A phase II, multicenter, single-arm study of parsaclisib, a PI3Kδ inhibitor, in relapsed or refractory follicular lymphoma in China: Updated data from the study.

Authors

null

Zhong Zheng

Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Zhong Zheng , Huilai Zhang , Keshu Zhou , Hui Zhou , Li Zhang , Caixia Li , Min Zhou , Wenbin Qian , Zhiming Li , Qingyuan Zhang , Ying Cheng , Peng Liu , Zhenyu Li , Liping Su , Fei Li , Xiuhua Sun , Jingwen Wang , Yuhuan Gao , Xielan Zhao , Weili Zhao

Organizations

Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, Tianjin Cancer Hospital, Tian Jin, China, Henan Cancer Hospital, Zheng Zhou, China, Hunan Cancer Hospital, Changsha, China, West China Hospital of Sichuan University, Chengdu, China, Suzhou First People's Hospital, Su Zhou, China, Cancer Center of Guangzhou Medical University, Guangzhou, China, The Second Affiliated Hospital, College of Medicine, Zhejiang University, Hang Zhou, China, Sun Yat-sen University Cancer Center, Guangzhou, China, Harbin Medical University Cancer Hospital, Harbin, China, Jilin Cancer Hospital, Changchun, China, Fudan University School of Medicine Affiliated Zhongshan Hospital, Shang Hai, China, The Affiliated Hospital of Xuzhou Medical University, Xu Zhou, China, Shanxi Cancer Hospital, Tai Yuan, China, The First Affiliated Hospital of Nanchang University, Nanchang, China, The Second Hospital of Dalian Medical University, Dalian, China, Beijing Tongren Hospital, Capital Medical University, Beijing, China, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China, Xiangya Hospital of Central South University, Changsha, China

Research Funding

Pharmaceutical/Biotech Company

Background: For Follicular lymphoma (FL) patients (pts) of 3rd or higher line, treatment options are limited. Parsaclisib is a potent, highly-selective, next-generation PI3Kδ inhibitor. Initial safety and efficacy data were previously presented (Zhong Zheng et al. ASH 2021; NCT04298879). Here, we report safety, efficacy and survival data of the multicenter, open-label phase 2 study of parsaclisib in 3rd or higher line FL pts in China. Methods: Key eligibility included, age ≥ 18 years, histologically confirmed FL grade 1, 2, or 3a, ≥ 2 prior systemic therapies, ECOG PS ≤ 2, and ineligible for hematopoietic stem cell transplantation (HSCT). Pts received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 2.5 mg QD, till disease progression (PD), unacceptable toxicity, death or withdrawn consent. Prophylaxis for Pneumocystis jirovecii pneumonia (PJP) was required. Primary endpoint was objective response rate (ORR) evaluated by an Independent Review Committee (IRC) according to Lugano 2014 criteria, secondary endpoints included: duration of response (DOR), PFS, OS, and safety and tolerability. Results: As of the data cutoff date (Dec 12, 2021), 61 pts (median age: 50yr; male [n = 35, 57.4%]) were enrolled. Forty-eight pts remained on treatment and 13 pts had discontinued study treatment mainly due to PD (n = 11). With a median follow-up time 9.5 months (range 6.0-19.7months), the median duration of treatment was 251.0 days (range: 23.0-589.0 days). All 61 pts were evaluable for response, the ORR and complete response rate (CRR) were 86.9% (n = 53, 95% CI: 75.8-94.2%) and 31.1% (n = 19, 95% CI: 19.9-43.3%), respectively. The median time to response (TTR) was 8.0 weeks (95% CI: 7.9-8.0%), and the median DOR was not reached (95% CI: 9.2 months-NC), and 43 of 53 pts with CR or PR still retained CR or PR. As data cutoff, eleven (17.9%) pts had disease progression, the median PFS was not achieved. Three pts died data as data cutoff, the median OS was not achieved. Among the 61 treated pts, 48 (95.1%) pts experienced at least 1 treatment-emergent adverse events (TEAEs), with the most common TEAEs being neutrophil count decreased (49.2%), white blood cell count decreased (32.8%). Twenty-seven patients (44.3%) experienced grade ≥ 3 TEAEs, the most common grade ≥ 3 TEAEs was neutrophil count decreased (n = 10, 16.4%). Conclusions: Parsaclisib demonstrated promising efficacy, and acceptable safety profile. These results suggest that parsaclisib could benefit 3rd or higher line Follicular lymphoma patients. Clinical trial information: NCT04298879.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies

Sub Track

Non-Hodgkin Lymphoma

Clinical Trial Registration Number

NCT04298879

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 7574)

DOI

10.1200/JCO.2022.40.16_suppl.7574

Abstract #

7574

Poster Bd #

226

Abstract Disclosures