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ASCO 2025 Late-Breaking Sessions

Late-Breaking Sessions | ASCO 2025

The ASCO 2025 Annual Meeting is set to unveil a wave of late-breaking clinical data that may redefine standards of care across the oncology spectrum. Spanning multiple cancer types, these abstracts bring forward transformative findings in immunotherapy, antibody-drug conjugates (ADCs), PROTAC degraders, tumor-treating fields, and targeted therapies. Major pharmaceutical and biotech players—AstraZeneca, Pfizer, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Arvinas, Corcept, Protagonist, Ipsen, and others—are leading the charge with practice-changing studies.

Breast Cancer at the Forefront

Hormone receptor-positive (HR+), and HER2-negative breast cancer take center stage, with late-breaking results from the SERENA-6 and VERITAC-2 trials evaluating camizestrant and vepdegestrant, respectively. These novel estrogen receptor degraders offer new hope for overcoming resistance in endocrine therapies. Meanwhile, ADCs continue to gain traction, with T-DXd (trastuzumab deruxtecan) and TRODELVY (sacituzumab govitecan) showing significant promise in HER2+ and triple-negative breast cancer, respectively. The DESTINY-Breast09 and ASCENT-04/KEYNOTE-D19 studies are poised to reshape treatment algorithms in metastatic settings.

Gastrointestinal and Pancreatic Cancers

The gastric and gastroesophageal cancer space is rich with innovation. The MATTERHORN study, investigating durvalumab + FLOT, highlights the role of immunotherapy in resectable disease. Additionally, the DESTINY-Gastric04 and disitamab vedotin-based regimens offer updated HER2-targeted strategies.

For pancreatic cancer, several phase III trials—PANOVA-3, NAPOLI-3, and others demonstrate advancements in both neoadjuvant and metastatic settings. The integration of tumor-treating fields (TTFields) and liposomal irinotecan-based regimens reflects a multidisciplinary push toward improved survival.

Precision Oncology in Colorectal and Lung Cancer

Late-breaking results from the BREAKWATER and ANCHOR trials spotlight encorafenib, cetuximab, anlotinib, and aspirin in colorectal cancer. These studies explore both first-line and adjuvant therapies in genetically defined subsets, including BRAF V600E and RAS/BRAF wild-type populations.

In non-small cell lung cancer (NSCLC), pivotal updates from CheckMate 77T, CheckMate 816, and PRAGMATICA-LUNG address both perioperative and advanced disease strategies. Agents such as nivolumab, ramucirumab, and pembrolizumab are being tested alone or in combination, aiming to extend survival in surgically resectable and immunotherapy-pretreated patients.

Expanding Therapeutic Frontiers

In gynecologic cancers, the FIRST/ENGOT-OV44 and ROSELLA trials examine combinations like niraparib + dostarlimab and relacorilant + nab-paclitaxel, respectively, in ovarian cancer settings with unmet need. Meanwhile, polycythemia vera takes a rare but meaningful spotlight with positive VERIFY trial results for rusfertide, a novel hepcidin mimetic.

Further innovations are emerging in melanoma, urothelial cancer, and prostate cancer, including combination strategies featuring cobolimab + dostarlimab (NEO-MEL-T) and padeliporfin VTP photodynamic therapy (ENLIGHTED trial).

Top 25 Late-Breaking Abstracts

Company

Drug

Trial ID/ Acronym

Phase

Patient Segment

Abstract ID

Session Type

Abstract Title

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Camizestrant in combination with palbociclib, abemaciclib or ribociclib

NCT04964934

III

HR+/​HER2-advanced breast cancer with detectable ESR1m before progression

LBA4

Plenary Session

Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase III, double-blind ctDNA-guided SERENA-6 trial

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Vepdegestrant

NCT05654623

III

ER+/ HER2–negative advanced breast cancer

LBA1000

Oral Abstract Session

Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: Results of the global, randomized, Phase III VERITAC-2 study

Durvalumab + FLOT chemotherapy

NCT04592913

III

Resectable gastric/gastroesophageal junction cancer (GC/GEJC)

LBA5

Plenary Session

Event-free survival (EFS) in MATTERHORN: A randomized, Phase III study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC)

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Trastuzumab deruxtecan (T-DXd)

NCT04704934

III

second-line treatment of patients with (HER2+) unresectable/metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GEJA)

LBA4002

Oral Abstract Session

Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, Phase III DESTINY-Gastric04 study

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Disitamab vedotin plus toripalimab and chemotherapy /trastuzumab

NCT05980481

II/III

First-line treatment of patients with HER2-expressing locally advanced or metastatic gastric cancer.

LBA4012

Rapid Oral Abstract Session

Disitamab vedotin (DV) plus toripalimab (Tor) and chemotherapy (C)/trastuzumab (Tra) as first-line (1L) treatment of patients (pts) with HER2-expressing locally advanced or metastatic (la/m) gastric cancer

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JEMPERLI + Cobolimab

NCT04139902

II

Resectable stage III or oligometastatic stage IV melanoma

LBA9504

Oral Abstract Session

Randomized phase II study of neoadjuvant (neoadj) anti-PD-1 dostarlimab (D) vs. D + anti-TIM-3 cobolimab (C) in high-risk resectable melanoma (mel) (NEO-MEL-T): Primary analysis.

