Zymeworks has announced preliminary Phase I results for the antibody-drug conjugate (ADC), ZW191, targeting folate receptor-alpha (FR⍺).
These outcomes were presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston, US, taking place on 22-26 October.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe Phase I study enrolled 41 participants with metastatic non-small cell lung cancer, platinum-resistant ovarian cancer, and metastatic endometrial cancer, irrespective of FR⍺ expression. Approximately 85% of participants remained on treatment.
ZW191 demonstrated an objective response rate (ORR) of 44% across all response-evaluable subjects. At doses between 6.4mg/kg and 9.6mg/kg, the ORR reached 53%.
Among response-evaluable gynaecological cancer subjects, the ORR was 50% across dose levels and 64% at doses from 6.4mg/kg to 9.6mg/kg.
Zymeworks clinical development senior vice-president Sabeen Mekan said: “These first clinical data from our Phase I study of ZW191 provide early validation of our innovative approach to designing novel ADCs, through combining a unique antibody design with our proprietary payload, ZD06519.
“We are encouraged by the early signs of anti-tumour activity and favourable safety profile in a heavily pretreated population, which supports best-in-class potential and strengthens our confidence in this approach.
“With dose optimisation planned to begin in the fourth quarter of this year and additional candidates such as ZW251 advancing in development, we remain focused on delivering meaningful new treatment options for patients with challenging cancers.”
The treatment exhibited a manageable safety profile with delays and low rates of dose modifications.
Grade three or higher treatment-related adverse events included thrombocytopenia (5%), anaemia (10%) and neutropenia (5%). No serious treatment-related adverse events, discontinuations or deaths were reported.
Following this data analysis, 11.2mg/kg was established as the maximum tolerated dose. The 6.4mg/kg and 9.6mg/kg dose levels were selected for optimisation, with nearly 30 participants planned per cohort to inform registration strategy.
ADC content on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Syngene. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
