March Toward More Tailored Treatments Continues at ASCO 2025

The term “precision medicine” is hardly new. But this year’s annual gathering of the American Society of Clinical Oncology (ASCO) will highlight how directing treatments toward specific patients has reached a new level, guided by advances in therapy, molecular, and artificial intelligence (AI).

Up to 40,000 people will descend on Chicago, Illinois, to attend ASCO 2025, which runs May 30 to June 3 with the theme, “Driving Knowledge to Action: Building a Better Future.” ASCO President Robin Zon, MD, Cincinnati Cancer Advisors, selected this concept that embraces the role of AI across cancer care, starting with the use of data to drive faster, more accurate diagnoses.

“My theme is based on two very strong beliefs I have to improve cancer care: knowledge and action. First, when you universally apply the power of knowledge, you can drive positive change. Knowledge is not only going to help us solve our problems, but also help us make better informed decisions,” Zon told The ASCO Post when she stepped into her role last year. “Second, to drive knowledge to action and build a better future for our patients, all of us—researchers, clinicians, patients, payers, government agencies, and industry and community leaders—must be committed to equitable, evidence-based decision-making, because together we are stronger than cancer.”

Zon will cochair a session on biomarker-driven therapeutics with the president of the European Society for Medical Oncology (ESMO) Fabrice André, MD, PhD, of Gustave Roussy and Université Paris-Saclay, in France. Already, organizers have released studies that represent what’s to come, including one that showed how AI can more accurately identify patients whose breast cancer tumors express even small levels of the HER2 protein. This makes patients candidates to be treated with the antibody drug conjugate (ADC) trastuzumab deruxtecan, or T-DXd (Enhertu, AstraZeneca/Daiichi Sanyko), a therapy that has been a star of ASCO in recent years.

Meeting organizers report that abstract submissions again broke records, and more than 5000 of them will be presented during the meeting. The first wave published May 22, with late-breaking abstracts publishing all 5 days of the meeting:

Friday: BREAKWATER and PhALLCON

Data being presented include late-breaking results from BREAKWATER (NCT04607421), involving firstline encorafenib plus cetuximab and chemotherapy in BRAF V600E-mutant metastatic colorectal cancer (CRC). Friday’s lineup includes sessions on use of circulating tumor DNA (ctDNA) to direct treatment of CRC, use of AI in decision support, and preventing tumor adaptation to immunotherapy.

Faculty from City of Hope, in Duarte, California, will present 2 noteworthy abstracts on Friday. Ibrahim Aldoss, MD, will present a post-hoc analysis minimal residual disease (MRD) negativeity at the end of the phase 3 PhALLCON trial (NCT03589326). Hope S. Rugo, MD, FASCO, who in April was named director of City of Hope’s Women’s Cancers Program, will present results regarding rechallenging patients with T-DXd following grade 1 interstitial lung disease.

Saturday: Breaking Ground in Breast Cancer

The use of testing will be front and center on the first full day of session, starting with, “The Future of Cancer Detection Is Coming,” which features presentations on blood-based multi-cancer early detection tests.

Late-breaking results will include a pair of groundbreaking breast cancer trials and a study evaluating the use biomarker testing to guide treatment in early stage non-small cell lung cancer (NSCLC).

Sara M. Tolaney, MD, MPH, FASCO, of Dana-Farber Cancer Institute, will present results from the phase 3 ASCENT-04/KEYNOTE-D19 study (NCT05382286). Topline results show an ADC, sacituzumab govitecan (Trodelvy, Gilead) combined the PD-1 inhibitor pembrolizumab (Keytruda, Merck) improved progression-free survival (PFS) over pembrolizumab and chemotherapy in untreated patients with PD-L1 expressing advanced or metastatic triple-negative breast cancer. This will be first for a combination of an ADC and immunotherapy.

