NEW YORK – Swiss pharmaceutical company Helsinn on Tuesday said that it has dosed the first patient in a Phase I/II trial of its RET inhibitor TAS0953/HM06 for advanced, RET-altered solid tumors, including non-small cell lung cancer.
The clinical trial, dubbed MARGARET, will enroll roughly 200 patients in Japan and the US whose tumors harbor RET gene abnormalities as determined by tissue- or liquid-based testing. Helsinn, which is co-developing the agent with Taiho Pharmaceuticals following a 2017 global agreement, said that in preclinical studies, TAS0953/HM06 has demonstrated "several differentiating features" versus other RET inhibitors, but did not elaborate.
The clinical trial of TAS0953/HM06 will be broken up into an initial Phase I dose escalation and expansion portion, followed by a Phase II portion that will assess patients' response rates as a primary endpoint. Secondary aims of the Phase II portion include evaluating patients' disease control rate, duration of response, progression-free survival, and overall survival, among other outcomes.
"We believe [TAS0953/HM06] has the potential to offer significant benefits for patients with NSCLC and other tumors which harbor RET abnormalities," Helsinn Vice Chairman and CEO Riccardo Braglia said in a statement. "We have had a very collaborative relationship with Taiho to date and are looking forward to continuing to work closely with them to advance this potential innovative treatment through the clinic."