The combination of durvalumab, tremelimumab, and chemotherapy can produce durable responses in patients with newly diagnosed, advanced-stage epithelial ovarian cancer, according to research presented at the 2023 SGO Annual Meeting on Women’s Cancer.
“KGOG3046/TRU-D is the first study reporting survival outcomes with dual immune checkpoint blockade in newly diagnosed, advanced-stage ovarian cancer,” said study presenter Jung-Yun Lee, MD, PhD, of Yonsei University College of Medicine in Seoul, South Korea. “The primary endpoint was met and showed durable responses.”
This phase 2 study (ClinicalTrials.gov Identifier: NCT03899610) included 23 evaluable patients with stage IIIC/IV, newly diagnosed epithelial ovarian cancer. Patients had a median age of 60 years (range, 44-77). Most patients had stage IV disease (87.0%) and high-grade serous carcinoma (87.0%).
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Patients received carboplatin and paclitaxel, durvalumab (1500 mg), and tremelimumab (75 mg) every 3 weeks for 3 cycles. This was followed by interval debulking surgery. After surgery, patients received 3 cycles of carboplatin and paclitaxel as well as 12 cycles of durvalumab (1120 mg).
After neoadjuvant treatment, the objective response rate was 95.7%, with 13.0% of patients having a complete response and 82.6% having a partial response. The pathologic complete response rate was 17.4%, and the R0 resection rate was 73.9%.
The median progression-free survival (PFS) was 17.5 months, the 12-month PFS rate was 63.6%, and the 30-month PFS rate was 40.0%. The median overall survival was not reached, and the 30-month overall survival rate was 89.1%.
The most common treatment-related adverse events were rash (69.6% any grade; 13.0% grade 3-4) and decreased neutrophil counts (52.2% any grade, 39.1% grade 3-4).
Surgery was delayed by grade 4 skin rash in 1 patient and pneumonitis in 1 patient. Dr Lee noted that all treatment-related adverse events resolved with the use of steroids.
Disclosures: This research was supported by AstraZeneca. Dr Lee declared affiliations with Alkermes, Ascendis Pharma, AstraZeneca, BeiGene, BerGenBio, Cellid, Clovis Oncology, Eisai, GII, Immunogen, Janssen, Merck, Mersana, MSD, Novartis, OncoQuest, ONO, Roche, Seagen, Synthon, and Takeda.
Reference
Lee JY, Park J, Lim MC, et al. Final primary analysis in the original cohort of KGOG3046/TRU-D: A phase II study of durvalumab and tremelimumab with front-line neoadjuvant chemotherapy in patients with advanced-stage ovarian cancer. SGO 2023. March 25-28, 2023.
