Table 2.
Adverse events leading to therapy discontinuation
| Clinical trial information | Serious AEs | Incidence | Therapy | Cancer type |
|---|---|---|---|---|
| NCT01938612 | Grade 2 pneumonitis | 1/22 | Durvalumab | Solid tumors |
| NCT02141347 | NM | 1/8 | Durvalumab | Solid tumors |
| NCT02087423 | NM | 9/333 | Durvalumab | NSCLC |
| NCT01693562 | Autoimmune hepatitis Pneumonitis NM |
1/191 1/191 1/191 |
Durvalumab | UCC |
| NCT02519348 | Grade 3 pneumonitis Grade 3 colitis/diarrhea Asymptomatic grade 4 elevated AST and ALT |
1/40 1/40 1/40 |
Durvalumab | HCC |
| NCT01693562 | Grade 1–2 pneumonitis Grade 4 pneumonitis Grade 2–3 colitis Grade 4 colitis |
5/304 1/304 4/304 1/304 |
Durvalumab | NSCLC |
| NCT02027961 | Grade 3 thrombocytopenia Grade 3 choroidal effusion |
1/50 1/50 |
Durvalumab + trametinib ± dabrafenib | Melanoma |
| NCT02143466 | Grade 3–4 ILD | 5/34 | Durvalumab + AZD9291 | NSCLC |
| NCT02088112 | Grade 3–4 increased ALT and/or AST Grade 3–4 pneumonitis |
3/20 1/20 |
Durvalumab + gefitinib | NSCLC |
| NCT02000947 | Colitis Diarrhea Pneumonitis NM |
9/102 5/102 5/102 10/102 |
Durvalumab + tremelimumab | NSCLC |
Abbreviations: AEs, adverse events; ALT, alanine transaminase; AST, aspartate aminotransferase; HCC, hepatocellular carcinoma; ILD, interstitial lung disease; NM, not mentioned; NSCLC, non-small-cell lung cancer; UCC, urothelial carcinoma.