Introduction

 

[Dr Westin] Hello! Thank you for joining us today. I’m Dr Shannon Westin, Professor and Clinical Medical Director in the Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center.

 

[Dr Backes] And I’m Dr Floor Backes, Professor in the Division of Gynecologic Oncology and Director of Gynecologic Cancer Research at The Ohio State University.

 

Today we will be discussing the aspects of the DUO-E trial design and our perspectives on how they may influence implementation into clinical practice.

 

[Dr Westin] Before we proceed, we need to note that the opinions expressed in this video are solely our own and do not reflect those of AstraZeneca.

 

Endometrial Cancer Prevalence

 

[Dr Backes] Now, let’s begin by highlighting the rising incidence of endometrial cancer and the shift in the treatment landscape.

 

Endometrial cancer is the most common gynecologic cancer and the fourth most common cancer overall in women in the United States.^1,2

 

Endometrial Cancer Incidence

 

[Dr Backes] In the United States, it’s estimated that over 67,000 new cases of endometrial cancer may arise and over 13,000 deaths may occur in 2024.³

 

Furthermore, the rate of new cases and death rates have been increasing over time. Specifically, incidence rates have continued to increase by 1% per year in White women, and 2 to 3% in women of all other racial and ethnic groups. Furthermore, the death rate has risen by 1.7% per year.²

 

The rising incidence of endometrial cancer may be associated with several risk factors, including obesity, diabetes, changes in hormone therapy use.^4,5

 

Endometrial Cancer Survival Rates and Unmet Need

 

[Dr Backes] Most patients diagnosed with endometrial cancer are diagnosed with localized disease, with 5-year survival rates around 95%. However, those diagnosed with distant or metastatic disease tend to have poorer outcomes, with 5-year survival rates below 20%.³

 

This difference between survival rates in localized and distant stages highlights the unmet need for effective treatment options for patients with advanced or recurrent endometrial cancer.^3,6

 

Regarding that treatment, the historical standard of care for advanced or recurrent endometrial cancer has been platinum-based chemotherapy with carboplatin plus paclitaxel regardless of biomarker status.⁷

 

However, the treatment landscape has evolved, with multiple combinations of immunotherapy plus chemotherapy now approved to treat patients with primary advanced or recurrent mismatch repair deficient endometrial cancer.^7-9

 

DUO-E Study Overview

 

[Dr Westin] The underlying unmet medical need we just discussed led to the design of the DUO-E study. DUO-E is the first global, randomized, double-blind, placebo-controlled Phase III trial to evaluate IMFINZI in combination with first-line carboplatin and paclitaxel, or CP, followed by IMFINZI alone or an investigational combination regimen for patients with newly diagnosed advanced or recurrent endometrial cancer.⁷

 

While DUO-E investigated 3 arms, the current FDA approval is based on a prespecified dMMR subgroup, of 95 patients, in an exploratory analysis based on data from 2 arms, the control arm and the IMFINZI arm.⁸

 

DUO-E Study Design

 

[Dr Westin] Patients were recruited to the trial based on specific eligibility criteria, including but not limited to the following characteristics⁷:

• All patients had newly diagnosed stage 3 or 4, or recurrent, endometrial cancer

• Patients could have received adjuvant chemotherapy, but only if it has been at least 12 months from the last treatment to relapse

• Patients with almost all histologies were included, including carcinosarcomas, but excluding sarcomas

 

Overall, 718 patients were randomized into the trial and were stratified based on mismatch repair status, geographical region, and disease status. 143 patients were randomized to the mismatch repair deficient, or dMMR, subgroup as part of a prespecified, exploratory analysis. Notably, stratification by MMR status was important for this trial, as dMMR tumors are more likely to produce abnormal proteins, or neoantigens, which may make them recognizable and susceptible to immunotherapy.^7,10

 

