American Association for Cancer Research
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Supplementary Table 3 from Phase II Study of Eribulin plus Pembrolizumab in Metastatic Soft-tissue Sarcomas: Clinical Outcomes and Biological Correlates

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posted on 2024-04-01, 07:24 authored by Candace L. Haddox, Michael J. Nathenson, Emanuele Mazzola, Jia-Ren Lin, Joanna Baginska, Allison Nau, Jason L. Weirather, Edwin Choy, Adrian Marino-Enriquez, Jeffrey A. Morgan, Gregory M. Cote, Priscilla Merriam, Andrew J. Wagner, Peter K. Sorger, Sandro Santagata, Suzanne George

Supplementary Table 3. Soft tissue cancer statistics with respect to incidence, age, race/ethnicity, and geographical distribution in the United States.

Funding

National Cancer Institute (NCI)

United States Department of Health and Human Services

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McEvoy Ball Family Fund

Catherine England Leiomyosarcoma Fund

David Liposarcoma Research Initiative

History

ARTICLE ABSTRACT

Eribulin modulates the tumor-immune microenvironment via cGAS-STING signaling in preclinical models. This non-randomized phase II trial evaluated the combination of eribulin and pembrolizumab in patients with soft-tissue sarcomas (STS). Patients enrolled in one of three cohorts: leiomyosarcoma (LMS), liposarcomas (LPS), or other STS that may benefit from PD-1 inhibitors, including undifferentiated pleomorphic sarcoma (UPS). Eribulin was administered at 1.4 mg/m2 i.v. (days 1 and 8) with fixed-dose pembrolizumab 200 mg i.v. (day 1) of each 21-day cycle, until progression, unacceptable toxicity, or completion of 2 years of treatment. The primary endpoint was the 12-week progression-free survival rate (PFS-12) in each cohort. Secondary endpoints included the objective response rate, median PFS, safety profile, and overall survival (OS). Pretreatment and on-treatment blood specimens were evaluated in patients who achieved durable disease control (DDC) or progression within 12 weeks [early progression (EP)]. Multiplexed immunofluorescence was performed on archival LPS samples from patients with DDC or EP. Fifty-seven patients enrolled (LMS, n = 19; LPS, n = 20; UPS/Other, n = 18). The PFS-12 was 36.8% (90% confidence interval: 22.5–60.4) for LMS, 69.6% (54.5–89.0) for LPS, and 52.6% (36.8–75.3) for UPS/Other cohorts. All 3 patients in the UPS/Other cohort with angiosarcoma achieved RECIST responses. Toxicity was manageable. Higher IFNα and IL4 serum levels were associated with clinical benefit. Immune aggregates expressing PD-1 and PD-L1 were observed in a patient that completed 2 years of treatment. The combination of eribulin and pembrolizumab demonstrated promising activity in LPS and angiosarcoma.