Safety and efficacy of immune checkpoint inhibitors (ICI) in advanced penile squamous cell carcinoma (PeCa): An international study from the Global Society of Rare Genitourinary Tumors (GSRGT).

Authors

null

Talal El Zarif

Dana-Farber Cancer Institute, Boston, MA

Talal El Zarif , Amin Nassar , Lijuan Jiang , Gregory Russell Pond , Tony Zhuang , Maud Velev , Andrew Warren Hahn , Sebastiano Buti , Pablo Álvarez , Rana R. McKay , Bruno Vincenzi , Edward El-Am , Gavin Hui , Jae-Lyun Lee , Tarek H. Mouhieddine , Matthew I. Milowsky , Harrison Matthews , Pedro C. Barata , Andrea B. Apolo , Guru P. Sonpavde

Organizations

Dana-Farber Cancer Institute, Boston, MA, Yale Cancer Center, New Haven, CT, Sun Yat-sen University, Guangzhou, China, McMaster University, Hamilton, ON, Canada, Department of Medicine, Emory University School of Medicine, Atlanta, GA, Gustave Roussy, Paris, France, University of Texas MD Anderson Cancer Center, Houston, TX, Department of Medicine and Surgery, University of Parma, Parma, Italy, 12 de Octubre University Hospital, Medical Oncology Department, Madrid, Spain, Moores Cancer Center, University of California San Diego, La Jolla, CA, PoUniversity Campus Bio Medico of Rome, Roma, Italy, Mayo Clinic, Rochester, MN, UCLA, Los Angeles, CA, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, Icahn School of Medicine at Mount Sinai, New York, NY, University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, Department of Medicine, Duke University Medical Center, Durham, NC, Department of Internal Medicine, University Hospitals Seidman Cancer Center, Cleveland, OH, National Cancer Institute, Bethesda, MD, AdventHealth Cancer Institute, Orlando, FL

Research Funding

No funding received
None.

Background: Management options for patients (pts) with advanced (locally advanced or metastatic) PeCa are limited. The GSRGT assembled an international cohort of pts with advanced PeCa treated with ICI to evaluate toxicity and clinical outcomes. Methods: We retrospectively collected data on pts with advanced PeCa receiving ≥1 cycle of ICI between 2015-2022 at 18 medical centers in the US, Europe, and Asia. Immune-related adverse events (irAE) were graded per the Common Terminology Criteria for Adverse Events v5.0. Overall survival (OS) and progression-free survival (PFS) were estimated by the Kaplan-Meier method. Objective response rate (ORR) was determined by the clinical investigator per RECIST 1.1 criteria, whenever feasible. Results: Among 72 pts with advanced PeCa treated with ICI, 24 (33%) were Hispanic and 7 (10%) were Black. 60 (83%) pts had metastases while the remainder had locally advanced disease. The median age was 64 (inter-quartile range (IQR): 54,70) years and 48 (67%) had ECOG performance status ≥1. Most pts (n=60, 83%) were treated in the ≥2nd line setting and received pembrolizumab (n=23), nivolumab (n=15), cemiplimab (n=15), nivolumab and ipilimumab (n=7), or other anti-PD1/L1-based therapies (n=12). Among 37 pts with available data on HPV status, 24 (65%) were HPV+. 3 (4%) pts were HIV+. irAE of any grade occurred in 18 (25%) pts, 7 (10%) were grade ≥3, 7 (10%) required steroids, 6 (9%) required hospitalization, and 8 (11%) led to treatment discontinuation. The median OS and 24-month OS and median PFS and 24-month PFS were 9.4 (95%CI: 6.8, 12.8) months and 19.3% (95%CI: 9.2, 32.1) and 2.8 (95%CI: 2.1, 3.9) months and 11.2 % (95%CI: 4.9, 20.2), respectively. Among 66 pts evaluable for response, ORR was 7/66 (11%) (2 with complete response, 5 with partial response), and 16 (24%) pts had stable disease for a disease control rate of 35%. The median duration of response was 7.9 (IQR: 3, not reached) months. Conclusions: In the largest retrospective cohort of ICI-treated advanced PeCa, ICI showed no new safety signals, however, overall anti-tumor activity was limited. Future translational studies are needed to identify pts that are more likely to derive clinical benefit from ICI.

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Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer

Sub Track

Therapeutics

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr 5)

DOI

10.1200/JCO.2023.41.6_suppl.5

Abstract #

5

Poster Bd #

D5

Abstract Disclosures