Dostarlimab and niraparib

NCT03602859

III

First-line treatment of  stage III or IV non-mucinous Epithelial Ovarian Cancer

LBA5506

Oral Abstract Session

FIRST/ENGOT-OV44: A phase III clinical trial of dostarlimab (dost) and niraparib (nira) in first-line (1L) advanced ovarian cancer (aOC)

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Niraparib with Abiraterone Acetate plus Prednisone

NCT04497844

III

HRR gene-mutated mCSPC

LBA5006

Oral Abstract Session

Phase III AMPLITUDE trial: Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) for metastatic castration-sensitive prostate cancer (mCSPC) patients (pts) with alterations in homologous recombination repair (HRR) genes

Becotatug (JMT-101) + Irinotecan

NCT06089330

II

mCRC

LBA3516

Rapid Oral Abstract Session

JMT101 in combination with irinotecan and SG001 versus regorafenib in patients with metastatic colorectal adenocarcinoma (mCRC): Results of a randomized, controlled, open-label, phase II study

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Benmelstobart

NCT04964479

III

Advanced NSCLC

LBA8502

Oral Abstract Session

CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC)—A randomized, single-blind, multicenter phase III study

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Relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy

NCT05257408

III

Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

LBA5507

Oral Abstract Session

ROSELLA: A phase III study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72)

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Rusfertide

NCT05210790

III

Polycythemia Vera

LBA3

Plenary Session

Results from VERIFY, a Phase III, double-blind, placebo (PBO)-controlled study of rusfertide for treatment of polycythemia vera (PV)


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Encorafenib plus cetuximab with or without chemotherapy

NCT04607421

III

metastatic BRAF V600E-mutant colorectal cancer

LBA3500

Oral Abstract Session

First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): Progression-free survival and updated overall survival analyses

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Chemotherapy With mFOLFIRINOX or PAXG

NCT04793932

III

Stage I-III pancreatic ductal adenocarcinoma

LBA4004

Oral Abstract Session

Results of a randomized phase III trial of pre-operative chemotherapy with mFOLFIRINOX or PAXG regimen for stage I-III pancreatic ductal adenocarcinoma

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TTFields, 150kHz concomitant with Gemcitabine and Nab-paclitaxel

NCT03377491

III

locally advanced pancreatic ductal adenocarcinoma (LA-PAC)

LBA4005

Oral Abstract Session

PANOVA-3: Phase III study of tumor treating fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC)

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NALIRIFOX

NCT04083235

III

metastatic pancreatic ductal adenocarcinoma

LBA4175

Poster Session

NAPOLI 3, a phase III study of NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Final overall survival (OS) analysis and characteristics of the long-term survivors

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Anlotinib

NCT04854668

III

RAS/BRAF Wild mCRC

LBA3502

Oral Abstract Session

Anlotinib versus bevacizumab added to standard first-line chemotherapy among patients with RAS/BRAF wild-type, unresectable metastatic colorectal cancer: A multicenter, prospective, randomized, phase III clinical trial (ANCHOR trial)

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Aspirin

NCT03326791

II/III

colorectal cancer liver metastases (ASAC)

LBA3511

Clinical Science Symposium

Aspirin as secondary prevention for colorectal cancer liver metastases (ASAC): A multicenter, randomized, double-blind, placebo-controlled, phase III trial

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padeliporfin VTP

NCT04620239

III

low-grade upper tract urothelial cancer

LBA4513

Rapid Oral Abstract Session

ENLIGHTED phase III study: Interim results of efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) in the treatment of low-grade upper tract urothelial cancer (LG UTUC)

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CYRAMZA (ramucirumab) + KEYTRUDA (pembro  lizumab)

NCT  05633602

III

stage IV or recurrent NSCLC

LBA8671

Rapid Oral Abstract Session

PRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer

OPDIVO (nivolumab)

NCT04025879

III

resectable stage II-III B NSCLC

LBA8010

Rapid Oral Abstract Session

Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T

OPDIVO (nivolumab) + chemotherapy

NCT02998528

III

Neo-adjuvant resectable NSCLC

LBA8000

Oral Abstract Session

Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816

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TRODELVY + KEYTRUDA

NCT05382286

III

locally advanced inoperable or metastatic Triple-Negative Breast Cancer

LBA109

Oral Abstract Session

Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized Phase III ASCENT-04/KEYNOTE-D19 study

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Trastuzumab deruxtecan (T-DXd) + pertuzumab (P)

NCT04784715

III

HER2-positive, first-line metastatic breast cancer

LBA1008

Oral Abstract Session

Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09

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Fulvestrant and Ipatasertib

NCT04650581

III

advanced HER-2 negative and estrogen receptor positive (ER+) breast cancer

LBA1005

Oral Abstract Session

A double-blind placebo controlled randomized Phase III trial of fulvestrant and ipatasertib as treatment for advanced HER2-negative and estrogen receptor positive (ER+) breast cancer following progression on first line CDK 4/6 inhibitor and aromatase inhibitor: The CCTG/BCT MA.40/FINER study (NCT04650581)

 

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Executive Summary

The ASCO 2025 Annual Meeting is set to unveil a wave of late-breaking clinical data that may redefine standards of care across the oncology spectrum.

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