SMMT · Company research

Summit Therapeutics Inc.

3 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

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.

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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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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SMMT headlines on this site

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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.

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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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Source: smmttx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
SMMT headlines on this site

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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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SMMT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Past catalysts

MilestoneSMMTSummitQ3 2026

First patient dosed: ivonescimab + GSK B7-H3 ADC combination study, in Q3 2026 (Jul–Sep). A company milestone for Summit (ivonescimab + GSK B7-H3 ADC for solid tumors): a step in the program rather than a decision or a data readout.

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Entry

First patient dosed: ivonescimab + GSK B7-H3 ADC combination study · Company milestone

Drug

ivonescimab + GSK B7-H3 ADC

For

solid tumors

Stage

early clinical

When

Q3 2026 · the company gave a window, not a day

Source note

Q2 2026 results PR dated Jul 23, 2026, so 'later this quarter' = Q3 2026. GSK clinical-trial collaboration announced July 2026.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SMMT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalSMMTSummitAug 12, 2026

Chinese regulators approved Summit’s ivonescimab (SMT112) for 1L advanced squamous NSCLC (China) on Aug 12, 2026. The company can now sell it in that market.

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Entry

China NMPA approves ivonescimab + chemo for 1L squamous NSCLC · Regulatory approval

Drug

ivonescimab (SMT112)

For

1L advanced squamous NSCLC (China)

Stage

Approved

When

Aug 12, 2026

Source note

Partner Akeso received NMPA marketing authorization in China for ivonescimab plus chemotherapy in first-line advanced squamous NSCLC, based on the HARMONi-6 trial. It is the third NMPA-approved indication for an ivonescimab regimen.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
SMMT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsSMMTSummitMay 31, 2026

Summit reported results from its Phase 3 study of ivonescimab (SMT112) for 1L advanced squamous NSCLC on May 31, 2026. The study met its main goal.

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Entry

Phase 3 HARMONi-6 met OS endpoint vs tislelizumab in 1L squamous NSCLC · Clinical trial results (readout / topline data)

Drug

ivonescimab (SMT112)

For

1L advanced squamous NSCLC

Stage

Phase 3 · the last stage before a drug can be approved

When

May 31, 2026

Source note

Akeso-run Phase 3 HARMONi-6 in China showed ivonescimab plus platinum chemotherapy improved overall survival versus tislelizumab plus chemotherapy (HR 0.66; median OS 27.89 vs 23.69 months), presented in the ASCO 2026 Plenary Session.

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Source: smmttx.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SMMT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsSMMTSummitApr 30, 2026

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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Entry

HARMONi-3 squamous interim PFS misses bar; iDMC recommends study continue · Clinical trial results (readout / topline data)

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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Source: s206.q4cdn.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SMMT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsSMMTSummitSep 8, 2024

Summit reported results from its Phase 3 study of ivonescimab for NSCLC on Sep 8, 2024. The linked source has what the numbers showed.

More details

Entry

HARMONi-2: ivonescimab beat pembrolizumab in PD-L1+ NSCLC · Clinical trial results (readout / topline data)

Drug

ivonescimab

For

NSCLC

Stage

Phase 3 · the last stage before a drug can be approved

When

Sep 8, 2024

Source note

First randomized data showing a bispecific outperforming Keytruda head-to-head (China study).

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SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SMMT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

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Pipeline trials

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