Efficacy and safety information of VENCLEXTA for CLL patients with 17p deletion who have received at least one prior therapy 1
Patients treated with VENCLEXTA ™ monotherapy achieved over 80 % ORR — including complete remissions
Percentage of patients
80
60
40
20
0
ORR per independent review committee ( IRC )
100 80.2 % ( 95 % CI : 71.3-87.3 ) ( n = 85 )
5.7 % ( n = 6 ) 1.9 % ( n = 2 ) 2.8 % ( n = 3 )
69.8 % ( n = 74 )
CR CRi nPR PR
Previously treated CLL with 17p deletion ( N = 106 )
7.5 % ( n = 8 )
COMPLETE REMISSION ( CR + CRi )
Rapid response in patients who responded to VENCLEXTA
• Results per IRC of an open-label , single-arm , multicenter clinical trial of 106 previously treated CLL patients with 17p deletion who had received at least one prior therapy
• Median number of prior therapies was 2.5 ( range : 1-10 ) and median time on treatment at time of evaluation was 12.1 months
• Efficacy was evaluated by ORR ( CR + CRi + nPR + PR ) as assessed by IRC using the iwCLL NCI-WG guidelines
• 17p deletion was confirmed in peripheral blood specimens from patients
• Patients received VENCLEXTA via a weekly ramp-up schedule starting at 20 mg and ramping to 50 mg , 100 mg , 200 mg to 400 mg once daily until disease progression or unacceptable toxicity
0.8 months
Median time to first response was less than 1 month ( range : 0.1 to 8.1 months )*
* Per IRC assessment ( n = 85 ). Time to first response : The number of days from date of first dose to the date of the first sign of response ( CR , CRi , nPR , or PR ). 2
Important Safety Information
Contraindication
• Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during ramp-up phase is contraindicated . a
Tumor Lysis Syndrome
• Tumor lysis syndrome ( TLS ), including fatal events and renal failure requiring dialysis , has occurred in previously treated CLL patients with high tumor burden treated with VENCLEXTA .
• VENCLEXTA poses a risk for TLS in the initial 5-week ramp-up phase . Changes in blood chemistries consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLEXTA and at each dose increase .
• Patients should be assessed for TLS risk , including evaluation of tumor burden and comorbidities , and should receive appropriate prophylaxis for TLS , including hydration and anti-hyperuricemics . Reduced renal function ( CrCl < 80 mL / min ) further increases the risk . Monitor blood chemistries and manage abnormalities promptly . Interrupt dosing if needed . Employ more intensive measures ( IV hydration , frequent monitoring , hospitalization ) as overall risk increases .
• Concomitant use of VENCLEXTA with strong or moderate CYP3A inhibitors and P-gp inhibitors may increase the risk of TLS at initiation and during the ramp-up phase , and may require dose adjustment due to increases in VENCLEXTA exposure .
VENCLEXTA™ is a trademark of AbbVie , Inc .
Neutropenia
• Grade 3 or 4 neutropenia occurred in 41 % ( 98 / 240 ) of patients treated with VENCLEXTA . Monitor complete blood counts throughout treatment . Interrupt dosing or reduce dose for severe neutropenia . Consider supportive measures including antimicrobials for signs of infection and use of growth factors ( e . g ., G-CSF ).
Immunization
• Do not administer live attenuated vaccines prior to , during , or after treatment with VENCLEXTA until B-cell recovery . Advise patients that vaccinations may be less effective .
Embryo-Fetal Toxicity
• VENCLEXTA may cause embryo-fetal harm when administered to a pregnant woman . Advise females of reproductive potential to avoid pregnancy during treatment .
Adverse Reactions
• Serious adverse reactions were reported in 43.8 % of patients . The most frequent serious adverse reactions ( ≥2 %) were pneumonia ( 5 %), febrile neutropenia ( 4.6 %), pyrexia ( 3.3 %), autoimmune hemolytic anemia ( 2.9 %), anemia ( 2.1 %), and TLS ( 2.1 %). b
• The most common adverse reactions ( ≥20 %) of any grade were neutropenia ( 45 %), diarrhea ( 35 %), nausea ( 33 %), anemia ( 29 %), upper respiratory tract infection ( 22 %), thrombocytopenia ( 22 %), and fatigue ( 21 %). a
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