For CLL patients, a VENCLYXTO fixed duration combination is not only a treatment journey – it’s a destination. A day, one or two years from starting, when the disease may be undetectable* and the treatment stops; a day when patients can throw out the ‘cancer patient’ label and start being themselves again.1-5†
THAT’S WHY WE DO IT.
HERE’S HOW.
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Starting with VENCLYXTO
Getting patients off to a good start on their VENCLYXTO fixed duration treatment journey is important. These dosing charts show what a typical treatment plan might look like, including any additional requirements such as side effect monitoring, to help them understand their treatment regimen.
Supporting their treatment
In these guides, your patients can learn a bit more about how their fixed duration treatment works, as well as how they can minimise their risk of experiencing certain side effects, and how to manage them if they do occur.
Completing their treatment
With the completion of their VENCLYXTO fixed duration treatment, your patients can start looking forward to the next chapter in their journey. This guide will help explain what completing treatment involves and answer some questions they may have.
A generally manageable safety profile1
The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving VENCLYXTO in the combination studies were neutropenia, diarrhoea, and upper respiratory tract infection.
The most frequently reported serious adverse reactions (≥2%) in patients receiving VENCLYXTO in the combination studies were pneumonia, sepsis, febrile neutropenia, and TLS.
*Undetectable disease is defined by uMRD at the threshold of <1 tumour cell per 104 white cells1-3
†CLL-14 was a Phase III, randomised, multicentre, open-label trial which evaluated VEN+O (n=216) vs Clb+O (n=216) in adult patients with previously untreated CLL (age ≥18 years) and coexisting medical conditions (total CIRS>6 or CrCl<70mL/min). MURANO (N=398) was a phase III, randomised, multicentre, open-label trial of VEN+R vs BR in patients with R/R CLL. The primary endpoint of investigator-assessed PFS was met in both these trials. uMRD was a secondary endpoint in both trials in the ITT population. CLL-14: 75.5% VEN+O (n=163/216) peripheral blood uMRD, 3 months after treatment completion vs 35% Clb+O (n=76/216) p<0.001.2 MURANO: 62% VEN+R (n=121/194) peripheral blood uMRD at 9 months vs BR 13% (n=26/195) ITT population, not tested for significance.3
1L=first line; BR=bendamustine + rituximab; CIRS=cumulative illness rating scale; Clb+O=chlorambucil + obinutuzumab; CLL=chronic lymphocytic leukaemia; CrCL=creatinine clearance; ITT=intent-to-treat; PFS=progression-free survival; R/R=relapsed/refractory; TLS=tumour lysis syndrome; VEN+O=VENCLYXTO + obinutuzumab; VEN+R=VENCLYXTO + rituximab; uMRD=undetectable minimal residual disease.
References
- VENCLYXTO Summary of Product Characteristics.
- Fischer K et al. N Engl J Med. 2019; 380: 2225–36.
- Seymour JF et al. N Engl J Med. 2018; 378(12): 1107–20.
- Leukaemia Care Living with Leukaemia 2018 Report. Available at: https://media.leukaemiacare.org.uk/wp-content/uploads/Living-with-Leukaemia-2018-Full-Report-Web-Version.pdf (accessed November 2022).
- Al-Sawaf O et al. Am J Hematol. 2021; 96(9): 1112–19. doi: 10.1002/ajh.26260.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores.
Adverse events should also be reported to AbbVie on [email protected]
UK-VNCCLL-230092. Date of preparation: March 2023