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4944 Combined Cytokine Blocking Therapy (CCBT) Using Basiliximab and Infliximab for Treatment of Steroid-Refractory Graft Versus Host Disease (SR-GvHD)

Program: Oral and Poster Abstracts
Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III
Hematology Disease Topics & Pathways:
Combination therapy, Therapies
Monday, December 11, 2023, 6:00 PM-8:00 PM

Hoda Pourhassan, MD1, Tina Nguyen2*, Dongyun Yang, PhD3*, Tamer Othman, MD4, Paul B. Koller, MD5, Amanda Blackmon, DO, MS5*, Vaibhav Agrawal, M.D.6, Brian J. Ball, MD5, Idoroenyi Amanam, MD7, Shukaib Arslan, MD5*, Salman Otoukesh, MD5, Karamjeet S. Sandhu, MD8, Ibrahim Aldoss, MD9, Haris Ali, MD2, Amandeep Salhotra, MD6, Ahmed Aribi, MD5*, Andrew Artz, MD, MS9, Pamela S. Becker, MD, PhD1, Vinod Pullarkat, MD7, Forest Marc Stewart, MD5, Eileen Patricia Smith, MD5, Anthony Stein, MD5, Guido Marcucci, MD5, Stephen J. Forman, MD, FACP10, Ryotaro Nakamura, MD11 and Monzr M. Al Malki, MD6

1Hematology/HCT, City of Hope, Duarte, CA
2City of Hope Medical Center, Duarte, CA
3Computational and Quantitative Medicine, City of Hope National Medical Center, Duarte, CA
4City of Hope, San Lorenzo, CA
5Hematology/HCT, City of Hope National Medical Center, Duarte, CA
6Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA
7City of Hope National Medical Center, Duarte, CA
8City of Hope National Medical Center, La Crescenta, CA
9City of Hope, Duarte, CA
10Department of Hematology and Hematopoietic Cell Transplantation, Gehr Family Center for Leukemia Research, City of Hope National Medical Center, Duarte, CA
11Cellular Immunotherapy Center, Department of Hematology and Hematopoietic Cell Transplantation, Beckman Research Institute of City of Hope, Duarte, CA


Despite improved advances in graft-vs-host disease (GvHD) prophylaxis regimens and post-allogeneic hematopoietic cell transplant (HCT) supportive care, clinically significant acute GvHD still develops in approximately 30-50% of HCT recipients (Lazaryan A et al. BMT 2016) and often results in increased transplanted-related morbidity and mortality and deterioration of quality of life (Choi J et al. Blood 2012). Standard first-line treatment is high-dose glucocorticoids have been limited including recently approved JAK2 inhibitor (ruxolitinib). The utilization of combined cytokine blockade therapy (CCBT) with the monoclonal antibodies infliximab (a TNF-α inhibitor, INF) and basiliximab (an IL-2 receptor blocker, BAS), has had limited discussion in the literature despite common utilization. The primary objective of this retrospective study was to determine overall response rate (ORR) at days 7, 14 and 28 for CCBT. Secondary outcomes included non-relapse mortality (NRM), and overall survival (OS).


60 patients who met the inclusion criteria were analyzed. Patients included were ≥18 years old and had undergone HCT using any donor or graft source with any conditioning regimen between 2010-2021 at City of Hope Medical Center in Duarte, CA. Patients had steroid refractory aGvHD, according to Mount Sinai Consortium guidelines (Harris AC et al. BMT 2016) and received at least one dose of BAS and at least one dose of INF. Patients with >1 allogeneic transplant, chronic GVHD including overlap syndrome, relapse of primary disease, graft loss, and glucocorticoid treatment for indications other than GVHD were excluded.


BAS was administered intravenously as 20mg doses given first as loading doses on days 1 and 4. Subsequent doses were given weekly starting 7 days after the final loading dose (day 4). INF was administered as 10 mg/kg doses infused weekly. Tacrolimus, sirolimus and cyclosporine dosing and monitoring were performed in accordance with institutional policies. All patients had clinical presentation of SR-GVHD defined as ≥1 of the following: GVHD increasing in stage in any organ or developing in a new organ after 3 days of ≥2 mg/kg methylprednisolone (MSPE) or equivalent, GVHD that has not improved in stage in ≥1 organ after 7 days of ≥2 mg/kg MSPE or equivalent, development of GVHD in a new organ after ≥1 mg/kg MSPE or equivalent for skin GVHD or patients who progress during tapering before a 50% decrease in glucocorticoids is achieved.


