|The following article features coverage from the American Society of Hematology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
The addition of the histone deacetylase inhibitor, romidepsin, to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) failed to improve outcomes over CHOP alone among patients with previously untreated peripheral T-cell lymphoma (PTCL), according to the final analysis of a phase 3 trial presented at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
“The addition of romidepsin to CHOP did not improve PFS, the primary endpoint of the study,” Emmanuel Bachy, MD, PhD, of the Hospices Civils De Lyon in France, and presenter of the study, said.
Romidepsin is approved by the US Food and Drug Administration for the treatment of PTCL after a least 1 prior treatment regimen. The aim of this study was to evaluate romidepsin in the first-line setting when combined with CHOP.
The multicenter, phase 3 trial randomly assigned 421 patients with treatment-naive PTCL to receive romidepsin plus CHOP or CHOP alone. Patients with ALK-positive anaplastic large cell lymphomas and EBV-positive extranodal natural killer/T-cell lymphomas were excluded. The primary endpoint was progression-free survival (PFS) and secondary endpoints included overall survival (OS), objective response rate (ORR), complete response (CR) plus CR-unconfirmed rates, and safety.
At baseline, the median age of patients was 65 years, 86% had Ann Arbor stage III/IV disease, and 80% had an International Prognostic Indicator score of at least 2.
PFS was similar between treatment groups, with a median of 12 months with romidepsin plus CHOP and 10.2 months with CHOP alone (hazard ratio [HR], 0.81; 95% CI, 0.63-1.04; P =.096). Median OS was also similar between groups, with a median of 51.8 months and 42.9 months in the romidepsin and CHOP-only groups, respectively (HR, 0.90; 95% CI, 0.68-1.20; P =.477).
The addition of romidepsin to CHOP also did not improve ORR, with a rate of 63% compared with 61% among patients treated with CHOP alone. The duration of response was longer with the addition of romidepsin at 36.3 months compared with 23.7 months with CHOP (HR, 0.68; 95% CI, 0.48-0.97; P =.032).
Treatment-emergent adverse events (TEAEs) were more common in the romidepsin plus CHOP arm, including grade 3 to 4 thrombocytopenia, neutropenia, anemia, and leukopenia.
“The high rates of TEAEs with the addition of romidepsin hampered the ability to adequately administer 6 cycles of CHOP,” Dr Bachy said. He noted that “it had an impact on the final results of the study,” but added that “dose modification of the CHOP backbone is only part of the answer.”
Treatment changes to CHOP due to AEs were also more common in the romidepsin arm compared with the CHOP-only arm, with 36% and 20% of patients, respectively, requiring dose interruption and 26% and 15% of patients, respectively, requiring dose reduction. Discontinuations were similar in the treatment arms; the rate was 3% in each arm.
Dr Bachy concluded that although “response rates and OS were similar between the 2 arms of treatment … additional exploratory analyses in specific patient subgroups are ongoing.”
Disclosures: Some of the presenters disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the presentation abstract.
Read more of Cancer Therapy Advisor‘s coverage of the ASH 2020 meeting by visiting the conference page.
Bachy E, Camus V, Thieblemont C, et al. Final analysis of the Ro-CHOP Phase III (conducted by LYSA): Romidepsin plus CHOP in patients with peripheral T-cell lymphoma. Presented at: 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-9, 2020. Abstract 39.