Phase 3 HARMONi-6 met OS endpoint vs tislelizumab in 1L squamous NSCLC
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.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Summit Therapeutics Inc. SMMT
- 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
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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- 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
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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- 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
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.
- Checked
- Checked by a person when it was added
- Verify it
- 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