Salvage Using Polatuzumab Vedotin Based Therapy in Relapsed Refractory Large B-Cell Lymphomas: Early Experience from a Real-World Middle-Income Setting Using Named-Patient Compassionate Access Program

Abstract

Polatuzumab vedotin is a novel immunotherapy antibody–drug conjugate targeting CD79b. It has been used in relapsed/refractory (R/R) large B-cell lymphomas since its FDA approval in 2019. Presently, this drug is unaffordable or unavailable for patients in Lower–Middle Income Countries (LMIC) like India. This is a retrospective study of adult (> 18 years) patients with R/R large B-cell lymphoma failing two prior lines of therapy, who received Polatuzumab based salvage therapy on a compassionate or named-patient access program. Between May 2019 and April 2022, 10 patients received Polatuzumab vedotin, and 9 were evaluable. The most common regimen used was Polatuzumab-Bendamustine-Rituximab. Out of 43 infusions administered, the adverse event profile was manageable [One grade-2 infusion reaction, 4 patients developed grade 3–4 hematological toxicity and none had grade 3–4 non-hematological toxicities]. Ten infusions were administered in the day care service. After a median of 4.5 cycles (range 1–8), 4 patients achieved CR, 2 had partial response (PR), and 3 had progressive disease (PD). With a median follow up of 491 days (range 8–1048 days), four patients are alive (three in CR and one in PR), three patients have died and three patients were lost to follow up. Early real-world experience from a LMIC setting demonstrates feasibility and a favourable safety profile of Polatuzumab vedotin based approach, along with encouraging response rates in a subset of patients.

Redefining Precision Management of r/r Large B-Cell Lymphoma: Novel Antibodies Take on CART and BMT in the Quest for Future Treatment Strategies

“…In anotherretrospective analysis conducted in the United States with 57 patients refractory to CAR-T, polatuzumab-rituximab (n = 54) and polatuzumab-BR (n = 35) showed cumulative CR in 14% with an ORR of 44% [47]. Different real-world data collections from different countries showed an ORR ranging from 47.9 to 71.4% and a CR rate of 18.2-40% [48][49][50][51]. The largest volume of real-world data comes from the United Kingdom, with 133 patients treated with polatuzumab-BR resulting in an ORR of 57.0% (CR, 31.6%) [52].…”