Conference · for clinicians

ESMO 2026 Presidential Symposium I: melanoma vaccine, bladder, SCLC and prostate

10/26/2026 · 7 min read · updated 31 Oct 2026

Presidential Symposium I, ESMO 2026, Madrid — Saturday 24 October. Four late-breaking abstracts (LBA1–4), all positive phase 3. VOLGA and DeLLphi-305 were published simultaneously in the NEJM; INTerpath-001 has been accepted by the NEJM; DASL-HiCaP is abstract-only so far. Figures below were re-checked on 31 Oct 2026 against the NEJM abstracts and sponsor press releases (cited inline).

Bottom line: OS gains at interim for VOLGA (cisplatin-ineligible MIBC) and DeLLphi-305 (ES-SCLC maintenance). INTerpath-001 and DASL-HiCaP met recurrence/metastasis end points; OS not yet significant.

LBA	Trial	Setting	Primary result	OS
1	INTerpath-001	Adjuvant, resected stage IIB–IV melanoma	RFS HR 0.58	HR 0.77, NS (immature)
2	VOLGA	MIBC, cisplatin-ineligible/refused	EFS HR 0.51 (durva + EV)	HR 0.58, P = .0027
3	DeLLphi-305	ES-SCLC, 1L maintenance	OS HR 0.42	Primary end point met
4	DASL-HiCaP	Very high-risk localised prostate, with RT + ADT	MFS HR 0.42	HR 0.88, NS

LBA1 — INTerpath-001 (intismeran autogene + pembrolizumab)

• Design: double-blind; n = 1137, 2:1. Intismeran (individualised mRNA neoantigen therapy) 1 mg IM q3w × 9 vs placebo; both + pembrolizumab 400 mg q6w × 9.
• RFS: HR 0.58 (95% CI 0.45–0.75; P < .001). 24-month RFS 82.2% (95% CI 79.3–84.8) vs 70.0% (65.0–74.5); median RFS not reached in either arm. Median follow-up 24.6 months. [Merck]
• Timing of benefit: no separation in first 6 months (HR 0.99; 95% CI 0.66–1.49); after the 6-month immunisation course, prespecified piecewise HR 0.42 (0.30–0.58).
• mITT sensitivity analysis (excluding those who never received intismeran/placebo): RFS HR 0.51 (0.39–0.67); DMFS HR 0.55 (0.40–0.77). [Merck]
• DMFS: HR 0.62 (95% CI 0.45–0.85; P = .002); 24-month DMFS 88.5% vs 80.2%. [Merck] OS: immature, HR 0.77 (95% CI 0.45–1.31; P = .33), not significant. [Targeted Oncology]
• Toxicity: grade 3–5 AEs (all causes) 23.6% vs 20.3%; treatment-related grade 3–5 AEs 14.2% vs 13.4%. Pyrexia 52.2% vs 8.2%, injection-site pain 51.0% vs 9.5%, fatigue 38.5% — mostly low grade, transient. [Merck]

INTerpath-001: 24-month recurrence-free survival

Intismeran + pembrolizumab82.2%

Placebo + pembrolizumab70.0%

LBA1, ESMO 2026, as reported by Targeted Oncology.

LBA2 — VOLGA (perioperative durvalumab ± tremelimumab + neoadjuvant enfortumab vedotin)

• Design: n = 695, 1:1:1. Neoadjuvant durvalumab + EV × 3 → cystectomy → adjuvant durvalumab × 9 (± tremelimumab) vs upfront cystectomy.
• Durva + EV vs control: EFS HR 0.51 (95% CI 0.38–0.67; P < .001); median EFS not reached vs 12.1 months; 24-month EFS 63.5% vs 45.1%. OS HR 0.58 (0.40–0.83; P = .003); 24-month OS 78.4% vs 69.4%; deaths 49 (21%) vs 74 (32%). Data cut-off 2 March 2026. [NEJM] [AZ]
• pCR: 45% vs 10% (local review).
• ctDNA (exploratory, n = 112): 60% cleared before surgery; 24-month EFS 81% if cleared vs 55% if persistent.
• Triplet (+ tremelimumab): 24-month EFS 60.1%; EFS HR 0.61 (0.47–0.80; P < .001); OS not significant (HR 0.77; 0.54–1.07). More toxicity: grade ≥ 3 AEs 79.5% (treatment-related 44.5%). [NEJM] [Targeted Oncology]
• Toxicity, doublet: grade ≥ 3 AEs (any cause) 71.1% vs 50.2% with surgery alone; treatment-related grade ≥ 3 30.7% (NEJM). AstraZeneca’s press release instead quotes grade 3–4 AEs (64% vs 44%); quote the NEJM grade ≥ 3 figures when comparing trials. Discontinuation for AEs 21%; immune-mediated AEs 33% vs 3%. [NEJM] [AZ] [Targeted Oncology]
• Regulatory: FDA granted Priority Review (September 2026) for perioperative durvalumab + neoadjuvant EV in cisplatin-ineligible/refusing MIBC. [AZ]

VOLGA: 24-month outcomes, durvalumab + EV vs cystectomy alone

EFS: durva + EV63.5%

EFS: control45.1%

OS: durva + EV78.4%

OS: control69.4%

LBA2, ESMO 2026; Powles et al., NEJM 2026 (Kaplan–Meier estimates).

