Rx Road Map: Durvalumab for Endometrial Cancer

Durvalumab is approved for use in patients with advanced/recurrent primary endometrial cancer.

For Whom Is Durvalumab Approved?

On June 14, 2024, the FDA approved durvalumab (Imfinzi) for the treatment of endometrial cancer in combination with carboplatin and paclitaxel, followed by single-agent durvalumab.^1,2 Durvalumab is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

What Efficacy Back Durvalumab’s Approval?

The efficacy of durvalumab in this indication was evaluated in the randomized, multicenter, double-blind, placebo-controlled DUO-E trial (NCT04269200). Investigators stratified patients by tumor MMR status, which was assessed using an immunohistochemistry tumor tissue test. Patients were randomized (1:1:1) to the following treatment arms:

• 1,120 mg of durvalumab with carboplatin with paclitaxel every 3 weeks for as many as 6 cycles. After completing chemotherapy, patients received 1,500 mg of durvalumab every 4 weeks as maintenance until disease progression.
• Placebo plus carboplatin and paclitaxel every 3 weeks for as many as 6 cycles. After completing chemotherapy, patients received placebo every 4 weeks until disease progression.
• An additional investigative regimen involving the use of olaparib (Lynparza) as maintenance therapy additional to durvalumab³

The primary end point was progression-free survival (PFS), determined by investigator assessment using RECIST v1.1.¹

Data demonstrated a statistically significant improvement in PFS in the overall population for durvalumab with carboplatin plus paclitaxel compared to carboplatin and paclitaxel alone. An exploratory analysis by tumor MMR status revealed PFS improvement was mostly in patients with dMMR tumors.

Median PFS was not reached (NR; 95% CI, NR-NR) in patients receiving durvalumab vs 7 months (95% CI, 6.7-14.8) for those receiving placebo in 95 patients with dMMR tumor status (HR, 0.42; 95% CI, 0.22-0.80).

How Does Durvalumab Work?

Durvalumab is a human monoclonal antibody that binds to programmed cell death ligand-1 (PD-L1), blocking it from interacting with the programmed death receptor-1 (PD-1) and CD80 receptors, resulting in an antitumor response.² Blocking this binding boosts the body’s immune system response against cancer cells.

How Is Durvalumab Administered?

Durvalumab is administered intravenously.⁴ There are no oral forms to this medication. The drug is infused over 60 minutes. Based on the guidelines no premedication is required for durvalumab administration. There are currently no contraindications for durvalumab.

Nurses must pay close attention to patients during infusion, educate patients about infusion reactions. It is recommended that the patient’s seat is close to the nurse’s station where they can be monitored. Nurses will follow chemotherapy/immunotherapy administration protocols to safely administer the drug.

What Is the Recommended Dose of Durvalumab in Endometrial Cancer?

The recommended dose of durvalumab is based on weight. Patients will be weighed before every treatment upon arrival at the infusion center.

Patients with a body weight less than 30 kg must receive weight-based dosing equivalent to 15 mg/kg of durvalumab in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles, then 20 mg/kg of durvalumab every 4 weeks.

For patients with a body weight equal to or greater than 30 kg, the recommended dose is 1,120 mg in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles, then 1,500 mg of durvalumab every 4 weeks.

Durvalumab is supplied as single-use vials that contain either 120 mg/2.4 mL or 500 mg/10 mL. Based on the dynamics of the drug there is no dose reduction for durvalumab. If adverse events (AEs) occur, durvalumab may be placed on hold or permanently discontinued.

How to Manage Associate AEs

It is not uncommon for patients to have AEs. Monitoring patients is critical during and after treatment as supportive care will be required to manage the symptoms. Per DUO-E safety data, the most common AEs, occurring in over 20% of patients and including laboratory abnormalities were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased alanine aminotransferase (32%), increased aspartate aminotransferase (30%), diarrhea (27%), vomiting (27%), cough (27%), hypokalemia (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%).^4,5

Immune-mediated AEs are common with durvalumab and could be severe or fatal. They can occur in any organ system or tissue during or after treatment. Patients should be closely monitored for symptoms of immune-mediated AEs. Based on the type and severity of AEs, referrals such as cardiology, pulmonary, endocrinology, or dermatology may be warranted to assist in effectively managing patients.

