EGFR-mutant non-squamous NSCLC post-3rd-gen EGFR TKI (e.g., osimertinib) — Akeso Biopharma (global) + Summit Therapeutics (US rights)
Discover KOL Sentiment on HARMONi →Design - Phase 3 global ivonescimab (PD-1 x VEGF bispecific) + chemotherapy vs placebo + chemotherapy, EGFR-mutant non-squamous NSCLC post-3rd-gen EGFR TKI (NCT05899608); primary endpoint progression-free survival.
PFS (primary, BICR) - Median 6.8 vs 4.4 mo, HR 0.52 (95% CI 0.41-0.66), P<0.00001 (global HARMONi primary, DCO Apr 2025); consistent with the single-region HARMONi-A (China).
OS - Immature - HR 0.75 (95% CI 0.58-0.98), P=0.036 nominal at 52% maturity (ASCO 2025); ESMO 2024 interim HR 0.79. Trend favors ivonescimab; continues to final analysis.
Safety - Grade >=3 AEs 54.3% vs 54.0%; grade >=3 neutropenia 41.8%; bleeding events all-grade 24.6% vs 14.1% (grade >=3 2.6% vs 1.2%, including 1 fatal hemoptysis) - bleeding is the key class-effect concern.
Regulatory - Investigational (US) - BLA accepted Jan 2026, PDUFA November 14, 2026; approved in China (NMPA). Distinct from HARMONi-A / HARMONi-2.
Sponsor / drug - Summit Therapeutics (US) + Akeso Biopharma; ivonescimab (PD-1 x VEGF bispecific).
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated July 21, 2026.
Top tweets by impressions — click to view on X
People are going to see into the $SMMT data what they want to see.
1) East-West reproducibility on PFS and impressive HR are encouraging
2) Lack of success on OS so far potentially jeopardizes the…
Dr. Jonathan Goldman presents the HARMONi data at #WCLC25. In EGFR NSCLC post TKI, adding ivonescimab (VEGF/PD1 bispecific) improves PFS (4.4 to 6.8m, HR 0.52). Numeric difference in OS in Western…
Awaited results of HARMONi trial evaluating ivonescimab, a PD1/VEGF bispecific presented by Dr. Jonathan Goldman presented
@IASLC #WCLC25
🔹PFS HR 0.52
🔹OS immature
How will this fit into a packed…
I deleted my previous $SMMT post because it was incorrect. Apologies.
Corrected version here:
$SMMT said ivonescimab PFS was stat sig and "consistent" between Chinese and western patient…
Summit $SMMT -24% now. I updated my story.
Summit is expected to present more specific data from the ivonescimab study at a future cancer research meeting, but for now, the sharp drop in the…
🔥🚨@OncoAlert Hot Off The Press
Big #NewsRelease by @SMMT_TX in time with #ASCO25
Results from the #HARMONi Phase III global trial evaluating:
#Ivonescimab + #Chemo vs #Chemo in pts with advanced…
Is this the end ? Or beginning? For ivonescimab. @Alfdoc2 @StephenVLiu @BalazsHalmosMD @RManochakian @OncBrothers @OncoAlert @chulkimMD @dr_yakupergun https://t.co/eqVdanRawk
Remarkable results in pretreated EGFR mutant lung cancer! In global trial, stellar benefit in progression-free survival for the addition of ivonescimab to platinum doublet chemo. Given tox profile…
$SMMT nicely trying to gatecrash #ASCO25 with its Harmoni reveal. Here's my preview of this readout from March: https://t.co/9gsDJeDhaa
𝐒𝐅 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐖𝐞𝐞𝐤: @SMMT_TX has filed for approval on the first indication of its PD1 x VEGF. Will it live up to its promise and set the next standard for cancer care? $SMMT
Full video:…
HARMONi is a positive phase 3 of ivonescimab (PD-1xVEGF bispecific) + chemotherapy vs. chemotherapy in EGFR-mutant non-squamous NSCLC after progression on a 3rd-generation EGFR TKI (e.g., osimertinib). Summit Therapeutics submitted a BLA in Q4 2025; the FDA accepted the BLA for filing in January 2026 with a PDUFA goal action date of November 14, 2026. Ivonescimab holds FDA Fast Track designation. If approved, ivonescimab would be the first PD-1xVEGF bispecific antibody approved in the United States. Ivonescimab is approved in China (NMPA, initial approval May 2024).
