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HARMONi-6 — Ivonescimab + chemo vs tislelizumab + chemo, 1L squamous NSCLC

Abstract: LBA4 · Session: Plenary, Sun May 31, 2026, Hall B1 · Embargo: lifted 7:00 AM CT May 31

At a glance

  • Sponsor: Akeso (partner: Summit Therapeutics)
  • Phase: 3 (China)
  • Design: Randomized; ivonescimab + platinum chemotherapy vs tislelizumab + platinum chemotherapy
  • Primary endpoint(s): OS (and PFS) — OS positive
  • Comparator: tislelizumab (anti–PD-1) + chemo — an active IO comparator, not placebo
  • Indication: previously untreated advanced squamous NSCLC
  • Line: first-line

Headline result

Ivonescimab + chemo delivered superior overall survival vs an active PD-1 + chemo comparator: median OS 27.89 vs 23.69 months. PFS was previously positive (ESMO 2025); the OS readout was the load-bearing watch-item of the meeting for this class and was selected for the Plenary. Beating an anti–PD-1 arm head-to-head on OS is the key result.

Mechanism / class

Ivonescimab is a PD-1 × VEGF bispecific antibody. HARMONi-6 is the most mature randomized OS evidence for the PD-1×VEGF class and is read as class-defining — though the comparator and population are China-based, framing the global-generalizability debate.

Discussant takeaway

Discussion centered on (1) generalizability of a China-only trial with a tislelizumab backbone to non-China practice, and (2) PD-1×VEGF as a platform class — read-through to AbbVie RC148, BMS pumitamig, and the broader bispecific wave.

Practice-changing?

Class-defining if it generalizes — first OS win for PD-1×VEGF over single-agent checkpoint + chemo; global registrational strategy (Summit) is the gating question for non-China practice.

  • JPM 2026: AbbVie RC148 (~$5.6B Day-1 deal), Summit/Akeso ivonescimab licensing, BMS pumitamig — the PD-1×VEGF dealmaking layer.
  • Theme: PD-1 × VEGF bispecific class and China-origin assets dominating the LBA slate.

Sources