Adding romidepsin to frontline chemotherapy does not improve progression-free survival (PFS) in patients with peripheral T-cell lymphoma (PTCL), according to phase 2 results presented at the 2021 American Society of Hematology (ASH) Annual Meeting.

The study’s primary endpoint was not met, so enrollment was stopped early, said Annalisa Chiappella, MD, of Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy, who presented the results at the meeting.

Dr Chiappella presented data from the phase 2 component of the PTCL13 trial (ClinicalTrials.gov Identifier: NCT02223208), which was designed to evaluate first-line romidepsin in combination with cyclophosphamide, doxorubicin, etoposide, vincristine, and prednisone (CHOEP) followed by hematopoietic stem cell transplant (HSCT).

The cohort included 86 patients — 33 with PTCL not otherwise specified, 31 with angioimmunoblastic/T follicular helper lymphoma, 21 with ALK-negative anaplastic large-cell lymphoma, and 1 patient who could not be classified.

The patients’ median age was 55 years (IQR, 49-60 years), 91% had stage III-IV disease, and 36% had an International Prognostic Index score greater than 2.

Patients received CHOEP-21 plus romidepsin at 14 mg/ms on days 1 and 8. After 3 cycles, responders went on to receive an additional 3 cycles. Patients with a partial response (PR) after 6 cycles went on to allogeneic HSCT, and patients with a complete response (CR) went on to autologous HSCT.

After 3 cycles, the overall response rate (ORR) was 88%, with 33% of patients achieving a CR and 55% having a PR. After 6 cycles, the ORR was 71%, the CR rate was 62%, and the PR rate was 9%. At the end of treatment, the ORR was 57%, the CR rate was 56%, and the PR rate was 1%.

The study’s primary objective was to demonstrate a 15% increase in 18-month PFS for CHOEP-romidepsin plus HSCT, compared with previous trials.

At a median follow-up of 26 months, the 18-month PFS was 48% (95% CI, 0.36-0.58), which did not meet the planned statistical threshold for continuation of the study. Therefore, enrollment was stopped.

The 18-month overall survival rate was 75% (95% CI, 0.64-0.83). Of the 24 deaths observed, 22 were due to lymphoma progression, 1 was transplant-related (septic shock), and 1 was due to a secondary malignancy.

The most common adverse events were hematologic toxicities. Grade 3-4 thrombocytopenia was observed in 34% of all 459 romidepsin-CHOEP cycles. Grade 3-4 neutropenia was observed in 33%, and grade 3-4 febrile neutropenia was seen in 4%.

Disclosures: This study was sponsored by Fondazione Italiana Linfomi ONLUS. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Read more of Cancer Therapy Advisor’s coverage of the ASH 2021 meeting by visiting the conference page.

References:

https://www.cancertherapyadvisor.com/home/news/conference-coverage/american-society-of-hematology-ash/ash-2021/ash-2021-lymphoma-in-depth/tcell-lymphoma-romidepsin-choep-falls-short-treatment-risk/