China’s regulatory agency recently accepted BeiGene’s new drug application (NDA) for tislelizumab, its investigational immune checkpoint inhibitor, for the potential treatment of patients with classical Hodgkin’s lymphoma who failed to respond or whose disease returned after prior therapies.
Acceptance of the new drug application by the National Medical Products Administration of China (NMPA) was based on clinical and non-clinical information, including the results of a pivotal Phase 2 clinical trial.
“The acceptance of our first NDA for tislelizumab represents an important milestone for BeiGene and for Chinese patients with Hodgkin’s lymphoma,” Jane Huang, MD, BeiGene’s chief medical officer of hematology, said in a press release.
Huang added that the company is “encouraged by the potential for tislelizumab to provide a new treatment option” for patients who relapse or don’t respond to chemotherapy or radiation, and who frequently have a poor prognosis.
Tislelizumab (BGB-A317) is an antibody against PD-1, a protein found on the surface of immune T-cells. Binding of PD-1 to PD-L1 in healthy and some cancer cells prevents immune attack. By targeting PD-1 and thereby blocking its interaction with PD-L1, tislelizumab is intended to boost the anti-cancer response.
The therapy candidate belongs to a class of compounds called immune checkpoint inhibitors. Examples of approved medications include Keytruda (pembrolizumab), Bavencio (avelumab), Opdivo (nivolumab), and Tecentriq (atezolizumab).
Because these medicines take the brakes off the immune system, patients may experience life-threatening complications caused by an overactive immune system. In such cases, the immune system attacks both healthy tissues and cancer cells, putting the patient at risk.
Tislelizumab, however, contains a specific modification that may minimize the risk of boosting the activity of immune cells against a patient’s healthy cells, as suggested by BeiGene’s preclinical data.
The Phase 2 trial (NCT03209973) included 70 patients with classical Hodgkin’s lymphoma who had either failed to respond or were ineligible for a stem cell transplant, and their illness had worsened following prior treatments.
A recent analysis, with a minimum of 24 weeks of follow-up and a median follow-up time of 7.85 months, showed that 85.7% of patients responded to the treatment, including 61.4% who achieved complete tumor clearance. These results are superior to those reported in July.
In addition, the frequency and severity of adverse events were consistent with those found in a prior Phase 1 trial, or consistent with other PD-1 antibodies used for classical Hodgkin’s lymphoma — particularly regarding immune-related events such as fever and hypothyroidism, the insufficient production of hormones by the thyroid gland.
BeiGene plans to present full results of the study at an upcoming medical conference.
“We are excited by the response rates, including high complete response rates,” said Wendy Yan, BeiGene’s global head of regulatory affairs, adding that the company is looking forward to working closely with the NMPA “to make tislelizumab available to patients in China as quickly as possible.”
Besides this Phase 2 study, BeiGene is also testing tislelizumab in Phase 3 trials of other cancer types, including non-small cell lung cancer and esophageal squamous cell carcinoma, and in Phase 2 studies of hepatocellular carcinoma, other types of lymphoma, and urothelial cancer.
Tislelizumab is being developed as a stand-alone treatment and in combination with other therapies. BeiGene is collaborating with Celgene in tislelizumab’s development outside Asia, except Japan.