1205P - Phase II Study of Two Eribulin Regimens in Combination with Erlotinib in Patients (PTS) with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

Abstract

ABSTRACT Background Eribulin, a microtubule dynamics inhibitor, is approved for pts with locally advanced/metastatic breast cancer that progressed after ≥2 chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and taxane unless not suitable. This randomized, multicenter study compared efficacy and tolerability of two eribulin regimens administered sequentially with erlotinib in pts with advanced NSCLC to establish an optimal dosing schedule. Table: 1205P 21D 28D Median no. cycles (range) Pts completing ≥6 cycles, % 3 (1-31) 36.5 4 (1-23) 36.7 ORR a Partial response (PR) b Stable disease (SD)b DCR (Complete response + PR + SD)a 12.7 (5.6, 23.5) 8 (12.7) 22 (34.9) 47.6 (34.9, 60.6) 16.7(8.3, 28.5 ) 10 (16.7) 28 (46.7) 63.3 (49.9, 75.4) PFSc OSc 3.5 (1.9, 4.7) 7.6 (6.3,12.1) 3.8 (3.3, 5.5) 8.5 (6.2,13.1) Adverse events of interest (grade ≥3), % Diarrhea Neutropenia Peripheral neuropathy Rash 6.3 44.4 3.2 6.3 1.7 38.3 0 1.6 a % (95% CI) b n (%) cmedian, months (95% CI). Methods Pts (ECOG ≤2; ≥1 prior anti-cancer therapy for advanced NSCLC including ≥1 platinum-based therapy) received 2.0 mg/m2 eribulin mesilate (2-5 min IV) on Day (D) 1 and 150 mg oral erlotinib on D2-16 (21D cycle), or 1.4 mg/m2 eribulin mesilate on D1 and D8 and 150 mg erlotinib on D15-28 (28D cycle). Primary endpoint was objective response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), safety, pharmacokinetics and biomarker (BM) assessment. Results 123 pts were treated (63 pts 21D cycle, 60 pts 28D cycle). Median age was 63 years (range 35-87), 53.7% male, 75.6% smokers, 65.9% stage IV disease and 91.1% ≥2 prior therapy for advanced NSCLC. ORR was 12.7% (21D) and 16.7% (28D); other efficacy parameters were also greater with the 28D cycle. Concomitant administration of erlotinib did not affect eribulin exposure and was well tolerated with no unexpected toxicities. BM analysis supported overall results. Conclusions Both regimens were associated with moderate activity in this heavily pre-treated population. The 28D regimen appears to have greater activity and less toxicity than the 21D. Disclosure S. Thongprasert: The author declares the following conflicts of interest: consultant/advisory role (Novartis/Pfizer/Eli Lilly), honoraria (AstraZeneca/Roche), and research funding (Novartis/Pfizer/Roche). D. Smith: The author declares the following conflicts of interest: research funding (Eisai). P. Gopalakrishna: The author declares the following conflicts of interest: employee (Eisai Ltd. C. Reynolds: The author declares the following conflicts of interest: honoraria/speakers bureau (Eisai). T.S.K. Mok: Consultant/advisory role (AstraZeneca /Pfizer/Eli Lilly/Roche/Merck Serono/Eisai/BMS/BeiGene/AVEO/Taiho/BI), honoraria (AstraZeneca/Roche Pfizer/Eli Lilly/ Merck Serono/Eisai/BMS/BeiGene/AVEO /Taiho/BI), research funding (AstraZeneca). All other authors have declared no conflicts of interest.