Use of the PD-1 inhibitor sintilimab in combination with ICE chemotherapy as a second-line treatment in classical Hodgkin lymphoma shows impressive response rates vs chemo alone in the phase 3 ORIENT-21 trial.
The programmed cell death protein 1 inhibitor drug sintilimab in combination with the standard chemotherapy regimen of ifosfamide, carboplatin, and etoposide shows significant benefit as a second-line treatment for classical Hodgkin lymphoma vs ICE chemotherapy alone, with relatively high rates of complete responses and favorable progression-free survival .
The results are from the phase 3 ORIENT-21 trial, conducted in China, which is believed to represent the first randomized study of a PD-1 inhibitor plus chemotherapy compared with chemotherapy alone in the challenging second-line setting of classical HL. The study included 81 patients with classical HL who failed first-line standard chemotherapy, with a median age of 33, including 12.3% over the age of 50. Of the patients, 23.5% had stage III disease, and 35.8% had stage IV disease; 56.8% were relapsed, and 43.2% were refractory. After a safety run-in phase, patients were randomized 1:1 to treatment either with sintilimab or placebo plus ICE for six cycles.With a median follow-up of 38.4 months in the modified intention-to-treat population , sintilimab plus ICE showed a significantly higher complete response rate of 61.8% compared with 32.4% with ICE alone , with more favorable PFS among CR patients vs non-CR patients in each treatment arm. Treatment-emergent adverse events were similar in both arms , with no TEAEs resulting in death.“As the second-line treatment for classical Hodgkin lymphoma, sintilimab plus ICE significantly improved complete response rates and showed a trend of improved PFS compared with placebo plus ICE,” said first author Peng Liu, of the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China. The results “may provide data for a stem-cell transplant-free approach for some patients in second-line classical Hodgkin lymphoma,” commented Sarah C. Rutherford, MD, associate professor of clinical medicine at Weill Cornell Medicine in New York City, a discussant for the study at the meeting.Longer follow-up is needed, “especially to understand the impact of no autologous stem cell transplantation,” Rutherford noted. Results from a larger sample size are warranted, the authors added. As the study was conducted in China, generalizability of the results to other populations should be considered.Rutherford’s disclosures include relationships with Abbvie, ADC Therapeutics, Bristol Myers Squibb, Genmab, Incyte, Karyopharm Therapeutics, Kite Pharma, Pfizer, and Seagen.All material on this website is protected by copyright, Copyright © 1994-2025 by WebMD LLC. This website also contains material copyrighted by 3rd parties.
Hodgkin Disease Hodgkin's Lymphoma Chemotherapy Lymphoma Malignant Lymphoma Stem Cell Research & Therapy Stem Cell Transplantation Stem Cell Therapy Stem Cell Research And Therapy Transplantation Of Stem Cells Stem Cell Cell Transplantation Cellular Transplant Cellular Transplantation Transplantation Transplant Cancer Malignant Neoplasia Carcinoma
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