VENCLYXTO® offers patients with CLL a chance to
BREAK FREE with longer progression-free survival1*†
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
In 2L+ CLL:
VENCLYXTO + rituximab
*Reduced risk of progression or death vs O+Clb (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]). Median follow‑up of 28 months. Median PFS not reached in either arm.
†Reduced risk of progression or death vs BR (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]). Median follow‑up of 23.8 months. Median PFS not reached with VEN+R vs 17 months (15.5–21.6) with BR.
TLS in clinical trials
TLS, including fatal events, has occurred in patients with CLL with high tumor burden when treated with VENCLYXTO. TLS was reduced in the phase 1 VENCLYXTO monotherapy dose‑finding studies through implementation of a 5‑week dose‑titration schedule with a well‑defined prophylactic and monitoring protocol approved for use with VENCLYXTO monotherapy.1
TLS in the CLL14 trial
- Current TLS prophylaxis and monitoring protocol was implemented in the CLL14 trial1
- Patients were assessed for risk of TLS and received prophylaxis accordingly prior to obinutuzumab administration2
- TLS occurred in 1.4% (3/212) of patients treated with VEN+O2
- All 3 TLS events resolved and did not lead to withdrawal from the study. Obinutuzumab administration was delayed in 2 cases in response to the TLS events2
TLS in the MURANO trial2
- After 77 patients were enrolled in the VEN+R or BR treatment arms of the MURANO study, the protocol was amended to incorporate the current TLS prophylaxis and monitoring measures (5‑week dose‑titration schedule)
- In the MURANO study, the incidence of laboratory TLS was 3% (6/194) in patients treated with VEN+R; all events of TLS occurred during the dose‑titration phase
- All TLS events resolved within 2 days
- All 6 patients completed the dose‑titration schedule and reached the recommended daily dose of 400 mg of VENCLYXTO
- No clinical TLS was observed in patients who followed the current 5‑week dose‑titration schedule and prophylaxis and monitoring measures
- Grade ≥3 laboratory abnormalities relevant to TLS were hyperkalemia (1%), hyperphosphatemia (1%), and hyperuricemia (1%)
CLL=chronic lymphocytic leukemia; 1L=first line; 2L+=second line + later lines of therapy; O+Clb=obinutuzumab + chlorambucil; HR=hazard ratio; CI=confidence interval; PFS=progression‑free survival; BR=bendamustine + rituximab; VEN+R=VENCLYXTO + rituximab; TLS=tumor lysis syndrome; VEN+O=VENCLYXTO + obinutuzumab.
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References: 1. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236. 2. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.>
GR-VNCCLL-200048 -JAN2021