Pumitamig + elfetabart drozuntecan late-breaking oral at WCLC 2026
BioNTech presented data on Pumitamig (BNT327) + elfetabart drozuntecan (BNT324) for Advanced/metastatic lung cancer at a medical meeting on Sep 15, 2026. The linked source has the details.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- BioNTech SE BNTX
- Drug
- Pumitamig (BNT327) + elfetabart drozuntecan (BNT324)
- For
- Advanced/metastatic lung cancer
- Stage
- Phase 1/2 · an early study that checks safety and takes a first look at effect
- When
- Sep 15, 2026
- Source note
- BioNTech Aug 20, 2026 PR (WCLC Seoul, Sept 12-15): late-breaking oral OA14.01 — first global combination data for a PD-(L)1xVEGF bispecific plus an ADC in lung cancer.
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- Source: stocktitan.net ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- BNTX headlines on this site
BioNTech expects to report results from its Phase 2/3 study of Pumitamig (BNT327) for Solid tumors (NSCLC, SCLC, TNBC, CRC, gastric, others) during 2026 (no exact date yet). Phase 2/3 is a combined mid- to late-stage study.
More details
- Entry
- Multiple pumitamig combination data readouts expected in 2026 · Clinical trial results (readout / topline data)
- Drug
- Pumitamig (BNT327)
- For
- Solid tumors (NSCLC, SCLC, TNBC, CRC, gastric, others)
- Stage
- Phase 2/3 · a combined mid- to late-stage study
- When
- 2026 · the company gave a window, not a day
- Source note
- BioNTech Aug 4, 2026 Q2 release; company guides only to '2026' for further pumitamig combination readouts.
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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
- BNTX headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
BioNTech expects to report results from its Phase 3 study of gotistobart (BNT316/ONC-392, anti-CTLA-4) for Squamous non-small cell lung cancer 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
- Gotistobart (BNT316) Phase 3 interim analysis in squamous NSCLC · Clinical trial results (readout / topline data)
- Drug
- gotistobart (BNT316/ONC-392, anti-CTLA-4)
- For
- Squamous non-small cell lung cancer
- 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
- BioNTech guidance: 'First interim analysis from Stage 2 of the two-stage Phase 3 clinical trial is expected in 2026' — encoded H2 2026 as the remaining window of the guided year.
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- Source: biontech.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
- BNTX headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
BioNTech expects to report results from its Phase 2/3 study of BNT113 (FixVac mRNA immunotherapy) + pembrolizumab for Unresectable recurrent/metastatic PD-L1+, HPV16+ head and neck squamous cell carcinoma in the second half of 2026 (no exact date yet). Phase 2/3 is a combined mid- to late-stage study.
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- Entry
- BNT113 AHEAD-MERIT Phase 3 first interim analysis in HPV16+ head and neck cancer · Clinical trial results (readout / topline data)
- Drug
- BNT113 (FixVac mRNA immunotherapy) + pembrolizumab
- For
- Unresectable recurrent/metastatic PD-L1+, HPV16+ head and neck squamous cell carcinoma
- Stage
- Phase 2/3 · a combined mid- to late-stage study
- When
- H2 2026 · the company gave a window, not a day
- Source note
- BioNTech FY2025 report (March 2026): 'data are expected in 2026 from the first interim analysis of the Phase 3 part'; encoded H2 2026 as the remaining window of the guided year.
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- Source: biontech.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
- BNTX headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Planned BLA filing for trastuzumab pamirtecan (BNT323), expected in the second half of 2026 (no exact date yet). A company milestone for BioNTech (trastuzumab pamirtecan (BNT323/DB-1303) for HER2-expressing endometrial cancer (initial filing indication; breast strategy pending data)): a step in the program rather than a decision or a data readout.
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- Entry
- Planned BLA filing for trastuzumab pamirtecan (BNT323) · Company milestone
- Drug
- trastuzumab pamirtecan (BNT323/DB-1303)
- For
- HER2-expressing endometrial cancer (initial filing indication; breast strategy pending data)
- Stage
- BLA preparation (Breakthrough Therapy designation)
- When
- H2 2026 · the company gave a window, not a day
- Source note
- BioNTech and DualityBio 'plan to file a biologics license application... in 2026'; optimal regulatory path across endometrial and breast indications to be finalized on complete data. Encoded H2 2026 (remaining window).
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- Source: biontech.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
- BNTX headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
BioNTech expects to report results from its Phase 3 study of trastuzumab pamirtecan (BNT323/DB-1303, HER2 ADC) for HR+/HER2-low metastatic breast cancer in Q4 2026 (Oct–Dec) (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
- Trastuzumab pamirtecan (BNT323) DYNASTY-Breast02 primary analysis · Clinical trial results (readout / topline data)
- Drug
- trastuzumab pamirtecan (BNT323/DB-1303, HER2 ADC)
- For
- HR+/HER2-low metastatic breast cancer
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- BioNTech Q2 2026 press release: 'Primary analysis is expected in the fourth quarter 2026' — one of three guided 2026 late-stage readouts (immunomodulator, ADC, mRNA immunotherapy).
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- Checked by a person when it was added
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- Source: biontech.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
- BNTX headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page