Christine Marie/Dela Cruz

Director, Medical Affairs, Therapeutic Expertise, Oncology and Hematology, ICON Biotech
ICON Clinical Research, PTE Limited
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25 years of industry experience with previous work at BMS, MSD, and Novartis. Global & Asia-Pacific clinical development strategy experience for a broad range of drug classes with in-depth experience with immune-oncology compounds (nivolumab, ipilimumab) and small molecules (TKIs) with related publications & congress abstracts. Experienced in Portfolio Strategy development for solid tumors, particularly for GI-tumors. Experienced with regulatory submissions and regulatory authority interactions including the US FDA, EU CHMP, Japan PMDA, China NMPA, Taiwan FDA, and Korea MFDS. Trial design experience included the development of a new trial endpoint, successfully defended at the EU CHMP & US-FDA. Current work covers monoclonal and bi-specific antibodies, ADCs, and cell & gene investigational agents.

Speech title & Synopsis

Taking an ADC into the Cancer Clinic: Medical Considerations

An ADC pipeline is considered a de-risked pipeline. The Probability of Technical and Regulatory Success (PTRS) for ADCs is generally higher than the overall PTRS for Oncology as a whole. Nonetheless, there remains a relatively high ADC clinical failure rate, ranging from 71% to 89.2%. Most of this failure occurs in the early phases of development. The probability of moving from Phase 1 to 2 is estimated at only 54.7%. In addition, the regulatory trends place more emphasis on the preclinical and early clinical phases of development. There is, therefore, an urgent need to take a closer look at the key aspects to consider when taking an ADC from pre-clinical to early clinical development. This talk will outline essential medical considerations for designing an early phase clinical trial covering dosing design considerations, patient population selection, and selection of tumor types.