Jung-Yun Lee, MD, PhD, Department of Obstetrics and Gynecology, Yonsei University College of Medicine, discusses primary efficacy and safety findings from the phase 2 KGOG3046/TRU-D trial (NCT03899610) in patients with newly diagnosed ovarian cancer.

The TRU-D study investigated the efficacy and safety of adding durvalumab (Imfinzi) and tremelimumab (Imjudo) to neoadjuvant chemotherapy in patients with newly diagnosed, advanced ovarian cancer. The primary end point of this trial was the 12-month progression-free survival (PFS) rate. Secondary end points included PFS, overall survival (OS), duration of response, pathologic complete response (pCR) rate after neoadjuvant chemotherapy, R0 rate at interval debulking surgery, and safety.

In TRU-D, eligible patients were biopsied at baseline, then received durvalumab and tremelimumab in addition to neoadjuvant chemotherapy, which consisted of carboplatin plus paclitaxel. Patients then underwent interval debulking surgery followed by adjuvant durvalumab plus chemotherapy consisting of carboplatin and paclitaxel.

Dr Lee on PFS Rates With Durvalumab Plus Tremelimumab in TRU-D

The 12-month PFS rate with the study combination was 63.6%, and the 30-month PFS rate was 40.0%. At a median follow-up of 29.2 months, the median PFS was 17.5 months. The 30-month OS rate was 89.1%. In addition, 17.4% of patients achieved a pCR after neoadjuvant chemotherapy.

Treatment with this regimen led to remarkable outcomes without the use of bevacizumab (Avastin) or PARP inhibitors, Lee says. Additionally, the long tails on the PFS curves indicate durable responses in this study, Lee explains.

Dr Lee on the Safety Profile of the TRU-D Regimen

The most common treatment-related adverse effects (TRAEs) were rash, with 69.6% of patients experiencing rash of any grade, and 3 patients experiencing grade 3/4 rash, Lee notes. Interval debulking surgery was delayed in 1 patient each because of grade 4 pneumonitis and grade 4 skin rash, respectively. All TRAEs were resolved with systemic steroids, Lee concludes.

Dr Lee reports advisory board positions, lecture positions, and/or reimbursements from AstraZeneca, Janssen, Eisai, Merck, MSD, Roche, and TAKEDA; and institutional financial interests with Ascendis Pharma, AstraZeneca, Beigene, BerGenBio, Cellid, Clovis Oncology, Eisai, GII, Immunogen, Janssen, Merck, Mersana, MSD, Novartis, OncoQuest, ONO, Roche, Seagen, Synthon, and TAKEDA.

Videos

Jung-Yun Lee, MD, PhD, discusses primary efficacy and safety findings from the phase 2 KGOG3046/TRU-D trial in patients with newly diagnosed ovarian cancer.

Jung-Yun Lee, MD, PhD

Articles

Dr Lee on Tremelimumab Plus Durvalumab in Ovarian Cancer