BeiGene (NASDAQ: BGNE) has released the latest results of the global Phase III RATIONALE 306 study, which evaluated the efficacy of its programmed death – 1 (PD – 1) inhibitor tislelizumab in combination with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have not previously received systemic therapy.
Study Design and Results
The study enrolled a total of 649 patients, who were randomized to receive either tislelizumab combined with chemotherapy or placebo combined with chemotherapy at a 1:1 ratio. Results from the RATIONALE 306 study demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) for patients receiving the tislelizumab regimen. The median OS was 17.2 months for the tislelizumab group compared to 10.6 months for the placebo group, representing a 34% reduction in the risk of death. The OS benefit of the combination chemotherapy regimen was observed regardless of the patient’s baseline PD – L1 expression status.
Safety Profile
The incidence of treatment – related adverse events (TRAEs) was similar in both groups. The most commonly reported TRAEs (incidence ≥20%) included anemia, decreased neutrophil count, decreased white blood cell count, decreased appetite, nausea, and peripheral sensation neuropathy.
Tislelizumab’s Approvals
Developed in – house by BeiGene, tislelizumab has secured nine indication approvals in China to date. These include:
- In combination with chemotherapy for first – line advanced squamous cell non – small cell lung cancer (sq NSCLC)
- In combination with chemotherapy for first – line advanced non – squamous (nsq) NSCLC
- As a monotherapy for second – or third – line locally advanced or metastatic NSCLC
China’s National Medical Products Administration (NMPA) has granted conditional approvals for tislelizumab as:
- A third – line treatment for classical Hodgkin’s lymphoma (cHL)
- For metastatic urothelial carcinoma (UC) with PD – L1 high expression and progressive disease following chemotherapy treatment or within 12 months of neoadjuvant or adjuvant treatment
- As a second – line therapy for hepatocellular carcinoma (HCC)
- For patients with unresectable or metastatic microsatellite instability – high (MSI – H) or mismatch repair deficient (dMMR) solid tumors
- As a second – line therapy for locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in patients with disease progression or intolerant to first – line chemotherapy
- And as a first – line therapy for recurrent or metastatic nasopharyngeal carcinoma (NPC) combined with chemotherapy.-Fineline Info & Tech
