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Efficacy and safety of rituximab and pembrolizumab in R/R WM: PembroWM trial

By Haimanti Mandal

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Sep 2, 2024

Learning objective: After reading this article, learners will be able to cite a new clinical development in Waldenström’s macroglobulinemia.


Results from a phase II, non-randomized, open-label, single-arm study (PembroWM; NCT03630042) evaluating efficacy and safety of pembrolizumab, a PD-1 inhibitor, and rituximab combination therapy in the treatment of relapsed/refractory (R/R) Waldenstrom's macroglobulinemia (WM) were published by Kothari et al.in British Journal of Haematology.

Key learnings:

A total of 17 patients were included; 88% of patients were pretreated with covalent Bruton’s tyrosine kinase inhibitors (cBTKi) and 71% were refractory/intolerant to cBTKi.

The primary endpoint was not met as overall response was only achieved in 7 patients (very good partial response, 1; partial response, 3; minor response, 3) at Week 24.

  • The median duration of response was 11.6 months.
  • At a median of 3.1 months, the best overall response rate was 52.9%.

Median progression-free survival (PFS) was 13.6 months; 1- and 2-year PFS rates were 58.2% and 19.4%, respectively.

Median overall survival (OS) was not reached; 1- and 2-year OS rates were 92.9% and 67%, respectively.

The 1- and 2-year time to next treatment rates were 72.7% and 43.1%, respectively.

Adverse events (AEs) were observed in 94% of patients.

  • Most common Grade 1–2 AEs were anemia, fatigue, fever, raised creatinine, infusion-related reactions, cough, dizziness, hypotension, and neutropenia.
  • Five deaths were reported, all unrelated to the treatment.
  • One immune-related AE was observed, in line with the known AEs with PD-1 inhibitors.

There were no significant improvements in quality-of-life scores in the majority of patients, except for emotional (p = 0.02) and cognitive functioning (p = 0.03).

The results indicate that the combination of pembrolizumab and rituximab is feasible and tolerable in patients with R/R WM, including those who have been heavily pretreated and are refractory to cBTKi. Further research is needed to explore the modulation of PD-1 axis in the management of WM.

‘The International Waldenstrom’s Macroglobulinemia Foundation (IWMF) and the Lymphoma Hub are working in collaboration for patients with Waldenstrom’s macroglobulinemia. This initiative aims to increase awareness of Waldenstrom's macroglobulinemia among healthcare professionals, patients, caregivers, and the patient advocacy community. 

This initiative is funded by Cellectar Biosciences and Eli Lilly. All content is developed independently by SES in collaboration with an expert steering committee; funders are allowed no direct influence on the content of the hub.

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