Treatment during the trial can be separated into an induction phase and a maintenance phase, with the treatment schedules and doses shown. Note that IMFINZI or placebo is given every 4 weeks as a single agent in the maintenance phase compared to every 3 weeks in the induction phase with CP, with adjustments in dosing according to the time frame. Patients were treated until disease progression, unacceptable toxicity, or meeting other discontinuation criteria.⁷

 

The select primary endpoint of the study was progression-free survival, or PFS, in the intent-to-treat, or ITT population.⁸

 

Secondary endpoints included overall survival, overall response rate, and duration of response in the ITT population.⁸

 

Exploratory endpoints included a prespecified subgroup analysis of PFS by mismatch repair status, and post-hoc subgroup analyses of overall survival, overall response rate, and duration of response, by mismatch repair status.^7,11,12

 

IMFINZI Endometrial Cancer Indication and Clinical Data

 

[Dr Westin] The reduction in risk of progression or death in the IMFINZI arm of the dMMR subgroup led to the FDA approval of IMFINZI in combination with CP followed by IMFINZI as a single agent for the treatment of adult patients with primary advanced or recurrent dMMR endometrial cancer. Please note that the prespecified PFS subgroup analysis was exploratory and not designed to assess a statistical significance between treatment arms.⁸

 

What’s great about the DUO-E indication is that it offers an additional treatment option for certain patients with advanced or recurrent disease that have had a historical 5-year survival rate below 20%.^5,8,13

 

DUO-E Trial Design Features Introduction

 

[Dr Backes] Yes. Now that we’ve described the DUO-E trial design and how the IMFINZI combination indication addresses an unmet need, we will take a deeper dive into several of the trial design features.

 

More specifically, we will discuss aspects of the DUO-E design along with our perspectives as physicians on how these features may influence implementation into clinical practice.

 

Study features we plan to discuss include the diverse geographic enrollment, inclusion of patients with characteristics associated with aggressive disease, chemotherapy-free interval for patients with recurrent endometrial cancer, treatment until progression or unacceptable toxicity, and the statistical analysis.^7,14

 

Diverse Geographic Trial Site Locations

 

[Dr Westin] So let’s begin the discussion by talking about geographic location. In the DUO-E trial, patients were enrolled from a variety of diverse geographic locations. DUO-E study sites were in Europe, North and South America, and Asia Pacific. Notably, 28% of the study population was of Asian ethnicity.⁷

 

Dr Backes, why do you think it’s important to enroll patients from diverse geographic locations in a clinical trial?

 

[Dr Backes] Thanks, Dr Westin. Overall, enrolling patients from many study locations around the world leads to an investigation in a diverse group of patients that may be representative of the real-world patient population. So, in my opinion, it’s critical for clinical trials to determine if an investigational treatment demonstrates safety and efficacy in diverse populations to help determine if the findings are generalizable to the patient population of patients at risk around the world.¹⁵

 

[Dr Westin] That’s a really good point to keep in mind for any clinical trial. When treating endometrial cancer with CP and immunotherapy regimens, how do you think geographic location may influence patient characteristics and treatment outcomes?

 

[Dr Backes] Well, we know that geographic location may be associated with factors like genetic alterations that can influence the diversity of the patient population and how a patient responds to treatment. Furthermore, genetic alterations associated with cancer development can be affected by many factors associated with geography, including ancestry, the environment, and lifestyle.¹⁶

 

And additionally, it’s important to note that different geographic locations follow different treatment practices, which may impact patient outcomes. For example, common treatment approaches vary for locally advanced disease. In some Asian countries, such as Japan, the standard treatment for locally advanced disease is surgery, with or without adjuvant chemotherapy, whereas, in western Europe and the United States, systemic therapy with or without radiation is more common.^7,17

 

[Dr Westin] That makes sense and helps to highlight why it was important to stratify patients by geographic location, as was done in the DUO-E trial to help account for these variables.⁷

 

In my opinion, it’s important to look at geographic enrollment in a study and to consider how this may influence data interpretation.

