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- Adi Diab
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Scott S. Tykodi
- University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA
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- Gregory A. Daniels
- University of California, La Jolla, San Diego, CA
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- Michele Maio
- Azienda Ospedaliera Universitaria Senese, Siena, Italy
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- Brendan D. Curti
- Providence Cancer Institute and Earle A. Chiles Research Institute, Portland, OR
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- Karl D. Lewis
- University of Colorado Cancer Center, Aurora, CO
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- Sekwon Jang
- Inova Schar Cancer Institute, Fairfax, VA
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- Ewa Kalinka
- Polish Mother's Memorial Hospital—Research Institute, Lodz, Poland
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- Igor Puzanov
- Roswell Park Comprehensive Cancer Center, Buffalo, NY
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- Alexander I. Spira
- Virginia Cancer Specialists, Fairfax, VA
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- Daniel C. Cho
- Perlmutter Cancer Center at NYU Langone Medical Center, New York, NY
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- Shanhong Guan
- Nektar Therapeutics, San Francisco, CA
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- Erika Puente
- Nektar Therapeutics, San Francisco, CA
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- Tuan Nguyen
- Nektar Therapeutics, San Francisco, CA
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- Ute Hoch
- Nektar Therapeutics, San Francisco, CA
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- Sue L. Currie
- Nektar Therapeutics, San Francisco, CA
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- Wei Lin
- Nektar Therapeutics, San Francisco, CA
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- Mary A. Tagliaferri
- Nektar Therapeutics, San Francisco, CA
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- Jonathan Zalevsky
- Nektar Therapeutics, San Francisco, CA
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- Mario Sznol
- Yale School of Medicine, New Haven, CT
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- Michael E. Hurwitz
- Yale School of Medicine, New Haven, CT
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説明
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> Therapies that produce deep and durable responses in patients with metastatic melanoma are needed. This phase II cohort from the international, single-arm PIVOT-02 study evaluated the CD122-preferential interleukin-2 pathway agonist bempegaldesleukin (BEMPEG) plus nivolumab (NIVO) in first-line metastatic melanoma. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> A total of 41 previously untreated patients with stage III/IV melanoma received BEMPEG 0.006 mg/kg plus NIVO 360 mg once every 3 weeks for ≤ 2 years; 38 were efficacy-evaluable (≥ 1 postbaseline scan). Primary end points were safety and objective response rate (blinded independent central review); other end points included progression-free survival, overall survival (OS), and exploratory biomarkers. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> At 29.0 months' median follow-up, the objective response rate was 52.6% (20 of 38 patients), and the complete response rate was 34.2% (13 of 38 patients). Median change in size of target lesions from baseline was −78.5% (response-evaluable population); 47.4% (18 of 38 patients) experienced complete clearance of target lesions. Median progression-free survival was 30.9 months (95% CI, 5.3 to not estimable). Median OS was not reached; the 24-month OS rate was 77.0% (95% CI, 60.4 to 87.3). Grade 3 and 4 treatment-related and immune-mediated adverse events occurred in 17.1% (7 of 41) and 4.9% (2 of 41) of patients, respectively. Increased polyfunctional responses in CD8+ and CD4+ T cells were seen in blood after treatment, driven by cytokines with effector functions. Early on-treatment blood biomarkers (CD8+ polyfunctional strength difference and eosinophils) correlated with treatment response. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> BEMPEG in combination with NIVO was tolerated, with relatively low rates of grade 3 and 4 treatment-related and immune-mediated adverse events. The combination had encouraging antitumor activity in first-line metastatic melanoma, including an extended median progression-free survival. Exploratory analyses associated noninvasive, on-treatment biomarkers with response, before radiologic evidence was observed. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 39 (26), 2914-2925, 2021-09-10
American Society of Clinical Oncology (ASCO)