Meeting
2024 ASCO Gastrointestinal Cancers Symposium
Initial uptake of durvalumab with or without tremelimumab for advanced hepatocellular carcinoma in routine clinical practice: Preliminary results of the international DT-real study.
Authors
Ciro Celsa
Department of Surgery and Cancer, Imperial College, Hammersmith Hospital, London, United Kingdom
Ciro Celsa , Naoshi Nishida , Ashwini Arvind , Susanna Varkey Ulahannan , Michael Li , Bernhard Scheiner , Claudia A.M. Fulgenzi , Antonio D'Alessio , Giulia F Manfredi , Bernardo Stefanini , Giuseppe Cabibbo , Alessio Cortellini , Matthias Pinter , Robin Kate Kelley , Paul Antoine El Tomb , Amit G. Singal , Masatoshi Kudo , David James Pinato
Organizations
Department of Surgery and Cancer, Imperial College, Hammersmith Hospital, London, United Kingdom, Kindai University, Osaka, Japan, University of Texas Southwestern Medical Center, Dallas, TX, Stephenson Cancer Center of the University of Oklahoma/Sarah Cannon Research Institute, Oklahoma City, OK, University of California, San Fransisco, San Francisco, CA, Divison of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria, Imperial College, London, United Kingdom, Department of Surgery and Cancer, Imperial College, London, United Kingdom, Università degli Studi di Palermo, Palermo, Italy, Division of Surgery and Cancer, Imperial College, London, United Kingdom, Hepatology AKH, Medical University of Vienna, Vienna, Austria, University of California, San Francisco, San Francisco, CA, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, Kindai University Faculty of Medicine, Osaka, Japan
Research Funding
No funding sources reported
Background: HIMALAYA trial showed that durvalumab plus tremelimumab (Single Tremelimumab Regular Interval Durvalumab; STRIDE) significantly improved overall survival (OS) and that durvalumab (DUR) was non-inferior compared to sorafenib in patients with hepatocellular carcinoma (HCC). However, real world outcomes on this regimen have not been described. Methods: In the context of a prospectively maintained database including 953 patients (pts) with unresectable HCC treated with immunotherapy, we analysed a subgroup of pts treated with STRIDE or DUR across 5 centres in USA, Asia and Europe. We assessed OS, progression-free survival (PFS), objective response rate (ORR) by RECIST 1.1 (per investigator) and treatment-related adverse events (TRAEs) per CTCAE v.5.0. Results: Between February and May 2023, 59 pts initiated treatment with STRIDE or DUR (mean age 67.2 years, male sex 81.4%). 33 pts (55.9%) were treated in first-line (1L) and 26 (44.1%) in second- or further-line (>1L). STRIDE regimen was administered in 24 patients (40.7%): 6 pts in 1L, 18 pts in >1L. Child-Pugh class was A in 32 pts (54.2%), being more common in pts treated with STRIDE than DUR (79.2% vs 37.1%, p=0.003). ECOG-PS was 0 in 35 pts (59.3%) and it was more common in pts treated with STRIDE than DUR (79.2% vs 47.0%, p=0.015). Outcomes are reported in Table. After a median follow-up of 3.2 months (95%CI 2.6-3.8), median OS was not reached and 6-month OS rate was 59.4%. In pts treated with STRIDE, median OS was not reached and 6-month OS rate was 95.8%, while median OS was 4.9 months (95%CI 3.2-4.9) for DUR. Median PFS was 2.5 months (95% CI 1.9-3.8) and ORR (evaluable in 43 pts, 72.9%) was 16.3% (95%CI 6.5-33.5%). Any grade TRAEs and grade 3-4 TRAEs were 42.4% (95%CI 27.4-62.5) and 10.2% (95%CI 3.7-22.1%), respectively. TRAEs requiring systemic corticosteroid therapy occurred in 3 pts (5.1%). Conclusions: Preliminary observational data from DT-real confirm uptake of STRIDE and DUR across various lines of therapy, with encouraging efficacy and safety outcomes in routine practice.
| Overall (N=59) | STRIDE (n=24, 40.7%) | DUR (n=35, 59.3%) | First-line (n=33, 55.9%) | Second- or further-lines (n=26, 44.1%) | |||
|---|---|---|---|---|---|---|---|
| STRIDE (n=6) | DUR (n=27) | STRIDE (n=18) | DUR (n=8) | ||||
| Median OS (months, 95%CI) | NR | NR | 4.9 (3.2-4.9) | NR | NR | NR | 3.2 (1.9-3.2) |
| 6-month OS (%,95%CI) | 59.4 | 95.8 | 59.4 | 100 | 50.9 | 94.4 | 47.6 |
| Median PFS (months, 95%CI) | 2.5 (1.9-3.8) | 2.1 (1.1-1.3) | 2.5 (1.9-3.8) | NR | 2.5 (1.9-3.8) | 1.6 (1.0-3.0) | 2.6 (1.4-3.2) |
| ORR (%,95%CI) (N=43) | 16.3 (6.5-33.5) | 13.0 (2.7-38.1) | 20.0 (5.5-51.2) | 16.7 (0.4-92.9) | 18.8 (3.9-54.8) | 11.8 (1.4-42.5) | 25 (0.6-100) |
| Any grade TRAEs (%,95%CI) | 42.4 (27.4-62.5) | 50.0 (25.8-87.3) | 37.1 (19.8-63.5) | 66.7 (18.2-100) | 22.2 (8.2-4.8) | 44.4 (19.2-87.5) | 87.5 (35.2-1.8) |
| Grade 3-4 TRAEs (%, 95%CI) | 10.2 (3.7-22.1) | 4.2 (0.1-23.2) | 14.3 (0.5-33.3) | 0 | 7.4 (0.9-26.7) | 5.5 (0.1-30.9) | 37.5 (7.7-100) |
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Track
Pancreatic Cancer,Hepatobiliary Cancer,Neuroendocrine/Carcinoid,Small Bowel Cancer
Sub Track
Therapeutics
Citation
J Clin Oncol 42, 2024 (suppl 3; abstr 501)
DOI
10.1200/JCO.2024.42.3_suppl.501
Abstract #
501
Poster Bd #
D8
Abstract Disclosures
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