ALXO also released prespecified interim phase 2 data from its ASPEN-06 trial of evorpacept plus trastuzumab, Cyramza and paclitaxel for HER2 positive gastric/gastroesophageal junction cancer.
The Cyramza estate is owned by Co LLY and Eli Lilly.
The study is based on data from 54 randomized patients with second and third-line gastric/GEJ cancer, including a significant number of patients previously treated with AstraZeneca Plc's AZN Enhertu and checkpoint inhibitors.
A confirmed overall response rate of 52% for evorpacept was demonstrated in combination with trastuzumab + Cyramza + paclitaxel compared to 22% for the control group of trastuzumab + Cyramza + paclitaxel.
The median response time for the evorpacept combination treatment arm was not reached, compared to 7.4 months for the control group.
The safety profile of evorpacept was consistent with previous clinical trials and was well-tolerated.
These interim results compare favorably to the efficacy reported in the RAINBOW study for Cyramza + paclitaxel, which is the regulatory benchmark and global standard of care for second-line gastric/GEJ cancer.
The ASPEN-06 study is the first global, randomized study in HER2-positive gastric cancer where prior Merck & Co Inc MRK Keytruda and Enhertu were allowed.
The company is looking forward to sharing the final analysis of the ongoing phase 2 ASPEN-06 study in Q2 2024, and plans to initiate the phase 3 portion of ASPEN-06 in late 2024.
Price action: Shares of AlXO rose 109.20% at $10.05 yesterday during the premarket session on the last check Tuesday.