Pertuzumab and trastuzumab in patients with ERBB2/3-altered urothelial or ovary/fallopian tube cancer: Results from the targeted agent and profiling utilization registry study

Authors

• John K. Chan, Sutter Cancer Research Consortium, San Francisco, CA.
• Michael Rothe, American Society of Clinical Oncology, Alexandria, VA.
• Elizabeth Garrett-Mayer, American Society of Clinical Oncology, Alexandria, VA.
• Evan Pisick, City of Hope Chicago, Zion, IL.
• Pooja Ghatalia, Fox Chase Cancer Center, Philadelphia, PA.
• Andrew Gregory, Advocate Health - MidwestFollow
• Mollie deShazo, O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham, AL.
• Kathryn F. Mileham, Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NC.
• Martina C. Murphy, University of Florida Health, Gainesville, FL.
• Olatunji B. Alese, Winship Cancer Institute of Emory University, Atlanta, GA.
• Elie G. Dib, Michigan Cancer Research Consortium, Ypsilanti, MI.
• Peter C. Kohler, Cancer Research Consortium of West Michigan, Cowell Family Cancer Center, Munson Medical Center, Traverse City, MI.
• Justin T. Moyers, The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Los Angeles, CA.
• Pam K. Mangat, American Society of Clinical Oncology, Alexandria, VA.
• Dominique C. Hinshaw, American Society of Clinical Oncology, Alexandria, VA.
• Abigail Gregory, American Society of Clinical Oncology, Alexandria, VA.
• Gina N. Grantham, American Society of Clinical Oncology, Alexandria, VA.
• Susan Halabi, Duke University Medical Center, Durham, NC.
• Richard L. Schilsky, American Society of Clinical Oncology, Alexandria, VA.

Recommended Citation

Chan JK, Rothe M, Garrett-Mayer E, et al. Pertuzumab and Trastuzumab in Patients With ERBB2/3-Altered Urothelial or Ovary/Fallopian Tube Cancer: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO Precis Oncol. 2026;10(4):e2501250. doi:10.1200/PO-25-01250

Affiliations

Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine

Abstract

Purpose: TAPUR is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations. Results of two cohorts of patients with urothelial (UC) or ovarian/fallopian tube cancer (OC/FTC) with ERBB2/3 alterations treated with pertuzumab plus trastuzumab (P + T) are reported.

Methods: Eligible patients had advanced cancer, measurable disease (RECIST), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, tumors with ERBB2/3 alterations, and no standard treatment options. The primary end point was disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16+ weeks duration. Simon's two-stage design is based on a null DC rate of 15% versus 35% (power = 0.85; α = .10). Secondary end points included OR, progression-free survival (PFS), overall survival (OS), duration of response, duration of SD, and safety.

Results: Patients with UC (n = 28) or OC/FTC (n = 25) with ERBB2/3 alterations were enrolled from March 2017 to June 2023. In the UC cohort, the DC and OR rates were 37% (90% CI, 24 to 100) and 25% (95% CI, 11 to 45), respectively. The null hypothesis of 15% DC rate was rejected (P = .005). In the OC/FTC cancer cohort, the DC and OR rates were 23% (90% CI, 9 to 100) and 8% (95% CI, 1 to 26), respectively. The null hypothesis of 15% DC rate was not rejected (P = .35). Six patients had at least one grade 3-5 adverse event (AE) or serious AE at least possibly related to treatment.

Conclusion: The combination of P + T met prespecified criteria to declare a signal of activity in patients with UC with ERBB2/3 alterations, but not in patients with OC/FTC.

Type

Article

PubMed ID

42060863