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Trial resultsApr 30, 2026180 days ago

HARMONi-3 squamous interim PFS misses bar; iDMC recommends study continue

Summit reported results from its Phase 3 study of ivonescimab (SMT112) for 1L metastatic squamous NSCLC on Apr 30, 2026. The study missed its main goal.

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DetailsClinical trial results · also called: readout / topline data
Company
Summit Therapeutics Inc. SMMT
Drug
ivonescimab (SMT112)
For
1L metastatic squamous NSCLC
Stage
Phase 3 · the last stage before a drug can be approved
When
Apr 30, 2026
Source note
Summit disclosed that the newly added interim PFS analysis in the squamous cohort of the global Phase 3 HARMONi-3 study did not clear the statistical bar needed to open an early regulatory conversation; the iDMC recommended the double-blind study continue as planned. Shares fell more than 25% on the disclosure.
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Summit Therapeutics Inc.
SMMT
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Trial resultsSMMTSummitH2 2026

Summit expects to report results from its Phase 3 study of Ivonescimab for First-line metastatic squamous NSCLC in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.

More details
Entry
HARMONi-3 squamous cohort final PFS analysis · Clinical trial results (readout / topline data)
Drug
Ivonescimab
For
First-line metastatic squamous NSCLC
Stage
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 PR: squamous cohort final PFS analysis events expected to be reached in second half of 2026, with interim OS analyses planned; enrollment complete.
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Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

FDA decisionSMMTSummitNov 14, 2026

The FDA is due to decide by Nov 14, 2026 whether to approve Summit’s Ivonescimab for EGFR-mutated locally advanced/metastatic non-squamous NSCLC after 3rd-gen EGFR TKI (with chemotherapy). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.

More details
Entry
PDUFA date for ivonescimab in EGFR-mutated NSCLC post-TKI · FDA decision due (PDUFA date)
Drug
Ivonescimab
For
EGFR-mutated locally advanced/metastatic non-squamous NSCLC after 3rd-gen EGFR TKI (with chemotherapy)
Stage
BLA under review
When
Nov 14, 2026
Source note
Company PR (Jan 29, 2026): FDA accepted the BLA based on Phase 3 HARMONi and set a PDUFA goal action date of November 14, 2026. First US BLA for a PD-1/VEGF bispecific. No advisory committee meeting announced as of Aug 20, 2026.
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Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsSMMTSummitH1 2027

Summit expects to report results from its Phase 3 study of Ivonescimab for First-line metastatic non-squamous NSCLC in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.

More details
Entry
HARMONi-3 non-squamous cohort PFS analysis · Clinical trial results (readout / topline data)
Drug
Ivonescimab
For
First-line metastatic non-squamous NSCLC
Stage
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
Q2 2026 PR: non-squamous cohort PFS events expected to be reached in the first half of 2027.
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Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page