How long does it take for Keytruda to work?
The time it takes for Keytruda to work can vary based on the type and stage of cancer. Typically, a response to treatment becomes apparent within 2-4 months of starting Keytruda. This timeframe is referred to as "time to response," which measures when a patient's cancer begins to show signs of responding to the treatment. You can find the specific "time to response" data from clinical trials in the table below.
Keytruda (pembrolizumab) is a medication used to treat various types of cancer. It's administered through a 30-minute intravenous infusion every 3-6 weeks. Keytruda is a type of immunotherapy that helps your immune system target cancer cells that may be hiding.
Time to response following treatment with Keytruda
Cancer Type (Trial name) |
Median Time to Response |
Melanoma (KEYNOTE-006) |
Keytruda: 85-86 days (range 32-251) vs Yervoy (ipilimumab): 87 days (range 80-250) |
Melanoma (KEYNOTE-002) |
Keytruda: 13-15 weeks (IQR 12-18) vs Investigator-choice (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine, or oral temozolomide): 13 weeks (12-18) |
Non-small cell lung cancer (KEYNOTE-189) |
Keytruda + pemetrexed + cisplatin or carboplatin: 1.4 months (1.2-3.0) vs Placebo + Alimta (pemetrexed) + cisplatin or carboplatin: 1.4 months (1.2-4.9) |
Non-small cell lung cancer (KEYNOTE-407) |
Keytruda + carboplatin + paclitaxel or Abraxane (nanoparticle albumin-bound paclitaxel): 1.4 months vs Placebo + carboplatin + paclitaxel or Abraxane: 1.4 months |
Non-small cell lung cancer (KEYNOTE-024) |
Keytruda: 2.2 months vs Investigator-choice (carboplatin plus pemetrexed, cisplatin plus pemetrexed, carboplatin plus gemcitabine, cisplatin plus gemcitabine, or carboplatin plus paclitaxel): 2.2 months |
Head and neck squamous cell cancer (KEYNOTE-012) |
Keytruda: 2 months (2-17) |
Classical Hodgkin lymphoma (KEYNOTE-204) |
Keytruda: 2.8 months (1.0-31.2) vs Adcetris (brentuximab vedotin): 2.8 months (1.0-7.3) |
Classical Hodgkin lymphoma (KEYNOTE-087) |
Keytruda: 2.8 months (2.1-16.5) |
Primary mediastinal large B-cell lymphoma (KEYNOTE-170) |
Keytruda: 2.9 months (2.4-8.5) |
Urothelial Carcinoma (KEYNOTE-052) |
Keytruda: 2.1 months (1.3-9.0) |
Urothelial Carcinoma (KEYNOTE-045) |
Keytruda: 2.1 months (1.4-6.3) vs Investigator-choice (paclitaxel, Taxotere (docetaxel), Javlor (vinflunine)): 2.1 months (1.7-4.9) |
Microsatellite instability-high or mismatch repair deficient cancer (KEYNOTE-164) |
Keytruda: Following ≥2 prior lines of standard chemotherapy - 4.3 months (1.8-24.9) Following ≥1 prior lines of standard chemotherapy - 3.9 months (1.8-12.5) |
Microsatellite instability-high or mismatch repair deficient cancer (KEYNOTE-012) |
Keytruda: 2 months (2-17) |
Microsatellite instability-high or mismatch repair deficient cancer (KEYNOTE-028) |
Keytruda: 2 months (1.7-3.7) |
Microsatellite instability-high or mismatch repair deficient cancer (KEYNOTE-158) |
Keytruda: 2.1 months |
Microsatellite instability-high or mismatch repair deficient colorectal cancer (KEYNOTE-177) |
Keytruda: 2.2 months (1.8-18.8) vs 5-fluorouracil–based therapy with or without Avastin (bevacizumab) or Erbitux (cetuximab): 2.1 (1.7-24.9) |
Gastric cancer (KEYNOTE-059) |
Keytruda: 2.1 months (1.7-6.6) |
Esophageal cancer (KEYNOTE-180) |
Keytruda: 4.1 months (2.0-6.3) |
Hepatocellular carcinoma (KEYNOTE-224) |
Keytruda: 2.1 months (1.8-4.8) |
Merkel cell carcinoma (KEYNOTE-017) |
Keytruda: 2.8 months (1.5-9.7) |
Renal cell carcinoma (KEYNOTE-426) |
Keytruda + Inlyta (axitinib): 2.8 months (1.5-16.6) vs Sutent (sunitinib): 2.9 months (2.1-15.1) |
Endometrial carcinoma (KEYNOTE-775) |
Keytruda + Lenvima (lenvatinib): 2.1 months vs Investigator choice (doxorubicin or paclitaxel): 2.1 months |
Cutaneous squamous cell carcinoma (KEYNOTE-629) |
Keytruda: 2.0 months (1.4-3.3) |
Biliary tract cancer (KEYNOTE-966) |
Not reported |
Related questions
References
- Keytruda Product Label. Revised 10/2023. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
- Robert C, Schachter J, Long GV, et al. Pembrolizumab versus Ipilimumab in Advanced Melanoma. N Engl J Med. 2015;372(26):2521-2532. doi:10.1056/NEJMoa1503093.
