Share this
Back

KEYTRUDA® in combination with carboplatin and paclitaxel, followed by KEYTRUDA® as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.1

The global burden of cervical and uterine cancers

Primary advanced or recurrent endometrial carcinoma

Eligible patients for KEYTRUDA® + chemotherapyb,1,3,4

aEndometrial carcinomas comprises more than 83% of the uterine corpus cancers reported.5
bChemotherapy: paclitaxel and carboplatin. Paclitaxel 175 mg/m2 and carboplatin AUC 5 mg/mL/min for 6 cycles, followed by KEYTRUDA® 400 mg every 6 weeks for up to 14 cycles.1

AUC: area under the curve.

The KEYNOTE-868/NRG-GY018 study

KEYNOTE-868/NRG-GY018 is the first phase III trial with an anti–PD–1 designed to independently assess the statistical significance of outcomes in both pMMR and dMMR populations.6

dMMR: deficient mismatch repair; PD-1: programmed death 1; pMMR: proficient mismatch repair.

In both pMMR and dMMR populations, at the interim analysis KEYTRUDA® + chemotherapyb showed a statistically significant improvement in PFS compared to placebo + chemotherapy.b

Events observed: 95/294 (32.2%) with KEYTRUDA® + chemotherapyb vs. 138/294 (46.9%) with placebo + chemotherapy.b

Events observed: 29/110 (26.4%) with KEYTRUDA® + chemotherapyb vs. 60/112 (53.6%) with placebo + chemotherapy.b

bChemotherapy: paclitaxel and carboplatin. Paclitaxel 175 mg/m2 and carboplatin AUC 5 mg/mL/min for 6 cycles, followed by KEYTRUDA® 400 mg every 6 weeks for up to 14 cycles.1
cBased on Cox regression model with the Efron method of tie handling with treatment as a covariate stratified by prior chemotherapy.4
dBased on stratified log-rank test (compared to an alpha boundary of 0.00116 for pMMR and of 0.00207 for dMMR).4

AUC: area under the curve; CI: confidence interval; dMMR: deficient mismatch repair; HR: hazard ratio; NR: not reached; PFS: progression-free survival; pMMR: proficient mismatch repair.

KEYNOTE-868/NRG-GY018 provided insights into the OS (secondary endpoint) of patients treated with KEYTRUDA® + chemotherapyb at ad-hoc analysis.

LIMITATION: The analysis of OS is ongoing as the data are immature, and the OS endpoint was not formally assessed within the multiplicity control. Results should be interpreted with caution. No conclusions can be drawn.

The information fraction was 46.4% in the pMMR population and 29.3% in the dMMR population.

Events observed: 77/298 (25.8%) with KEYTRUDA® + chemotherapyb vs. 92/299 (30.8%) with placebo + chemotherapy.b

Median OS: 28.9 months with KEYTRUDA® + chemotherapyb (95% CI, 26.8–NR) vs. 28.7 months (95% CI, 24.0-34.6) with placebo + chemotherapy.b

Events observed: 17/110 (15.5%) with KEYTRUDA® + chemotherapyb vs. 27/112 (24.1%) with placebo + chemotherapy.b

Median OS: NR KEYTRUDA® + chemotherapyb (95% CI, NR–NR) vs. 42.7 months (95% CI, 42.7–NR) with placebo + chemotherapy.b

bChemotherapy: paclitaxel and carboplatin. Paclitaxel 175 mg/m2 and carboplatin AUC 5 mg/mL/min for 6 cycles, followed by KEYTRUDA® 400 mg every 6 weeks for up to 14 cycles.1
cBased on Cox regression model with the Efron method of tie handling with treatment as a covariate stratified by prior chemotherapy.4

AUC: area under the curve; CI: confidence interval; dMMR: deficient mismatch repair; HR: hazard ratio; NR: not reached; OS: overall survival; pMMR: proficient mismatch repair.

In patients with recurrent or primary advanced EC receiving KEYTRUDA® + chemotherapy,b AEs were generally similar to those observed with KEYTRUDA® alone or chemotherapyb with the exception of rash (33% all grades; 2.9% grades 3-4).1

pMMR population6

  • Common AEs (≥20%) in the KEYTRUDA® + chemotherapyb group: fatigue (63.4%), peripheral sensory neuropathy (55.4%), anemia (55.1%), nausea (43.8%), constipation (43.5%), diarrhea (35.9%), neutropenia (31.5%), thrombocytopenia (30.1%), arthralgia (22.5%), dyspnea (21%), rash (20.7%).
  • Common AEs (≥20%) in the placebo + chemotherapyb group: fatigue (60.2%), peripheral sensory neuropathy (57.3%), anemia (52.6%), nausea (41.6%), constipation (38.7%), diarrhea (32.1%), arthralgia (27.4%), neutropenia (26.6%), thrombocytopenia (21.5%).

