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Phase II studies in second-line SCLC met primary endpoint of
overall response
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Pooled analysis of Phase II trials confirmed cardiac safety
profile of Amrubicin
Celgene Corporation (NASDAQ: CELG) today announced the presentation of
final results from two company-sponsored studies of Amrubicin in
relapsed small cell lung cancer (SCLC) at the 13th World
Conference on Lung Cancer in San Francisco, Calif. The presentations
included safety and efficacy data of two phase II studies of the
next-generation therapy in second-line patients with SCLC both sensitive
and refractory to first-line platinum based chemotherapy, respectively.
A third presentation detailed the results of a pooled cardiac safety
analysis from the phase II studies.
Amrubicin is an anthracyline-like molecule with potent topoisomerase II
inhibition and represents the first solid tumor-focused compound to
complete phase II studies for Celgene.
The first study compared Amrubicin to topotecan, a common and approved
treatment for SCLC, in patients with extensive-disease SCLC who were
sensitive to first-line platinum-based chemotherapy. Dr. Robert Jotte,
of the Rocky Mountain Cancer Centers in Denver, Colo., presented the
results from the trial where patients were randomized to either 40 mg/m2
IV of Amrubicin on days 1-3 of a 21-day cycle (n=50) or topotecan 1.5
mg/m2 IV daily on days 1-5 of a 21-day cycle (n=26). Of the
76 patients enrolled in the study, 72 were treated.
The study demonstrated that the overall response rate (ORR) was
significantly higher in patients treated with Amrubicin (44.0%) compared
to patients treated with topotecan (11.5%) (p=0.005), meeting the
primary endpoint of the study (to demonstrate an Amrubicin ORR of ≥
25%). In addition, the complete response rate was 12% for the Amrubicin
arm compared to 4% for the topotecan arm. Of note, for patients aged 65
years or older, the ORR for patients receiving Amrubicin was 46%
compared to 7% for patients receiving topotecan.
The median overall survival for patients receiving Amrubicin was 9.3
months (95% CI, range 5.8-12.2) compared to 7.7 months for patients
receiving topotecan (95% CI, range 4.5-14.0). Median progression-free
survival was 4.6 months for the Amrubicin arm (95% CI:2.1, 6.1) compared
to 3.3 months for the topotecan arm (95% CI: 2.2., 5.4) and the median
time to progression was 5.6 months for the Amrubicin arm (95% CI: 2.8,
6.9) compared to 3.0 months for the topotecan arm(95% CI: 1.4, 4.4).
In the study, the most common grade 3 or higher adverse events for
patients receiving Amrubicin compared to topotecan were neutropenia
(61.2% vs. 78.3%, respectively), thrombocytopenia (38.8% vs. 60.9%) and
leukopenia (38.8% vs. 39.1%). Dose reductions, primarily due to
reversible myelosuppression, took place in 43% of Amrubicin patients and
44% of topotecan patients. Additionally, 4 patients in the Amrubicin arm
and 1 patient in the topotecan arm died due to neutropenic complications.
In the second presentation, Dr. David S.
