On Wednesday, ALX Oncology Holdings Inc ( ALXO ). released topline data from its Phase 2 ASPEN-06 clinical trial.

ASPEN-06 is evaluating evorpacept in combination with trastuzumab, Cyramza (ramucirumab), and paclitaxel (collectively, TRP) against TRP alone for HER2-positive gastric/GEJ cancer, where all patients had received an anti-HER2 agent in prior lines of therapy.

The ASPEN-06 study is testing a new treatment combination for advanced stomach and gastroesophageal cancer in patients who have already undergone other treatments. This combination includes a drug named evorpacept, added to a standard therapy mix.

Results so far show that this new combination helps patients respond better and for a longer duration compared to the standard therapy alone.

Also Read: ALX Oncology Has ‘Elevated Valuation’ – Analyst Downgrades Stock, Highlights Need For Development De-Risking Beyond Gastric Cancer.

In the full intent-to-treat population (N=127), the addition of evorpacept to TRP demonstrated an overall response rate (ORR) of 40.3% compared to the TRP control ORR of 26.6%.

The company released prespecified interim Phase 2 data from its ASPEN-06 trial in October 2023.

The data showed a confirmed overall response rate (ORR) of 52% for evorpacept in combination with trastuzumab + Cyramza + paclitaxel compared to 22% for the control group of trastuzumab + Cyramza + paclitaxel.

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.

The median duration of response (DOR) in the evorpacept arm was 15.7 months compared to the TRP control of 7.6 months.

Secondary endpoints of progression-free survival (PFS) and overall survival (OS) were immature at the time of analysis.

Evorpacept, in combination with TRP, was generally well tolerated and consistent with TRP control.

“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,” said Sophia Randolph, chief medical officer at ALX Oncology ( ALXO ).

The FDA has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. The FDA and European Commission have also granted Orphan Drug Designation for this indication.

Price Action: ALXO stock is down 34.40% at $3.15 during the premarket session at the last check on Thursday.

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