BeiGene Announces Updated Results from a Pivotal Phase 2 Study of Tislelizumab in Chinese Patients with Relapsed or Refractory Classical Hodgkin Lymphoma at the 24th Congress of the European Hematology Association (EHA)
“The encouraging clinical results from this study further support our new drug application for tislelizumab in patients with R/R cHL that is currently under priority review in China,” said
“Tislelizumab demonstrated high anti-tumor activity in patients with R/R cHL – evidenced by an overall response rate of 87% and a complete response rate of 63%, and was generally well tolerated in these patients,” said
Summary of Clinical Results
Abstract Number: PF469
This single-arm, multi-center, pivotal Phase 2 study of tislelizumab as a monotherapy in Chinese patients with R/R cHL (clinicaltrials.gov identifier: NCT03209973) enrolled 70 patients who were either R/R to autologous stem cell transplantation (ASCT), or received at least two prior lines of systemic therapy for cHL and were not candidates for ASCT. Patients were treated with tislelizumab, dosed at 200 mg intravenously every three weeks. The primary endpoint of the trial is overall response rate (ORR) assessed by independent review committee (IRC) according to the Lugano Classification 2014.
- With a minimum of 23.8 weeks of follow-up and a median follow-up time of 13.9 months at the data cutoff, the ORR by IRC was 87.1% (61/70); 44 patients (62.9%) achieved a complete response (CR), and 17 patients (24.3%) achieved a partial response (PR);
- The median duration of response (DOR) has not been reached;
- Twelve-month progression-free survival (PFS) was estimated at 73.8% and median PFS has not been reached;
- The majority of adverse events (AEs) were grade 1 or 2 in severity. The most frequently reported treatment-emergent adverse events (TEAEs) of any grade include pyrexia (57.1%), weight increase (34.3%), upper respiratory tract infection and hypothyroidism (32.9% each), pruritus, white blood cell (WBC) count decreased, and cough (18.6%, each);
- Grade ≧3 TEAEs occurred in 30% of patients, with the most frequently reported being hypertension, pneumonitis, neutrophil count decrease, upper respiratory tract infection, and weight increase (2.9%, each); only 2.9% of patients reported grade 4 TEAEs and there were no fatal TEAEs.
- Four patients (5.7%) discontinued treatment due to TEAEs, including pneumonitis (n=2), focal segmental glomerulosclerosis (n=1), and organizing pneumonia (n=1); and
- Immune-related (ir) TEAEs reported in more than 5% of patients included thyroid disorder (22.9%), skin adverse reactions (8.6%)*, and pneumonitis (7.1%).
Mid-2019 Clinical Data Update Conference Call and Webcast Information:
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About Classical Hodgkin Lymphoma
Hodgkin’s lymphoma is one of the two major types of lymphoma that begin in the lymph nodes and tissues of the lymphatic system. All other lymphomas are classified as non-Hodgkin’s lymphomas. Classical Hodgkin lymphoma, the most common form representing about 95% of patients with Hodgkin’s lymphoma, is characterized by the presence of very large cells called Reed-Sternberg cells. There were approximately 2,100 diagnosed cases of Hodgkin’s lymphoma in China in 2012.i Although the cancer can occur in both children and adults, it is most commonly diagnosed in young adults between the ages of 15 and 35 and in older adults over age 50.
Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologic program, and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
Tislelizumab is being studied in a broad clinical program.
New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with previously treated locally advanced or metastatic UC have been accepted by the
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the encouraging clinical data from clinical trials of tislelizumab, the mechanism of action of tislelizumab, and BeiGene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of tislelizumab. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including
* Skin ir TEAEs included dermatitis, erythema nodosum, pruritus (3), vitiligo
ii ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of
Source: BeiGene, LTD.