Objective response rate (ORR)
Oncology· appears in 400+ cited findings in this library
What it is and how the reviews use it
Objective response rate (ORR) is an endpoint used in regulatory review documents to measure the proportion of patients who experience a reduction in tumor size or disappearance of cancer after treatment. For patients with PD-L1-high status, the expected ORR range is 17%-33%, as noted in the AstraZeneca PLC — Imfinzi FDA Review (BLA761069, ORIG 1, 2017).
This metric is frequently used across various drug reviews. For instance, the Objective Response Rate for Lynparza was 33% in the AstraZeneca PLC — Lynparza FDA Review (NDA/BLA 208558, 2025). Keytruda showed an objective response rate of 45% in the Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2024). Additionally, the Overall Response Rate (ORR) for Retevmo was 84% in the Eli Lilly and Company — Retevmo FDA Review (NDA/BLA 213246, 2026).
Real examples — cited to the source page
| AstraZeneca PLC — Lynparza | Objective Response Rate | 33 | Lynparza FDA Review, p.59 |
| Merck & Co., Inc. — Keytruda | objective response rate | 45% | Keytruda FDA Review, p.89 |
| Bristol-Myers Squibb Company — Augtyro | ORR in Asian patients | 61.9 | Augtyro FDA Review, p.134 |
| Eli Lilly and Company — Retevmo | Overall Response Rate (ORR) | 84% | Retevmo FDA Review, p.26 |
| Cheplapharm — Tarceva | objective response rate | 15.5 | Tarceva EMA EPAR variation assessment report, p.30 |
| AbbVie Inc. — Venclexta | Overall Response Rate (ORR) (Obinutuzumab + Chlorambucil) | 71 | Venclexta FDA Review, p.44 |
| Amgen Inc. — Lumakras | ORR (Pemetrexed) | 8.5 | Lumakras FDA Review, p.30 |
| AstraZeneca PLC — Calquence | investigator-assessed ORR including PRL | 92.2 | Calquence EMA EPAR public assessment report, p.88 |
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.