Duration of response (DoR)
Oncology· appears in 400+ cited findings in this library
What it is and how the reviews use it
Duration of Response (DoR) is an endpoint used in regulatory review documents to measure the length of time that a tumor continues to respond to treatment without progression. The documents define DoR in various ranges, such as 4.6 to 30.5+ months per BICR, RECIST v1.1 for Yervoy (BRISTOL MYERS SQUIBB — Yervoy FDA Review, p.74), and 1.0+ to 13.8+ months for Opdivo (BRISTOL MYERS SQUIBB — Opdivo FDA Review, p.49). It is also described with ranges like 5.6 to 24.2+ months for Ibrutinib in previously treated CLL (ASTRAZENECA — Calquence FDA Review, p.57) and 4.2 to 25.1+ months for Keytruda (Merck & Co., Inc. — Keytruda FDA Review, p.137).
In the regulatory reviews, DoR is frequently reported as a median value, indicating the central tendency of response duration. For instance, the median DoR per Investigator assessment for Tabrecta was 13.83 months (Novartis AG — Tabrecta EMA EPAR public assessment report, p.90). Opdivo showed a median duration of response of 23.0 months (BRISTOL MYERS SQUIBB — Opdivo FDA Review, p.59), while Yervoy had a median duration of response of 23.2 months (BRISTOL MYERS SQUIBB — Yervoy FDA Review, p.77). DoR can also be presented with confidence intervals, such as the 95% CI for median DoR in NSCLC for Lumykras, which was 6.9, 15.0 months (Amgen Inc. — Lumykras EMA EPAR public assessment report, p.75).
Real examples — cited to the source page
| Tabrecta | median DOR per Investigator assessment | 13.83 | Novartis AG — Tabrecta EMA EPAR public assessment report, p.90 |
| Loqtorzi | BIRC-determined DOR Median | 5.7 | Topalliance Biosciences — Loqtorzi EMA EPAR public assessment report, p.139 |
| Opdivo | Median duration of response | 23.0 | BRISTOL MYERS SQUIBB — Opdivo FDA Review, p.59 |
| Lumykras | 95% CI for median DOR in NSCLC | 6.9, 15.0 | Amgen Inc. — Lumykras EMA EPAR public assessment report, p.75 |
| Keytruda | median duration of response | 13.8 | Merck & Co., Inc. — Keytruda FDA Review, p.87 |
| Padcev | Median duration of response | 8.11 | Astellas Pharma Inc. — Padcev EMA EPAR public assessment report, p.127 |
| Yervoy | Median duration of response | 23.2 | BRISTOL MYERS SQUIBB — Yervoy FDA Review, p.77 |
| Aucatzyl | Median Duration of Remission (DOR) in Cohort IIA (infused set) | 11.6 | Autolus — Aucatzyl EMA EPAR public assessment report, p.69 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
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Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.