 

Inclusion of Patients With Characteristics Associated With Aggressive Disease

 

[Dr Westin] Next, let’s discuss the inclusion of patients with characteristics associated with aggressive disease.^7,14

 

In the dMMR subgroup, 37% of patients had newly diagnosed stage 4 advanced disease, 54% of patients had recurrent disease, 89% of patients had measurable disease at baseline, and 22% of patients had serous carcinoma, carcinosarcoma, mixed carcinoma, clear cell adenocarcinoma, and other histologies.¹⁴

 

Dr Backes, how do you think the patient characteristics in this trial compare to those of patients you see in your own practice? And are there any interesting characteristics you’d like to highlight?

 

[Dr Backes] Absolutely. These characteristics reflect what we typically encounter in our practice. One interesting characteristic is the inclusion of patients with carcinosarcomas, who represent a particularly challenging population to treat. Previously, these patients were excluded from trials because carcinosarcomas were considered a sarcoma, so they were overlooked in endometrial cancer clinical trials. Further, their rarity complicates the epidemiologic understanding of their nature.¹⁸

 

Endometrial carcinosarcoma cases are typically diagnosed at an advanced stage, display aggressive behavior, and are associated with a poor prognosis. Despite rising incidence rates and high recurrence rates of gynecologic carcinosarcomas, the optimal treatment has not been well established. Therefore, there is a need to investigate treatment regimens in these patients.^18,19

 

[Dr Westin] All great points to keep in mind.

 

Within this study, it’s important to note that we cannot draw specific conclusions about how this treatment affects patients with carcinosarcomas specifically, as the number of patients enrolled with this histology type is too small. Within the dMMR subgroup, about 5% of patients had carcinosarcomas.¹⁴

 

However, we know from our practice that patients with aggressive disease are generally difficult to treat.

 

Overall, it was important to include patients with characteristics associated with aggressive disease in the DUO-E study, as this could increase the likelihood that findings might be relevant for these patients in real world clinical practice.

 

Chemotherapy-free Interval for Patients With Recurrent Endometrial Cancer

 

[Dr Westin] Now, let’s move on to discuss another criterion for trial eligibility in the DUO-E study. For patients with recurrent disease, prior adjuvant chemotherapy was allowed if at least 12 months had passed from last treatment to relapse. This represented approximately 12% of patients in the dMMR subgroup of the DUO-E study.^7,14

 

Dr Backes, what do you think of this inclusion criterion? How might a 12-month timeframe between the last chemotherapy treatment and disease recurrence influence data interpretation?

 

[Dr Backes] Well, in my opinion, patients with disease recurrence soon after chemotherapy generally have a poorer prognosis compared to those with more time between prior treatment and disease recurrence. The influence of platinum-free intervals on patient outcomes has been investigated and validated in ovarian cancer, but there is a lack of comparable studies in endometrial cancer. So, there is definitely a need to further investigate platinum sensitivity in endometrial cancer to address this question. Additionally, the sample size of patients that had prior chemotherapy in the dMMR subgroup of the DUO-E study is too small to draw any conclusions based on this data alone.^20-22

 

[Dr Westin] Great points. It is clear that more research in endometrial cancer is needed to determine if this patient characteristic is an important consideration, and if so, how it may influence response to another treatment.^21,22

 

Treatment Until Disease Progression or Unacceptable Toxicity

 

[Dr Westin] Next, let’s discuss the fact that the clinical trial design continued treatment until disease progression or unacceptable toxicity. More specifically, during the induction phase, patients received IMFINZI and CP treatment every 3 weeks for a maximum of 6 cycles. After chemotherapy treatment concluded, patients were treated with IMFINZI alone every 4 weeks as maintenance treatment until disease progression or unacceptable toxicity. The IMFINZI dose during the induction phase was 1120 mg, followed by a dose of 1500 mg during the maintenance phase (unless the patient weighed less than 30 kg).^7,8

 

[Dr Backes] In your opinion, Dr Westin, why could a maintenance dosing regimen until progression be a valuable clinical trial design feature?

