The Swiss Big Pharma Novartis (NYSE:NVS) announced that the anti-PD-1 immune checkpoint inhibitor tislelizumab with chemotherapy improved overall survival in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in a Phase 3 study.
The RATIONALE 306 trial of tislelizumab and chemotherapy met its primary endpoint at interim analysis. The study pitted the combination therapy against chemotherapy as a monotherapy.
Novartis noted that the study focusing on first-line ESCC follows on the heels of FDA and EMA accepting tislelizumab in a second-line context.
The company is optimistic that the drug could treat a variety of solid tumors.
To date, tislelizumab has been the subject of more than 200 clinical studies.
Novartis licensed rights to the drug from BeiGene in February 2021 for $650 million upfront plus another $1.55 billion in potential milestone payments.
The Swiss company noted that it would collaborate with BeiGene in presenting the recent data at a medical meeting.
“People living with esophageal cancer experience painful everyday challenges and typically have a poor prognosis, with a five-year survival rate of around five percent for metastatic cases, underscoring the urgency for more immunotherapy options,” said Jeff Legos, executive vice president, global head of oncology and hematology development at Novartis. “We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients,” Legos continued in a press release.
Novartis has made recent headlines over reports that it is planning a significant reorganization that could lead to thousands of layoffs, according to BioSpace.