FDA Approves Imfinzi (durvalumab) for Mismatch Repair Deficient Primary Advanced or Recurrent Endometrial Cancer
On June 14, 2024, the Food and Drug Administration approved Imfinzi (durvalumab), AstraZeneca UK Limited, with carboplatin plus paclitaxel followed by single-agent Imfinzi for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
The approval by the Food and Drug Administration (FDA) was based on the results from DUO-E (NCT04269200), a randomized, multicenter, double-blind, placebo-controlled trial in patients with primary advanced or recurrent endometrial cancer. Tumor MMR status was a stratification factor and was assessed using an immunohistochemistry tumor tissue test. Patients were randomized (1:1:1) to one of the following treatment arms:
- Imfinzi 1,120 mg with carboplatin plus paclitaxel every 3 weeks for a maximum of 6 Following completion of chemotherapy, patients received Imfinzi 1,500 mg every 4 weeks as maintenance until disease progression.
- Placebo with carboplatin and paclitaxel every 3 weeks for a maximum of 6 cycles. Following completion of chemotherapy, patients received placebo every 4 weeks until disease progression.
- An additional investigational combination regimen.
The major efficacy outcome measure was progression-free survival (PFS), determined by investigator assessment using RECIST v1.1.
While a statistically significant improvement in PFS was observed in the overall population for Imfinzi (durvalumab) with carboplatin plus paclitaxel compared to carboplatin and paclitaxel alone, the improvement in the overall population was primarily attributed to patients with dMMR tumors based on an exploratory analysis by tumor MMR status.
In 95 patients with dMMR tumors, median PFS was not reached (NR) (95% CI: NR, NR) in the Imfinzi (durvalumab) arm and was 7 months (95% CI: 6.7, 14.8) in the placebo arm (hazard ratio: 0.42 [95% CI: 0.22, 0.80]). Overall survival, an additional efficacy outcome measure, was immature at the PFS analysis.
Adverse Effects
The most common adverse reactions (>25%) with Imfinzi (durvalumab) in combination with carboplatin and paclitaxel were peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, diarrhea, vomiting, and cough. The prescribing information provides the complete adverse reactions.
Imfinzi Dose for Primary Advanced or Recurrent Endometrial Cancer that is Mismatch Repair Deficient (dMMR)
The recommended Imfinzi (durvalumab) dose for patients with a body weight ≥ 30 kg is 1,120 mg with carboplatin plus paclitaxel every 3 weeks for 6 cycles, followed by single- agent durvalumab 1,500 mg every 4 weeks.
The recommended Imfinzi (durvalumab) dose for patients with a body weight of < 30 kg is 15 mg/kg with carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by durvalumab 20 mg/kg every 4 weeks.
Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.
Source: FDA
Posted: June 2024
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Imfinzi (durvalumab) FDA Approval History
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