Brentuximab vedotin fares well for CTCL in real-world study

Interim findings from a prospective real-world study in Poland demonstrated favourable clinical outcomes and a tolerable safety profile for the CD30-directed antibody-drug conjugate brentuximab vedotin in patients with CD30-expressing cutaneous T-cell lymphoma (CTCL).

In the full analysis set, median modified severity-weighted assessment tool (mSWAT) score dropped significantly from baseline. At week 0, median mSWAT score was 61.5. By week 24, the score was 15.6. Median percentage change in mSWAT from baseline was -55.0 percent. This was more than twice the percentage change seen at week 6 (-23.7 percent). [EADV 2023, abstract 6587]

“There was a significant decrease in skin involvement,” said Dr Adam Reich from the Institute of Medical Sciences, Medical College of Rzeszów University, Rzeszów, Poland, at EADV 2023. “However, none achieved complete response (ie, 100-percent clearance of skin lesions).”

At week 24, 10 patients had a partial response, which was twice the rate seen at week 6. Partial response was defined as 50–99 percent clearance of skin disease from baseline without new tumours. Eight had stable disease and four experienced progressive disease.

Of the brentuximab vedotin-related adverse events (AEs), the most common were nervous system disorders (n=6), mostly polyneuropathy (n=4).

Unfavourable prognosis

“CTCLs are a heterogeneous group of lymphomas primarily affecting the skin and negatively impacting quality of life. Advanced stages of CTCL have an unfavourable prognosis, as many patients are refractory to available treatments or have poor tolerance to them,” explained Reich.

Systemic chemotherapy is only reserved for individuals with relapsed/refractory disease following topical treatments, or for those who have advanced nodal/visceral disease at presentation. [J Natl Compr Canc Netw 2020;18:522-536; Mediterr J Hematol Infect Dis 2022;14:e2022029] “We really need effective treatment for more advanced stages,” Reich stressed.

To better understand the real-world efficacy of brentuximab vedotin, Reich and his team consecutively enrolled 22 patients with CD30-positive CTCL (median age 62 years, 72.7 percent male) in this open-label study. Of these, 19 had transformed mycosis fungoides, while three had primary cutaneous anaplastic large cell lymphoma.

More than half (54.5 percent) of the participants had stage IIB CTCL, while almost 14 percent had stage IIIA disease. About 60 percent had a grade 1 score on the ECOG scale. Median time from diagnosis to brentuximab vedotin treatment was 4.6 years. Previous treatments included systemic (95.5 percent), skin-directed (59.1 percent), and radiation (40.9 percent) therapies, and surgery (9.1 percent).

Boosts previous data

A phase III trial showed the potential of brentuximab vedotin to improve objective responses and progression-free survival in CD30-expressing CTCL compared with methotrexate or bexarotene. [Blood Adv 2021;5:5098-5106] Findings from a retrospective chart review study correlated with these results and showed favourable real-world outcomes with brentuximab vedotin. [Blood 2022;140(Suppl 1):5167-5169]

The current outcomes confirm the efficacy and acceptable safety profile of brentuximab vedotin and add to the growing body of existing evidence. “These findings indicate the potential of brentuximab vedotin therapy in CTCL management, but these underscore the need for continued evaluation of its long-term efficacy and safety,” concluded Reich.