Pertuzumab Plus Trastuzumab in Patients With Endometrial Cancer With ERBB2/3 Amplification, Overexpression, or Mutation: Results From the TAPUR Study

Author:

Ahn Eugene R.1,Rothe Michael2,Mangat Pam K.2ORCID,Garrett-Mayer Elizabeth2ORCID,Ali-Ahmad Hussein M.3,Chan John4ORCID,Maitland Michael L.56ORCID,Patel Sapna R.7,Reese Zachary8,Balmanoukian Ani S.9,Drescher Charles W.10ORCID,Li Rui11,Tsimberidou Apostolia M.12ORCID,Leath Charles A.13,O'Lone Raegan2,Grantham Gina N.2ORCID,Halabi Susan14ORCID,Schilsky Richard L.2

Affiliation:

1. Cancer Treatment Centers of America—Chicago, part of City of Hope, Zion, IL

2. American Society of Clinical Oncology, Alexandria, VA

3. Michigan Cancer Research Consortium, Lansing, MI

4. Sutter Cancer Research Consortium, San Francisco, CA

5. Inova Schar Cancer Institute, Fairfax, VA

6. University of Virginia Comprehensive Cancer Center, Charlottesville, VA

7. Cancer Research Consortium of West Michigan, St Joseph, MI

8. Intermountain Healthcare, Murray, UT

9. The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Los Angeles, CA

10. Swedish Cancer Institute, Seattle, WA

11. Providence Cancer Institute, Providence Portland Medical Center, Portland, OR

12. The University of Texas MD Anderson Cancer Center, Houston, TX

13. O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham School of Medicine, Birmingham, AL

14. Duke University Medical Center, Durham, NC

Abstract

PURPOSE The TAPUR Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from a cohort of patients with endometrial cancer (EC) with ERBB2 or ERBB3 (ERBB2/3) amplification, overexpression, or mutation treated with pertuzumab plus trastuzumab (P + T) are reported. METHODS Eligible patients had advanced EC, no standard treatment options, measurable disease (RECIST v1.1), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and tumors with ERBB2/3 amplification, overexpression, or mutation. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16 weeks (SD16+) duration. Secondary end points include safety, duration of response, duration of SD, progression-free survival (PFS), and overall survival (OS). RESULTS Twenty-eight patients were enrolled from March 2017 to November 2019; all patients were evaluable for efficacy and toxicity. Seventeen patients had tumors with ERBB2/3 amplification and/or overexpression, eight with both ERBB2 amplification and ERBB2/3 mutations, and three with only ERBB2 mutations. Ten patients had DC (two partial response and eight SD16+); all 10 had ERBB2 amplification, and 6 of the 10 patients with DC had >1 ERBB2/3 alteration. DC and OR rates were 37% (95% CI, 21 to 50) and 7% (95% CI, 1 to 24), respectively; the median PFS and median OS were 16 weeks (95% CI, 10-28) and 61 weeks (95% CI, 24-105), respectively. One patient experienced a grade 3 serious adverse event (muscle weakness) at least possibly related to P + T. CONCLUSION P + T has antitumor activity in heavily pretreated patients with EC with ERBB2 amplification and warrants additional study.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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