Kyprolis® (carfilzomib) for Injection: 003-A1 Phase 2 Study Results*
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22.9% OVERALL RESPONSE RATE (ORR) (95% CI: 18.0, 28.5)1
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7.8-MONTH MEDIAN DURATION OF RESPONSE (95% CI: 5.6, 9.2)1
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Most patients across all phase 2 studies (85%) did not need to discontinue therapy due to an adverse event1,2
- Adverse reactions leading to discontinuation included congestive heart failure (2%), cardiac arrest,
dyspnea, increased blood creatinine, and acute renal failure (1% each)1
*Study PX-171-003 was a single-arm, multicenter clinical trial of KYPROLIS in 266 patients with relapsed multiple myeloma who had received
at least two prior therapies (including bortezomib and thalidomide and/or lenalidomide) and whose disease had a ≤25% response to the
most recent therapy or had disease progression during or within 60 days of the most recent therapy. At the time of study entry, patients had
received a median of 5 prior lines of therapy. The primary endpoint was ORR. Response was determined by Independent Review Committee
assessment using International Myeloma Working Group criteria.
considered to be at greater risk for TLS. Prior to receiving
KYPROLIS, ensure that patients are well hydrated. Monitor
for evidence of TLS during treatment, and manage promptly.
Interrupt KYPROLIS until TLS is resolved.
Thrombocytopenia: KYPROLIS causes thro