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305 Golidocitinib in Treating Refractory or Relapsed Peripheral T- Cell Lymphoma: Full Analysis of the Multinational Pivotal Study Results (JACKPOT8)

Program: Oral and Poster Abstracts
Type: Oral
Session: 624. Hodgkin Lymphomas and T/NK Cell Lymphomas: Clinical and Epidemiological: Advances in Treating T Cell Lymphomas
Hematology Disease Topics & Pathways:
drug development, Therapies
Saturday, December 9, 2023: 5:00 PM

Yuqin Song, MD1, Luis Malpica, MD2*, Qingqing Cai, PhD3*, Weili Zhao4, Keshu Zhou, MD5*, Jianqiu Wu6*, Huilai Zhang, MD7*, Kaiyang Ding8*, Yao Liu, PhD, MD9, Zengjun Li10*, Neha Mehta-Shah, MD11, Liling Zhang12*, Meifang Zheng13*, Jie Jin14, Haiyan Yang15, Yuerong Shuang16*, Dok Hyun Yoon, MD, PhD17*, Sujun Gao18*, Wenyu Li19*, Zhimin Zhai, MD20, Liqun Zou, MD, PhD21*, Yaming Xi22*, Youngil Koh, MD23, Fei Li24*, Miles Prince, MBBS (Hons), MD, FRACP, FRCPA, AFRCMA, MACD, FAHMS25, Hui Zhou26, Lie Lin, MD27*, Hui Liu28*, Zhenfan Yang, PhD29, Won Seog Kim, MD, MPH, PhD30* and Jun Zhu, PhD31

1Peking University Cancer Hospital and Institute, Beijing, China
2Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX
3Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China
4Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
5Department of Hematology, Cancer Hospital Affiliated to Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China
6Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China
7Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
8Anhui Provincial Cancer Hospital, Hefei, China
9Department of Hematology-Oncology, Chongqing University Cancer Hospital, Chongqing, China
10Department of Lymphoma and Hematology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Ji'nan, Shandong, China
11Division of Oncology, Washington University School of Medicine, Saint Louis, MO
12Wuhan Tongji Union Hospital, Wuhan, China
13Linyi Cancer Hospital, Linyi, China
14The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China
15Department of Lymphatic Oncology, Zhejiang Cancer Hospital, Hangzhou, China
16Jiangxi Cancer Hospital, Nanchang, China
17Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South)
18The First Hospital of Jilin University, Changchun, China
19Guangdong Provincial People's Hospital, Guangzhou, China
20The Second Affiliated Hospital of Anhui Medical University, Hefei, China
21West China Hospital of Sichuan University, Chengdu, China
22The First Hospital of Lanzhou University, Lanzhou, CHN
23Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea, Republic of (South)
24The First Affiliated Hospital of Nanchang University, Nanchang, China
25Epworth Hospital, Melbourne, Australia
26Hunan Cancer Hospital, Changsha, China
27Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University, Haikou, China
28Beijing Hospital, Beijing, China
29Dizal Pharmaceutical, China, Shanghai, China
30Samsung Medical Center, Seoul, Korea, Republic of (South)
31Peking University Cancer Hospital, Beijing, China


Golidocitinib is the first JAK1 selective inhibitor to enter into pivotal clinical development for the treatment of relapsed/refractory peripheral T cell lymphoma (r/r PTCL). Preliminary analysis of the JACKPOT8 study (NCT04105010) has shown promising antitumor efficacy and a manageable safety profile of golidocitinib. Here we reported the full analysis of the phase 2 multinational pivotal study JACKPOT8 Part B.


This study enrolled r/r PTCL patients who had undergone at least one line of systemic therapies. All patients received golidocitinib at 150 mg once daily (QD) until disease progression or pre-defined discontinuation criteria were met. The primary endpoint was a CT-based objective response rate (ORR) assessed by an independent review committee (IRC) per Lugano 2014 criteria. Other efficacy endpoints included duration of response (DoR), progression-free survival (PFS), and overall survival (OS). The efficacy analysis set included patients whose pathological diagnosis of PTCL has been retrospectively confirmed by a central laboratory and who had at least one measurable lesion at the baseline assessed by IRC. The safety analysis set included all dosed patients.