dMMR population6

  • Common AEs (≥20%) in the KEYTRUDA® + chemotherapyb group: fatigue (71.6%), peripheral sensory neuropathy (65.1%), anemia (57.8%), nausea (50.5%), constipation (43.1%), diarrhea (42.2%), thrombocytopenia (34.9%), arthralgia (29.4%), dyspnea (27.5%), myalgia (26.6%), neutropenia (25.7%), vomiting (20.2%).
  • Common AEs (≥20%) in the placebo + chemotherapyb group: peripheral sensory neuropathy (62.3%), fatigue (55.7%), anemia (54.7%), nausea (41.5%), constipation (37.7%), diarrhea (34.0%), neutropenia (32.1%), thrombocytopenia (29.2%), arthralgia (29.2%).

bChemotherapy: paclitaxel and carboplatin. Paclitaxel 175 mg/m2 and carboplatin AUC 5 mg/mL/min for 6 cycles, followed by KEYTRUDA® 400 mg every 6 weeks for up to 14 cycles.1
eEight patients (1.5%) in the pMMR cohort (six in the KEYTRUDA® group and two in the placebo group) died from Grade 5 AEs: sepsis in four patients, cardiac arrest in two patients, and small intestinal obstruction and sudden death not otherwise specified in one patient each. Three patients (1.4%) in the dMMR cohort (one in the KEYTRUDA® group and two in the placebo group) died from Grade 5 AEs: cardiac arrest, sepsis, and lower gastrointestinal hemorrhage in one patient each.6
fThe events of interest are those with a possible immune-related cause and are considered regardless of attribution by the investigator. Some patients may have had more than one AE of interest.6

AE: adverse event; AUC: area under the curve; dMMR: deficient mismatch repair; EC: endometrial carcinoma; pMMR: proficient mismatch repair.

Study design: The efficacy of KEYTRUDA® in combination with paclitaxel and carboplatin was investigated in KEYNOTE-868/NRG-GY018, a phase 3, international, double-blind, randomized, placebo-controlled trial in patients with advanced or recurrent endometrial cancer. Outcomes were analyzed in two independent cohorts — patients with dMMR disease and those with pMMR disease — as determined on the basis of central immunohistochemical analysis. Randomization was stratified according to MMR status, ECOG PS (0 or 1 vs. 2), and prior adjuvant chemotherapy. Patients in each cohort were randomly assigned in a 1:1 ratio to receive paclitaxel 175 mg/m2 IV plus carboplatin AUC 5mg/mL/min IV every 3 weeks along with either KEYTRUDA® 200 mg IV or placebo every 3 weeks for 6 cycles, which was followed by KEYTRUDA® 400 mg IV or placebo maintenance every 6 weeks for up to 14 cycles; a maximum of 20 cycles of KEYTRUDA® or placebo could be administered. Patients received 200 mg of KEYTRUDA® or placebo administered intravenously in a 30-minute infusion every 3 weeks in combination with chemotherapy, followed by 400 mg of KEYTRUDA® or placebo maintenance, administered intravenously in a 30-minute infusion every 6 weeks. Treatment continued until disease progression, unacceptable toxicity, or a maximum of 20 cycles (up to approximately 24 months). Patients with measurable disease who had RECIST-defined stable disease or partial response at the completion of cycle 6 were permitted to continue receiving paclitaxel and carboplatin with KEYTRUDA® or placebo for up to 10 cycles as determined by the investigator. Assessment of tumor status was performed every 9 weeks for the first 9 months and then every 12 weeks thereafter.

Primary endpoints: PFS as assessed by the investigator according to RECIST.

Secondary endpoints: Key secondary outcomes included safety, OS, and health-related quality of life. Quality-of-life assessments were performed only in the pMMR cohort.

Inclusion criteria: Adult women with confirmed advanced-stage, metastatic, or recurrent endometrial cancer of any histologic subtype except for carcinosarcoma. All patients had newly diagnosed Stage III or IVA disease according to RECIST version 1.1 for measurable disease, or Stage IVB or recurrent endometrial cancer with or without measurable disease. Patients who had received previous adjuvant chemotherapy were eligible if their chemotherapy-free interval was at least 12 months.

Exclusion criteria: Patients with endometrial sarcoma, including carcinosarcoma, or patients with active autoimmune disease or a medical condition that required immunosuppression were ineligible.

Results: At the interim analysis, the trial demonstrated statistically significant improvements in PFS for patients randomized to KEYTRUDA® in combination with paclitaxel and carboplatin compared to placebo in combination with paclitaxel and carboplatin in both the dMMR and pMMR populations. At this interim analysis, OS data were immature.

AUC: area under the curve; dMMR: deficient mismatch repair; EGOC PS: Eastern Cooperative Oncology Group performance status; MMR: mismatch repair; OS: overall survival; PFS: progression-free survival; pMMR: proficient mismatch repair; RECIST: Response Evaluation Criteria in Solid Tumors.

