BeiGene's Poster For Upcoming Conference Reveals Promising Lung Cancer Data

BeiGene Ltd's BGNE Phase 3 RATIONALE 315 study met its dual primary endpoints of major pathological response (MPR) by Blinded Independent Pathology Review (BIPR) and event-free survival (EFS).

RATIONALE 315 Phase 3 trial evaluated neoadjuvant tislelizumab plus platinum-based doublet chemotherapy, followed by surgery and subsequent adjuvant tislelizumab, compared to placebo plus neoadjuvant platinum-based doublet chemotherapy followed by surgery and subsequent adjuvant placebo for resectable Stage II or IIIA Non-Small Cell Lung Cancer (NSCLC).

Also Read: Chinese Drugmaker BeiGene And Novartis Move Out From Second Cancer Drug Pact.

In the study, 56.2% of NSCLC patients treated with tislelizumab in combination with chemotherapy before surgery achieved MPR, compared to 15.0% of patients treated with chemotherapy alone (difference: 41.1%).

The tislelizumab plus chemotherapy regimen also showed a statistically significant improvement in pathological complete response (pCR), the key secondary endpoint, after neoadjuvant therapy versus chemotherapy. 

Additionally, 40.7% of patients on the tislelizumab-based regimen achieved pCR, defined as no viable residual tumor after neoadjuvant therapy, compared to 5.7% of patients treated with chemotherapy alone (difference: 35.0%)

Tislelizumab plus chemotherapy was generally well tolerated, with no new safety signals identified.

BeiGene also announced results from the final analysis of the Phase 3 RATIONALE 305 trial, showing tislelizumab plus chemotherapy improved overall survival (OS) in the intent-to-treat (ITT) population as a first-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). No new safety signals were identified. 

In the trial, tislelizumab plus chemotherapy was associated with a higher objective response rate (ORR) (47.3% vs. 40.5%) and median duration of response (mDoR) (8.6 months vs. 7.2 months) compared to placebo plus chemotherapy alone. 

Median progression-free survival (PFS) for tislelizumab plus chemotherapy was 6.9 months vs. 6.2 months, respectively.

Price Action: BGNE shares are down 2.39% at $167.45 on the last check Wednesday.