Trials — ESMO 2026¶
The primary artifact of this vault: one Markdown file per trial / readout. ESMO 2026 is a clinical-readout meeting (the European counterpart to ASCO), so the unit of analysis is the trial — not the speaker, not the tool, not the company.
Status: Template + master index, meeting 5 months out (as of May 11, 2026). Per-trial pages will be populated as embargoes lift — ESMO releases accepted abstracts on/around the day of presentation, with LBAs day-of. The official ESMO 2026 program won't be public until ~July/August 2026, so the table below is a very tentative watch list seeded from H2 2026 phase-3 readout timing previews + ASCO 2026 follow-up candidates. Everything is flagged
*expected, program not yet public*until the ESMO Online Programme posts. Numbers can — and will — shift on the actual abstract reveal.
Per-trial template¶
Each trial file (e.g., harmoni-6-os.md) follows this schema. Copy and fill:
# <Trial acronym / name> — <Drug regimen, indication, line>
> **Abstract:** <abstract #, e.g., LBA1> · **Session:** <Presidential Symposium I / Proffered Paper / Mini-Oral, date, time CEST, hall> · **Embargo:** <date>
## At a glance
- **Sponsor:** <pharma / cooperative group — note EORTC / GETUG / GBG / AGITG / GERCOR / ICORG / academic sponsor if applicable>
- **PI / presenter:** <name, institution>
- **NCT ID / EudraCT:** <NCTxxxxxxxx / 20xx-xxxxxx-xx>
- **Phase:** <1 / 2 / 3 / 2-3>
- **Design:** <arms, randomization, blinding>
- **N:** <enrolled / analyzed>
- **Primary endpoint(s):** <PFS / OS / EFS / DFS / ORR / pCR / iDFS>
- **Comparator:** <SOC / placebo / active comparator>
- **Indication:** <tumor type, subtype, biomarker selection>
- **Line:** <neoadjuvant / adjuvant / 1L / 2L / 3L+ / perioperative>
- **Regulatory framing:** <EMA / FDA / both — sized for which filing>
## Headline result
<One paragraph. Numbers + HR + p-value if known. If pre-embargo, mark
`*expected per <company> topline <date>*` or `*pre-embargo per <analyst source>*`.>
## Mechanism / class
<Drug class, target, prior approvals if any. Cross-link to related AACR
mechanism sessions and ASCO 2026 readouts.>
## Discussant takeaway
<Named discussant + key framing once known. Discussant identity is itself a
signal — ESMO assigns senior European figures to Presidential Symposium LBAs,
and the discussant framing typically defines the EU narrative.>
## Practice-changing?
<Yes / no / pending, with rationale: ESMO Clinical Practice Guideline implications,
EMA filing path, NCCN read-through, prior SOC.>
## Cross-links
- **ASCO 2026:** <related Plenary / oral / abstract — frequent, since ESMO often follows ASCO with OS / longer follow-up>
- **AACR 2026:** <related plenary / session / poster, if applicable>
- **AACR 2025:** <prior-year mechanism work>
- **Other ESMO 2026 trials:** <same class, same indication>
- **JPM 2026:** <sponsor presentation / deal>
- **Tools:** <if a biomarker / ctDNA / spatial method anchored the trial>
## Sources
- Annals of Oncology Abstract Book entry / DOI: <URL or "pending embargo">
- OncologyPRO session page: <URL>
- Company press release: <URL>
- Trade-press recap: <OncLive / Targeted Oncology / ESMO Daily Reporter URL>
- ClinicalTrials.gov / EudraCT: <NCT / EudraCT URL>
Master trial index¶
The watch list for pre-meeting stub creation. All entries below are speculative this far out — the ESMO 2026 program is not yet public. These are candidates flagged because they have (a) a known H2 2026 phase-3 readout target per sponsor IR, (b) an ASCO 2026 PFS readout that would mature to ESMO OS, or (c) a prior-year ESMO presence with a known follow-up data cut. Result column entries marked italic are speculative / company topline only.