- Ribas A, Puzanov I, Dummer R, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015;16(8):908-918. doi:10.1016/S1470-2045(15)00083-2.
- Horinouchi H, Nogami N, Saka H, et al. Pembrolizumab plus pemetrexed-platinum for metastatic nonsquamous non-small-cell lung cancer: KEYNOTE-189 Japan Study. Cancer Sci. 2021;112(8):3255-3265. doi:10.1111/cas.14980.
- Paz-Ares L, Luft A, Vicente D, et al. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2018;379(21):2040-2051. doi:10.1056/NEJMoa1810865.
- Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016;375(19):1823-1833. doi:10.1056/NEJMoa1606774.
- Mehra R, Seiwert TY, Gupta S, et al. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012. Br J Cancer. 2018;119(2):153-159. doi:10.1038/s41416-018-0131-9.
- OncLive. Pembrolizumab Approved in Europe for Adult and Pediatric Relapsed/Refractory Classical Hodgkin Lymphoma. March 17, 2021. Available from: https://www.onclive.com/view/pembrolizumab-approved-in-europe-for-adult-and-pediatric-relapsed-refractory-classical-hodgkin-lymphoma.
- Chen R, Zinzani PL, Lee HJ, et al. Pembrolizumab in relapsed or refractory Hodgkin lymphoma: 2-year follow-up of KEYNOTE-087. Blood. 2019;134(14):1144-1153. doi:10.1182/blood.2019000324.
- Armand P, Rodig S, Melnichenko V, et al. Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma. J Clin Oncol. 2019;37(34):3291-3299. doi:10.1200/JCO.19.01389.
- Vuky J, Balar AV, Castellano D, et al. Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2020;38(23):2658-2666. doi:10.1200/JCO.19.01213.
- Fradet Y, Bellmunt J, Vaughn DJ, et al. Randomized phase III KEYNOTE-045 trial of pembrolizumab versus paclitaxel, docetaxel, or vinflunine in recurrent advanced urothelial cancer: results of >2 years of follow-up. Ann Oncol. 2019;30(6):970-976. doi:10.1093/annonc/mdz127.
- Le DT, Kim TW, Van Cutsem E, et al. Phase II Open-Label Study of Pembrolizumab in Treatment-Refractory, Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: KEYNOTE-164. J Clin Oncol. 2020;38(1):11-19. doi:10.1200/JCO.19.02107.
- Ott PA, Elez E, Hiret S, et al. Pembrolizumab in Patients With Extensive-Stage Small-Cell Lung Cancer: Results From the Phase Ib KEYNOTE-028 Study. J Clin Oncol. 2017;35(34):3823-3829. doi:10.1200/JCO.2017.72.5069.
- Borcoman E, Le Tourneau C. Keynote-158 study, FDA granted accelerated approval of pembrolizumab for the treatment of patients with advanced PD-L1-positive cervical cancer. Ann Transl Med. 2020;8(23):1611. doi:10.21037/atm-20-2656.
- André T, Shiu KK, Kim TW, et al. Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer. N Engl J Med. 2020;383(23):2207-2218. doi:10.1056/NEJMoa2017699.
- Fuchs CS, Doi T, Jang RW, et al. Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial [published correction appears in JAMA Oncol. 2019 Apr 1;5(4):579]. JAMA Oncol. 2018;4(5):e180013. doi:10.1001/jamaoncol.2018.0013.
- Shah MA, Kojima T, Hochhauser D, et al. Efficacy and Safety of Pembrolizumab for Heavily Pretreated Patients With Advanced, Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus: The Phase 2 KEYNOTE-180 Study. JAMA Oncol. 2019;5(4):546-550.
- Zhu AX, Finn RS, Cattan S. et al. KEYNOTE-224: Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib. Journal of Clinical Oncology 2018 36:4_suppl, 209-209.
- Nghiem P, Bhatia S, Lipson EJ, et al. Durable Tumor Regression and Overall Survival in Patients With Advanced Merkel Cell Carcinoma Receiving Pembrolizumab as First-Line Therapy. J Clin Oncol. 2019;37(9):693-702. doi:10.1200/JCO.18.01896.
- Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019;380(12):1116-1127. doi:10.1056/NEJMoa1816714.
- OncLive. Phase 3 KEYNOTE-775 Trial in Advanced Endometrial Cancer. May 5, 2021. Available from: https://www.onclive.com/view/phase-3-keynote-775-trial-in-advanced-endometrial-cancer.
- Hughes BGM, Munoz-Couselo E, Mortier L, et al. Pembrolizumab for locally advanced and recurrent/metastatic cutaneous squamous cell carcinoma (KEYNOTE-629 study): an open-label, nonrandomized, multicenter, phase II trial [published online ahead of print, 2021 Jul 20]. Ann Oncol. 2021;S0923-7534(21)02186-4. doi:10.1016/j.annonc.2021.07.008.
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer. Nov 1, 2023. https://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-plus-gemcitabine-cisplatin-patients-locally-advanced-6135.html
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- Keytruda prescribing info & package insert (for Health Professionals)
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