 

[Dr Westin] I believe that having a maintenance dosing regimen until progression or unacceptable toxicity provides the opportunity to collect efficacy and safety data in an organized manner to ensure important data are not missed after a specific cutoff time. What do you think of this trial design decision?

 

[Dr Backes] I think having a study designed to treat patients until progression or unacceptable toxicity provides a valuable contribution to the endometrial cancer treatment data landscape.

 

[Dr Westin] While we’re discussing treatment duration, I’d also like to note that when reviewing clinical trial data, it’s helpful to check the median duration of treatment and exposure, as well as the data maturity. The medians help offer a sense of the real-world impact of treating until progression or unacceptable toxicity and the data maturity provides context for how likely it is that information could change at the next data analyses.

 

For the dMMR subgroup in the DUO-E trial, we know that median duration of exposure to IMFINZI with CP was 14.8 months (with a range of 0.7 to 31.7 months).⁸

 

It will be interesting to see how the median duration of exposure and treatment changes at future DUO-E data analyses as the data continue to mature.

 

Statistical Analysis Plan

 

[Dr Westin] We’ve covered a lot, but let’s look at the final trial design feature we’d like to discuss today: the prespecified statistical analysis plan. The DUO-E trial was designed to assess progression-free survival in the intent-to-treat population for its primary endpoint. Investigators planned a prespecified exploratory subgroup analysis by mismatch repair status which was not designed to determine statistical significance between arms. However, the FDA agreed results from the dMMR subgroup analysis were clinically meaningful and thus granted AstraZeneca an approval for IMFINZI in combination with CP followed by IMFINZI as a single agent for the treatment of adult patients with primary advanced or recurrent dMMR endometrial cancer.^7,8

 

Dr Backes, how confident are you in the data that support the IMFINZI FDA-approved indication?

 

[Dr Backes] Yes, the FDA approval provides support that the DUO-E data in the dMMR subgroup is clinically meaningful. I think this instills confidence to consider the IMFINZI regimen as another treatment option for patients with primary advanced or recurrent mismatch repair deficient endometrial cancer.

 

[Dr Westin] I agree.

 

Endometrial Cancer Treatment Landscape

 

[Dr Westin] Dr Backes and I covered a lot of information in a short amount of time, so we’ll use this opportunity to provide some key takeaways.

 

Following the approval of chemotherapy in the early 2000s to treat advanced or recurrent endometrial cancer, there was a lull in approvals. In 2023 and 2024, the treatment options expanded to incorporate immunotherapy and chemotherapy combination regimens as additional options to treat advanced or recurrent endometrial cancer, with IMFINZI and CP being approved in 2024 for the treatment of primary advanced or recurrent dMMR endometrial cancer.^9,23

 

DUO-E Trial Design Features Conclusion

 

[Dr Westin] When evaluating these data, it’s important to remember that there are many trial design nuances that may influence implementation into clinical practice.

 

Several features discussed today include geographic location diversity, inclusion of characteristics associated with aggressive disease, the chemotherapy-free interval for patients with recurrent endometrial cancer, treatment until progression or unacceptable toxicity, and the statistical analysis plan.^7,14

 

Dr Backes, are there any other key takeaways that you would like to add today?

 

DUO-E Trial Design Key Points

 

[Dr Backes] Yes, I have a few. The DUO-E study was designed to be representative of a diverse patient population, with trial sites around the world, and included patients with aggressive disease characteristics. These inclusive features are important to consider when implementing data into clinical practice.⁷

 

Overall, the DUO-E data add to the body of evidence that supports immunotherapy plus chemotherapy as a treatment option for primary advanced or recurrent endometrial cancer that is mismatch repair deficient. Also, testing patients for mismatch repair deficiency as soon as possible at diagnosis will be critical to ensure patients can access precision medicine treatments.^5,8,9

 

[Dr Westin] That’s true. I think the most important takeaway to end with is that the IMFINZI plus chemotherapy combination indication offers an additional treatment option to treat patients with primary advanced or recurrent dMMR endometrial cancer.^8,9

IMPORTANT SAFETY INFORMATION

 

There are no contraindications for IMFINZI^® (durvalumab).

