Verastem Oncology Presents Phase 3 DUO Data Evaluating COPIKTRA (Duvelisib) in Patients with CLL/SLL Who Have Progressed Following Two Prior Lines of Therapy
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Outcome per IRC | COPIKTRA
N = 95 |
Ofatumumab
N = 101 |
|||||||||
PFS | |||||||||||
Number of events, n (%) | 55 (58) | 70 (69) | |||||||||
Progressive disease | 44 | 62 | |||||||||
Death | 11 | 8 | |||||||||
Median PFS (SE), months?a | 16.4 (2.1) | 9.1 (0.5) | |||||||||
Hazard Ratio (SE),?b
COPIKTRA/ofatumumab |
0.40 (0.2) | ||||||||||
Response rate | |||||||||||
ORR, n (%)?c | 74 (78) | 39 (39) | |||||||||
CR | 0 (0) | 0 (0) | |||||||||
PR | 74 (78) | 39 (39) | |||||||||
Difference in ORR, % (SE) | 39 (6.4) | ||||||||||
- Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
- Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
- CYP3A Inducers: Coadministration with a strong CYP3A inducer may reduce COPIKTRA efficacy. Avoid coadministration with strong CYP3A4 inducers.
- CYP3A Inhibitors: Coadministration with a strong CYP3A inhibitor may increase the risk of COPIKTRA toxicities. Reduce COPIKTRA dose to 15 mg BID when coadministered with a strong CYP3A4 inhibitor.
- CYP3A Substrates: Coadministration of COPIKTRA with sensitive CYP3A4 substrates may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.