China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced two late-breaking presentations of Phase III data for its programmed death-1 (PD-1) inhibitor tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2023. The presentations include an oral presentation for tislelizumab in combination with chemotherapy for advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) and a mini oral presentation for its use in Stage II or IIIA non-small cell lung cancer (NSCLC).
Tislelizumab in GC/GEJC Treatment
The Phase III RATIONALE 305 trial data, presented at ESMO, assessed tislelizumab plus chemotherapy as a first-line treatment for GC/GEJC. The final analysis of 997 intent-to-treat patients showed a median overall survival (OS) of 15.0 months compared with 12.9 months for chemotherapy alone (HR: 0.80 [95% CI: 0.70, 0.92]; P = 0.0011), suggesting the regimen’s potential as a new first-line option.
Tislelizumab in NSCLC Treatment
Data from the RATIONALE 315 study, also presented at ESMO, showed that tislelizumab plus chemotherapy met its dual primary endpoints of statistically significant improvement in major pathological response (MPR) and event-free survival (EFS) for NSCLC. Patients treated with tislelizumab plus chemotherapy achieved an MPR of 56.2% versus 15% for chemotherapy alone, with 40.7% achieving pathological complete response (pCR) compared to 5.7% of the chemotherapy treatment group.
Future Implications
BeiGene’s results indicate that tislelizumab can be effectively integrated into the treatment paradigm for NSCLC patients undergoing surgery at an earlier stage. These findings presented at ESMO 2023 underscore tislelizumab’s potential to transform treatment outcomes for patients with GC/GEJC and NSCLC, highlighting BeiGene’s commitment to advancing cancer care through innovative therapies.-Fineline Info & Tech