RATIONALE 307: A randomized phase 3 trial in nearly 355 patients with 1L, locally advanced or metastatic Non-squamous NSCLC
The safety and tolerability was consistent with the known profile of PD-1 inhibitors in combination with chemotherapy†2,5‒7
| TEAEs, n (%) | ETAPIDI + PC (n=120) |
ETAPIDI + nab-PC (n=118) |
PC (n=117) |
|---|---|---|---|
| Patients with ≥1 TEAE | 120 (100.0) | 117 (99.2) | 117 (100.0) |
| Patients with Grade ≥3 TEAE | 106 (88.3) | 102 (86.4) | 98 (83.8) |
| Serious TEAE | 44 (36.7) | 45 (38.1) | 29 (24.8) |
| TEAE leading to discontinuation | 15 (12.5) | 35 (29.7) | 18 (15.4) |
| TEAE leading to death | 4 (3.3) | 5 (4.2) | 5 (4.3) |
| Incidence of grade ≥3 TEAEs occurring in ≥5% patients² | |||
| Event, n (%) | ETAPIDI + PC (n=120) Grade ≥3 |
ETAPIDI + nab-PC (n=118) Grade ≥3 |
PC (n=117) Grade ≥3 |
| Anaemia | 9 (7.5) | 27 (22.9) | 14 (12.0) |
| Neutrophil count decreased | 62 (51.7) | 54 (45.8) | 53 (45.3) |
| White blood cell count decreased | 27 (22.5) | 32 (27.1) | 28 (23.9) |
| Leukopenia | 19 (15.8) | 30 (25.4) | 21 (17.9) |
| Neutropenia | 40 (33.3) | 32 (27.1) | 47 (40.2) |
| Platelet count decreased | 5 (4.2) | 16 (13.6) | 2 (1.7) |
| Thrombocytopenia | 7 (5.8) | 15 (12.7) | 7 (6.0) |
• At the final analysis (median follow-up: 18.7 months), TEVIMBRA plus chemotherapy was tolerable and
no new safety signals were identified compared with the interim analysis‡3
Reference: 1. etapidi. Prescribing Information. BeOne Medicines USA, Inc.; 2025.