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A. Armour
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-027 - Phase I and PK Study of the Folate Receptor-Targeted Small Molecule Drug Conjugate (SMDC) EC1456 in Advanced Cancer: Lung Cancer Subset (ID 5202)
14:30 - 14:30 | Author(s): A. Armour
- Abstract
Background:
EC1456 is composed of folic acid conjugated through a releasable linker system to a potent microtubule inhibitor, tubulysin B hydrazide. EC1456 targets folate receptor (FR)-expressing cancer cells, which occur in approximately 60% of NSCLC cases and 14% of SCLC.
Methods:
The objectives of the ongoing Phase 1 are to determine the safety, PK, and optimal dosing schedule of EC1456 in advanced cancer pts. FR expression (not required for enrollment) is characterized in all pts using [99m]Tc-etarfolatide.
Results:
63 pts were dosed weekly (QW) or twice-weekly (BIW), for 2 consecutive weeks of a 3-week cycle. 8 NSCLC and 3 SCLC pts received doses ranging from 1.0-12.5 mg/m[2]. Toxicities are primarily Grade (Gr) 1 and 2. Common adverse events (AE) are GI, fatigue, and metabolic changes. Gr 3 infusion reaction (4.5 mg/m[2]) and Gr 3 headache (10.0 mg/m[2]) were seen in the QW cohort. The safety profile in lung cancer pts was similar to the overall population.
Response and durability of response is demonstrated in the figure: Figure 1BIW (N=32) QW (N=31) BIW Lung (N=4) QW Lung (N=7) All Drug Related All Drug Related All Drug Related All Drug Related ≥ 1 AE 32 (100%) 25 (78%) 29 (94%) 23 (74%) 4 (100%) 4 (100%) 7 (100%) 4 (57%) ≥ 1 grade 3 or 4 AE 19 (59%) 6 (19%) 14 (45%) 4 (13%) 2 (50%) 0 (0%) 1 (14%) 0 (0%) ≥ 1 serious AE 12 (38%) 2 (6%) 14 (45%) 5 (16%) 1 (25%) 0 (0%) 2 (29%) 0 (0%) Serious drug related AEs Constipation (2/63 pts); Abd pain, Anemia, Headache, Infusion reactions, and SVT(1/63 pts each)
Conclusion:
EC1456 is well tolerated, with early indications of efficacy suggested by durable stable disease, and responses in this refractory population. Updated safety, PK, and efficacy data will be presented at the meeting.
