Tisagenlecleucel plus pembrolizumab may be effective in patients with high-risk, relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), according to research published in Blood Advances.

In the phase 1b PORTIA study (ClinicalTrials.gov Identifier: NCT03630159), researchers tested tisagenlecleucel plus pembrolizumab in adults with R/R DLBCL who received 2 or more prior lines of therapy and had an ECOG performance status of 0-1.

Patients received a tisagenlecleucel infusion on day 1 and pembrolizumab (200 mg) every 21 days, for up to 6 doses. The patients were separated into 3 cohorts that initiated pembrolizumab on day 15 (n=4), day 8 (n=4), or day -1 (n=4).

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The study enrolled 15 patients, but 3 patients discontinued prior to receiving tisagenlecleucel — 2 due to adverse events (AEs) and 1 due to death.

Of the remaining 12 patients, 3 patients completed 6 cycles of pembrolizumab — 2 who initiated on day 15 and 1 who initiated on day –1. A total of 7 patients discontinued pembrolizumab — 5 due to disease progression, 1 due to an AE, and 1 due to patient decision.

Overall, 4 patients had a complete response (33.3%), 2 had a partial response (16.7%), and 5 had disease progression (50.0%). The overall response rate was 50%. The cohort initiating pembrolizumab on day -1 had the highest response rate, at 75%.

The study was terminated early based on the data analysis and in consideration of other therapies with similar efficacies.

“Limited data suggest that the combination of tisagenlecleucel and pembrolizumab was feasible and showed a manageable safety profile, with no DLTs [dose-limiting toxicities] or significant exacerbation of tisagenlecleucel-related AEs,” the investigators wrote.

Disclosures: This research was supported by Novartis Pharmaceuticals Corporation. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Jaeger U, Worel N, McGuirk JP, et al. Safety and efficacy of tisagenlecleucel plus pembrolizumab in patients with r/r DLBCL: results from the phase Ib PORTIA study. Blood Adv. Published online August 31, 2022. doi:10.1182/bloodadvances.2022007779

This article originally appeared on Hematology Advisor