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Poster display session

4285 - A Phase II Trial of Mirvetuximab Soravtansine in Patients with Localized Triple-Negative Breast Cancer (TNBC) with Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NACT) Including a Lead-in Cohort to Establish Activity in Patients with Metastatic TNBC.

Date

11 Sep 2017

Session

Poster display session

Presenters

Senthil Damodaran

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

S. Damodaran1, F. Symmans2, T. Helgason1, E.A. Mittendorf3, D. Tripathy4, K. Hess5, J. Litton6, S. Moulder1

Author affiliations

  • 1 Breast Medical Oncology, The M. D. Anderson Cancer Center, 77030 - Houston/US
  • 2 Department Of Pathology, MD Anderson Cancer Center, Houston/US
  • 3 Breast Surgical Oncology, University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 4 Department Of Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 5 Department Of Biostatistics, MD Anderson Cancer Center, Houston/US
  • 6 Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
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Resources

Abstract 4285

Background

While TNBC patients with pCR/RCB-0 or RCB-1 have excellent survival, those with extensive residual disease (RCB-II or RCB-III) after NACT have poor prognosis. At MD Anderson, through the Moonshot Initiative, we have created a biomarker-driven drug development strategy, ARTEMIS (A Randomized, TNBC Enrolling trial to confirm Molecular profiling Improves Survival) to identify novel targeted therapies for tumors that are predicted to be insensitive to standard NACT. Molecular profiling along with imaging is used to identify patients with chemo-insensitive disease and inform second phase of therapy incorporating targeted agents to improve responses. Folate receptor α (FRα) is a GPI-anchored surface protein encoded by FOLR1 gene that is overexpressed in multiple cancers including TNBC. Mirvetuximab soravtansine is an antibody-drug conjugate that consists of a monoclonal antibody against FRα conjugated to maytansinoid, a microtubule inhibitor. Nearly 40% of TNBC express high levels of FRα, suggesting that FRα directed therapy is a viable therapeutic strategy.

Trial design

The study will include a lead in cohort (Cohort A) to establish efficacy in metastatic TNBC patients and a neoadjuvant cohort (Cohort B) to determine activity in chemo-insensitive, localized TNBC patients. If > 2 patients in Cohort A have response, the neoadjuvant cohort will be activated. Patients deemed to have chemo-insensitive, FRα+ TNBC identified through the ARTEMIS are eligible for Cohort B. The primary objectives are to determine the response rate of single agent mirvetuximab in metastatic FRa+ TNBC (> 2 lines of therapy) and to determine if mirvetuximab would improve the rates of neoadjuvant pathologic response (pCR or RCB-I) from 5% to 20% in patients with high risk, chemo-insensitive, FRa+ TNBC. A two-stage Gehan-type design with 14 patients in the first stage will be employed for the neoadjuvant cohort (n = 37). Mirvetuximab will be given IV every 21 days (6 mg/kg). Correlatives include assessment of FOLR1/FRα and characterization of biomarkers of immune modulation.

Clinical trial identification

NCT03106077

Legal entity responsible for the study

M.D. Anderson Cancer Center

Funding

NCCN

Disclosure

All authors have declared no conflicts of interest.

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