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The combination of the anti–PD-1 tislelizumab and chemotherapy was found to significantly improve progression-free survival compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial.
The combination of the anti–PD-1 tislelizumab (BGB-A317) and chemotherapy was found to significantly improve progression-free survival (PFS) compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial (NCT03924986).1
The improvement with the regimen was noted in the intent-to-treat population, per independent review committee (IRC) assessment. Moreover, the toxicity profile of tislelizumab proved to be consistent with what has previously been reported with the agent. Notably, no new safety signals observed with the addition of chemotherapy.
BeiGene, Ltd., shared that they will be presenting these data at an upcoming medical meeting and will also discuss these results with health authorities.
“We are excited to see a clinically meaningful improvement in PFS in our phase 3 trial for tislelizumab plus chemotherapy in patients with nasopharyngeal cancer. This is our fifth positive phase 3 readout for tislelizumab, which we are developing broadly as a potentially differentiated anti–PD-1 antibody,” Yong (Ben) Ben, MD, chief medical officer of Immuno-Oncology at BeiGene, stated in a press release. “We are grateful for the patients and clinicians who participated in this trial and hopeful that they may have a new treatment option in the future.”
In the double-blind, placebo-controlled, phase 3 trial, investigators sought to examine the safety and efficacy of tislelizumab plus gemcitabine and cisplatin compared with placebo plus gemcitabine/cisplatin in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer.
To be eligible for enrollment, patients needed to be aged between 18 and 75 years and have histologically or cytologically confirmed, recurrent, or metastatic nasopharyngeal cancer.2 Patients also needed to have an ECOG performance status of 0 to 1, at least 1 measurable lesion per RECIST v1.1 criteria and be treatment naïve for recurrent or metastatic disease. The ability to provide fresh or archival tumor tissues was also required.
Anyone with a local recurrence eligible for curative surgery or radiotherapy, who received an approved systemic anticancer therapy, any immunotherapy or previous therapies targeting PD-1 or PD-L1, who had active leptomeningeal disease or uncontrolled, untreated brain metastases, were excluded from the study.
A total of 263 Asian participants were randomized 1:1 to the tislelizumab/chemotherapy arm or the placebo/chemotherapy arm. Those in the experimental arm received 200 mg of intravenous (IV) tislelizumab once every 3 weeks plus IV gemcitabine at 1 g/m2 on days 1 and 8 of each 3-week cycle for 4 to 6 cycles, and IV cisplatin at 80 mg/m2 on day 1 of each 3-week cycle for 4 to 6 cycles. In the control arm, patients received the same dose and schedule of chemotherapy, without tislelizumab.
The primary end point of the trial was PFS per IRC assessment, while secondary end points comprised overall survival, IRC-assessed objective response rate and duration of response, as well as investigator-assessed PFS.
The China National Medical Products Administration has given tislelizumab market authorization in the following indications:
Moreover, 3 supplemental biologics license application for the drug have been accepted by the Center for Drug Evaluation and are under review in China for the following indications: