Deciphera B V — Qinlock EMA EPAR public assessment report (EMEA/H/C/005614, 2021)
Deciphera B V · 2021 · EMA EPAR public assessment report
Report summary
Qinlock (ripretinib) received a positive CHMP opinion for marketing authorization as an orphan medicinal product for advanced gastrointestinal stromal tumor (GIST) in adults previously treated with three or more kinase inhibitors, including imatinib. This addresses an unmet medical need due to resistance to existing therapies. Non-clinical studies demonstrated ripretinib's potent inhibitory activity against various KIT and PDGFRA mutations, including resistant ones, with a favorable safety profile. Clinical trials, notably the Phase 3 INVICTUS study, showed significant improvement in progression-free survival and clinically relevant overall survival benefits compared to placebo, with an acceptable and manageable safety profile. Pharmacokinetic studies detailed its absorption, distribution, metabolism, and excretion, linking higher exposure to improved progression-free survival and some adverse events.
Key findings — cited to the page
| Abdominal pain (Grade 3/4, ripretinib arm) | 7.1 % | DCC-2618-03-001 (INVICTUS) · p.121 |
| Any Grade 3/4 event (ripretinib arm) | 49.4 % | DCC-2618-03-001 (INVICTUS) · p.129 |
| Probability of any grade PPES (low exposure) | 20.1 % | · p.53 |
| Anaemia (Grade 3/4, ripretinib arm) | 9.4 % | DCC-2618-03-001 (INVICTUS) · p.121 |
| Any Grade 3/4 event (placebo arm) | 44.2 % | DCC-2618-03-001 (INVICTUS) · p.121 |
| Anaemia (Grade 3/4, placebo arm) | 14.0 % | DCC-2618-03-001 (INVICTUS) · p.121 |
| Probability of any grade myalgia (low exposure) | 27.5 % | · p.53 |
| Probability of any grade myalgia (high exposure) | 64.1 % | · p.53 |
| Probability of any grade PPES (high exposure) | 60.9 % | · p.53 |
| Any Grade 3/4 event (ripretinib arm) | 49.4 % | DCC-2618-03-001 (INVICTUS) · p.121 |
| Hypertension (Grade 3/4, ripretinib arm) | 7.1 % | DCC-2618-03-001 (INVICTUS) · p.121 |
| Anaemia (Grade 3/4, ripretinib arm) | 9.4 % | DCC-2618-03-001 (INVICTUS) · p.129 |
Source: Deciphera B V ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →