The ALX Oncology Holdings Inc (NASDAQ: ALXO) stock price soared 108.7% after releasing positive interim Phase 2 ASPEN-06 clinical trial results of Evorpacept for treating advanced HER2-Positive Gastric Cancer.
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Evorpacept was the first CD47 blocker to demonstrate activity in a global, randomised study of solid tumours. The interim efficacy results showed the confirmed overall response rate for Evorpacept combination treatment was 52% compared to 22% for the control group.
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The immuno-oncology company develops therapies that block the CD47 immune checkpoint pathway. Everopacept is the firm’s CD47-blocking therapeutic combined with CYRAMZA® (ramucirumab) and paclitaxel to treat patients with HER2-positive gastric/gastroesophageal junction (GEJ) cancer.
The interim results were obtained from 54 randomised patients with second and third-line gastric/GEJ cancer. A number of the patients were previously treated with checkpoint inhibitors and ENHERTU® (trastuzumab deruxtecan). The patients were treated with Evorpacept at 30 mg/kg every two weeks.
The treatment schedule was very similar to the treatment cycle of trastuzumab, paclitaxel and CYRAMZA. The study’s median duration of response (“mDOR”) was not reached for the evorpacept combination treatment arm compared to 7.4 months for the control group.
The safety profile of evorpacept was consistent with previous clinical trials and was well-tolerated. The interim results compare favourably to the efficacy reported for CYRAMZA + paclitaxel in the RAINBOW study, with an ORR of 28% and mDOR of 4.4 months. The RAINBOW study is the regulatory benchmark and global standard of care for second-line gastric/GEJ cancer.
Sophia Randolph, M.D., PhD, ALX Oncology’s Chief Medical Officer, said: “The ASPEN-06 clinical trial validates the potential of evorpacept both in solid tumors and in combination with anti-cancer antibodies, and these data highlight the drug’s potential as a first-in-class foundational immunotherapy. We are highly encouraged by these initial randomised efficacy and safety results in gastric cancer that build upon the activity previously seen in our first-in-human study and represent the first positive randomised clinical trial data presented for any CD47 blocker. In addition, ASPEN-06 is the first global, randomised study in HER2-positive gastric cancer where prior KEYTRUDA® (pembrolizumab) and ENHERTU were allowed.”
ALX Oncology (ALXO) stock price.
The ALX Oncology (ALXO) stock price soared 108.73% to trade at $10.04, rising from Monday’s closing price of $4.81.
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