Why Cancer-Focused ALX Oncology Stock Gained Over 100% Today?

ALX Oncology Holdings Inc ALXO released prespecified interim Phase 2 data from its ASPEN-06 trial of evorpacept plus trastuzumab, Cyramza (ramucirumab) and paclitaxel for HER2-positive gastric/gastroesophageal junction cancer. 

Cyramza (ramucirumab) is owned by Eli Lilly And Co LLY.

The prespecified interim analysis represents results from 54 randomized patients with second and third-line gastric/GEJ cancer, including a meaningful number of patients previously treated with AstraZeneca Plc's AZN Enhertu (trastuzumab deruxtecan) and checkpoint inhibitors. 

A confirmed overall response rate (ORR) of 52% was demonstrated for evorpacept in combination with trastuzumab + Cyramza + paclitaxel compared to 22% for the control group of trastuzumab + Cyramza + paclitaxel.

The 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.

These interim results compare favorably to the efficacy reported for Cyramza + paclitaxel in the RAINBOW study (ORR of 28% and mDOR of 4.4 months), which is the regulatory benchmark and global standard of care for second-line gastric/GEJ cancer.

The company says the ASPEN-06 trial is the first global, randomized study in HER2-positive gastric cancer where prior Merck & Co Inc MRK Keytruda (pembrolizumab) and Enhertu were allowed. 

The company looks forward to reporting the final analysis from 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: ALXO shares 109.20% at $10.05 during the premarket session on the last check Tuesday.