• Immune-Mediated Pneumonitis: Commonly seen in patients who have had a history of thoracic radiation. Patients should be advised to report any respiratory symptoms such as a new or worsening cough, chest pain, or shortness of breath. For grade 1 or 2 pneumonitis, treatment will be placed on hold. For grade 3 or 4 pneumonitis, treatment will be permanently discontinued. Management consists of a combination of supportive care corticosteroids, oxygen therapy, and pulmonary rehabilitation.⁶
• Immune-Mediated Endocrinopathies: Thyroid Disorders (thyroiditis, hyperthyroidism, and hypothyroidism, adrenal insufficiency, hypophysitis, Type 1 diabetes mellites. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Thyroid function should be monitored before and during treatments. Patients will also require insulin management if they develop diabetes.^4,5
• Immune-Mediated Dermatology reactions: Including rash and dermatitis. PD-1/PD-L1 have been linked with exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN). Topical emollients with or without topical corticosteroids may be used to manage mild to moderate non-exfoliative rashes.⁷

What to Inform Patients About to Start Treatment

Patient education is key. Patient should be educated on why durvalumab is ordered, frequency, AEs, and route of administration. Prior to every treatment, laboratory work will be drawn to monitor complete blood count, comprehensive metabolic panel, and other values. Healthcare providers will determine the number of treatments needed. Patients must notify health care teams of any AEs that they experience.

Advice for Nurses Who Administer This Agent

This drug has a wide range of side effects. Nurses should pay attention to immune-mediated AEs. Durvalumab should not be co-administered with other medications through the same infusion line. Providers must pay close attention to reproduction and lactation. It is important to closely monitor patients during infusion to assess for infusion related reactions.

How to Safely Handle Durvalumab

All nurses and other staff who will be in the infusion areas where hazardous drugs are handled must adhere to safety protocols. It is important that all nurses wear appropriate personal protective equipment such as gloves, gowns, shoe covers and eye protection. All staff members should be familiar with the spill kit in the event there is a spill (chemotherapy/immunotherapy spill).

References

1. FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer. FDA. June 14, 2024. Accessed September 9, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-chemotherapy-mismatch-repair-deficient-primary-advanced-or-recurrent
2. Imfinzi plus chemotherapy approved in the US for mismatch repair deficient advanced or recurrent endometrial cancer. AstraZeneca. News release. June 17, 2024. Accessed September 9, 2025. https://www.astrazeneca-us.com/media/press-releases/2024/imfinzi-durvalumab-plus-chemotherapy-approved-in-the-us-for-mismatch-repair-deficient-advanced-or-recurrent-endometrial-cancer.html
3. Durvalumab with or without olaparib as maintenance therapy after first-line treatment of advanced and recurrent endometrial cancer (DUO-E). ClinicalTrials.Gov. February 13, 2020. Updated February 11, 2025. Accessed September 11, 2025. https://clinicaltrials.gov/study/NCT04269200
4. Imfinzi. Prescribing information. AstraZeneca; 2025. Accessed September 11, 2025. https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/9496217c-08b3-432b-ab4f-538d795820bd/9496217c-08b3-432b-ab4f-538d795820bd_viewable_rendition__v.pdf
5. Imfinzi. For the treatment of primary advanced for recurrent dMMR endometrial cancer. Accessed September 11, 2025. https://www.imfinzihcp.com/dmmr-endometrial-cancer.html
6. Schneider BJ, Naidoo J, Santomasso BD, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update. J Clin Oncol. 2021;39(36):4073-4126. doi:10.1200/JCO.21.01440
7. Geisler AN, Phillips GS, Barrios DM, et al. Immune checkpoint inhibitor-related dermatologic adverse events. J Am Acad Dermatol. 2020;83(5):1255-1268. doi:10.1016/j.jaad.2020.03.132