 

Immune-Mediated Adverse Reactions

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

 

Immune-Mediated Pneumonitis

IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

 

Immune-Mediated Colitis

IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

 

Immune-Mediated Hepatitis

IMFINZI can cause immune-mediated hepatitis.

 

Immune-Mediated Endocrinopathies

• Adrenal Insufficiency: IMFINZI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.

• Hypophysitis: IMFINZI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.

• Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism): IMFINZI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.

  • IMFINZI with Carboplatin and Paclitaxel

    • Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.

• Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.

 

Immune-Mediated Nephritis with Renal Dysfunction

IMFINZI can cause immune-mediated nephritis.

 

Immune-Mediated Dermatology Reactions

IMFINZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

 

Other Immune-Mediated Adverse Reactions

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI or were reported with the use of other PD-1/PD-L1 blocking antibodies.

• Cardiac/vascular: Myocarditis, pericarditis, vasculitis.

• Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.

• Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include 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.

• Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.

• Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.

• Endocrine: Hypoparathyroidism.

• Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.

 

Infusion-Related Reactions

IMFINZI can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.

 

Complications of Allogeneic HSCT after IMFINZI

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.

 

Embryo-Fetal Toxicity

Based on their mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and advise them to use effective contraception during treatment with IMFINZI and for 3 months after the last dose of IMFINZI.

 

Lactation

There is no information regarding the presence of IMFINZI in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI, advise women not to breastfeed during treatment and for 3 months after the last dose.

 

Adverse Reactions

• In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (≥3%) were constipation (4.5%) and fatigue (4.5%).

• In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (≥4%) were constipation (4.5%) and rash (4.5%).

 

The safety and effectiveness of IMFINZI has not been established in pediatric patients.

 

Indication:

IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test.

 

Please see Full Prescribing Information including Medication Guide for IMFINZI at IMFINZIhcp.com.

 

You are encouraged to report side effects related to AstraZeneca products by calling 1-800-236-9933. If you prefer to report these to the FDA, please call 1-800-FDA-1088.

 

©2025 AstraZeneca. All rights reserved.

US-94254 Last Updated 5/25

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3. National Cancer Institute (NCI). Cancer Stat Facts: Uterine Cancer. Accessed March 2025. https://seer.cancer.gov/statfacts/html/corp.html

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7. Westin SN, Moore K, Chon HS, et al. Durvalumab plus carboplatin/paclitaxel followed by maintenance durvalumab with or without olaparib as first-line treatment for advanced endometrial cancer: The Phase III DUO-E Trial. J Clin Oncol. 2024;42(3):283-299.

8. IMFINZI^® (durvalumab) [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025.

9. Tillmanns T, Masri A, Stewart C, et al. Advanced endometrial cancer-The next generation of treatment: A society of gynecologic oncology journal club clinical commentary. Gynecol Oncol Rep. 2024;55:101462.

10. Zhao P, Li L, Jiang X, Li Q. Mismatch repair deficiency/microsatellite instability-high as a predictor for anti-PD-1/PD-L1 immunotherapy efficacy. J Hematol Oncol. 2019;12(1):54.

11. Baurain J-F, Chon HS, Thomes-Pepin J, et al. Durvalumab + carboplatin/paclitaxel followed by durvalumab +/- olaparib as a first-line treatment for endometrial cancer: overall survival and additional secondary efficacy endpoints by mismatch repair status in the DUO-E/GOG-3041/ENGOT-EN10 trial. Presented at: Society of Gynecologic Oncology Annual Meeting on Women’s Cancer; March 16-18, 2024; San Diego, CA.

12. Chon HS, Thomes-Pepin J, Sundborg MJ, et al. Durvalumab + carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer (DUO-E/GOG-3041/ENGOT-EN10): objective response rate and duration of response by mismatch repair status. Presented at: Society of Gynecologic Oncology Annual Meeting on Women’s Cancer; March 16-18, 2024; San Diego, CA.