Business
ALX Oncology Announces New Data from ASPEN-01, the Phase 1b Study of ALX148, Showing Robust Objective Response in Patients with Gastric or Gastroesophageal Junction Cancer
-- ORR of 72% Observed in Patients with >2L HER2 Positive Gastric or Gastroesophageal Junction Cancer -- Estimated OS at 12 months of 76% -- ALX Oncology to
About this update from Alx Oncology Holdings Inc.
[{"type":"text","content":"-- ORR of 72% Observed in Patients with >2L HER2 Positive Gastric or Gastroesophageal Junction Cancer -- Estimated OS at 12 months of 76% -- ALX Oncology to Host Conference Call on July 6th at 8:30 a.m. ET BURLINGAME, Calif., July 03, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced the presentation of updated clinical data from its ongoing ASPEN-01 trial evaluating ALX148 in combination with trastuzumab and chemotherapy for the treatment of gastric or gastroesophageal junction cancer (“GC”). The new results, shared in an oral presentation at the 23rd World Congress on Gastrointestinal Cancer, show that ALX148 in combination with trastuzumab and chemotherapy is highly active and well-tolerated in patients with second-line or greater (“>2L”) HER2 positive GC [abstract SO-31]. “The data that continue to emerge from this clinical trial are tremendously encouraging, suggesting that the combination of ALX148 with trastuzumab, ramucirumab and paclitaxel may offer an important advancement for patients who have progressed on or after prior trastuzumab and chemotherapy,” said Hyun Cheol Chung, M.D., Yonsei Cancer Center, South Korea, an investigator for ASPEN-01. “Importantly, these results also support ALX148’s tolerability profile, further differentiating it as a unique CD47 blocker that may be used in combination with an array of anti-cancer drugs, including chemotherapy.” As of the data cut-off of May 3, 2021, 18 patients had been treated with either 10 mg/kg or 15 mg/kg of ALX148 once weekly with standard dosing regimens of trastuzumab, ramucirumab, and paclitaxel. In patients with >2L HER2 positive GC, whose tumors have progressed upon prior trastuzumab therapy, ALX148 demonstrates a promising initial confirmed objective response rate (“ORR”) of 72% and estimated overall survival (“OS”) at 12 months of 76%. These results compare favorably to randomized historical control studies; RAINBOW reported an ORR of 28% and OS at 12 months of 40%, and DESTINY-01 reported an ORR of 41% and OS at 12 months of 52%.Preliminary data suggest that ALX148 can be combined with trastuzumab, ramucirumab and paclitaxel with no maximum tolerated dose reached. The maximum administered dose of ALX148 in ...