Oncology Learning NetworkIbrutinib Combined with Obinutuzumab and Venetoclax for the Frontline Treatment of Older Patients with CLL

A Q&A with Jennifer Ann Woyach, MD, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.

At the recent ASCO annual meeting, Dr. Woyach presented the findings of a phase 3 study comparing two treatment regimens for older patients with chronic lymphocytic leukemia (CLL). The study, A041702, aimed to evaluate the efficacy of ibrutinib combined with obinutuzumab and venetoclax versus ibrutinib plus obinutuzumab, with a particular focus on the potential for therapy discontinuation.

Key Points:

• Study Design: Randomized 1-to-1 into two arms, IO (ibrutinib plus obinutuzumab) and IVO (ibrutinib, venetoclax, obinutuzumab), with patients aged 65 and older; median age was 74.
• Treatment Duration: Obinutuzumab treatment for 6 months, followed by a year of continued treatment; response evaluation at the end of 14 cycles.
• Results: No superiority of IVO over IO; 19 patients in IVO arm died of COVID, compared to 11 in IO arm; similar PFS curves, with trends favoring different arms depending on COVID-related censoring.
• Toxicity: Non-hematologic toxicity was identical between IVO and IO; hematologic toxicity slightly higher in IVO.

Additional Points:

• COVID-19 Impact: The study was significantly affected by COVID-19, with more deaths in the IVO arm.
• Next Steps: Long-term follow-up is essential to determine potential benefits from the addition of venetoclax and therapy discontinuation.

Conclusion:

• The study did not demonstrate the superiority of IVO over IO in this patient population, and the results were notably impacted by COVID-19. Further investigation and long-term follow-up are needed to fully understand the potential benefits and risks of these treatment regimens.

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