top of page
Search

Onco-Summaries: Daily Oncology Updates at a Glance

29/04/2025


ALX Oncology’s Phase 2 ASPEN-03 & ASPEN-04 trials failed to meet the primary endpoint of ORR (Ref 1)


ALX Oncology hit with a double blow in first-line R/M SCCHN as their Phase 2 ASPEN-03 & ASPEN-04 trials evaluating evorpacept, a CD47-blocker, in combination with pembrolizumab with or without chemotherapy did not meet the primary endpoints of improved ORR.


  • While data showed trends in improvement versus historical controls, the signals were not strong enough to advance the regimen into a registrational study

  • The safety profile for the combination was consistent with historical data of pembrolizumab and chemotherapy in this setting

  • These Phase 2 trials were initiated based on promising outcomes reported in the Phase 1 ASPEN-01 trial evaluating evorpacept + pembrolizumab + chemotherapy 

    • The triplet had elicited an ORR of 38.5% and mPFS of 5.6 mos, while mOS was not reached in a small pool of 13 patients

    • These results had also led to the US FDA granting the fast track designation to the regimen 



The Phase 3 KEYNOTE-689 trial of neoadjuvant pembro followed by adjuvant pembro + SOC met the primary endpoint of EFS (Ref 2, Ref 3):


Merck & Co./MSD reported results from the Phase 3 KEYNOTE-689 trial of pembrolizumab (anti-PD-1) as a perioperative treatment regimen for patients with stage III or IVA, resected, locally advanced HNSCC during a Plenary Session at the AACR Annual Meeting 2025.


  • Neoadjuvant pembrolizumab followed by adjuvant pembrolizumab + SOC significantly improved EFS vs SOC alone

    • mEFS: 51.8 vs 30.4 mos (HR: 0.73; p=0.0041)

    • MPR: 9.4% vs 0.0%

  • At the first interim analysis, the OS did not reach the statistical significance in PD-L1 CPS ≥ 10 patients; additional follow-up is ongoing

    • mOS: NR vs 61.8 mos; HR: 0.72; p=0.02

    • Due to the statistical testing hierarchy, formal testing was not performed in the CPS ≥1 and ITT populations. OS will be evaluated at the next interim analysis

  • A supplemental Biologics License Application for the regimen is under priority review with the FDA, and a PDUFA date of June 23, 2025 has been set


תגובות

אי אפשר יותר להגיב על הפוסט הזה. לפרטים נוספים יש לפנות לבעל/ת האתר.
bottom of page