The FDA reviewed the efficacy and safety of IXEMPRA based on the analysis of two multi-center, multinational trials that included 878 patients and evaluated IXEMPRA either as a monotherapy or in combination with capecitabine in patients with metastatic or locally advanced breast cancer.
(Phase II, Monotherapy Trial: -081) The single-arm Phase II trial evaluated the efficacy and safety of IXEMPRA as a monotherapy. This study enrolled 126 patients with metastatic or locally advanced breast cancer resistant to three prior therapies (an anthracycline, a taxane and capecitabine). Resistance was defined as disease progression while on therapy in the metastatic setting (defined as progression while on treatment or within eight weeks of last dose) or recurrence within six months of the last dose in the adjuvant or neoadjuvant setting (only for anthracycline and taxane). HER2 positive patients must also have progressed during or after discontinuation of trastuzumab. The primary endpoint was objective response rate, which is an assessment of tumor shrinkage in response to treatment. Results determined by an independent radiology review (IRR) showed an objective partial response of 12.4% (95% CI, 6.9-19.9) in 113 response-evaluable patients.
Treatment-related non-hematological adverse events (greater than or
equal to 20%) included: peripheral sensory neuropathy 62% (Grade 3/4: 14%),
fatigue/asthenia 56% (Grade 3/4: 13%), myalgia/arthralgia 49% (Grade 3/4:
8%), alopecia 48% (Grade 3/4: 0%), nausea 42% (Grade 3/4: 2%),
stomatitis/mucositis 29% (Grade 3/4: 6%), vomiting 29% (Grade 3/4: 1%),
diarrhea 22% (Grade 3/4: 1%), and musculoskeletal pain 20% (Grade 3/4: 3%).
Treatment-related hematological adverse events (greater than or equal to
20%) included: neutropenia (Gr
|SOURCE Bristol-Myers Squibb Company|
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