The iPRIME phase 2 trial reported that adding durvalumab and tremelimumab to standard neoadjuvant carboplatin and paclitaxel did not meet its primary efficacy endpoint in advanced high-grade serous ovarian cancer. The experimental arm was assessed using the rate of CRS 3 after three cycles. In 40 evaluable patients, the CRS 3 rate in the Du-T-NACT arm was 32.5%, which did not reach the pre-specified target. Radiological response after treatment was similar between arms, with 45% in the immunotherapy group versus 50% in the chemotherapy-alone arm (p=0.82). The study’s non-comparative design meant the primary endpoint was evaluated within the experimental arm, but the similar secondary responses still reinforce that the dual checkpoint strategy did not translate into improved depth of response using this regimen. The results will likely force sponsors and investigators to re-check biomarker approaches, scheduling, and combination logic for checkpoint blockade in frontline ovarian settings where response enhancement remains difficult.
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