Key Points

• In general, PD-1 immune checkpoint inhibitors like Keytruda have been shown to significantly prolong overall survival (OS) in some patients over a wide range of cancer types.
• But it’s important to know that these cancer treatments do not work for everyone.
• The success rate of Keytruda depends upon the type of cancer you have, the stage of your cancer, your previous treatments, your overall health and many other factors.
• Cancer treatment is always individual, and what you may experience may be different from someone else. Only your doctor treating your cancer can answer how well Keytruda might work for you.

Keytruda (pembrolizumab) is a prescription medicine used to treat many different types of cancers, including solid tumors and blood cancers. It might be used alone or in combination with other medicines for advanced cancers, cancers that have spread in the body, or cancers no longer responding to treatment.

Related: FDA approval history and clinical trials for Keytruda

Keytruda is used for cancers such as:

• melanoma or Merkel cell carcinoma (types of serious skin cancer)
• squamous cell carcinoma
• lung cancer
• head and neck cancer
• classical Hodgkin lymphoma
• primary mediastinal large B-cell lymphoma
• cancer of the kidney, bladder, and urinary tract
• liver cancer
• cancer of the cervix or uterus
• endometrial cancer
• advanced stomach cancer or esophageal cancer
• triple negative breast cancer
• a type of cancer that laboratory testing proves to have certain specific DNA mutations, including colorectal cancer

In clinical studies of the cancer types that Keytruda is approved to treat, researchers studied groups of patients to better understand how well Keytruda works and the side effects. These study results can help to inform you and your doctor which treatment might work best for you. Ask your doctor about the success rates from the Keytruda studies that evaluated your specific type of cancer.

As an example, three types of cancer approved by the FDA for Keytruda treatment are non-small cell lung cancer, advanced melanoma (a serious form of skin cancer), and bladder cancer. Here are success rates from some of these studies.

Advanced non-small cell lung cancer (advanced NSCLC)

When used as an initial therapy, Keytruda + chemotherapy has been shown to help patients with advanced nonsquamous NSCLC live longer than using chemotherapy alone.

In one study, half of the patients receiving Keytruda + chemotherapy were alive without their cancer spreading, growing, or getting worse at 8.8 months, compared to 4.9 months for patients treated with the chemotherapy regimen alone. Cancer did not progress in 40% of patients receiving Keytruda + chemotherapy compared to 19% of patients receiving chemotherapy alone.

• Researchers evaluated patients with advanced, nonsquamous, non-small cell lung cancer who had never received treatment and did not have an abnormal EGFR or ALK gene (KEYNOTE-189).
• In this study, 410 patients received 200 mg of Keytruda every 3 weeks plus chemotherapy (pemetrexed and a platinum), and 206 patients received chemotherapy alone. At evaluation, 69% (283 / 410) of patients were alive in the Keytruda + chemotherapy group, and 48% (98 / 206) patients were alive in the chemotherapy only group.
• In addition, 48% (195 / 410) of patients receiving Keytruda + chemotherapy saw their tumors shrink, compared to 19% (39 / 206) of patients receiving chemotherapy alone.

Advanced melanoma (skin cancer)

Keytruda has also been studied in advanced melanoma, a skin cancer that cannot be removed by surgery or has spread in your body (metastatic). It can also be used after surgery to lower the risk of cancer coming back. Keytruda can help shrink tumors and help you live longer.

Researchers found that Keytruda can help patients with advanced melanoma live longer when compared to treatment with ipilimumab (brand name: Yervoy), another immunotherapy drug (KEYNOTE-006).

• In studies, patients received either 10 mg/kg of Keytruda every 2 weeks (279 patients) or every 3 weeks (277 patients). These groups were compared with those who received Yervoy 3 mg/kg every 3 weeks for 4 doses (278 patients).
• At evaluation, 67% (185 / 227) of patients were alive in the Keytruda every 3 weeks group, compared to 60% (166 / 278) of patients in the Yervoy group.
• At 4.1 months, the cancer in half of the patients in the Keytruda group had not spread, grown larger, or worsened. Keytruda given every 3 weeks reduced the risk of cancer spreading, growing, or getting worse by 42% compared to Yervoy.
• Half (50%) of the patients who received Keytruda every 3 weeks were alive at 4.1 months, compared to 2.8 months for patients receiving Yervoy. Keytruda was shown to reduce the risk of dying by 31% compared to Yervoy.

Advanced bladder and urinary tract cancer (urothelial carcinoma)

Keytruda was evaluated in a clinical study of patients with urothelial cancer who had previously received a platinum-based chemotherapy regimen (KEYNOTE-045). For the patients receiving Keytruda, the chemotherapy had either never worked or stopped working. Overall, patients receiving Keytruda lived longer than those receiving chemotherapy.

• Patients were split into two groups of about 270 patients each. Each group was given either 200 mg of Keytruda every 3 weeks or chemotherapy every 3 weeks.
• At evaluation, 43% of patients (115 / 270) were alive compared to 34% of patients (93 / 272) receiving chemotherapy. Patients receiving Keytruda lived for 10.3 months (median overall survival) compared to 7.4 months with chemotherapy.
• An equal number of patients (81%) in both the Keytruda and chemotherapy groups had their cancer spread, grow, or get worse. Half of patients on chemotherapy were alive at 3.3 months without their cancer spreading, growing, or getting worse, compared to 2.1 months with Keytruda.
• A greater number of patients receiving Keytruda had their bladder cancer tumors shrink (21%) compared to chemotherapy (11%).

Bottom Line

• In general, PD-1 immune checkpoint inhibitors like Keytruda have been shown to significantly prolong overall survival (OS) in some patients with various cancer types, but Keytruda does not always work for everyone.
• The success rate of Keytruda depends upon many factors, including your cancer type, previous treatments and general overall health. Keytruda is approved to treat over a dozen different types of cancer.
• Your cancer doctor is the best person to ask about Keytruda. Discuss study results, side effects and how this information applies to you.

This is not all the information you need to know about Keytruda (pembrolizumab) for safe and effective use. Review the full Keytruda information here, and discuss this information and any questions you have with your doctor or other health care provider.