly, MedImmune, Medivation, Merck, Millennium, Novartis, Pfizer, Progenics, Roche Laborato¬ries, Sanofi Aventis, Seattle Genetics, Sotio; Consultant: Amgen, Astellas, AstraZeneca, Bayer, Bellicum, Bristol-Myers Squibb, Clovis, Dendreon, Exelixis, Ferring, Johnson & Johnson, Lilly, Medivation, Millennium, Pfizer, Roche Laboratories, Sanofi Aventis, Seattle Genetics; Shareholder: Bellicum, Tyme.

Elizabeth Plimack, MD
Chief, Division of Genitourinary Medical Oncology
Director, Genitourinary Clinical Research
Associate Professor, Department of Hematology/Oncology
Fox Chase Cancer Center, Temple Health
Philadelphia, PA

Disclosures: Grant/Research Support: Astellas, Bristol-Myers Squibb, Genentech, Merck, Peloton, Pfizer; Consultant: Bristol-Myers Squibb, Flatiron, Janssen, Merck, Seattle Genetics, AstraZeneca, Pfizer.

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 or treatment 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^® or any of the companies that provided commercial support for this program.

PER Pulse^™ Recaps

1 of 3

This online continuing medical education activity, Cancer Summaries and Commentaries™: Report From Chicago on Advancements in Genitourinary (GU) Malignancies, featured 2 renowned experts in GU who provided commentary on the clinical importance of 5 GU abstracts presented at a major oncology meeting in Chicago, Illinois, in June 2019. The activity reviews 5 abstracts with some of the most compelling and clinically relevant GU cancer presentations from the meeting.

This first of 3 PER Pulse™ Recaps reviews investigational therapies using cabazitaxel for patients with metastatic castration-resistant prostate cancer (mCRPC) and darolutamide in nonmetastatic CRPC (nmCRPC).

Below are some highlights from the activity, featuring audio clips from Dr Petrylak,MD:

• There was a higher clinical benefit rate for cabazitaxel versus abiraterone or enzalutamide – a higher proportion of patients with stable disease in those treated with cabazitaxel
• This study also evaluated potential biomarkers of treatment response evaluated through circulating tumor DNA (ctDNA) levels.
• In terms of genomic characteristics, genomic alterations in AR and TP53 were prognostic of worsened outcomes, and patients with concurrent defects in TP53 and RB1 showed a trend toward shorter progression-free survival (PFS) and overall survival (OS) versus patients with TP53 defects alone.
• These data indicate a potential role for ctDNA in determining patient prognosis during therapy.
• The impact of darolutamide on pain and quality of life in patients with nmCRPC was evaluated.
• The duration of metastasis-free survival was significantly longer than with placebo, with a 59% lower risk of metastatic progression (40.4 vs 18.4 months; HR, 0.41; 95% CI, 0.34-0.50; P <.001). In addition, an interim analysis of OS indicated a survival benefit with darolutamide, with a 29% lower risk of death (HR, 0.71; 95% CI, 0.50-0.99; P = .045).

“In conclusion, there was a higher clinical benefit rate for those patients receiving cabazitaxel versus abiraterone or enzalutamide in poor-prognosis castration-resistant prostate cancer. There was also a higher proportion of patients with stable disease.”
—Daniel Petrylak, MD

“There was no deterioration in the quality-of-life parameters in those patients receiving darolutamide versus placebo in this particular study.”
—Daniel Petrylak, MD

2 of 3

This online continuing medical education activity, Cancer Summaries and Commentaries™: Report From Chicago on Advancements in Genitourinary Malignancies, featured 2 renowned experts in GU who provided commentary on the clinical importance of 5 GU abstracts presented at a major oncology meeting in Chicago, Illinois, in June 2019. The activity reviews 5 abstracts with some of the most compelling and clinically relevant GU cancer presentations from the meeting.

This second of 3 PER Pulse™ Recaps reviews investigational therapies for patients with locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy and immune checkpoint inhibitors.

Below are some highlights from the activity, featuring audio clips from Dr Petrylak, MD:

• Results of the EV-201 trial of enfortumab vedotin monotherapy for patients with locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors were reviewed.
• Enfortumab vedotin showed strong clinical activity in patients with locally advanced or metastatic urothelial carcinoma who previously received both platinum-containing chemotherapy and immune checkpoint therapy, according to topline results from the pivotal phase II EV-201 trial.
• In the single-arm EV-201 trial, enfortumab vedotin induced a 44% ORR per independent review.
• These results for enfortumab vedotin indicate that the agent may be able to help patients whose urothelial cancer progresses following treatment with standard chemotherapy and a PD-1 or PD-L1 inhibitor.

“There are few options available for treatment for patients who failed either chemotherapy [or] checkpoint inhibition therapy for metastatic disease. There is an unmet medical need for these particular patients.”
—Daniel Petrylak, MD

“EV-201 demonstrated significant activity, enfortumab vedotin, with a 44% response rate, a complete response rate of 12%, and a response rate in [the] liver, which was comparable to [that of] the overall population. Seeing these response rates in the liver is…unique, and these results, along with the phase I data, justify the submission to the FDA for accelerated approval.”
—Daniel Petrylak, MD

3 of 3

This online continuing medical education activity, Cancer Summaries and Commentaries™: Report From Chicago on Advancements in Genitourinary Malignancies, featured 2 renowned experts in GU who provided commentary on the clinical importance of 5 GU abstracts presented at a major oncology meeting in Chicago, Illinois, in June 2019. The activity reviews 5 abstracts with some of the most compelling and clinically relevant GU cancer presentations from the meeting.

This third of 3 PER Pulse™ Recaps reviews investigational therapies for patients with advanced renal cell carcinoma (aRCC) and metastatic RCC.

Below are some highlights from the activity, featuring audio clips from Dr Plimack, MD:

• The phase III JAVELIN Renal 101 trial in previously untreated patients with aRCC demonstrated a PFS benefit and higher ORR with avelumab plus axitinib (A + Ax) versus sunitinib (S).
• PD-L1 expression (≥1% immune cells) was associated with the longest PFS in the A + Ax arm and the shortest in the S arm (HR, 0.63; 95% CI, 0.49, 0.81).
• Significant treatment arm–specific differences in PFS were observed relative to wild-type when mutations in genes such as CD1631L, PTEN, and DNMT1 were present.
• These findings define molecular features that differentiate therapy-specific outcomes in first-line aRCC and may inform personalized therapy strategies for patients with aRCC.
• In the MK-3475-426/KEYNOTE-426 trial, pembrolizumab plus axitinib significantly improved OS (HR, 0.53; P <.0001), PFS (HR, 0.69; P = .0001), and ORR (59.3% vs 35.7%; P <.0001) versus sunitinib and had manageable toxicity as first-line therapy for metastatic RCC.
• The pembrolizumab-plus-axitinib benefit was observed across all International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups and regardless of PD-L1 expression.
• The main conclusion of this study was that pembrolizumab plus axitinib provides benefit in the combined population of patients with IMDC intermediate or poor risk and in patients whose tumors had sarcomatoid features.

“At least 3 genes showed relevant differences in the avelumab/axitinib group: CD1631L, DNMT1, and PTEN.”
—Elizabeth Plimack, MD

“Patients with sarcomatoid features are those who should really get combination therapy.”
—Elizabeth Plimack, MD