How effective Is Keytruda for metastatic melanoma?
Keytruda (pembrolizumab) is an immunotherapy known as a PD-1 inhibitor, approved by the FDA for the treatment of unresectable or metastatic melanoma. This therapy has transformed the outlook for many patients with advanced melanoma, offering the potential for extended survival and durable responses in some cases. In this article, we will review how Keytruda works to treat metastatic melanoma and its effectiveness.
Clinical Effectiveness
Keytruda’s effectiveness has been demonstrated in several large clinical trials, most notably the KEYNOTE-006 study. Here are the key findings:
- Survival Outcomes: At 10 years, 34% of patients treated with Keytruda were still alive, compared to 23.6% for those treated with ipilimumab, another immunotherapy. The median overall survival (OS) for Keytruda was 32.7 months, more than double that of ipilimumab (15.9 months).
- Progression-Free Survival (PFS): Median PFS was 9.4 months for Keytruda versus 3.8 months for ipilimumab.
- Response Rates: In clinical trials, 27% of patients experienced partial tumor shrinkage, and 6% had complete disappearance of tumors with Keytruda. In contrast, only 10% and 1% of patients achieved these responses with ipilimumab, respectively.
- Long-Term Benefit: Approximately one in three patients treated with Keytruda for metastatic melanoma are alive at 10 years, underscoring the potential for long-lasting benefit in responders.
It’s important to note that while Keytruda can offer significant benefits, not all patients respond to treatment. However, those who do respond often experience prolonged disease control and improved quality of life.
Mechanism of Action: How Does Keytruda Work for Melanoma?
Keytruda works by targeting the PD-1 pathway, a mechanism that some cancer cells use to hide from the immune system. By blocking PD-1, Keytruda helps reactivate T cells, enabling the immune system to recognize and attack melanoma cells throughout the body. Unlike chemotherapy, which kills cancer cells directly, Keytruda empowers the immune system to do the work, potentially leading to more durable responses.
Related questions
- What is the success rate of Keytruda?
- How long does it take for Keytruda to work?
- What are Monoclonal Antibodies and how do they work?
Treatment Duration and Administration
Keytruda is given as an intravenous (IV) infusion, typically every 3 or 6 weeks, depending on the dosing schedule. Each dose is given over approximately 30 minutes. Treatment continues until the cancer progresses or the patient experiences unacceptable side effects, often for up to two years. Some patients may stop earlier if they achieve a complete response or cannot tolerate the therapy.
Eligibility for Metastatic Melanoma Treatment
Keytruda is suitable for patients with unresectable or metastatic melanoma, regardless of whether their tumors carry a BRAF mutation. It is often used as a first-line treatment and can be considered for patients who have not previously received immunotherapy, as well as those who have progressed after other treatments.
Key Takeaways
Keytruda offers the possibility of significantly-improved survival for a subset of patients with advanced melanoma. While not everyone responds, those who do may experience durable, life-extending benefits. As always, treatment decisions should be personalized, considering individual health factors and discussed with an oncology team.
This is not all the information you need to know about Keytruda (pembrolizumab) for safe and effective use and does not take the place of your doctor’s directions. Review the full patient medication guide and discuss this information and any questions you have with your doctor or other health care provider.
References
- Keytruda. How Keytruda Works. Accessed on June 24, 2025 at https://www.keytruda.com/how-does-keytruda-work/
- Keytruda [package insert]. Updated June 2025. Merck Sharp & Dohme LLC. Accessed on June 24, 2025 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287
- Long, G. V., et. al. 2024. Pembrolizumab versus ipilimumab for advanced melanoma: 10-year follow-up of the phase III KEYNOTE-006 study. In: Annals of Oncology. DOI: https://doi.org/10.1016/j.annonc.2024.08.2330
- National Comprehensive Cancer Network. 2025. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Melanoma: Cutaneous. Accessed on June 24, 2025 at https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf
- Robert, C., Schachter, J., Long, G. V., Arance, A., Grob, J. J., Mortier, L., Daud, A., Carlino, M. S., McNeil, C., Lotem, M., Larkin, J., Lorigan, P., Neyns, B., Blank, C. U., Hamid, O., Mateus, C., Shapira-Frommer, R., Kosh, M., Zhou, H., Ibrahim, N., … KEYNOTE-006 investigators (2015). Pembrolizumab versus Ipilimumab in Advanced Melanoma. The New England journal of medicine, 372(26), 2521–2532. https://doi.org/10.1056/NEJMoa1503093
Read next
What is the difference between Opdivo and Keytruda?
Opdivo (nivolumab) and Keytruda (pembrolizumab) are two immunotherapy drugs for various cancers. Both are monoclonal antibodies, known as PD1 inhibitors, first approved in 2014. Opdivo is from Bristol Myers Squibb, and Keytruda is from Merck & Co. The main differences lie in dosing, combination therapies, and approved cancer types. Continue reading
Pembrolizumab vs. nivolumab: How do they compare?
Pembrolizumab and nivolumab are both prescription medications used to treat various types of cancers, including solid tumors and blood cancers. They may be used alone or in combination with other medicines for cancers that are more advanced, have spread in the body, or are no longer responding to previous treatments. Continue reading
How is Keytruda used for lung cancer?
Keytruda (pembrolizumab) is a type of immunotherapy that has significantly changed the treatment landscape for lung cancer, especially non-small cell lung cancer (NSCLC). It works by helping the immune system recognize and attack cancer cells more effectively, mainly by blocking the PD-1 pathway that tumors use to evade immune detection.
Continue readingSee also:
Aimovig
Learn about Aimovig (erenumab-aooe) a once-monthly, injectable medication that can be ...
Nurtec ODT
Nurtec ODT (rimegepant) is used to treat acute migraines and prevent episodic migraines, by ...
Botox
Botox is used cosmetically to reduce facial lines and wrinkles and for medical purposes for ...
Depakote
Depakote is used to treat various types of seizure disorders. Learn about side effects ...
Topamax
Topamax (topiramate) is used to prevent seizures in adults and children and to prevent migraine ...
Emgality
Emgality (galcanezumab-gnlm) is a CGRP antagonist for the preventive treatment of migraine and for ...
Timolol
Timolol is used for angina, heart attack, high blood pressure, migraine, migraine prevention
Valproic acid
Valproic acid is used for bipolar disorder, cluster-tic syndrome, epilepsy, headache ...
Divalproex sodium
Divalproex sodium is used for bipolar disorder, borderline personality disorder, cyclothymic ...
Propranolol
Propranolol is a beta-blocker that is used to treat tremors, chest pain, high blood pressure, heart ...
Related medical questions
- When is Keytruda used for prostate cancer?
- Can you take prednisone with Keytruda?
- Is Keytruda covered by Medicare / Medicaid?
- How are Inlyta and Keytruda used in kidney cancer?
- How is pembrolizumab (Keytruda) administered?
- Is lenvatinib / pembrolizumab used in endometrial cancer?
- Is Xalkori the same as Opdivo or Keytruda?
- What are biologic drugs and how do they work?
Drug information
- Keytruda Information for Consumers
- Keytruda prescribing info & package insert (for Health Professionals)
- Side Effects of Keytruda (detailed)
- Keytruda user reviews (259)
Related support groups
- Keytruda (22 questions, 63 members)
- Melanoma - Metastatic (8 questions, 30 members)