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ASCO 2025 | PROCEADE-CRC-01: precemtabart tocentecan, an anti-CEACAM5 ADC, in mCRC
Scott Kopetz, MD, PhD, FASCO, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses findings from the dose optimization phase of the PROCEADE-CRC-01 trial (NCT05464030), which assessed precemtabart tocentecan in previously treated metastatic colorectal cancer (mCRC). The anti-CEACAM5 antibody-drug conjugate (ADC) demonstrated encouraging antitumor activity with a manageable safety profile across both tested doses. Higher response rates were observed at 2.8 mg/kg, supporting this dose as the recommended Phase II dose. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
Certainly. So the PROCEADE-CRC-01 study is an evaluation of precemtabart tocentecan. It’s an anti-CEACAM5 ADC with an tocentecan payload. This was evaluated in patients with metastatic colorectal cancer. The study was reporting out the randomized portion of the dose optimization between patients treated with a 2.8 milligram per kilogram and a 2.4 milligram per kilogram every three-week dose...
Certainly. So the PROCEADE-CRC-01 study is an evaluation of precemtabart tocentecan. It’s an anti-CEACAM5 ADC with an tocentecan payload. This was evaluated in patients with metastatic colorectal cancer. The study was reporting out the randomized portion of the dose optimization between patients treated with a 2.8 milligram per kilogram and a 2.4 milligram per kilogram every three-week dose. This is a study that is really addressing an unmet need in colorectal cancer, which are active therapies that induce tumor regression in third line and beyond. CCR5 is ubiquitously expressed on colorectal cancer patients. And the results from the study really demonstrated that we had substantial activity of the agent even without needing to test for CCR5 levels on the tumor. So these are just ubiquitously high in colorectal cancer. The promising results were a 31% response rate that we saw in the ongoing study. This is the unconfirmed response rate at the 2.8 milligram per kilogram level. The progression-free survival in both the 2.8 and the 2.4 milligrams was right around the seven months. So very promising response rates and durability. Importantly, the regimen was well-tolerated, mostly hematologic side effects, very low levels of GI side effects, and no toxicities that we saw that were associated with ADCs, such as no pneumonitis or ocular toxicities. So, a very active regimen in a population that has very high levels of CCR5 expression. Development in other tumor types will likely have some further enrichment for the tumors with the CCR5. But this is encouraging. We have lots of biomarkers in colorectal cancer, as you mentioned, but having a regimen that does not require biomarker testing is certainly encouraging. Okay. Thank you.
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