Yes, we present the first results of the CHIMERA phase 2 study. The CHIMERA study is a phase 2 clinical trial, a single-arm trial, enrolling patients with potentially resectable epithelioid or biphasic pleural mesothelioma. Patients received three cycles of induction, chemoimmunotherapy with platinum, pemetrexed and pembrolizumab, followed by lung-sparing surgery and adjuvant pembrolizumab, up to 14 cycles...
Yes, we present the first results of the CHIMERA phase 2 study. The CHIMERA study is a phase 2 clinical trial, a single-arm trial, enrolling patients with potentially resectable epithelioid or biphasic pleural mesothelioma. Patients received three cycles of induction, chemoimmunotherapy with platinum, pemetrexed and pembrolizumab, followed by lung-sparing surgery and adjuvant pembrolizumab, up to 14 cycles. The particular thing of this trial is that the surgical procedure was centralized at two high-volume centers and the enrollment of the 41 patients was across eight Italian centers in 12 months. So, among the primary endpoints was the pathological complete response rate and among these 41 patients enrolled, 39 proceeded to surgery with a complete macroscopic resection rate of 95% and the pathological complete response was 10.3%. So, the statistical planning plan to enroll 41 patients to demonstrate an advantage in terms of a PCR from 5 to 18% with at least five pathological complete responses, which deserve interest. And the clinical trial, unfortunately, was negative for the primary endpoint, but the near-pathological response rate was quite interesting, about 23.1%. Now, what is the point that the viable residual tumor rate across surgical specimens was extremely heterogeneous and now translational analyses are currently ongoing in order to identify which patients benefit more from this multimodality approach.
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