| Trial | Sponsor | Indication | Phase | Endpoint | Result (pre-program) | Discussant | Practice-changing? |
|---|---|---|---|---|---|---|---|
| HARMONi-6 (OS update) | Akeso / Summit | 1L advanced squamous NSCLC | 3 | OS | expected, program not yet public; PFS+ at ESMO 2025, OS at ASCO 2026 Plenary; ESMO 2026 may carry longer follow-up | TBD | TBD |
| Rasolute-302 (OS confirm / subgroup) | Revolution Medicines | 2L pancreatic PDAC, RAS-mut | 3 | OS / subgroups | expected, program not yet public; ASCO 2026 Plenary readout April 13 topline mOS 13.2 vs 6.7 mo | TBD | TBD — class-defining at ASCO, ESMO is confirmatory |
| DESTINY-Breast05 (full data / OS) | AZ / Daiichi Sankyo | High-risk HER2+ primary BC with residual disease post-neoadj | 3 | iDFS / OS | expected, program not yet public; interim at ESMO 2025 | TBD | Likely yes if iDFS holds — T-DXd vs T-DM1 |
| DESTINY-Breast11 (follow-up) | AZ / Daiichi Sankyo | High-risk HER2+ EBC, neoadjuvant | 3 | pCR / iEFS follow-up | pCR positive at ESMO 2025 (67.3% vs 56.1%); ESMO 2026 may carry iEFS | TBD | TBD |
| evERA Breast Cancer (follow-up) | Roche | ER+/HER2- mBC post-CDK4/6 | 3 | PFS / OS | expected, program not yet public; PFS+ at ESMO Breast 2026 (May) | TBD | Confirmatory; positions giredestrant + everolimus |
| DESTINY-Gastric05 | AZ / Daiichi Sankyo | 1L HER2+ advanced/metastatic gastric/GEJ | 3 | PFS / OS | expected, program not yet public; AZ IR flagged H2 2026 candidate | TBD | TBD — vs trastuzumab + chemo SOC |
| IMvigor011 (follow-up) | Roche | ctDNA-guided adjuvant atezo MIBC | 3 | DFS / OS | primary at ESMO 2025; ESMO 2026 may carry OS | TBD | TBD |
| DYNAMIC-III (follow-up) | AGITG / academic | ctDNA-guided adjuvant CTX stage III CRC | 3 | DFS | primary at ESMO 2025; ESMO 2026 may carry longer follow-up | TBD | TBD |
| SATEEN | Gilead / academic | mHER2+ BC post-Enhertu (sacituzumab + trastuzumab) | 2 | ORR / PFS | expected, program not yet public; flagged at ESMO Breast 2026 | TBD | First prospective ADC-after-ADC sequencing |
| frontMIND (OS / follow-up) | Incyte / MorphoSys | 1L DLBCL high IPI | 3 | OS | PFS+ HR 0.75 at ASCO 2026; ESMO 2026 OS / subgroup candidate | TBD | TBD |
| ASCENT-04 (OS / PFS2 follow-up) | Gilead | 1L PD-L1+ mTNBC | 3 | OS | PFS+ at AACR/SABCS 2025; PFS2 at ASCO 2026; ESMO 2026 OS candidate | TBD | TBD |
| SERENA-6 (follow-up) | AZ | 1L ER+/HER2- ESR1-mut BC (switch design) | 3 | PFS2 / OS | PFS+ at ASCO 2025; PFS2 at ASCO 2026; ESMO 2026 may carry longer cut | TBD | Strengthens ctDNA-switch paradigm |
| LIBRETTO-432 (OS / subgroup) | Lilly (Loxo) | Adjuvant RET+ NSCLC | 3 | EFS / OS | EFS+ at ASCO 2026 Plenary; ESMO 2026 candidate for OS / subgroup | TBD | TBD |
| PEACE-3 (follow-up) | EORTC / Bayer / Pfizer | mCRPC (enza + Ra-223) | 3 | rPFS / OS | primary at ESMO 2024; ESMO 2026 may carry mature OS | TBD | TBD |
| LITESPARK-022 (follow-up) | Merck | Adjuvant pembro + belzutifan RCC | 3 | DFS / OS | DFS+ candidate at ASCO 2026; ESMO 2026 may carry follow-up | TBD | TBD |
| KEYNOTE-B15 (full) | Merck / Pfizer / Astellas | Perioperative EV + pembro MIBC | 3 | pCR / EFS | expected at ASCO 2026; ESMO 2026 carries EFS / full data | TBD | Likely yes — perioperative EV+pembro vs gem/cis |
Additional shortlist categories to populate when the program publishes (~Jul/Aug 2026):
- European-led cooperative groups: EORTC trials (PEACE series, EORTC-BCG series, EORTC-1325 melanoma adjuvant follow-up); GETUG GU trials; GBG breast trials (GeparX / NeoTRIP follow-ups); AGITG GI trials (DYNAMIC follow-ups); GERCOR GI trials; ICORG; SAKK; FFCD.
