ESMO Asia 2025 | Assessing precemtabart tocentecan for CRC in the PROCEADE-CRC-01 trial

Okay, so my name is Ken Kato from the National Cancer Center of South Tokyo. So I have presented the result of the present tablet, toposyntekin, so named as M9140, phase one, that proceeds as the CRC01 study, dose optimization cohort. And so in this time, so the ASEAN cohort, ASEAN patients have been presented in the SMOA meeting this year so uh you know the uh the petrocent ctc uh is uh so a DC drug and anti-silicon 5 DC and the uh the so uh the payload has a top one inhibitor, presenetabot. After the dose-finding study, the part 2A cohort, randomly compared to the dose of 2.8 mg per kilogram as a arm A1 and 2.4 mg per kilogram for as a arm A2 and in Asian subgroup and approximately the 30 patients with a load for each arm and it also results show the response rate was so objective response rate is a confirmed response rate is 44 percent for the 2.8 mg cohort and 77 percent for the 2.4 mg cohort. Though the response was different from each cohort, the progression-free survival review is a very similar result with the median PFS of 2.8 mg with 6.9 months and 7.0 months but 2.4 mg. So our overall survival of each cohort does not reach the median survival but it also the median survival has reached only the 2.4 mg per cohort. So the response rate is higher in the 2.8 mg and the similar progression-free survival is observed but it is relatively more effective with the 2.8 mg cohort and the safety result is similar to the overall the global cohort and the main so a of this drug is so hematologic toxicity uh and the neutropenia and the thrombocytopenia and this uh this uh decreasing uh slightly there so uh worsened the uh the phase as grade three uh the neutropenia and its thrombocytopenia uh this decreasing is observed 2.8 but mostly manageable and finally so in conclusion we did so the 2.8 mg and the 2.4 mg is both the acceptable and manageable the toxicity and the recommended data so the further investigation of the combination therapy now in this trial the part 2c and part 2b is a combination regimen with a 5-FU and or Avastin or 5-FU and Avastin with 2.4 mg every 2 weeks or 2.8 mg every 2 weeks. And then the 4-distract, so more the investigation for the phase 3 trials will be planned to evaluate it so this drug combination or monotherapy a combination with bevacizumab or monotherapy on this third-line chemotherapy so for the third-line setting, the standard care is FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab. So this drug shows the efficacy even after the refractory to the irinotecan and the low rate of the ILD was observed so I think I believe this drug will be as the have a promising result even in the so the third line as a therapy for the colorectal cancer.

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