A total of 88 efficacy evaluable patients with r/r PTCL were included in the analysis. The median age was 57.5 years, and the majority (64.8%) were male. The major pathological subtypes included PTCL NOS (56.8%), AITL (18.2%), and ALCL (11.4%). At the baseline, 54.5% of patients had ECOG PS of 1, 52.3% had elevated LDH levels, and 21.6% had bone marrow involvement. The median prior lines of therapies were two. All patients had been treated with chemotherapies, 50% had been treated with histone deacetylase inhibitors, and 10.2% had received CD30 targeted therapy.

Per IRC assessment based on CT imaging, 39 patients achieved tumor response, with an ORR of 44.3% (95% CI: 33.7%, 55.3%), and 26 patients (29.5%) achieved complete response. The primary endpoint met the pre-defined target with statistical significance (p < 0.0001). Tumor response was observed in various subtypes, irrespective of age, gender, baseline bone marrow involvement, and ECOG PS. With a median follow-up time of 10.4 months for DoR, 59% of responders were still event-free. The median DoR has not been reached, with an estimated 12-month DoR rate of 70.2%. With a median follow-up time of 9.6 months for PFS, the median PFS was 5.6 months. The longest PFS was 20 months, and the patient was still responding. Per investigator assessment, 34 patients achieved tumor response (ORR: 38.6%). The DoR and PFS by investigator assessment were similar to that of IRC assessed results.

With a median follow-up time of 15.1 months for OS, approximately 60% of patients were still alive, with an estimated median OS of 19.2 months.

A total of 112 patients were included in the safety analysis set. The median relative dose intensity was 100%. A total of 62 patients (55.4%) reported ≥ grade 3 treatment-emergent adverse events (TEAEs). The most common drug-related ≥ grade 3 TEAEs were hematological adverse events in nature, including neutropenia (25%), leukopenia (23.2%), and lymphopenia (18.8%). The majority of TEAEs were reversible and clinically manageable. Treatment-related AEs leading to dose interruption, reduction, and discontinuation were reported in 36.6%, 7.1%, and 8% of patients, respectively.


This pivotal study met its primary objective, suggesting golidocitinib can be an effective treatment option with a manageable safety profile for patients with r/r PTCL. The updated data will be presented at the conference.

Disclosures: Mehta-Shah: Karyopharm Therapeutics: Consultancy; Celgene: Research Funding; Daiichi Sankyo: Consultancy, Research Funding; Kyowa Hakko: Consultancy; Janssen: Consultancy; Corvus Pharmaceuticals: Research Funding; C4 Therapeutics: Consultancy, Research Funding; Genentech/Roche: Research Funding; Bristol Myers-Squibb: Research Funding; AstraZeneca: Consultancy, Research Funding; Innate Pharmaceuticals: Research Funding; Ono Pharmaceuticals: Consultancy; Secura Bio/Verastem: Consultancy, Research Funding; Genentech: Consultancy. Yoon: Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Kirin Pharm: Honoraria, Speakers Bureau; Boryung: Research Funding; BMS: Honoraria, Speakers Bureau; Roche: Honoraria, Research Funding, Speakers Bureau; Pharos iBio: Consultancy; Beigene: Consultancy; Abclon: Consultancy; Samyang: Research Funding; Novartis: Consultancy, Honoraria, Speakers Bureau; GI cell: Consultancy; GC cell: Consultancy. Koh: Sanofi Genzyme: Research Funding; Proteina: Current holder of stock options in a privately-held company; Curocell: Current equity holder in private company; Deep Metrics: Current equity holder in private company; Novartis Korea: Consultancy; Takeda Korea: Consultancy; BMS Korea: Consultancy; Genome Opinion: Current Employment, Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees; Tomocube: Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees; Janssen Korea: Consultancy. Prince: Takeda: Speakers Bureau; Mallinkrodt: Speakers Bureau; Mundipharma: Speakers Bureau; Merck: Speakers Bureau. Yang: Dizal Pharmaceutical: Current Employment. Kim: Donga: Research Funding; Boryung: Research Funding; Sanofi: Research Funding; Roche: Research Funding; Kyowa-Kirin: Research Funding; Beigene: Research Funding.

*signifies non-member of ASH