A phase Ib/II study of eribulin (ERI) plus pembrolizumab (PEMBRO) in metastatic triple-negative breast cancer (mTNBC) (ENHANCE 1)
| Autor: | Vassiliki Karantza, Sharon Wilks, Michaela L. Tsai, Dongyuan Xing, Grace Wang, Debra A. Patt, Yuan Yuan, D. R. D'Adamo, Sara M. Tolaney, Kevin Kalinsky, Peter A. Kaufman, Gursel Aktan, Virginia G. Kaklamani, Sami Diab, Ella Kleynerman, Eleni Andreopoulou, Ruth O'Regan |
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| Rok vydání: | 2020 |
| Předmět: |
Antitumor activity
Cancer Research business.industry Blocking (radio) medicine.medical_treatment Immunotherapy Pembrolizumab 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Oncology chemistry 030220 oncology & carcinogenesis Microtubule Inhibitor medicine Cancer research business Triple-negative breast cancer 030215 immunology Programmed death Eribulin |
| Zdroj: | Journal of Clinical Oncology. 38:1015-1015 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2020.38.15_suppl.1015 |
| Popis: | 1015 Background: As monotherapies, both ERI (a chemotherapeutic microtubule inhibitor) and PEMBRO (a programmed death [PD]-1 blocking immunotherapy) have shown promising antitumor activity in mTNBC. Emerging data suggest that the addition of immunotherapy to traditional chemotherapy holds promise for mTNBC. This open-label, single-arm, phase 1b/2 study evaluated the safety and efficacy of ERI + PEMBRO in mTNBC. Methods: Patients (pts) with mTNBC and ≤2 prior systemic anticancer therapies for metastatic disease were enrolled and stratified by prior number of therapy (Stratum 1, 0; Stratum 2, 1–2). Pts received IV ERI 1.4 mg/m2 on day (d)1 and d8 and IV PEMBRO 200 mg on d1 of a 21-d cycle. The primary objectives were safety and objective response rate (ORR per RECIST 1.1 by independent imaging review). Assessments also included efficacy outcomes by PD ligand-1 (PD-L1) expression status; PD-L1+ was defined as a combined positive score ≥1 using the PD-L1 IHC 22C3 pharmDx. Results: As of data cutoff (July 31, 2019), 167 pts (Stratum 1, n=66; Stratum 2, n=101) were enrolled and treated. No dose-limiting toxicities were observed. The most common treatment-emergent adverse events were fatigue (66%), nausea (57%), peripheral sensory neuropathy (41%), alopecia (40%), and constipation (37%). No deaths were considered treatment related. The overall ORR was 23.4% (95% CI: 17.2–30.5). Efficacy outcomes by PD-L1 status (PD-L1+, n=74; PD-L1-, n=75) and stratum are presented (table). Conclusions: ERI + PEMBRO has activity in pts with mTNBC. There was a trend toward more robust activity for the combination among patients with PD-L1+ tumors compared to PD-L1- tumors in the first-line setting (Stratum 1); whereas, in the later-line setting (Stratum 2) similar survival outcomes were observed among the PD-L1+ and PD-L1- pts. ERI + PEMBRO shows promise for mTNBC with efficacy that appears greater than historical reports of either agent alone. Clinical trial information: NCT02513472 . [Table: see text] |
| Databáze: | OpenAIRE |
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