Eisai announce updated analysis of a global Phase Ib/II clinical study of its in-house anticancer agent eribulin mesylate in combination with the anti-PD-1 therapy pembrolizumab developed by Merck

Eisai Co., Ltd. have announced that a presentation on the updated analysis of a global Phase Ib/II clinical study (ENHANCE 1 / Study 218) of its in-house discovered and developed anticancer agent eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: Halaven®, “eribulin”) in combination with the anti-PD-1 therapy pembrolizumab (product name: KEYTRUDA®) developed by Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), in patients with metastatic triple-negative breast cancer was given at a spotlight session of the 40th Annual San Antonio Breast Cancer Symposium (SABCS) held from December 5 to 9, 2017.

Both companies are cooperatively developing the combination.

ENHANCE 1 is a multicenter, single-arm, open-label Phase Ib/II clinical study which examined the activity and safety of eribulin in combination with pembrolizumab in patients with metastatic triple-negative breast cancer previously treated with 0 – 2 lines of chemotherapy in the metastatic setting. The primary objective of the Phase Ib part was safety and tolerability, and the primary objective of the Phase II part was objective response rate (ORR).

This presentation reported on an updated analysis of 106 evaluable patients out of the 107 patients enrolled in the study as of May 31, 2017. Eribulin (1.4 mg/m² intravenously on Day 1 and Day 8) and pembrolizumab (200 mg intravenously on Day 1) were administered to patients over 21 day cycles. The combination achieved an ORR of 26.4% (3 patients experienced a complete response and 25 patients experienced a partial response, 95% CI = 18.3-35.9). In addition, the ORRs were similar regardless of PD-L1 status or prior chemotherapy, and of the 3 patients who experienced a complete response, 1 patient was PD-L1 negative.
Regarding secondary objectives, favorable results were suggested with median progression free survival (PFS) of 4.2 months (95% CI = 4.1-5.6) and median overall survival (OS) of 17.7 months (95% CI = 13.7-not estimable). Furthermore, median duration of response (DOR) was 8.3 months for the 28 patients who achieved a complete or partial response.
In this study, the five most common treatment-emergent adverse events in patients were fatigue, peripheral neuropathy, nausea, alopecia, and constipation.

Other presentations at the symposium include an update from a Phase II clinical study of administration of eribulin in 14 day cycles as well as the latest non-clinical data on H3B-6545 (selective estrogen receptor α covalent antagonist), discovered by Eisai’s U.S. research subsidiary H3 Biomedicine Inc.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. As exemplified by this combination regimen, Eisai remains committed to providing further clinical evidence for eribulin aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, cancer patients, their families, and healthcare providers.

^*KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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Eisai, Merck