Oct. 3 Quick Takes: Rare dose of upbeat CD47 data lifts ALX shares

ALX Oncology Holdings Inc. (NASDAQ:ALXO) rose $2.70 (56%) to $7.51 on interim Phase II data showing that evorpacept, the company’s mAb targeting CD47, demonstrated an overall response rate (ORR) of 52% in patients with HER2-positive gastric/gastroesophageal junction cancer compared with 22% for the control group. The study, ASPEN-06, is comparing trastuzumab, Cyramza ramucirumab from Eli Lilly and Co. (NYSE:LLY) and paclitaxel with or without evorpacept. ALX said evorpacept is the first CD47 blocker to show activity in a global randomized study in solid tumors and follows a string of bad news for the CD47 target including the discontinuation by Gilead Sciences Inc. (NASDAQ:GILD) of several magrolimab studies; the decision by AbbVie Inc. (NYSE:ABBV) to return a CD47 program to I-Mab Biopharma (NASDAQ:IMAB); and ALX’s discontinuation of its ASPEN-02 and ASPEN-05 studies of evorpacept in myelodysplastic syndrome and acute myelogenous leukemia, respectively. Top-line final results from the Phase II part of ASPEN-06 are expected in 2Q24.

Ahead of Thursday’s meeting of FDA’s Oncologic Drugs Advisory Committee (ODAC) to discuss KRAS inhibitor Lumakras sotorasib from Amgen Inc. (NASDAQ:AMGN), FDA reviewers suggested in a briefing document that a confirmatory study of the drug was not well-controlled, casting doubt that the agency will convert Lumakras’ accelerated approval to full approval. The study, CodeBreaK 200, compared single agent oral Lumakras with intravenous docetaxel; the reviewers noted a high dropout rate in the docetaxel arm, said steps were not properly taken to minimize the potential for bias in the study, and described violations of the trial’s imaging charter and study protocol, among other issues. CodeBreaK’s overall survival outcome also favored the docetaxel arm...