The AACR Annual Meeting 2025 will showcase the results of cutting-edge clinical trials in a series of sessions devoted to clinical research.

Clinical trials are often the final step a new therapy must undergo to earn regulatory approval from agencies like the U.S. Food and Drug Administration (FDA). The clinical trial programs at recent AACR Annual Meetings have proudly highlighted trials that later led to FDA approvals, including last year’s KRYSTAL-1 trial that garnered an approval for adagrasib (Krazati) and cetuximab (Erbitux) for KRAS G12C-mutated colorectal cancer. In 2023, researchers presented the AEGEAN trial that led to the approval of a perioperative durvalumab (Imfinzi)-based regimen for certain non-small cell lung cancers (NSCLC).

This year promises no shortage of exciting clinical trials to be presented across four Clinical Trials Plenary Sessions and three Clinical Trials Minisymposia, each highlighting advances in a specific subject area.

“This year’s clinical trial program contains an exciting mix of practice-changing studies, as well as promising new experimental agents across several therapeutic classes,” said Ryan B. Corcoran, MD, PhD, from Mass General Research Institute, a cochair of this year’s Annual Meeting Clinical Trials Committee.

The Clinical Trials Plenary Sessions kick off today with a double feature—one session devoted to advances in immunotherapy and another focused on precision medicine. The Advances in Immunotherapy session will include studies of neoadjuvant and adjuvant PD-1 inhibitors either alone or in combination with other agents, including PARP inhibitors. One study will discuss the use of circulating tumor DNA (ctDNA) to guide the use of adjuvant immunotherapy. The second Clinical Trials Plenary Session will highlight inhibitors of BRAF, KRAS, and the Werner helicase (WRN), as well as a topical treatment for EGFR inhibitor-induced rashes.

“We’re seeing potentially curative neoadjuvant, adjuvant, and even nonoperative approaches in both the immune-oncology and targeted therapy space,” said Jayesh Desai, MBBS, from Peter MacCallum Cancer Centre, a cochair of this year’s Annual Meeting Clinical Trials Committee. “These novel approaches offer the potential to shift the bar toward better outcomes for patients with advanced disease.”

The third Clinical Trials Plenary Session will take place Monday and will feature a slate of new drugs targeting HER2, TIGIT, ROS1, and EGFR in NSCLC. In the final Clinical Trials Plenary Session on Tuesday, researchers will discuss two new T-cell engagers, a CAR T-cell therapy for thyroid cancer, and an optimized CD40 agonist for bladder cancer.

“T-cell engagers and novel biologic agents are beginning to gain traction in several solid tumor types,” Corcoran noted.

The Clinical Trials Minisymposia, which also begin today, provide additional opportunities for attendees to hear about exciting clinical studies. Sunday’s Minisymposium will focus on antibody-drug conjugates (ADCs) and immunotherapy, Monday’s will highlight new adjuvant and neoadjuvant treatment approaches, and Tuesday’s will discuss novel targeted therapies.

“The Minisymposia give us some really interesting early insights into what’s coming,” Desai said. “We have some exciting novel compounds, including first-in-class agents, that give us hints of the discovery science that is moving into the clinic.”

For the most up-to-date information on session dates, times, and locations, check the Annual Meeting App and Online Itinerary Planner. Sessions will be recorded and will remain available on-demand via the virtual meeting platform through October 2025.

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CTPL01: Advances in Immunotherapy

Sunday, April 27, 1-3 p.m. CT
Arie Crown Theater, McCormick Lakeside Center (Level 2)

Session Chairs: Jayesh Desai, MBBS, Peter MacCallum Cancer Centre, and Antoni Ribas, MD, PhD, FAACR, UCLA Health Jonsson Comprehensive Cancer Center

This session will include updates on KEYNOTE-689, KEYLYNK-007, and other immunotherapy-focused trials.

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CTPL02: New Frontiers in Precision Oncology

Sunday, April 27, 3:30-5:30 p.m. CT
Arie Crown Theater, McCormick Lakeside Center (Level 2)

Session Chairs: Ryan B. Corcoran, MD, PhD, Mass General Research Institute, and Elena Elimova, MD, Princess Margaret Cancer Centre

The session will include data on the investigational drugs RO7589831, RG6344, LUT014, and zoldonrasib (RMC-9805).

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CTPL03: Therapeutic Advances in NSCLC

Monday, April 28, 10:15 a.m. to 12:15 p.m. CT
Arie Crown Theater, McCormick Lakeside Center (Level 2)

Session Chairs: Stephen V. Liu, MD, Georgetown University, and Everett E. Vokes, MD, University of Chicago Medical Center

This session will provide updates on Beamion LUNG-1, SKYSCRAPER-01, AENEAS2, and other clinical trials focusing on treatments for NSCLC.

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CTPL04: Biologics and T-cell Engagers

Tuesday, April 29, 10:15 a.m. to 12:15 p.m. CT
Arie Crown Theater, McCormick Lakeside Center (Level 2)

Session Chairs: Crystal L. Mackall, MD, FAACR, Stanford University, and Jedd D. Wolchok, MD, PhD, FAACR, Weill Cornell Medicine/Sandra and Edward Meyer Cancer Center

This session features four early-phase clinical trials demonstrating the efficacy of biologics and T-cell engagers in solid tumors.

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CTMS01: ADCs and Immuno-oncology-focused Biological Approaches

Sunday, April 27, 3-5 p.m. CT
Room S100 A (Grand Ballroom A), McCormick Place South (Level 1)

Session Chairs: Jia Liu, MD, PhD, The Kinghorn Cancer Centre, and Michael Cecchini, MD, Yale School of Medicine

In this session, researchers will highlight a variety of new ADCs with targets including EGFR and CLDN18.2. Two therapeutic vaccines and an off-the-shelf CAR NK therapy will also be discussed.

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CTMS02: Aiming for a Cure: Adjuvant and Neoadjuvant Approaches

Monday, April 28, 2:30-4:30 p.m. CT
Room S406 (Vista Ballroom), McCormick Place South (Level 4)

Session Chairs: Robert G. Maki, MD, PhD, Memorial Sloan Kettering Cancer Center, and Aparna Parikh, MD, Mass General Hospital

Researchers will discuss neoadjuvant immunotherapy, CDK4/6 inhibitors, and radiation, as well as a potential new adjuvant treatment for NSCLC. The session will also highlight the use of ctDNA monitoring to guide adjuvant therapy and the treatment of metastatic disease.

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CTMS03: Innovative Approaches to Key Molecular Targets

Tuesday, April 29, 2:30-4:40 p.m. CT
Room S406 (Vista Ballroom), McCormick Place South (Level 4)

Session Chairs: Jordi Rodon Ahnert, MD, PhD, The University of Texas MD Anderson Cancer Center, and Anna Spreafico, MD, PhD, Princess Margaret Cancer Centre

This session highlights results from early-phase clinical trials testing new KRAS inhibitors, a peptide vaccine, and a molecular glue, among other innovative targeted therapies.