Ivonescimab (Summit/Akeso) — Western HARMONi OS Data

Track; not yet

Why

The topline HR 0.76 is a genuinely notable and improving Western signal, corroborated independently via ClinicalTrials.gov (trial design, Western multi-country sites) and a secondary analyst writeup, but it rides on a small subgroup (n≈165) whose hazard ratio has swung from near-null (0.98) to strong (0.76) across three data cuts without a disclosed significance test, safety detail is withheld, the primary claims are company press releases (tier-1, not primary regulatory/peer-reviewed documents), and the BLA is still mid-review under standard (non-priority) FDA timelines -- premature to treat as validated until the Nov 2026 decision and mature stats land.

Next

Re-check after the FDA's PDUFA action on 2026-11-14 and after Summit/Akeso publish the full statistical readout (p-value/CI) for the Western subgroup at a medical conference (WCLC/ESMO/ASCO); only promote past "Track" once Western-subgroup significance and an FDA approval decision are both confirmed.