PB2144: PEARL: A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PENPULIMAB PLUS LENALIDOMIDE, RITUXIMAB, GEMCITABINE AND OXALIPLATIN IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA

Background: Relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) patients have limited treatment strategies and are associated with poor prognosis, so it is necessary to explore the treatment options for these patients. Penpulimab, an anti-PD1 antibody of IgG1 isotype, has demonstrated high response rate and very good tolerance, and is now approved in R/R classic Hodgkin lymphoma. The immunomodulatory agent lenalidomide has demonstrated direct anti-tumor effects in lymphoma. The regimen of rituximab, gemcitabine and oxaliplatin is used for the treatment of R/R DLBCL, which is recommend by current National Comprehensive Cancer Network guideline. Aims: The PEARL study aims to assess the efficacy and safety of penpulimab Plus lenalidomide, rituximab, gemcitabine and oxaliplatin (Pen-R2-GemOx) in Patients With R/R DLBCL. Methods: PEARL (NCT05186558) is a Phase II, multicenter, single-arm, open label study (Figure 1). An estimated 54 patients will be enrolled. Eligible patients are aged 18 to 80 years with relapsed or refractory after one prior treatment, CD20-positive DLBCL, and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. All patients will be treated with Pen-R2-GemOx scheme (penpulimab, 200 mg, q2w, d0; lenalidomide, 10 mg, d1-7; rituximab, 375 mg/m2, d0; gemcitabine, 1000 mg, d1; oxaliplatin, 100 mg/m2, d1; 14d/cycle) during induction therapy, and they will be assessed the efficacy after four cycles by computed tomography (CT). Patients who achieve stable disease/progressive disease (SD/PD) will exit the study. Patients who achieve complete response/unconfirmed complete response/partial response (CR/CRu/PR) will receive Pen-R2-GemOx again for two cycles and be assessed the efficacy by positron emission tomography-CT (PET-CT). Afterwards, patients who achieve PD will withdraw the study. Patients who achieve CR/CRu/PR and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT, while patients who are not eligible for ASCT will directly receive penpulimab and lenalidomide as maintenance treatment. During maintenance treatment, the combination of penpulimab and lenalidomide will be used for 6 months, followed by lenalidomide monotherapy for 18 months. The primary endpoint is CR rate. Secondary endpoints include progression-free survival (PFS) rate, overall survival (OS) rate of 2 years and toxicity. Patients will be followed up from their end-of-induction treatment visit until the end of the study, including clinical evaluation every 3 months in the first year and every 6 months in the second year for patients undergoing ASCT and maintenance treatment. The expected study duration from first patient’s first visit to last patient’s last visit is approximately 3 years. Enrollment for the study will begin in Q2 of 2022. Results: Results for this study are not yet available. Image:Summary/Conclusion: Conclusion for this study is not yet available.