In This Article:
Merck KGaA’s antibody-drug conjugate (ADC), precemtabart tocentecan, has shown to be safe and tolerable in a Phase Ib trial.
The ongoing PROCEADE-CRC-01 study (NCT05464030) is investigating the dose, safety and tolerability of intravenous (IV) precemtabart tocentecan in approximately 200 patients with metastatic colorectal cancer (mCRC). The study is also looking at early signs of efficacy. Two doses of the drug, 2.4mg/kg and 2.8mg/kg, are being investigated, with patients dosed every three weeks.
Merck KGaA is presenting the data during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 30 May to 3 June 2025 in Chicago, Illinois.
As of the March 25 data cut-off, 42% of patients enrolled in the dose expansion phase of the Phase Ib study remain on treatment, with three patients having continued treatment for nine months.
The median duration of response (DoR) is 23.3 weeks, with nearly 60% of patients having had six cycles of treatment. The median progression free survival (PFS) is 6.9 months, and there was a 72% disease control rate at week 12.
In the study, the most common adverse events (AEs) were anaemia and neutropenia, with no cases of interstitial lung disease (ILD) or ocular toxicity noted in the study. There were no discontinuations or treatment related deaths.
One of the investigators, Scott Kopetz from the MD Anderson Cancer Center said: “This ADC compares favourably versus the current monotherapy in third-plus line treated mCRC where response rates are in the single digits. Therefore, we think this represents a very active regimen, even in patients that have been previously treated with irinotecan as we're seeing in this population.”
Precemtabart tocentecan is an anti-CEACAMS that acts by selectively delivering a cytotoxic topoisomerase 1 inhibitor payload (exatecan). Beyond mCRC, it is being investigated in several oncology indications with CEACAM5 expression, including gastric cancer (GC), non-small cell lung cancer (NSCLC), and pancreatic ductal adenocarcinoma (PDAC) in the ongoing Phase Ib/II PROCEADE-PanTumor study (NCT06710132)
Merck KGaA added that the data supports advancing precemtabart tocentecan in mCRC, with plans to move ahead with the 2.8kg/mg dose.
Merck KGaA has another ADC, M3554, in Phase I clinical trials and two ADCs in preclinical development.
According to GlobalData analysis, the ADC market was valued at $8.6bn in 2023, with expectations to exceed $45bn by 2030. There are already several blockbuster drugs on the market such as Roche’s Polivy (polatuzumab vedotin), Gilead Science’s Trodelvy (sacituzumab govitecan), and Daiichi Sankyo/AstraZeneca’s Enhertu (trastuzumab deruxtecan), with Enhertu being the highest grossing ADC of the year.