Type C meeting responses from the FDA have led to the finalization of the clinical development approach of STAR-OLZ, a multi-day transdermal olanzapine patch, for the treatment of chemotherapy induced nausea and vomiting.
Type C meeting responses from the FDA have led to the finalization of the clinical development approach of STAR-OLZ, a multi-day transdermal (TDS) olanzapine patch, for the treatment of chemotherapy induced nausea and vomiting (CINV), according to a press release by Starton Therapeutics.
The phase 2 study will be the first to use a total control primary end point in a superiority study.
STAR-OLZ is a 5-day transdermal patch for the delivery of olanzapine, a powerful antiemetic. However, the agent has not been approved for any vomiting or nausea indications. A phase 1 study was completed in December 2019 and a phase 2/3 clinical trial is currently in development.
A standard 3- or 4-drug regimen is recommended by current guidelines for the prevention of CINV. However, between 60% to 70% of patients still experience nausea and vomiting. STAR-OLZ is meant to replace NK1 receptor antagonists for the treatment of CINV.2
“STAR-OLZ represents the first product to be developed for FDA approval using the total control primary end point, which we believe will generate more clinically meaningful data for evaluating CINV treatment than prior trials for currently approved therapies,” said Jamie Oliver, chief medical officer of Starton Therapeutics, in a press release. “Total control is a measure of no nausea, no vomiting, and no rescue medications; existing antiemetics have been approved using a complete response (CR) end point which only measures vomiting and rescue medications.”
A recent meta-analysis of 13 studies were included in a HEC-treated analysis. In the 24 to 120 hours after chemotherapy, 58% of patients treated with olanzapine reported they did not experience nausea or vomiting, compared to 38% of patients in the control group (P = .0004). Additionally, the meta-analysis found in the acute phase, 0 to 24 hours after chemotherapy treatment, 73% of patients treated with olanzapine reported no nausea versus the 57% treated with the best standard of care. Despite the differences in the rate of nausea between the olanzapine group and the standard of care group, CR was similar between the 2 arms.
The Type C meeting was requested as an extension of a positive pre-investigational new drug meeting held with the FDA in July 2020 in order to best agree on the clinical development of STAR-OLZ in CINV. The meeting provided the guidance on the design of a planned phase 2 clinical study as well as the end point strategy. Additionally, the meeting also helped to establish and support the validation of a nausea scale.
Clinical development is slated to advance in the later months of 2021 along with the phase 2 TROPIC-I dose-optimization study comparing STAR-OLZ to a standard NK1-regimen for CINV. The aimed enrollment of the study is approximately 60 people and is looking to enroll at an estimated 20 clinical sites across the United States.