Department of Lymphoma, Peking University Cancer Hospital & Institute (Beijing Cancer Hospital), No. 52 Fucheng Road, Haidian District, Beijing, 100142, China.
Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Invest New Drugs. 2023 Aug;41(4):606-616. doi: 10.1007/s10637-023-01376-1. Epub 2023 Jul 8.
We conducted two indirect comparisons to estimate the efficacy of zanubrutinib versus orelabrutinib in Chinese patients with relapsed or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or R/R mantle cell lymphoma (MCL). An unanchored matching-adjusted indirect comparison (MAIC) was performed in R/R CLL/SLL patients. Individual patient data from zanubrutinib trial (BGB-3111-205) were adjusted to match the aggregated data from the orelabrutinib trial (ICP-CL-00103). A naïve comparison was performed in R/R MCL for the different response assessment methodology and efficacy analysis set between the zanubrutinib (BGB-3111-206) and orelabrutinib (ICP-CL-00102) trials. Efficacy outcomes included ORR and PFS. In R/R CLL/SLL patients, after matching, IRC-assessed ORR was comparable (86.6% vs. 92.5%; risk difference, -5.9% [95% CI: -15.8%-3.8%]); IRC-assessed PFS was similar with a favorable trend in zanubrutinib over orelabrutinib (HR, 0.74 [95% CI: 0.37-1.47]) and the 18-month PFS rate was numerically higher in zanubrutinib (82.9% vs. 78.7%). In R/R MCL patients, naïve comparison showed investigator-assessed ORR was similar (83.7% vs. 87.9%; risk difference, -4.2% [95% CI: -14.8%-6.0%]), and CR rate was significantly higher in zanubrutinib over orelabrutinib (77.9% vs. 42.9%; risk difference, 35.0% [95% CI: 14.5%, 53.7%]). Investigator-assessed PFS was similar with a favorable trend (HR, 0.77 [95% CI: 0.45-1.32]) in zanubrutinib over orelabrutinib and the 12-month PFS rate was numerically higher in zanubrutinib (77.5% vs. 70.8%). MAIC result showed zanubrutinib demonstrated favorable PFS over orelabrutinib for R/R CLL/SLL patients. The naïve comparison showed zanubrutinib had favorable PFS and higher CR rate than orelabrutinib for R/R MCL patients.
我们进行了两项间接比较，以评估zanubrutinib 与orelabrutinib 在中国复发或难治性（R/R）慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）或 R/R 套细胞淋巴瘤（MCL）患者中的疗效。在 R/R CLL/SLL 患者中进行了无锚定匹配调整间接比较（MAIC）。将 zanubrutinib 试验（BGB-3111-205）的个体患者数据调整为匹配orelabrutinib 试验（ICP-CL-00103）的汇总数据。在 R/R MCL 中，由于 zanubrutinib（BGB-3111-206）和 orelabrutinib（ICP-CL-00102）试验之间的不同反应评估方法和疗效分析集，进行了盲目比较。疗效结局包括 ORR 和 PFS。在 R/R CLL/SLL 患者中，匹配后 IRC 评估的 ORR 相当（86.6% vs. 92.5%；风险差异，-5.9% [95%CI：-15.8%-3.8%]）；IRC 评估的 PFS 相似，zanubrutinib 具有优于 orelabrutinib 的有利趋势（HR，0.74 [95%CI：0.37-1.47]），18 个月的 PFS 率在 zanubrutinib 中数值更高（82.9% vs. 78.7%）。在 R/R MCL 患者中，盲目比较显示研究者评估的 ORR 相似（83.7% vs. 87.9%；风险差异，-4.2% [95%CI：-14.8%-6.0%]），并且 zanubrutinib 的 CR 率明显高于 orelabrutinib（77.9% vs. 42.9%；风险差异，35.0% [95%CI：14.5%-53.7%]）。研究者评估的 PFS 相似，在 zanubrutinib 中具有有利的趋势（HR，0.77 [95%CI：0.45-1.32]）优于 orelabrutinib，12 个月的 PFS 率在 zanubrutinib 中数值更高（77.5% vs. 70.8%）。MAIC 结果表明，在 R/R CLL/SLL 患者中，zanubrutinib 具有优于 orelabrutinib 的 PFS。盲目比较表明，在 R/R MCL 患者中，zanubrutinib 的 PFS 和更高的 CR 率优于 orelabrutinib。