KEYTRUDA® (Pembrolizumab) Selected Safety Information (SSI)

Selected Indications: In combination with carboplatin and paclitaxel, followed by KEYTRUDA® as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. In combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by a validated test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. As a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by a validated test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Dosage & Administration: KEYTRUDA® 200 mg every 3 weeks or 400 mg every 6 weeks. KEYTRUDA® is administered over a 30-minute intravenous infusion.

Monotherapy: In adult patients with MSI-H or dMMR endometrial carcinoma, the dose is 200 mg every 3 weeks or 400 mg every 6 weeks, until disease progression or unacceptable toxicity, or up to 24 months.

Combination Therapy: In adult patients with endometrial carcinoma, the dose is 200 mg every 3 weeks or 400 mg every 6 weeks (administer KEYTRUDA® in combination with lenvatinib 20 mg orally once daily), until disease progression or unacceptable toxicity, or, for KEYTRUDA®, up to 24 months. In adult patients with endometrial carcinoma, the dose is 200 mg every 3 weeks or 400 mg every 6 weeks (administer KEYTRUDA® in combination with chemotherapy for 6 cycles [carboplatin and paclitaxel] followed by KEYTRUDA® monotherapy), until disease progression or unacceptable toxicity, or, for KEYTRUDA®, up to 24 months.

Contraindications: None.

Precautions/Warnings: KEYTRUDA® can cause severe and fatal immune-mediated adverse reactions, which can occur in any organ system or tissue, as immune-mediated pneumonitis, immune-mediated colitis, hepatotoxicity and immune-mediated hepatitis, immune-mediated nephritis with renal dysfunction, immune-mediated endocrinopathies (such as adrenal insufficiency, hypophysitis, hyperthyroidism, hypothyroidism, thyroiditis, and type 1 diabetes mellitus), and immune-mediated dermatologic adverse reactions. KEYTRUDA® can cause other immune-mediated adverse reactions, such as myocarditis, pericarditis, vasculitis, meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy, pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis, hypoparathyroidism, myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica, hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection; other transplant (including corneal graft) rejection, uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. KEYTRUDA® can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis. KEYTRUDA® can cause complications of allogeneic HSCT. Increased mortality in patients with multiple myeloma when KEYTRUDA® is added to a thalidomide analogue and dexamethasone. KEYTRUDA® can cause fetal harm when administered to a pregnant woman.

Adverse Reactions: The most common adverse reactions (reported in ≥20% of patients) were:

  • KEYTRUDA® as a single agent: fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritus, dyspnea, constipation, pain, abdominal pain, nausea, and hypothyroidism.
  • KEYTRUDA® in combination with chemotherapy or chemo-radiotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, insomnia, palmar-plantar erythrodysesthesia, urinary tract infection, and hypothyroidism, radiation skin injury, dysphagia, dry mouth, and musculoskeletal pain.
  • KEYTRUDA® in combination with chemotherapy and bevacizumab: peripheral neuropathy, alopecia, anemia, fatigue/asthenia, nausea, neutropenia, diarrhea, hypertension, thrombocytopenia, constipation, arthralgia, vomiting, urinary tract infection, rash, leukopenia, hypothyroidism, and decreased appetite.

Please refer to the full prescribing information of KEYTRUDA® for more information.

dMMR: deficient mismatch repair; HSCT: hematopoietic stem cell transplantation; MSI-H: microsatellite instability-high; 
pMMR: proficient mismatch repair.

Think KEYTRUDA® from the start in rNSCLC

For your eligible rNSCLC patients, start with KEYTRUDA® in the neoadjuvant setting —and continue with KEYTRUDA® after surgery. Review KEYNOTE-671 data to see OS benefits for your patients.

Dive into OS data

Unlock new possibilities in renal cell carcinoma

Now is the time to go beyond surveillance for your eligible patients with RCC. Dive into the KEYNOTE-564 data and discover how you can improve survival outcomes for your patients with KEYTRUDA®.

Rethink post-nephrectomy care

References:

1. KEYTRUDA®. Prescribing Information. 2. Ferlay J, Ervik M, Lam F, et al. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. 2024. Available at: https://gco.iarc.who.int/today. Accessed November 16, 2025. 3. Eskander RN, Sill MW, Beffa L, et al. Pembrolizumab plus chemotherapy in advanced endometrial cancer. Supplementary appendix. N Engl J Med 2023. 4. Eskander RN, Sill MW, Beffa L, et al. Pembrolizumab plus chemotherapy in advanced or recurrent endometrial cancer: overall survival and exploratory analyses of the NRG GY018 phase 3 randomized trial. Nat Med. 2025;31(5):1539-46. 5. Mahdy H, Vadakekut ES, Crotzer D. Endometrial cancer. StatPearls. Treasure Island (FL): StatPearls Publishing Copyright © 2025, StatPearls Publishing LLC.; 2025. 6. Eskander RN, Sill MW, Beffa L, et al. Pembrolizumab plus chemotherapy in advanced endometrial cancer. N Engl J Med 2023;388:2159-70.

AE-KEY-00992 I Expiry date: 16.11.2027