Keytruda(pembrolizumab)
Oncology· 24441 cited findings· 17 source documents
Company: Merck & Co., Inc. →
What the regulatory reviews say
Keytruda (pembrolizumab) is indicated for various cancers, including unresectable or metastatic melanoma, adjuvant treatment of Stage IIB, IIC, or III melanoma, and several forms of non-small cell lung cancer (NSCLC). For NSCLC, it is indicated in combination with chemotherapy for metastatic nonsquamous and squamous types, as a single agent for first-line treatment of NSCLC with PD-L1 expression (TPS ≥1%), and as adjuvant treatment following resection and platinum-based chemotherapy for Stage IB, II, or IIIA NSCLC.
In the KEYNOTE-811 trial for locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma, the Objective Response Rate (ORR) in the pembrolizumab arm was 74.4%, compared to 51.9% in the placebo arm (one-sided p-value for ORR: 0.00006). The Complete Response (CR) rate was 11.3% in the pembrolizumab arm versus 3.1% in the placebo arm. The median Duration of Response (DoR) was 10.6 months in the pembrolizumab arm and 9.5 months in the placebo arm.
Dosage modifications for Keytruda include withholding or permanently discontinuing treatment for adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis with renal dysfunction, depending on severity.
Key figures — cited to the source page
| Objective Response Rate (pembrolizumab arm) | 74.4 | Keytruda FDA Review, p.132 |
| Objective Response Rate (placebo arm) | 51.9 | Keytruda FDA Review, p.132 |
| Complete Response Rate (pembrolizumab arm) | 11.3 | Keytruda FDA Review, p.132 |
| Complete Response Rate (placebo arm) | 3.1 | Keytruda FDA Review, p.132 |
| Median Duration of Response (pembrolizumab arm) | 10.6 | Keytruda FDA Review, p.132 |
| Median Duration of Response (placebo arm) | 9.5 | Keytruda FDA Review, p.132 |
| Participants remaining on treatment (pembrolizumab + SOC group) | 58.5 | Keytruda FDA Review, p.168 |
| Participants remaining on treatment (SOC group) | 48.1 | Keytruda FDA Review, p.168 |
Source documents
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2026) (2026)
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2026) (2026)
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2026) (2026)
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2024) (2024)
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2023) (2023)
- Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2023) (2023)
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023) (2023)
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023) (2023)
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023) (2023)
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023) (2023)
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2022) (2022)
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2021) (2021)
- MERCK SHARP DOHME — Keytruda FDA Summary Review (NDA/BLA 125514, 2020) (2020)
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2020) (2020)
- MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2019) (2019)
- Merck & Co., Inc. — Keytruda EMA EPAR public assessment report (EMEA/H/C/003820, 2015) (2015)
- Merck & Co., Inc. — Keytruda EMA EPAR variation assessment report (EMEA/H/C/003820, 2015) (2015)
Compared with
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.