Novartis' Antibody Boosts Survival for Squamous Cell Carcinoma
The Phase 3 study found that the IgG4 anti-PD-1 monoclonal antibody improved progression-free survival, objective response rate, duration of response, and safety.
Novartis recently announced that its IgG4 anti-PD-1 monoclonal antibody, tislelizumab, plus chemotherapy, significantly improved overall survival (OS) compared to chemotherapy in esophageal squamous cell carcinoma (ESCC) patients.
The RATIONALE 306 Phase 3 study enrolled 649 participants with unresectable, locally advanced, recurrent, or metastatic ESCC. All patients were randomized to receive either tislelizumab plus chemotherapy or chemotherapy alone. The primary endpoint of the study was OS.
The secondary endpoints included progression-free survival, objective response rate, duration of response, health-related quality of life measures, and safety. Novartis will submit the trial data to regulatory authorities and collaborate with BeiGene to present them at an upcoming 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 5% for metastatic cases, underscoring the urgency for more immunotherapy options," Jeff Legos, executive vice president and global head of oncology & hematology development at Novartis, said in the announcement.
"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.
ESCC is the most common type of esophageal cancer, with an estimated 604,000 new cases and 544,000 deaths internationally in 2020. Experts estimate that there will be over 20,000 new diagnoses and more than 16,000 deaths from esophageal cancers in the United States this year.
FDA and the European Medicines Agency (EMA) are currently reviewing tislelizumab for advanced or metastatic ESCC after prior chemotherapy. The EMA is also reviewing the drug for advanced or metastatic NSCLC after prior chemotherapy and combined with chemotherapy.
In September 2021, FDA accepted Novartis' Biologics License Application for tislelizumab to treat unresectable recurrent locally advanced metastatic ESCC based on the Phase 3 RATIONALE 302 trial data, which found that tislelizumab reduced the risk of death in patients by 30%.
Additionally, the drug extended median overall survival by 2.3 months compared to chemotherapy in individuals with unresectable recurrent locally advanced or metastatic ESCC who received prior systemic therapy.
