The phase 3 RATIONALE 309 trial highlighted the combined efficacy of tislelizumab and chemotherapy in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer.
Patients with recurrent or metastatic nasopharyngeal cancer experienced superior progression-free survival (PFS) following frontline treatment with the PD-1 inhibitor tislelizumab (BGB-A317) and chemotherapy compared with chemotherapy alone, hitting the primary end point of the phase 3 RATIONALE 309 trial (NCT03924986).1
An independent review committee (IRC) assessment confirmed the improvement in the intent-to-treat population. In addition, tislelizumab was not tied to any new safety signals when administered alongside chemotherapy; its toxicity profile was consistent with previous reports.
At an upcoming medical meeting, BeiGene, Ltd., the developer of tislelizumab, plans to present these data and will also share the full results with regulatory 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.
Evaluable participants were between the age of 18 and 75 years, had histologically or cytologically confirmed, recurrent, or metastatic nasopharyngeal cancer, had an ECOG performance status of 0 to 1, at least 1 measurable lesion per RECIST v1.1 criteria, and were treatment naïve for recurrent or metastatic disease.2 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:
This article was originally published on OncLive as “Frontline Tislelizumab Plus Chemo Improves PFS in Recurrent or Metastatic Nasopharyngeal Cancer”