Chair and Presenter, Prof. John G. Gribben, MD, DSc, Prof. Dr. med. Barbara Eichhorst, Nitin Jain, MD, Anthony R. Mato, MD, MSCE, and Terry Evans prepared useful Practice Aids pertaining to chronic lymphocytic leukemia for this CME/MOC activity titled “Fine-Tuning the Wave of Innovation in CLL: Personalized Models for Upfront and Sequential Care With Groundbreaking Treatment.” For the full presentation, downloadable Practice Aids, and complete CME/MOC information, and to apply for credit, please visit us at https://bit.ly/3PM4c4s. CME/MOC credit will be available until January 8, 2024.
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Fine-Tuning the Wave of Innovation in CLL: Personalized Models for Upfront and Sequential Care With Groundbreaking Treatment
1. Ask the Experts
CLL Support Groups
Weekly Email for CLL
Breaking News
cllsociety.org/ask-the-expert
cllsociety.org/cll-specific-
patient-support-groups
cllsociety.org/newsletter-sign-up
The mission of the CLL Society is to be an
inclusive, patient-centric, physician-curated
nonprofit organization that addresses the
unmet needs of the CLL community through
patient education, advocacy, support, and
research. Here you will find highlights of helpful
resources from cllsociety.org to better inform
your practice.
Test Before Treat™ Resources and Handouts
cllsociety.org/cll-101/test-before-treat
Current NCCN and iwCLL guidelines indicate the importance
of obtaining biomarker testing before the first treatment
and again before every subsequent therapy
Patient Education ToolKIT
cllsociety.org/cll-sll-patient-education-toolkit/
Free resource for healthcare providers and CLL/SLL patients
TM
Dedicated CAR-T
Resources
cllsociety.org/CAR-T
CLL Society Resources
Full abbreviations, accreditation, and disclosure information available at PeerView.com/NMB40
2. Agent Indications/Current Status in CLL Dosing (All PO)
Covalent
BTKi
Acalabrutinib2,3
• Adults with CLL or SLL
• In combination with obinutuzumab for TN CLL
• Adults with TN CLL or ≥1 prior therapy
(EMA approval)
100 mg every 12 hours until disease
progression or unacceptable toxicity
Covalent
BTKi
Ibrutinib4,5
• Adults with R/R CLL or SLL ± del(17p) (as a
single agent, in combination with rituximab or
obinutuzumab, or in combination with BR)
• Adults with TN CLL or ≥1 prior therapy
(EMA approval)
420 mg twice daily
• Adults with TN CLL in combination with venetoclax
(EMA approval)
BCL-2i Venetoclax1
• Adults with CLL or SLL
• In combination with obinutuzumab for TN CLL
• In combination with rituximab for R/R CLL
5-week ramp-up
dosing schedule
Week 1: 20 mg
Week 2: 50 mg
Week 3: 100 mg
Week 4: 200 mg
Week 5 and
beyond: 400 mg
• With
obinutuzumab:
initiate on
cycle 1, day 22
• With
rituximab: start
rituximab at
400 mg once
daily for 7 days
after cycle 1
Guide to Novel Oral Agents in CLL: Indications and Dosing
Full abbreviations, accreditation, and disclosure information available at PeerView.com/NMB40
3. Non-covalent
BTKi
Pirtobrutinib9 • Adults with R/R CLL or SLL (phase 3 testing)
200 mg once daily until disease
progression or unacceptable toxicity
Covalent
BTKi
Zanubrutinib6,7 • Adults with TN CLL or SLL without del(17p)
(phase 3 testing)
160 mg twice daily until progressive
disease or unacceptable toxicity
(SEQUOIA trial dosing)
Agent Indications/Current Status in CLL Dosing (All PO)
Non-covalent
BTKi
Nemtabrutinib8 • Adults with R/R CLL or SLL (phase 2 testing) 65 mg once daily (preliminary RP2D)
PI3Ki Duvelisib10 • Adults with R/R CLL or SLL after ≥2 prior
therapies
25 mg twice daily
(modify dosage for toxicity)
PI3Ki Idelalisib11
• Adults with R/R CLL in combination with rituximab
• In patients for whom rituximab alone would be
considered appropriate therapy due to other
comorbidities
150 mg twice daily with or without food
until disease progression or
unacceptable toxicity
Guide to Novel Oral Agents in CLL: Indications and Dosing
Full abbreviations, accreditation, and disclosure information available at PeerView.com/NMB40
1. Venclexta (venetoclax) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s013lbl.pdf. 2. Calquence (acalabrutinib) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210259s000lbl.pdf.
3. Calquence (acalabrutinib) EMA Prescribing Information. https://www.ema.europa.eu/en/documents/product-information/calquenceepar-product-information_en.pdf. 4. Imbruvica (ibrutinib) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/
label/2015/205552s002lbl.pdf. 5. Imbruvica (ibrutinib) EMA Prescribing Information. https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf. 6. Tam CS et al. ASH 2021. Abstract 396. 7. https://www.cancernetwork.com/
view/sequoia-trial-meets-primary-pfs-end-point-improvement-with-frontline-zanubrutinib-for-cll. 8. Woyach J et al. EHA 2022. Abstract P682. 9. https://clinicaltrials.gov/ct2/show/NCT04666038. 10. Copiktra (duvelisib) Prescribing Information. https://www.accessdata.fda.gov/
drugsatfda_docs/label/2018/211155s000lbl.pdf. 11. Zydelig (idelalisib) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206545lbl.pdf.