Nicholas Hornstein: HARMONi-2 Brings a New PD-1 and VEGF Strategy Into Focus
Nicholas Hornstein/ LinkedIn

Nicholas Hornstein: HARMONi-2 Brings a New PD-1 and VEGF Strategy Into Focus

Nicholas Hornstein, Assistant Professor at Northwell Health, shared on LinkedIn:

World Lung is in full swing, which means the press releases are coming fast (before the papers or the sessions).

Why do we care in GI?

Because all the shiny things start in lung and eventually make their way over here.

HARMONi-2 compared ivonescimab vs pembrolizumab in PD-L1+ advanced NSCLC.

We already knew the PFS result was kind of wild (in a China-only study):

  • 11.1 vs 5.8 months
  • HR 0.51

Now OS:

  •  30.8 vs 22.6 months
  •  HR 0.73
  • PD-L1 ≥50%: HR 0.58
  • PD-L1 1–49%: HR 0.85

So now this PD-1 x VEGF bispecific has beaten pembrolizumab for both PFS and OS in a randomized phase III trial.

Yes, China only.
Yes, pembro monotherapy is not really the comparator most of us would want for PD-L1 1–49%.
Still. An 8-month OS difference is quite a bit.

GI oncologists should be paying attention because this is already cooking in the first line mCRC setting with HARMONi-GI3.
mFOLFOX6 + ivonescimab vs mFOLFOX6 + bevacizumab

Is this an end-run around patent protection laws and PD1/PDL1’s run out of time? (yes)

Does the strategy have synergystic benefit?
Time will tell.”