- EMA-track adjuvant TKI / IO registrations: any trial sized specifically for first EMA filing (often academic-led or where the US sponsor has chosen ESMO over ASCO).
- Asian-origin assets with European OS: ivonescimab follow-ups, sacituzumab tirumotecan follow-ups, anbenitamab post-ASCO data, sunvozertinib follow-ups.
- PD-1×VEGF bispecific class: AbbVie RC148 first phase-2 / phase-3 data (per JPM 2026 $5.6B deal); BMS pumitamig; Akeso/Summit pipeline beyond ivonescimab.
- ADC sequencing: SATEEN-style ADC-after-ADC (TROP2 → HER2, HER2 → TROP2); novel target ADCs (B7-H3, c-Met, FRα, CDH6).
- Radioligands: post-PSMA-617 generation (actinium-225 PSMA, FAP-targeted, GRPR, SSTR2 next-gen).
- CAR-T solid-tumor: any randomized data; claudin18.2 CAR-T gastric (CARsgen); GD2 CAR-T neuroblastoma adjuvant.
- Precision oncology platform trials: EU equivalents to NCI-MATCH; CANCER-ID / academic biomarker trials.
- Geriatric oncology + supportive care: an ESMO traditional strength relative to ASCO; cachexia, GLP-1s, exercise oncology.
Cross-cutting themes (for themes.md)¶
To synthesize across trials/ once populated (provisional, will be reconciled post-meeting):
- OS confirmation of ASCO 2026 PFS winners. HARMONi-6, Rasolute-302, frontMIND, ASCENT-04, SERENA-6, LIBRETTO-432 are the candidates. ESMO is often the "did the OS hold?" follow-up venue for trials that read PFS at ASCO.
- ADC sequencing becomes a clinical question. SATEEN (TROP2 + HER2 post-Enhertu), Dato-DXd patient-reported follow-ups, novel-target ADCs entering phase 3. The clinical narrative shifts from "does the ADC work?" (settled) to "what comes after the ADC?".
- CDK4/6 post-progression endocrine continuation. evERA giredestrant + everolimus and SERENA-6 PFS2 mature; positions next-gen oral SERDs vs the AI + CDK4/6 backbone.
- PD-1×VEGF bispecific class read-through expands. HARMONi-6 OS confirmation, plus first phase-2 / phase-3 data from AbbVie RC148 (Summit-licensed) and BMS pumitamig. Continuation of the JPM 2026 "PD-1×VEGF class" thread.
- ctDNA-guided trial designs continue. ESMO 2025 Presidential featured IMvigor011 (MIBC) and DYNAMIC-III (stage III CRC) — both will likely have follow-up. New entrants likely.
- Perioperative IO matures. KEYNOTE-B15 (bladder), PROTEUS (prostate) OS / EFS follow-ups from ASCO 2026 readouts.
- EMA vs FDA filing geography. Several ESMO 2026 trials are sized for EMA-first filings. Worth tagging in per-trial sheets.
- European cooperative-group trial volume. EORTC, GETUG, GBG, AGITG, GERCOR — the ESMO-native sponsors. ASCO undercovers these; ESMO is their home venue.
All speculation above will be reconciled against the ESMO Online Programme when it publishes (~July/August 2026). The watch list will be re-ordered, trimmed, and expanded then. Until then, treat the table as a starting orientation, not a forecast.