Background:

Venetoclax plus obinutuzumab (V+Obi) as well as acalabrutinib and zanubrutinib (BTKi) are approved as first line treatment options for TP53 negative CLL. Here we have analyzed the real-world data on comparing these treatments.

Methods:

TrinetX, a global federated research network, provides a dataset of electronic medical records from different healthcare organizations (HCOs), was utilized. Initial query was made to isolate patients with CLL excluding ones with TP53 mutation or Li-Fraumeni syndrome. The population was further divided into two groups, those who received V+Obi and those who received the newer second generation BTKi. Further, propensity score matching (PSM) was carried out to match age, sex, and race. Descriptive analysis was used for demographic data and for overall survival. Kaplan Meier analysis using log-rank test, as well as Cox regression for hazard ratio (HR) was used.

Results:

3,849 CLL patients were identified to have no aberration in the TP53 gene and received some form of treatment (2,777 in BTKi group and 1,072 in V+Obi group). Patients who received BTKi were older (71.9±10.4 vs 66.7±10.6, p<0.0001) compared to V+Obi recipients. Males were the predominant gender in both the groups, but more females received BTKi compared to V+Obi (35% vs 29%, p=0.0003). Caucasians were the predominant race in both groups, and was more statistically significant in the BTKi group (79% vs 70%, p<0.0001). Patients with unknown race were significantly less in the BTKi group (12% vs 20%, p<0.00001). Median follow up was 420 days and 544 days in the BTKi and the V+Obi group respectively. More deaths occurred in the BTKi group (328 (11.86%) vs 105 (9.83%), p=0.0732, OR = 1.236 (0.98-1.559). The Kaplan Meier curve was separated in favor of V+Obi, with log-rank test p = 0.0028, and HR = 1.397 (1.121-1.741). After PSM, both groups had about 1,000 patients, with no significant difference in deaths (105 (10.07%) vs 103 (9.86%), p=0.8723, OR = 1.024 (0.769-1.363)). The Kaplan Meier curves were not separated, with log-rank test showing p=0.3366 and HR = 1.143 (0.87-1.5).

Conclusion:

Our analysis shows that using V+Obi is non inferior to BTKi in impacting overall survival. With V+Obi's fixed duration, it is an excellent option for CLL patients, as compared to BTKi's indefinite treatment, especially for younger patients.

Disclosures

No relevant conflicts of interest to declare.

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2024
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