ALX Oncology has revealed topline data from its Phase II ASPEN-06 clinical trial, indicating that evorpacept, in combination with standard therapies, enhanced tumour response in patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer.
The international, randomised, multi-centre trial assessed evorpacept, an investigational CD47-blocking therapeutic, combined with trastuzumab, CYRAMZA (ramucirumab), and paclitaxel (TRP) compared to TRP alone.
Go deeper with GlobalData
The trial enrolled 127 subjects who had previously been treated with an anti-HER2 agent.
Overall response rate (ORR) was the trial’s primary endpoint while key secondary endpoints included safety, median duration of response (mDOR), progression-free survival (PFS), and overall survival (OS).
The study’s findings showed a clinically meaningful improvement in ORR and mDOR among the participants.
In the full intent-to-treat population, the ORR for the evorpacept plus TRP group was 40.3%, compared to 26.6% for the TRP control group.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataA more pronounced effect was seen in patients with fresh HER2-positive biopsies, where the evorpacept combination achieved an ORR of 54.8% against 23.1% for the control.
The median DOR for the evorpacept arm was 15.7 months, significantly longer than the 7.6 months observed in the TRP control group.
Although the secondary endpoints of PFS and OS were not mature at the time of analysis, the combination of evorpacept with TRP was generally well tolerated and consistent with the TRP control’s safety profile.
ALX Oncology CEO Jason Lettmann said: “The topline results from the ASPEN-06 clinical trial confirm the robust response that evorpacept can deliver, generating a clinically meaningful impact on key measures of anti-cancer activity for patients with gastric cancers and continuing to surpass benchmarks in the field.
“Additionally, they provide valuable insight beyond the interim data previously reported, offering a more conclusive look at the impact of evorpacept and identifying the most responsive patient population.
“Importantly, the level of clinical benefit seen in this trial provides support for developing evorpacept in combination with anti-cancer antibodies in additional tumour types and drives ALX’s development strategy.”
In October last year, the company reported positive interim results from the Phase II/III ASPEN-06 trial of evorpacept to treat advanced HER2-positive gastric cancer.
