OnCo readout calendar

2026-09-23: FDA advisory committee: Galleri multi-cancer early detection test (PMA)

2026-09-23T00:00:00Z

Advisory committee, confirmed.

Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee reviews GRAIL's premarket approval application. The first FDA-level judgement on a multi-cancer blood screening test.

Related: galleri, grail, mced, nhs-galleri, pathfinder-2

Source: https://www.prnewswire.com/news-releases/grail-announces-fda-advisory-committee-meeting-to-review-premarket-approval-application-for-the-galleri-multi-cancer-early-detection-test-302846154.html

2026-10-23: ESMO Congress 2026, Madrid (23 to 27 October)

2026-10-23T00:00:00Z

Congress, confirmed.

Europe's largest oncology congress. Watch for: TROPION-Breast05, first-line ADC + IO data, late-breaking radioligand and bispecific ADC results.

2026-Q4: TROPION-Breast05: Dato-DXd ± durvalumab vs pembrolizumab + chemotherapy, first-line PD-L1+ TNBC (expected, editorial estimate)

2026-11-15T00:00:00Z

Expected readout, expected (editorial estimate).

Primary completion per registry falls in 2026; timing of topline is our estimate. Would complete the ADC + IO first-line picture alongside ASCENT-04.

Related: tropion-breast05, datopotamab-deruxtecan, durvalumab, tnbc

Source: https://clinicaltrials.gov/study/NCT06103864

2026-Q4: INTerpath-001 full data: intismeran autogene + pembrolizumab, adjuvant melanoma (expected, editorial estimate)

2026-11-15T00:00:00Z

Expected readout, expected (editorial estimate).

Topline positive 19 August 2026; hazard ratios and curves expected at a late-2026 congress (ESMO or SMR), with regulatory filings to follow.

Related: interpath-001, intismeran-autogene, melanoma

Source: https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/

2026-Q4: NHS England decision on Galleri rollout after full NHS-Galleri results (expected, editorial estimate)

2026-11-15T00:00:00Z

Policy, expected (editorial estimate).

Full results presented at ASCO 2026 (primary stage III to IV endpoint not met; stage IV reduction reported). NHS England said it would wait for final results before any rollout decision; timing of a decision is not announced.

Related: nhs-galleri, galleri, mced

Source: https://grail.com/press-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting/

2026-12-08: San Antonio Breast Cancer Symposium 2026 (8 to 11 December)

2026-12-08T00:00:00Z

Congress, confirmed.

The breast cancer congress. Post-neoadjuvant TNBC ADC trials (ASCENT-05, TROPION-Breast03) and sac-TMT first-line TNBC data are candidates for presentation here or at ESMO.

Related: tnbc, breast-hr-positive, breast-her2-positive

Source: https://sabcs.org/media/future-symposia/

2026-12-12: ASH Annual Meeting 2026, New Orleans (12 to 15 December)

2026-12-12T00:00:00Z

Congress, confirmed.

Haematology's main congress: CAR-T, bispecifics, menin inhibitors, BCL-2 combinations.

Related: aml, dlbcl, multiple-myeloma, cll, all-leukemia

Source: https://www.hematology.org/meetings/annual-meeting

2027-Q1: RASolute 302: daraxonrasib vs chemotherapy, second-line metastatic pancreatic cancer (expected, editorial estimate)

2027-02-15T00:00:00Z

Expected readout, expected (editorial estimate).

Fully enrolled; event-driven OS endpoint. Sponsor has guided to a readout in 2026 or 2027. The first pivotal test of a pan-RAS inhibitor.

Related: daraxonrasib, revolution-medicines, pancreatic, kras

Source: https://clinicaltrials.gov/study/NCT06625320

2027-04-02: AACR Annual Meeting 2027, Orlando (2 to 7 April)

2027-04-02T00:00:00Z

Congress, confirmed.

Early science and first-in-human data: next-generation ADC payloads, degraders, in vivo CAR-T.

2027-Q2: IZABRIGHT-Breast01: iza-bren vs chemotherapy, first-line TNBC (PD-(L)1 ineligible) (expected, editorial estimate)

2027-05-15T00:00:00Z

Expected readout, expected (editorial estimate).

Global first-line trial of the EGFR×HER3 bispecific ADC; timing is an estimate from enrolment start (2025).

Related: izabright-breast01, izalontamab-brengitecan, tnbc

Source: https://clinicaltrials.gov/study/NCT06926868

2027-06-04: ASCO Annual Meeting 2027, Chicago (4 to 8 June)

2027-06-04T00:00:00Z

Congress, confirmed.

Where most practice-changing phase 3 trials are first presented.

2027: US regulatory decision on sacituzumab tirumotecan (sac-TMT): first indication (expected, editorial estimate)

2027-06-30T00:00:00Z

PDUFA date, expected (editorial estimate).

Merck holds a Commissioner's National Priority Voucher (July 2026) that promises a 1 to 2 month review once filed. No PDUFA date has been disclosed; indication (TNBC vs EGFR-mutant NSCLC) and filing timing are not public.

Related: sacituzumab-tirumotecan, merck, kelun-biotech

Source: https://www.pharmacytimes.com/view/fda-grants-national-priority-vouchers-to-enlicitide-decanoate-sacituzumab-tirumotecan

2027: ASCENT-05 / OptimICE-RD: sacituzumab govitecan + pembrolizumab, post-neoadjuvant residual TNBC (expected, editorial estimate)

2027-06-30T00:00:00Z

Expected readout, expected (editorial estimate).

Event-driven iDFS endpoint in patients with residual disease after KEYNOTE-522-type therapy. Would be the first ADC in the curative TNBC setting.

Related: ascent-05, sacituzumab-govitecan, pembrolizumab, tnbc

Source: https://clinicaltrials.gov/study/NCT05633654

2027-Q4: TROPION-Breast03: Dato-DXd ± durvalumab, post-neoadjuvant residual TNBC (expected, editorial estimate)

2027-11-15T00:00:00Z

Expected readout, expected (editorial estimate).

Registry estimated primary completion 20 September 2027; topline may lag.

Related: tropion-breast03, datopotamab-deruxtecan, durvalumab, tnbc

Source: https://clinicaltrials.gov/study/NCT05629585