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Poster display session

3344 - Sacituzumab govitecan (IMMU-132) for patients with pretreated metastatic urothelial uancer (UC): interim results

Date

10 Sep 2017

Session

Poster display session

Presenters

Scott Tagawa

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

S.T. Tagawa1, B. Faltas1, E. Lam2, P. Saylor3, A. Bardia3, J. Hajdenberg4, A.K. Morgans5, E. Lim6, K. Kalinsky6, D.P. Petrylak7, M. Guarino8, M.D. Galsky9, P. Maliakal10, B. Mudenda10, R. Sharkey10, W. Wegener10, D. Goldenberg10

Author affiliations

  • 1 Hematology And Medical Oncology, Weill Cornell Medical College, 10065 - New York/US
  • 2 Division Of Medical Oncology, University of Colorado, Denver/US
  • 3 Medical Oncology, Massachusetts General Hospital, Boston/US
  • 4 Medical Oncology, University of Florida Health Cancer Center, Orlando/US
  • 5 Medical Oncology, Vanderbilt Ingram Cancer Center, Nashville/US
  • 6 Medical Oncology, Columbia University-Herbert Irving Comprehensive Cancer Center, New York/US
  • 7 Smilow Cancer Center, Yale University School of Medicine Medical Oncology, 06520-8032 - New Haven/US
  • 8 Helen F. Graham Cancer Center, Christiana Care Health System, Newark/US
  • 9 Department Of Medicine, Icahn School of Medicine at Mount Sinai, New York/US
  • 10 Oncology, Immunomedics, Inc., Morris Plains/US
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Resources

Abstract 3344

Background

Pts with metastatic UC have limited therapy options. Immune checkpoint inhibitors (CPI) are now given to patients with advanced UC, but only about 25% respond. We are studying the safety and efficacy of sacituzumab govitecan (IMMU-132), an anti-Trop-2/SN-38 antibody-drug conjugate, in pts with UC refractory to other therapies.

Methods

In this phase I/II study (NCT01631552), pts with metastatic UC who progressed after ≥1 prior systemic therapy were treated with IMMU-132 at 10 mg/kg on days 1 and 8 of 21-day cycles, until progression or unacceptable toxicity. All intention-to-treat (ITT) pts, including those who relapsed/progressed after CPI therapy, are evaluated for safety, ORR by RECIST 1.1 (confirmed PR/CR), PFS, and OS. Response-evaluable (RE) pts received ≥ 2 doses and ≥ 1 post-baseline CT (RECIST 1.1) assessment.

Results

41 pts (39M/2F; median age 68 y, range 50-91) were enrolled (RE = 36); ECOG 0/1: 31%/69%; median of 3 (range 1-6) prior therapies, including 34/41 platinum and 15/41 CPI regimens. Metastatic sites: lymph node 68%, lungs 54%, liver 32%, bone 27%; overall visceral disease, 31/41 (76%). Pts received a median of 12 (range 1-58) doses. ORR in the ITT population was 34% [14/41 (1 CR, 13 PR); ORR was 39% in the RE group, including 5/13 (39%) with liver mets]; 14 SD (39%); 8 PD (20%), and 5 inevaluable. In responders, 13/14 had prior platinum, 8/14 (57%) ≥3 prior therapies, and 4 prior CPI [4/13 in the RE group (31%), where IMMU-132 was ≥4th line of therapy in 11/13 pts]. Median time to response: 1.9 mos. Median duration of response: 12.9 mos (95%CI, 5.1-12.9), with 8/14 continuing therapy. Clinical benefit rate (CR+PR+SD≥6 mos) is 44%; 56% for SD ≥ 4 mos. In the 41 ITT pts, median PFS and OS are 7.2 (95% CI, 5.0-10.7) and 15.5 mos (95% CI, 8.9-17.2), respectively. Grade ≥3 adverse events ≥5% were 28% neutropenia, 9% febrile neutropenia, 9% fatigue, 9% anemia, 6% diarrhea.

Conclusions

With an ITT ORR of 34%, PFS of 7.2 mos, OS of 15.5 mos, and duration of response of 12.9 mos in 41 unselected pts with advanced pretreated UC (median of 3 prior therapies), these interim results show IMMU-132 is a promising agent in pts relapsed/refractory to chemotherapy and immune checkpoint inhibitors.

Clinical trial identification

NCT01631552

Legal entity responsible for the study

Immunomedics, Inc.

Funding

Immunomedics, Inc.

Disclosure

S.T. Tagawa: Received honoraria for consulting from Immunomedics; Weill Cornell has received research funding from Immunomedics. B. Faltas: Weill Cornell received research funding from Immunomedics, Inc. P. Maliakal, B. Mudenda, R. Sharkey, W. Wegener, D. Goldenberg: Employed by Immunomedics, Inc. All other authors have declared no conflicts of interest.

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