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Poster Discussion session -Gastrointestinal, non-colorectal

2247 - CARRIE: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Istiratumab (MM-141) plus Nab-Paclitaxel and Gemcitabine versus Nab-Paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer


19 Oct 2018


Poster Discussion session -Gastrointestinal, non-colorectal


Cytotoxic Therapy;  Clinical Research

Tumour Site

Pancreatic Adenocarcinoma


Andrew Ko


A.H. Ko1, A. Cubillo2, M. Kundranda3, S.F. Zafar4, E. Meiri5, J. Bendell6, H. Alguel7, F. Rivera Herrero8, E. Ahn9, D. Watkins10, U.-. Pelzer11, V. Charu12, W. Downing13, B. Wang13, G. Kuesters13, J.M. Pipas13, S.L. Santillana13, V. Askoxylakis13

Author affiliations

  • 1 Medicine (hematology & Oncology), University of California San Francisco Cancer Center, 94143-1705 - San Francisco/US
  • 2 Medical Oncology, Hospital Madrid Norte San Chinarro Centro Integral Oncologico Clara Campal, 28050 - Madrid/ES
  • 3 Gastrointestinal Medical Oncology, Medical Oncology, Banner MD Anderson Cancer Center, 85234 - Gilbert/US
  • 4 Medical Oncology, Florida Cancer Specialists, 33908 - Fort Myers/US
  • 5 Medical Oncology, Cancer Treatment Centers of America, 30265 - Newnan/US
  • 6 Gi Oncology Research, Sarah Cannon Research Institute/Tennessee Oncology, 37923 - Nashville/US
  • 7 Gastrointestinal Tumors And Inflammation Research, Rechts der Isar Hospital, 81675 - Munich/DE
  • 8 Medical Oncology, Hospital Universitario Marques de Valdecilla, 39008 - Santander/ES
  • 9 Medical Oncology And Hematology, Cancer Treatment Centers of America, 60099 - Zion/US
  • 10 Gastrointestinal Unit/medical Oncology, Royal Marsden Hospital, SM2 5PT - Sutton/GB
  • 11 Department Of Hematology, Oncology And Tumor Immunology, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, 13353 - Berlin/DE
  • 12 Hematology/oncology, Pacific Cancer Medical Center, 92801 - Anaheim/US
  • 13 Clinical research, Merrimack Pharmaceuticals, Inc., MA 02139 - Cambridge/US


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Abstract 2247


High serum IGF-1 levels have been associated with more aggressive pancreatic cancer (PDAC). Pre-clinical data suggest that dual blockade of the IGF-1 and HER3 pathways has superior activity to IGF-1 blockade alone in PDCA. We tested whether istiratumab, an IGF-1R and ErbB3 bi-specific antibody, can enhance the efficacy of standard of care (SOC) chemotherapy in patients with high serum IGF-1 levels.


CARRIE was a randomized, double-blind, placebo-controlled, international Phase 2 study of nab-paclitaxel/gemcitabine alone or in combination with istiratumab in front-line metastatic PDAC. In Part 1, 10 patients were evaluated for PK and safety. In Part 2, patients with high free serum IGF-1 levels were randomized 1:1 to receive either istiratumab (2.8 g. IV Q2W) or placebo plus nab-paclitaxel/gemcitabine at the approved dose schedule. Heregulin (HRG) was tested in pre-treatment tumor samples. The co-primary endpoints were Progression Free Survival (PFS) in patients with high IGF-1 levels and in patients with both high IGF-1 levels and HRG+ tumors. Key secondary endpoints included Overall Survival (OS), Objective Response Rate (ORR) by RECIST v1.1, and adverse events (AEs) rate.


A total of 317 patients were screened to enroll 88 patients (experimental arm n=43; control n=45) in Part 2. In the high IGF-1 cohort, median PFS was 3.6 and 7.3 months in the experimental vs. control arms, respectively (HR=1.88, p=0.027). In the combined high IGF-1/HRG+ subgroup (n=44), median PFS was 4.1 and 7.3 months, respectively (HR=1.39, p=0.42). Median OS and ORR for the overall population were similar between two arms (8.9 and 11.7 months, HR=1.36, p=0.22 and 39.5 vs. 51.2%, p=0.33, respectively). No significant difference in serious or Grade > 3 AEs was observed, although low-grade AEs leading to early discontinuation were higher in the experimental (39.5%) vs. control arm (24.4%).


Istiratumab failed to improve the efficacy of SOC chemotherapy in the front-line treatment of patients with metastatic PDAC and high IGF-1. High serum IGF-1 levels did not appear to be an adverse prognostic factor in this setting.

Clinical trial identification

Clinical trial information: NCT02399137.

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