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| Clinical Data Evaluating Amrubicin(R) as Potential Therapy for Patients with Small Cell Lung Cancer Presented at 13th World Conference on Lung Cancer |
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
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. 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. In the study, 75 patients who had no response to first-line chemotherapy or progression within 3 months of treatment completion were enrolled. Of these, 69 received 40 mg/m2 IV of Amrubicin on days 1-3 of a 21-day cycle and treatment continued until disease progression, unacceptable toxicity or withdrawal. The ORR was 21.3%, with 1 patient (1.3%) achieving a complete response. In patients who did not respond to platinum-based first line therapy (e.g. progressive or stable disease as best response), the ORR was 16%, and the response in elderly patients (≥ 65 years) was 20% which was similar to the overall population (21.3%). The median duration of response was 4.3 months (95% CI: 3.1, 5.8) and the median time to progression was 3.8 months (95% CI: 2.7, 4.2). Additionally, median progression free survival for patients in the study was 3.3 months (95% CI: 2.5, 4.0) and median overall survival was 6.1 months (95% CI: 4.9, 7.2). In the study, the most commonly occurring grade 3 or higher adverse events were neutropenia (66.7%), thrombocytopenia (40.6%), leukopenia (34.8%) and anemia (30.4%). Dose reductions occurred in 38% of patients and 3 patients experienced fatal serious adverse events that were not related to disease progression with 1 case considered possibly related to study treatment. “Advances in small cell lung cancer are particularly relevant as there have been few new options for patients in recent years,” said Dr. Ettinger. “The data presented today show that Amrubicin is an active compound with a manageable safety profile in an area of significant unmet need. We look forward to the results of future studies in this disease with this drug.”
In the final presentation, Dr. The pooled analysis evaluated 117 patients treated with Amrubicin across the two trials. In the study, 115 patients had a baseline LVEF percentage recorded (median 60%: range 50-85) and were evaluated based on changes in LVEF level from this mark, as well as according to cumulative Amrubicin dosing range. The study demonstrated minimal changes in LVEF percentage from the baseline, and the median LVEF figures were similar across all cumulative dosing ranges, including patients who received a cumulative dose >1000 mg/m2 of Amrubicin (n=16), where the median change in LVEF from the baseline was 2%. In the pooled study, cardio specific grade 3 or higher adverse events were acute myocardial infarction (n=2), atrial fibrillation (n=2) and atrial flutter (n=1). No treatment-related cardiac mortalities occurred on the study. “The data from these studies are encouraging as they demonstrate that Amrubicin compares favorably to both historical data and currently utilized therapies across multiple patient groups, including elderly patients and those with poor prognostic factors,” said Dr. Jotte. “Additionally, these data suggest that Amrubicin has an improved cardiotoxicity profile compared to traditional anthracyclines. We believe these results warrant further study of Amrubicin in this hard to treat area of disease.” About Amrubicin Amrubicin is a third-generation, synthetic anthracycline analogue that has demonstrated substantial clinical efficacy in the treatment of small cell lung cancer. Amrubicin is a potent topoisomerase II inhibitor and is being studied as a single agent and in combination with anti-cancer therapies for a variety of solid tumors, including lung and breast cancers.
Amrubicin is currently approved and marketed in About Small Cell Lung Cancer Small cell lung cancer is a disease in which malignant cells form in the tissues of the lung, and which occurs almost exclusively in people who smoke. While small cell lung cancer constitutes approximately 15 percent of all lung cancers, SCLC tends to be more aggressive and fast growing than the more common non-small cell lung cancer. Of the estimated 65,000 patients diagnosed with SCLC each year in the US and EU, approximately 60 percent of patients have extensive disease at diagnosis, and the remaining 40 percent present with localized, or limited stage, disease.
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