Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 27, No 15S (May 20 Supplement), 2009: 5501
© 2009 American Society of Clinical Oncology

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Abstract

A randomized phase II placebo-controlled trial using maintenance therapy to evaluate the vascular targeting agent BIBF 1120 following treatment of relapsed ovarian cancer (OC)

CR-UK & UCL Cancer Trials Centre, London, United Kingdom; Mount Vernon Cancer Centre, Northwood, United Kingdom; Royal Marsden Hospital, Sutton, United Kingdom; Christie Hospital, Manchester, United Kingdom; Imperial College, London, United Kingdom; Boehringher Ingelheim, Bracknell, United Kingdom

5501

Background: BIBF 1120 is a new targeted therapeutic agent for maintenance therapy in OC. It is a unique triple angiokinase inhibitor, targeting 3 receptor classes involved in the formation of blood vessels (VEGFR, PDGFR, and FGFR). Methods: Continuous BIBF 1120 (250 mg, oral, twice daily) for up to 9 months (mo) was compared with placebo in a novel application of a randomized double-blind trial in pts who responded to their last (at least second line) chemotherapy. The primary endpoint, progression-free survival at 36 weeks, was confirmed by CT assessment, performed at 12-week intervals. Results: 84 pts were randomized (44 BIBF 1120; 40 placebo), mean age 60y (range 27–76). All had responded according to GCIG criteria. Treatment-free interval before prior chemotherapy was <6 mo for 41% and 6–12 mo for 59% of pts. Median treatment duration was 116 days (d), range, 2–281d (BIBF 1120) and 101 d, 2–239d (placebo). Five BIBF 1120 pts completed 9 mo of treatment vs 0 placebo pts. The 36-wk PFS rates (95% confidence interval [CI]) were 15.6% (3.8, 27.3) for BIBF 1120 and 2.9% (0.0, 8.4) for placebo. Although the trial was not powered for a direct comparison, the PFS hazard ratio was 0.68 (95% CI: 0.42, 1.09). Median time to RECIST progression (mo) was 4.8 for BIBF 1120, and 2.8 for placebo. There were no deaths during treatment. Grade 3 and 4 adverse events (AE) were seen in 54 and 7% (BIBF 1120) and 25 and 3% (placebo) of pts. Expected gastrointestinal toxicities occurred slightly more frequently in the BIBF 1120 arm (16 vs 10%, all gd 3; no gd 4 events). Elevated liver enzymes occurred in 43% (BIBF 1120) vs. 6.3% (placebo). Conclusions: Our trial suggests that maintenance BIBF 1120 could delay disease progression in OC pts who had previously responded to chemotherapy. A large phase III trial is needed to confirm the efficacy of this drug.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Boehringer Ingelheim Boehringer Ingelheim Advisory Board Boehringer Ingelheim Advisory Board Boehringer Ingelheim

Abstract presentation from the 2009 ASCO Annual Meeting