LBA3 — DeLLphi-305 (tarlatamab + durvalumab maintenance)

• Population: ES-SCLC without progression after 1L platinum–etoposide–durvalumab. n = 563, open-label.
• OS (primary, interim; cut-off 7 July 2026; median follow-up ~16 months): median 21.1 (95% CI 20.8–NE) vs 12.7 months (11.2–14.8); HR 0.42 (95% CI 0.32–0.54; P < .001). 12-month OS 79% vs 53%. [NEJM] [Amgen]
• PFS: 7.4 (5.6–9.1) vs 1.9 months (1.9–2.0); HR 0.34 (0.28–0.42). ORR 26.4% vs 4.1%. [NEJM] [Amgen]
• Subgroups: brain metastases HR 0.49; liver metastases HR 0.41.
• Toxicity: grade ≥ 3 AEs (any cause) 46.8% vs 40.6%; treatment-related grade ≥ 3 20.9% vs 10.8% (commonest: neutropenia, decreased appetite, asthenia). CRS 49.6% (one grade 3); ICANS 1.1%. No treatment-related deaths with the combination. [NEJM] [Amgen]

DeLLphi-305: median overall survival

Tarlatamab + durvalumab21.1 mo

Durvalumab alone12.7 mo

LBA3, ESMO 2026, interim analysis (61% information fraction).

LBA4 — DASL-HiCaP / ANZUP1801 (darolutamide + ADT + RT)

• Design: placebo-controlled; n = 1106. Darolutamide 600 mg BD × 96 weeks vs placebo; all had 96 weeks ADT + RT (85% primary, 15% salvage). 71–74% Gleason 9–10; 29% pelvic nodes.
• MFS by conventional imaging (interim, after 87 events; median follow-up 3.8 years): HR 0.42 (95% CI 0.27–0.66; P = .0001); 27 vs 63 events. 4-year MFS 95% vs 88%. [Bayer] [Targeted Oncology]
• Secondary: PSA-PFS HR 0.47 (0.33–0.67), 4-year 91% vs 83%; prostate cancer-specific survival HR 0.58 (0.17–1.97); time to castration resistance HR 0.22. [Bayer]
• OS: HR 0.88 (95% CI 0.49–1.59), not significant; 4-year OS 97% vs 95% (21 vs 24 deaths). [Bayer]
• Toxicity: any grade ≥ 3 AE 43% vs 36%. Grade ≥ 2 AEs of special interest: fatigue/asthenia 14% vs 10%, hypertension 7% vs 9%, fractures 2% vs 3%, cardiac events 3% vs 3%. [Bayer]

DASL-HiCaP: 4-year outcomes, darolutamide vs placebo (both + ADT + RT)

MFS: darolutamide95%

MFS: placebo88%

PSA-PFS: darolutamide91%

PSA-PFS: placebo83%

LBA4, ESMO 2026 interim analysis, as reported by Bayer.

What is not yet known

• Full peer-reviewed papers for INTerpath-001 (accepted by NEJM) and DASL-HiCaP, and final OS for both (DASL-HiCaP: 130 MFS events planned for the final analysis).
• Regulatory decisions — none of these combinations is approved for these indications yet.
• Cost-effectiveness; individualised mRNA therapy needs tumour sequencing and bespoke manufacture.

Sources

1. Powles T, et al. Durvalumab, Tremelimumab, and Enfortumab Vedotin in Muscle-Invasive Bladder Cancer (VOLGA). N Engl J Med, published online 24 Oct 2026 (PMID 42929692)
2. Pérol M, et al. Tarlatamab–Durvalumab Maintenance for Extensive-Stage Small-Cell Lung Cancer (DeLLphi-305). N Engl J Med, published online 24 Oct 2026 (PMID 42929702)
3. Merck/Moderna press release — INTerpath-001 detailed results, ESMO 2026 LBA1 (22 Oct 2026)
4. AstraZeneca press release — VOLGA results, ESMO 2026 LBA2 (24 Oct 2026)
5. Amgen press release — DeLLphi-305 results, ESMO 2026 LBA3 (24 Oct 2026)
6. Bayer — DASL-HiCaP interim analysis, ESMO 2026 LBA4 (24 Oct 2026)
7. Targeted Oncology — Late-breaking phase 3 data headline ESMO 2026 Presidential Symposium I (24 Oct 2026)
8. touchONCOLOGY — ESMO 2026 quick guide to the Presidential Symposia
9. ESMO Congress 2026 — official programme
10. ClinicalTrials.gov — INTerpath-001 (NCT05933577)
11. ClinicalTrials.gov — VOLGA (NCT04960709)
12. ClinicalTrials.gov — DeLLphi-305 (NCT06211036)
13. ClinicalTrials.gov — DASL-HiCaP / ANZUP1801 (NCT04136353)

Educational summary, not medical advice. Opinions are labelled as such and are the author's own. Approvals and availability in India (CDSCO) may differ from the US/EU.

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