Emerging Phase II Data Show Evorpacept Improved Tumor Response in Patients with Gastric Cancer
The trial demonstrated clinically meaningful improvements in overall response rate and duration of response in its patient population.
Evorpacept, a CD47 blocker, has returned positive data from the Phase II ASPEN-06 clinical trial. ALX Oncology’s potential therapy, in combination with trastuzumab, CYRAMZA (ramucirumab), and paclitaxel (TRP) demonstrated clinically meaningful improvements in overall response rate (ORR) and duration of response among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.1
According to ALX, topline results from the trial included:
- In the full intent-to-treat population (N=127), the addition of evorpacept to TRP demonstrated an ORR of 40.3% compared to the TRP control ORR of 26.6%.
- In patients with fresh HER2-positive biopsies (n=48), evorpacept plus TRP demonstrated an ORR of 54.8% compared to 23.1% for the TRP control.
- Median duration of response (DOR) in the evorpacept arm was 15.7 months [95% CI: 11.0; NE] compared to the TRP control of 7.6 months [95% CI: 6.3; NE] in the full intent-to-treat population.
“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,” Jason Lettmann, chief executive officer at ALX Oncology said in a press release. “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 tumor types and drives ALX’s development strategy.”
The Phase II ASPEN-06 trial (NCT05002127) is a randomized open-label, multi-center, international study. It enrolled 127 patients in the Phase II portion—the Phase III portion will be double-blinded.
“By meeting our clinically meaningful and pre-specified threshold of greater than 10% difference in response between the evorpacept treatment and control arms, these new data validate the mechanism of action and potential clinical utility of evorpacept for patients. Notably, this is now the first CD47 blocker to demonstrate clinical benefit and a well-tolerated safety profile in a randomized trial,” Sophia Randolph, MD, PhD, chief medical officer at ALX Oncology said in the press release. “ASPEN-06 also provides valuable insights into responding patient populations and the importance of HER2 target expression that will inform our clinical program. These data represent a significant advancement for immuno-oncology.”
In October of 2023, ALX shared interim results from the ASPEN-06 trial. The interim analysis showed that patients treated in the evorpacept arm experienced a confirmed ORR of 52% compared to 22% for patients treated with the trastuzumab/ramucirumab/paclitaxel combination alone.2
“The ASPEN-06 clinical trial validates the potential of evorpacept both in solid tumors and in combination with anticancer antibodies, and these data highlight the drug’s potential as a first-in-class foundational immunotherapy,” Randolph said in an earlier press release. “We are highly encouraged by these initial randomized efficacy and safety results in [patients with] gastric cancer that build upon the activity previously seen in our first-in-human study and represent the first positive randomized clinical trial data presented for any CD47 blocker.”
ALX reports that evorpacept is the first CD47 blocker to show a durable clinical benefit and well-tolerated safety profile in a prospective randomized trial.
References
1. ALX Oncology Reports Topline Data From ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Improves Tumor Response in Patients With HER2-Positive Gastric Cancer. News release. ALX Oncology. July 31, 2024. Accessed August 1, 2024. https://ir.alxoncology.com/news-releases/news-release-details/alx-oncology-reports-topline-data-aspen-06-phase-2-trial
2. Evorpacept Plus Trastuzumab/Ramucirumab/Paclitaxel Improves ORR in Pretreated, Advanced HER2+ Gastric/GEJ Cancer. OncLive. October 3, 2023. Accessed August 1, 2024. https://www.onclive.com/view/evorpacept-plus-trastuzumab-ramucirumab-paclitaxel-improves-orr-in-pretreated-advanced-her2-gastric-gej-cancer
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