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Cancer Therapy: Clinical

Phase II Clinical Trial of Amatuximab, a Chimeric Antimesothelin Antibody with Pemetrexed and Cisplatin in Advanced Unresectable Pleural Mesothelioma

Raffit Hassan, Hedy L. Kindler, Thierry Jahan, Lyudmila Bazhenova, Martin Reck, Anish Thomas, Ira Pastan, Jeff Parno, Daniel J. O'Shannessy, Penny Fatato, Julia D. Maltzman and Bruce A. Wallin
Raffit Hassan
1Thoracic and GI Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
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  • For correspondence: hassanr@mail.nih.gov
Hedy L. Kindler
2University of Chicago, Chicago, Illinois.
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Thierry Jahan
3University of California, San Francisco, California.
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Lyudmila Bazhenova
4University of California, San Diego, California.
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Martin Reck
5Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Stormarn, Germany.
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Anish Thomas
1Thoracic and GI Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
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Ira Pastan
6Laboratory of Molecular Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
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Jeff Parno
7United BioSource Corp., Blue Bell, Pennsylvania.
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Daniel J. O'Shannessy
8Morphotek, Inc., Exton, Pennsylvania.
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Penny Fatato
8Morphotek, Inc., Exton, Pennsylvania.
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Julia D. Maltzman
8Morphotek, Inc., Exton, Pennsylvania.
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Bruce A. Wallin
8Morphotek, Inc., Exton, Pennsylvania.
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DOI: 10.1158/1078-0432.CCR-14-0804 Published December 2014
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Abstract

Purpose: Amatuximab is a chimeric monoclonal antibody to mesothelin, a cell surface glycoprotein highly expressed in malignant pleural mesothelioma (MPM). On the basis of its synergy with chemotherapy in preclinical studies, we evaluated the antitumor activity of amatuximab plus pemetrexed and cisplatin in patients with unresectable MPM.

Experimental Design: In a single-arm phase II study, amatuximab (5 mg/kg) was administered on days 1 and 8 with pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) on day 1 of 21-day cycles for up to six cycles. Patients with response or stable disease received amatuximab maintenance until disease progression. Primary endpoint was progression-free survival (PFS) at 6 months. Secondary endpoints were overall survival (OS), response rate, and safety.

Results: Eighty-nine patients were enrolled at 26 centers. Median of five cycles (range, 1–6) of combination treatment was administered, and 56 (63%) patients received amatuximab maintenance. Combination therapy resulted in no overlapping toxicities. Eleven patients (12.4%) had amatuximab-related hypersensitivity reactions. Responses included partial responses in 33 (40%) and stable disease in 42 (51%). Six-month PFS rate was 51% [95% confidence interval (CI), 39.1–62.3)], median PFS was 6.1 months (95% CI, 5.8–6.4), and median OS was 14.8 months (95% CI, 12.4–18.5) with 29 patients alive at data cut-off.

Conclusions: Amatuximab with pemetrexed and cisplatin was well tolerated with objective tumor response or stable disease rate of 90% by independent radiologic review. Although PFS was not significantly different from historical controls, the median OS was 14.8 months with a third of patients alive and 5 continuing to receive amatuximab at the time of analysis. Clin Cancer Res; 20(23); 5927–36. ©2014 AACR.

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Received April 2, 2014.
  • Revision received July 15, 2014.
  • Accepted August 27, 2014.
  • ©2014 American Association for Cancer Research.
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Clinical Cancer Research: 20 (23)
December 2014
Volume 20, Issue 23
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Phase II Clinical Trial of Amatuximab, a Chimeric Antimesothelin Antibody with Pemetrexed and Cisplatin in Advanced Unresectable Pleural Mesothelioma
Raffit Hassan, Hedy L. Kindler, Thierry Jahan, Lyudmila Bazhenova, Martin Reck, Anish Thomas, Ira Pastan, Jeff Parno, Daniel J. O'Shannessy, Penny Fatato, Julia D. Maltzman and Bruce A. Wallin
Clin Cancer Res December 1 2014 (20) (23) 5927-5936; DOI: 10.1158/1078-0432.CCR-14-0804

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Phase II Clinical Trial of Amatuximab, a Chimeric Antimesothelin Antibody with Pemetrexed and Cisplatin in Advanced Unresectable Pleural Mesothelioma
Raffit Hassan, Hedy L. Kindler, Thierry Jahan, Lyudmila Bazhenova, Martin Reck, Anish Thomas, Ira Pastan, Jeff Parno, Daniel J. O'Shannessy, Penny Fatato, Julia D. Maltzman and Bruce A. Wallin
Clin Cancer Res December 1 2014 (20) (23) 5927-5936; DOI: 10.1158/1078-0432.CCR-14-0804
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