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
Distributed and marketed by AbbVie , Inc ., 1 North Waukegan Road , North Chicago , IL 60064 Marketed by Genentech USA , Inc ., 1 DNA Way , South San Francisco , CA 94080-4990 © 2017 AbbVie , Inc . and Genentech USA , Inc . 750-1930518 / November 2017 Printed in USA
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
• Results per IRC of an open-label,
ORR per independent review committee (IRC)
100
80
single-arm, multicenter clinical trial of
106 previously treated CLL patie �G2v�F��wFV�WF���v���B&V6V�fVBB�V7@���R&��"F�W&����"P���RR4��s�2Ӄr�2����ӃR��r�RR��ӂ��4���UDP�$Tԕ54��ࢄ5"�5&���R�rR���b���R���"��"�R���2��c �(
"�VF���V�&W"�b&��"F�W&�W2v0�"�R�&�vS����B�VF��F��R��G&VF�V�BBF��R�bWf�VF���v0�"����F�0�c��R���sB��(
"Vff�67�v2Wf�VFVB'��% �5 �C ��5"�5&���"�"�276W76VB'��$0�W6��rF�R�t4���4��trwV�FVƖ�W0�5&��� �# �(
"wFV�WF���v26��f�&�VB��W&��W&�� � �&���B7V6��V�2g&��F�V�G0�(
"F�V�G2&V6V�fVBdT�4�U�Df��&Wf��W6ǒG&VFVB4��v�F�wFV�WF������b��&�B&W7��6R��F�V�G2v��&W7��FVBF�dT�4�U�D�〧vVV�ǒ&��W66�VGV�R7F'F��r@�#�r�B&���rF�S�r��r��#�rF�C�r��6RF�ǒV�F��F�6V6P�&�w&W76����"V�66WF&�RF���6�G���VF��F��RF�f�'7B&W7��6Rv2�W72F�����F��&�vS��F������F�2������F�0��W"�$276W76�V�B��ӃR��F��RF�f�'7B&W7��6S�F�R�V�&W"�bF�2g&��FFR�bf�'7BF�6RF�F�RFFR�bF�Rf�'7B6�v��b&W7��6R�5"�5&���"��""�� ����'F�B6fWG���f�&�F����WWG&�V��6��G&��F�6F���(
"6��6�֗F�BW6R�bdT�4�U�Dv�F�7G&��r5�4�憖&�F�'2@���F�F����BGW&��r&��W�6R�26��G&��F�6FVB��GV��"Ǘ6�27��G&��P�(
"GV��"Ǘ6�27��G&��R�D�2����6�VF��rfF�WfV�G2�B&V��f��W&P�&WV�&��rF�Ǘ6�2��2�67W'&VB��&Wf��W6ǒG&VFVB4��F�V�G2v�F����v�GV��"'W&FV�G&VFVBv�F�dT�4�U�D�(
"dT�4�U�D�6W2&�6�f�"D�2��F�R��F��R�vVV�&��W�6R�6��vW2��&���B6�V֗7G&�W26��6�7FV�Bv�F�D�2F�B&WV�&R&��@���vV�V�B6��67W"2V&ǒ2bF����W'2f����v��rF�Rf�'7@�F�6R�bdT�4�U�D�BBV6�F�6R��7&V6R�(
"F�V�G26��V�B&R76W76VBf�"D�2&�6����6�VF��rWf�VF����`�GV��"'W&FV��B6���&&�F�F�W2��B6��V�B&V6V�fR&�&�FP�&������2f�"D�2���6�VF��r��G&F����B�F�և�W'W&�6V֖72�&VGV6VB&V��gV�7F����7$6�Ã���֖�gW'F�W"��7&V6W2F�R&�6�����F�"&���B6�V֗7G&�W2�B��vR&��&�ƗF�W2&��Fǒख�FW''WBF�6��r�b�VVFVB�V������&R��FV�6�fR�V7W&W2��`���G&F����g&WVV�B���F�&��r���7�FƗ�F���2�fW&��&�6����7&V6W2�(
"6��6�֗F�BW6R�bdT�4�U�Dv�F�7G&��r�"��FW&FR5�4��憖&�F�'2�B�w�憖&�F�'2����7&V6RF�R&�6��bD�2B��F�F����BGW&��rF�R&��W�6R��B��&WV�&RF�6RF�W7F�V�BGVP�F���7&V6W2��dT�4�U�DW��7W&R�(
"w&FR2�"B�WWG&�V��67W'&VB��CR����#C��bF�V�G0�G&VFVBv�F�dT�4�U�D����F�"6���WFR&���B6�V�G0�F�&�Vv��WBG&VF�V�B���FW''WBF�6��r�"&VGV6RF�6Rf� �6WfW&R�WWG&�V��6��6�FW"7W�'F�fR�V7W&W2��6�VF��p��F�֖7&�&��2f�"6�v�2�b��fV7F����BW6R�bw&�wF�f7F�'0��R�r��r�54b�ख��V旦F���(
"F���BF֖�7FW"ƗfRGFV�VFVBf66��W2&��"F��GW&��r�� �gFW"G&VF�V�Bv�F�dT�4�U�DV�F��"�6V��&V6�fW'��Gf�6P�F�V�G2F�Bf66��F���2��&R�W72VffV7F�fR�V�''���fWF�F���6�G��(
"dT�4�U�D��6W6RV�''���fWF��&�v�V�F֖�7FW&V@�F�&Vv��Bv����Gf�6RfV��W2�b&W&�GV7F�fP��FV�F��F�f��B&Vv��7�GW&��rG&VF�V�B�GfW'6R&V7F���0�(
"6W&��W2GfW'6R&V7F���2vW&R&W�'FVB��C2�R�bF�V�G2�F�R��7Bg&WVV�B6W&��W2GfW'6R&V7F���2�(�S"R�vW&P��WV����RR��fV'&��R�WWG&�V��B�bR���&W���2�2R���WF����V�R�V��ǗF�2�V֖�"�R���V֖�"�R���@�D�2�"�R�� �(
"F�R��7B6�����GfW'6R&V7F���2�(�S#R��b�w&FP�vW&R�WWG&�V��CRR��F�'&�V�3RR���W6V�32R����V֖�#�R��WW"&W7�&F�'�G&7B��fV7F����#"R���F�&��&�7�F�V��#"R���BfF�wVR�#R���dT�4�U�D(J"�2G&FV�&��b&%f�R���2�F�7G&�'WFVB�B�&�WFVB'�&%f�R���2����'F�vV�Vv�&�B���'F�6��6v����cc@��&�WFVB'�vV�V�FV6�U4���2��D�v��6�WF�6�g&�6�66��4�C��C�� �*�#r&%f�R���2��BvV�V�FV6�U4���2�sS��3S����fV�&W"#r&��FVB��U4