RATIONALE 303: A randomized phase 3 trial in nearly 792 patients with 2L, locally advanced or metastatic NSCLC (Squamous or Non-squamous)
The safety and tolerability was consistent with the known profile of PD-1 inhibitors in previously treated NSCLC patients*2
- Fewer grade ≥3 TEAEs were reported in patients treated with TEVIMBRA vs docetaxel in both the overall population and the non-Asian subgroup2,3
- In the overall population, TRAEs were lower in severity and occurred in a lower proportion of patients in the etapidi arm vs docetaxel arm:2
• Any grade: 74.9% vs 93.8%
• Grade ≥3: 15.7% vs 66.3%
| ETAPIDI (n=534) |
Docetaxel (n=258) |
|
|---|---|---|
| Median duration of exposure (weeks) | 24.0 | 9.1 |
| Median number of treatment cycles | 8.0 | 3.0 |
| Grade ≥3 TEAE, n (%) | 225 (42.1) | 193 (74.8) |
| Treatment-related | 84 (15.7) | 171 (66.3) |
| TEAE leading to death, n (%) | 34 (6.4) | 12 (4.7) |
| Treatment-related | 8 (1.5) | 4 (1.6) |
| TEAE leading to permanent treatment discontinuation, n (%) | 64 (12.0) | 34 (13.2) |
| Treatment-related | 36 (6.7) | 26 (10.1) |
| Grade ≥3 TRAEs occurring in ≥10% of patients (safety population), n (%) | ||
| ALT increased | 5 (0.9) | 0 (0.0) |
| AST increased | 4 (0.7) | 1 (0.4) |
| Anaemia | 5 (0.9) | 13 (5.0) |
| Hypothyroidism | 0 (0.0) | 0 (0.0) |
| Asthenia | 1 (0.2) | 10 (3.9) |
| Decreased appetite | 1 (0.2) | 2 (0.8) |
| Nausea | 0 (0.0) | 1 (0.4) |
| Diarrhoea | 2 (0.4) | 5 (1.9) |
| White blood cell count decreased | 1 (0.2) | 46 (17.8) |
| Constipation | 0 (0.0) | 0 (0.0) |
| Leukopenia | 0 (0.0) | 40 (15.5) |
| Neutrophil count decreased | 1 (0.2) | 70 (27.1) |
| Neutropenia | 0 (0.0) | 70 (27.1) |
| Alopecia | 0 (0.0) | 2 (0.8) |
| Febrile neutropenia | 0 (0.0) | 33 (12.8) |
Reference: 1. etapidi. Prescribing Information. BeOne Medicines USA, Inc.; 2025.