The median age was 53 years (range, 5-78) at time of HCT. Of 60 patients, 65% were males and with 18.3% of male patients receiving grafts from female donor. HCT-CI at the time of HCT was 3 or more in 47% of the patients. Conditioning for those patients was ablative in 43.3% of patients with 76.7% of patients receiving PBSC grafts from mostly MSD/MUD in 75% of patients. Most patients had grade 3 or 4 overall acute GVHD (grade 3: n=35, 58.3%, grade 4: n=20, 33.3%). Median time to start of BAS after start of steroid was 7 days while time to start of INF after steroid was 11 days. Ruxolitinib was initiated in 33.3% (20/60) of patients prior to CCBT. ORR for CCBT therapy at day 7, 14, and 28 were 28.3% (17/60; CR 5.0%), 38.3% (23/60; CR 11.7%), and 38.3% (23/60; CR 23.3%), respectively. Patients who received ruxolitinib prior to CCBT had lower ORR (25%) compared to those who did not (47.5%).

37 patients died—20 of aGVHD, 4 of infection, 1 of sudden cardiac death and 1 of leukemia relapse. OS was 41.7% at 6 months and 36.5% at 12 months (Figure 1A). Cumulative incidence of NRM was 51.7% at 6 months and 55% at 12 months (Figure 1B). Cumulative incidence of any cGvHD was 33.6% at 12 months while it was 30% for extensive cGvHD at the same 12-month interval. In patients with and without ruxolitinib initiated prior to CCBT, OS at 12 months was 30% vs 40%, respectively (Figure 2A) while NRM at 12 months was 65% and 50%, respectively (Figure 2B).


CCBT has potential efficacy in steroid refractory aGVHD. The observed ORR is reflective of both advanced and highly refractory aGVHD with one-third of patients progressing on ruxolitinib. Given the favorable observed ORR in this difficult to treat population, CCBT is a potentially promising approach and suitable alternative in the second line or as salvage therapy in patients failing Ruxolitinib.

Disclosures: Koller: treadwell therapuetics: Consultancy, Other: safety review committee; NOVARTIS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; takeda: Consultancy, Speakers Bureau. Sandhu: Autolus Therapeutics: Consultancy; City of Hope Medical Center: Current Employment. Aldoss: KiTE: Consultancy; Sobi: Consultancy; Jazz: Consultancy; Pfizer: Consultancy; Amgen: Consultancy, Honoraria; Takeda: Consultancy. Salhotra: Rigel Pharma: Research Funding; Jazz Pharma: Research Funding; Sobi: Membership on an entity's Board of Directors or advisory committees; BMS: Research Funding; OrcaBio: Research Funding; Sanofi: Speakers Bureau; Kura Oncology: Research Funding; Gilead: Research Funding. Aribi: Kite, a Gilead Company: Consultancy; Seagen: Consultancy. Artz: Magenta Therapeutics: Other: Advisory Board; Astra Zeneca: Other: Advisory Board; Abbvie: Consultancy; Radiology Partner: Current equity holder in private company, Other: Spouse equity interest. Becker: Glycomimetics: Research Funding; Accordant Health Services: Membership on an entity's Board of Directors or advisory committees; Notable Labs: Research Funding; GPCR Therapeutics: Research Funding; Pfizer: Research Funding. Pullarkat: Amgen: Consultancy, Speakers Bureau; Servier: Consultancy, Speakers Bureau; Genentech: Consultancy, Speakers Bureau; Jazz Pharmaceuticals: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; AbbVie: Consultancy, Speakers Bureau. Stein: Sanofi: Current Employment, Current holder of stock options in a privately-held company. Marcucci: Ostentus Therapeutics: Current equity holder in private company, Research Funding. Nakamura: Sanofi: Consultancy; NCCN: Other: guideline panel for HCT; Blue Bird: Consultancy; Omeros: Consultancy; Jazz Pharmaceuticals: Consultancy, Other: research collaboration; Napajen: Consultancy; International Consortium: Other: consortium chair; Miyarisan: Research Funding; Leukemia & Lymphoma Society: Other: grant reviewer; BMT CTN Steering Committee: Membership on an entity's Board of Directors or advisory committees; Mt. Sinai: Other: Acute GVHD; NCTN Lymphoma Steering Committee: Membership on an entity's Board of Directors or advisory committees. Al Malki: Tscan: Consultancy.

*signifies non-member of ASH