Abstract 421P
Background
LEN is a multikinase inhibitor of VEGFRs 1–3, FGFRs 1–4, PDGFRα, RET, and KIT that resulted in significantly prolonged progression-free survival (PFS) compared with PBO in pts with RR-DTC in a phase III study (SELECT). However, SELECT did not include pts from China. As data in Chinese pts are required for approval of LEN for RR-DTC in China, we conducted a phase III study of RR-DTC treated with LEN vs PBO in Chinese pts.
Methods
This randomized, multicenter, double-blind, PBO-controlled study enrolled pts aged ≥18 years with RR-DTC and confirmed disease progression in the past 12 months. Pts were stratified by tumor subtype (papillary or follicular), number of prior VEGF/VEGFR-targeted therapies (0 or 1), and age (≤65 years or >65 years). LEN starting dose was 24 mg/day. The primary endpoint was PFS by independent imaging review based on RECIST v1.1. A one-sided significance level of 0.01 was utilized in the planned interim analysis. Secondary endpoints included overall response rate (ORR), overall survival, and safety.
Results
Overall, 151 Chinese pts (median age, 60 years; 52% men) were randomized 2:1 (LEN, n = 103; PBO, n = 48). At the recommendation of the Independent Data Monitoring Committee at the time of the interim analysis, the randomization phase of this study was stopped early because of positive efficacy and we conducted the primary analysis using the interim analysis cutoff date. In the LEN and PBO arms, the median durations of follow-up were 14.8 and 15.6 months, respectively. PFS was significantly improved with LEN (median 23.9 months; 95% CI 12.9–not estimable) vs PBO (median 3.7 months; 95% CI 1.9–5.6) (hazard ratio = 0.16, 95% CI 0.10–0.26; P < 0.0001 [logrank]). ORR was 69.9% with LEN and 0% with PBO. The most common treatment-related grade ≥3 adverse events (LEN, PBO) were hypertension (62.1%, 4.2%), proteinuria (23.3%, 0%), and palmar-plantar erythrodysesthesia syndrome (9.7%, 0%).
Conclusions
LEN significantly prolonged PFS compared with PBO in Chinese pts with RR-DTC, similar to the global phase III SELECT results. There were no new or unexpected toxicities with LEN in Chinese pts with RR-DTC.
Clinical trial identification
NCT02966093.
Editorial acknowledgement
Medical writing was provided by Oxford PharmaGenesis Inc., Newtown, PA, USA, and was funded by Eisai Inc., Woodcliff Lake, NJ, USA, and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Legal entity responsible for the study
Eisai Co., Ltd., Tokyo, Japan, and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA.
Funding
Eisai Inc. and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Disclosure
T. Kubota, T. Suzuki, H. Ikezawa: Full/Part-time employment: Eisai Co., Ltd. All other authors have declared no conflicts of interest.
Resources from the same session
14P - BRCA mutation and clinical outcomes in breast cancer focusing on survivals and failure patterns: A long-term follow-up study of Koreans
Presenter: Hakyoung Kim
Session: e-Poster Display Session
15P - Designing of multimodal targeted tumor-seeking nanomedicine for triple-therapeutic effect
Presenter: Vellingiri Yasothamani
Session: e-Poster Display Session
16P - Topical henna cream in prevention of radiation-induced dermatitis in breast cancer: A randomized double-blind clinical trial
Presenter: Mansour Lesan
Session: e-Poster Display Session
17P - Comparison of dose distribution in the postoperative breast cancer patients irradiated with the technique of deep inspiratory breath hold and dynamic techniques
Presenter: Ewa Telka
Session: e-Poster Display Session
18P - A prospective randomized study comparing cosmetic outcome of sequential electron boost versus simultaneous integrated boost with IMRT to lumpectomy cavity during adjuvant radiotherapy to breast following BCS in carcinoma breast in Indian patients
Presenter: Sravya Bommera
Session: e-Poster Display Session
19P - Musculoskeletal pain and health-related quality of life among breast cancer patients
Presenter: Aslin Valiyagath
Session: e-Poster Display Session
20P - Molecular parallelisms and divergences between human and canine cancers
Presenter: Sadaf Ambreen
Session: e-Poster Display Session
21P - Neoadjuvant trastuzumab and pertuzumab in real-world data population in two medical institutions in Portugal
Presenter: Isabel Gomes Fernandes
Session: e-Poster Display Session
22P - Correlation of muscle strength and quality of life in Indonesian breast cancer patients who underwent chemotherapy
Presenter: Devina Halim
Session: e-Poster Display Session
23P - Oncotype DX RS correlation with clinicopathologic risk factors and chemotherapy: Follow up based on TAILORx study
Presenter: Faroug Ali
Session: e-Poster Display Session