CLINICAL NEWS hematopoiesis of indeterminate potential ) predicts for hematopoietic malignancy and cardiovascular disease .
An overhead view of a poster session during the 2016 ASH Annual Meeting .
VENCLEXTA™ is an oral BCL-2 inhibitor approved for the treatment of patients with chronic lymphocytic leukemia ( CLL ) with 17p deletion , as detected by an FDA-approved test , who have received at least one prior therapy .
This indication is approved under accelerated approval based on overall response rate . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial .
HIGH
• Results per independent review committee ( 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 ( range : 0 to 21.5 months )
• Efficacy was evaluated by ORR as assessed by IRC using the International Workshop for Chronic Lymphocytic Leukemia ( iwCLL ) and National Cancer Institute – sponsored Working Group ( 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
ORR = overall response rate ( CR + CRi + nPR + PR ); CR = complete remission ; CRi = CR with incomplete marrow recovery ; nPR = nodular PR ; PR = partial remission .
With VENCLEXTA monotherapy , patients achieved over 80 % ORR — including complete remissions
Percentage of patients
VENCLEXTA : ORR in an open-label , single-arm , multicenter clinical trial
100
80.2 % ( n = 85 )
80
60
40
20
Print-only content
0
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 )
• Median time to first response was 0.8 months ( range : 0.1 to 8.1 months )
• Median duration of response has not yet been reached with approximately 12 months of follow-up ; range is 2.9 to 19 + months
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
Drug Interactions
• For patients who have completed the ramp-up phase and are on a steady daily dose of VENCLEXTA , reduce the dose by at least 75 % when used concomitantly with strong CYP3A inhibitors . Resume the VENCLEXTA dose that was used prior to initiating the CYP3A inhibitor 2 to 3 days after discontinuation of the inhibitor .
• Avoid concomitant use of moderate CYP3A inhibitors or P-gp inhibitors . If an inhibitor must be used , reduce the VENCLEXTA dose by at least 50 %. Monitor patients more closely for signs of VENCLEXTA toxicities . Resume the VENCLEXTA dose that was
used prior to initiating the CYP3A inhibitor or P-gp inhibitor 2 to 3 days after discontinuation of the inhibitor .
• Patients should avoid grapefruit products , Seville oranges , and starfruit during treatment as they contain inhibitors of CYP3A .
• Avoid concomitant use of strong or moderate CYP3A inducers .
• Avoid concomitant use of narrow therapeutic index P-gp substrates . If these substrates must be used , they should be taken at least 6 hours before VENCLEXTA .
• Monitor international normalized ratio ( INR ) closely in patients receiving warfarin .
Lactation
• Advise nursing women to discontinue breastfeeding during treatment with VENCLEXTA .
Females and Males of Reproductive Potential
• Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for at least 30 days after the last dose .
• Based on findings in animals , male fertility may be compromised by treatment with VENCLEXTA . a
VENCLEXTA [ package insert ]. North Chicago , IL : AbbVie Inc . b
Data on file , AbbVie Inc .
Please see Brief Summary of full Prescribing Information on the following page .
Learn more at VENCLEXTA . com