Clinical outcomes by progression of disease within 24 months (pod24) in patients with relapsed/refractory (r/r) follicular lymphoma (fl) treated with linperlisib

Introduction: Linperlisib, a PI3Kδ inhibitor, has shown clinically efficacy and manageable safety profile as third- or further-line treatment in patients with R/R FL from a multicenter phase 2 trial (NCT04370405). We aimed to perform a subgroup analysis to evaluate the impact of POD24, a well-established indicator of poor survival, on the efficacy of linperlisib. Methods: This phase 2 study was conducted at 25 sites in China between April 2019 and September 2020. Linperlisib 80 mg was given orally once daily until disease progression, intolerable toxicity or withdrawal from the study. Response was assessed by an independent review committee according to the International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017). The primary endpoint was objective response rate (ORR). Results: The POD24 group had a lower median age (49 vs. 53 years) and lower proportion of patients with at least three lines of prior therapies (73.8% vs. 87.0%) than the non-POD24 group. All patients in both groups had received prior anti-CD20 antibody and alkylating agent. The ORR (77.1%, 47/61) in the POD24 group was numerically lower than that (87.0%, 20/23) in the non-POD24 group, but without statistical significance (p = 0.314). Both groups showed similar progression-free survival (13.7 months vs. 11.5 months). The most common grade ≥3 treatment-related adverse events were infectious pneumonia (19.7%), decreased neutrophil count (14.8%), and interstitial lung disease (4.9%) in the POD24 group, and decreased neutrophil count (17.4%) and infectious pneumonia (17.4%) in the non-POD24 group (Table). Conclusions: For R/R FL, patients with POD24 could also benefit from subsequent linperlisib treatment, with similar prognosis to those without POD24. Linperlisib could be an appropriate option for this difficult-to-treat population. The research was funded by: Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (2022-I2M-1-022) and Shanghai Yingli Pharmaceutical Co., Ltd. Keyword: molecular targeted therapies No conflicts of interests pertinent to the abstract.