Median: 6.8 months (ivonescimab + chemo) vs. 4.4 months (placebo + chemo). HR 0.52 (95% CI 0.41-0.66), P<0.00001, by BICR (global HARMONi primary analysis, DCO Apr 2025). Consistent with the single-region HARMONi-A (China): 7.1 vs. 4.8 mo, HR 0.46 months, HR 0.41 (0.30-0.57), P<0.0001. Crossed prespecified efficacy boundary at interim.
HR 0.75 (95% CI 0.58-0.98), P=0.036 nominal (52% maturity, immature) ASCO 2025 update: OS HR 0.75 (52% maturity, immature). ESMO 2024 interim: HR 0.79 (38% maturity). Trend favoring ivonescimab; continues to final OS analysis.
Grade ≥3 adverse events: 54.3% (ivo_chemo) vs. 54.0% (chemo). Key AEs: neutropenia (G≥3: 41.8%), anemia, thrombocytopenia, bleeding events (all-grade 24.6% vs. 14.1%; G≥3 2.6% vs. 1.2%, including 1 fatal hemoptysis in combo arm). Bleeding is the key class-effect concern for PD-1xVEGF bispecific. Rates of hypertension comparable to chemo alone.
⚠️ BLA accepted for filing by FDA; PDUFA goal date November 14, 2026. HARMONi is a positive phase 3 of ivonescimab (PD-1xVEGF bispecific) + chemotherapy vs. chemotherapy in EGFR-mutant non-squamous NSCLC after progression on a 3rd-generation EGFR TKI (e.g., osimertinib). Summit Therapeutics submitted a BLA in Q4 2025; the FDA accepted the BLA for filing in January 2026 with a PDUFA goal action date of November 14, 2026. Ivonescimab holds FDA Fast Track designation. If approved, ivonescimab would be the first PD-1xVEGF bispecific antibody approved in the United States. Ivonescimab is approved in China (NMPA, initial approval May 2024).
HARMONi is the global Phase 3 trial (NCT05899608) of ivonescimab, a PD-1 x VEGF bispecific antibody, plus chemotherapy versus placebo plus chemotherapy in EGFR-mutant non-squamous NSCLC that progressed after a 3rd-generation EGFR TKI such as osimertinib. Progression-free survival was the primary endpoint. It is distinct from HARMONi-A and HARMONi-2, which were China-only trials and have their own KOL Pulse pages.
In the global HARMONi primary analysis (data cut-off April 2025), median progression-free survival by blinded independent central review was 6.8 versus 4.4 months (HR 0.52; 95% CI 0.41-0.66; P<0.00001) for ivonescimab plus chemotherapy versus placebo plus chemotherapy. This was consistent with the earlier single-region HARMONi-A study conducted in China.
No. Ivonescimab is investigational in the United States and not FDA approved. Summit Therapeutics' Biologics License Application was accepted for filing by the FDA in January 2026 with a PDUFA goal date of November 14, 2026. Ivonescimab is approved in China (NMPA, initially May 2024), but a US approval decision is still pending.
Overall survival remained immature: the ASCO 2025 update reported a hazard ratio of 0.75 (95% CI 0.58-0.98; P=0.036 nominal) at 52% maturity, following an ESMO 2024 interim hazard ratio of 0.79 - a trend favoring ivonescimab that continues to the final analysis. On safety, grade 3 or higher adverse events were similar between arms (54.3% versus 54.0%), but bleeding events were more frequent with ivonescimab (all-grade 24.6% versus 14.1%), including one fatal hemoptysis; bleeding is the key class-effect concern for a VEGF-directed agent.
EGFR-mutant NSCLC that progresses after a 3rd-generation EGFR TKI such as osimertinib is an area of high unmet need. HARMONi is a positive Phase 3 trial showing that adding the PD-1 x VEGF bispecific ivonescimab to chemotherapy roughly halved the risk of progression (HR 0.52). If approved, it could offer a new post-osimertinib option, pending the FDA decision expected by November 14, 2026 and the maturing overall survival data.