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ASCO 2022: Four-year Follow-Up From a Phase 2 Study of Obinutuzumab, Ibrutinib, and Venetoclax in CLL

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What follows is our patient-friendly summary of this research.

Bottom Line:

Remissions remained durable in both treatment-naive (TN) and relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) patients treated with a fixed duration of obinutuzumab, ibrutinib, and venetoclax, but the triplet does lead to low blood counts in most patients,

Who Performed the Research and Where Was it Presented:

At the American Society of Clinical Oncology (ASCO) Annual Meeting in 2022, Dr. Kerry Rogers of OSU presented the results of the four-year follow-up from a phase 2 study of obinutuzumab, ibrutinib, and venetoclax in CLL.

Background:

Targeted therapies have revolutionized the management of CLL, but the best sequencing or combinations of therapies is not yet defined. This study looks at a potent triple combination for a fixed period of time.

Methods and Participants:

Initially, 25 TN and 25 R/R patients with CLL were enrolled. A later cohort added another 25 TN CLL patients. The average age was 58, 64% were men, and 8% had del(17p).

Treatment was given for over a year (14 cycles of 28-day each).

Results:

For those who were followed for 48 months, the estimated progression-free survival (PFS) and overall survival (OS) for the TN RR cohorts were 96%, and in the R/R cohort, they were 85% and 100%, respectively. Unfortunately, there was a death of a R/R at 51 months.

The most frequent adverse events were low neutrophils seen in 95%, with 73% having a severe drop. Similar but fewer severe decreases in counts were seen in the total white blood cells, lymphocytes, and platelets. Hypertension was seen in 85% and was more severe in 39%. Atrial fibrillation occurred in 11% of patients.

Conclusions and Comments:

This is a powerful combination with impressively durable responses in both TN and R/R patients.

The price of these strong responses is the high levels of low blood counts, a special concern during the pandemic. However, it is reassuring that infection was not listed as a common adverse event.

The unanswered question is whether these triplet results are better than that doublet of ibrutinib and venetoclax (I+V) already studied in the CAPTIVATE and GLOW trials. Also, does adding the obinutuzumab improve outcomes, or is it just making patients more immunosuppressed? More follow-up and research are needed to give the answers.

Links and Resources:

Watch my monologue on the abstract below:

Here is the ASCO publication: Four-year Follow-Up From a Phase 2 Study of Obinutuzumab, Ibrutinib, and Venetoclax in CLL.

Here is an interview with Dr. Rogers with more up-to-date data from VJ Onc.

Stay strong.  We are all in this together.

Brian

Brian Koffman MDCM (retired) MS Ed (he, him, his)
Co-Founder, Executive VP, and Chief Medical Officer, CLL Society, Inc. 

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