OnCo
News & evidence

Readout calendar

Regulatory decisions, advisory committees, expected trial readouts, and the congresses where results land. Confirmed items carry a source. Expected items are our editorial estimate from trial registrations and sponsor statements, and can slip by quarters.

6 confirmed8 expectedRegulatory decisionAdvisory committeeExpected readoutCongressPolicy

  1. September 2026

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

    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.

    GalleriGRAILMulti-cancer early detection (MCED)NHS-GalleriPATHFINDER 2
    Source

  2. October 2026

    2026-10-23Congressconfirmed
    ESMO Congress 2026, Madrid (23–27 October)

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

    European Society for Medical Oncology (ESMO)
    Source

  3. December 2026

    2026-12-08Congressconfirmed
    San Antonio Breast Cancer Symposium 2026 (8–11 December)

    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.

    Triple-negative breast cancer (TNBC)HR-positive / HER2-negative breast cancerHER2-positive breast cancer
    Source
    2026-12-12Congressconfirmed
    ASH Annual Meeting 2026, New Orleans (12–15 December)

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

    Acute myeloid leukaemiaDiffuse large B-cell lymphomaMultiple myelomaChronic lymphocytic leukaemiaAcute lymphoblastic leukaemia
    Source

  4. Q4 2026 (approximate)

    2026-Q4Expected readoutexpected
    TROPION-Breast05: Dato-DXd ± durvalumab vs pembrolizumab + chemotherapy, first-line PD-L1+ TNBC

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

    TROPION-Breast05Datopotamab deruxtecanDurvalumabTriple-negative breast cancer (TNBC)
    Source
    2026-Q4Expected readoutexpected
    INTerpath-001 full data: intismeran autogene + pembrolizumab, adjuvant melanoma

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

    INTerpath-001 (V940-001)Intismeran autogeneMelanoma
    Source
    2026-Q4Policyexpected
    NHS England decision on Galleri rollout after full NHS-Galleri results

    Full results presented at ASCO 2026 (primary stage III–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.

    NHS-GalleriGalleriMulti-cancer early detection (MCED)
    Source

  5. Q1 2027 (approximate)

    2027-Q1Expected readoutexpected
    RASolute 302: daraxonrasib vs chemotherapy, second-line metastatic pancreatic cancer

    Fully enrolled; event-driven OS endpoint. Sponsor has guided to a 2026–27 readout. The first pivotal test of a pan-RAS inhibitor.

    DaraxonrasibRevolution MedicinesPancreatic ductal adenocarcinomaKRAS
    Source

  6. April 2027

    2027-04-02Congressconfirmed
    AACR Annual Meeting 2027, Orlando (2–7 April)

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

    American Association for Cancer Research (AACR)
    Source

  7. June 2027

    2027-06-04Congressconfirmed
    ASCO Annual Meeting 2027, Chicago (4–8 June)

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

    American Society of Clinical Oncology (ASCO)
    Source

  8. Q2 2027 (approximate)

    2027-Q2Expected readoutexpected
    IZABRIGHT-Breast01: iza-bren vs chemotherapy, first-line TNBC (PD-(L)1 ineligible)

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

    IZABRIGHT-Breast01Izalontamab brengitecanTriple-negative breast cancer (TNBC)
    Source

  9. Q4 2027 (approximate)

    2027-Q4Expected readoutexpected
    TROPION-Breast03: Dato-DXd ± durvalumab, post-neoadjuvant residual TNBC

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

    TROPION-Breast03Datopotamab deruxtecanDurvalumabTriple-negative breast cancer (TNBC)
    Source

  10. 2027 (timing not announced)

    2027Regulatory decisionexpected
    US regulatory decision on sacituzumab tirumotecan (sac-TMT) — first indication

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

    Sacituzumab tirumotecanMerck & Co. (MSD)Sichuan Kelun-Biotech
    Source
    2027Expected readoutexpected
    ASCENT-05 / OptimICE-RD: sacituzumab govitecan + pembrolizumab, post-neoadjuvant residual TNBC

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

    ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)Sacituzumab govitecanPembrolizumabTriple-negative breast cancer (TNBC)
    Source

Missing a date? Add it to src/data/calendar.ts with a source. Expected readouts become confirmed only when a sponsor or registry gives a date.