Erika P. Hamilton, MD, of Sarah Cannon Research Institute, will present the phase 3 VERITAC-2 study (NCT05654623), comparing vepdegestrant, a PROTAC estrogen receptor (ER) degrader, with fulvestrant in ER-positive/HER2–negative advanced breast cancer. Sponsors Pfizer and Arvinas announced that the trial met its PFS end point among patients with ESR1 mutated cancer following treatment with a CDK4/6 inhibitor plus endocrine therapy.

Also from Sarah Cannon, David R. Spigel, MD, will present results from a prospective randomized trial (NCT01817192) that used a 14-gene assay to identify high-risk patients with stage IA to IIA NSCLC and offer adjuvant chemotherapy.

Saturday will also bring sessions and poster presentations on important policy topics, with ASCO and the American Association for Cancer Research hosting a joint session on access to gene therapy. An afternoon poster session on quality care and health services research will examine questions about withdrawals of FDA accelerated approvals, the likelihood of overtreatment in clinical trials, and the comparative lack of funding from the National Institutes of Health for cancers with the highest mortality rates, among other topics.

Sunday: Plenary Session and Prevention

The plenary session, ASCO’s high point, will feature 2 trials of therapies from AstraZeneca. Company officials previously announced positive results from an interim analysis of SERENA-6 (NCT04964934), a phase 3 trial evaluating the next-generation oral selective estrogen receptor degrader (SERD), camizestrant, with CDK4/6 inhibitors in cases where ctDNA testing ESR1 mutations in HR+/HER2- advanced breast cancer. before progression Study authors state that the strategy is to “treat ESR1m clones and extend the duration of control of ER-driven tumor growth, delaying the need for chemotherapy.”

A second phase 3 trial, MATTERHORN (NCT04592913), met its end point of event-free survival; the study evaluated adding durvalumab (Imfinzi) to standard-of-care chemotherapy before surgery for gastric/gastroesophageal junction cancer, followed by durvalumab plus chemotherapy and then durvalumab alone, compared with perioperative chemotherapy.

Sunday will also bring some provocative discussions of use of therapy to prevent cancer; an early morning session will look into possible uses of low-dose endocrine therapy to prevent breast cancer, use of glucagon-like peptide-1 receptor agonists in preventing cancers related to obesity, and circumstances for preventive therapy for prostate cancer.

Ian Flinn, MD, PhD, chief scientific officer for OneOncology will present interim findings from the phase 2 MorningSun study, which is examining fixed duration subcutaneous (SC) mosunetuzumab for newly diagnosed patients with follicular lymphoma and high tumor burden; this abstract has been honored with a “Best of ASCO” designation.

Monday: DESTINY-Breast09, Updates in Blood Cancers

Tolaney will present the most anticipated results for Monday with DESTINY-Breast09 (NCT04784715), which compares T-DXd with or without pertuzumab (Perjeta) against a taxane chemotherapy, trastuzumab, and pertuzumab for firstline treatment of patients with HER2-positive advanced/metastatic breast cancer. In a statement on topline results in April, AstraZeneca described the findings as “the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current firstline standard of care.”

The hematological malignancies session will feature the first results of LINKER-MM2 (NCT03761108), evaluating linvoseltamab and bortezomib in patients with relapsed/refractory multiple myeloma. Saad Z. Usmani, MD, MBA, FRCP, FASCO, will present a subgroup analysis of newly diagnosed, transplant ineligible patients in the phase 3 CEPHEUS trial (NCT03652064) treated with the anti-CD38 agent daratumumab (Darzalex Faspro).

Tuesday: A Look Ahead to Trispecifics

Coming on the final day is the phase 3 AMPLITUDE trial (NCT04497844), which studies the PARP inhibitor niraparib (Zejula) with abiraterone acetate, an androgen deprivation therapy, and prednisone in patients with metastatic castration-sensitive prostate cancer patients with alterations in homologous recombination repair genes.

A noteworthy abstract in a session on hematologic malignancies Tuesday will be the first-in-human results for JNJ-79635322, a trispecific antibody that targets both BCMA and GPRC5D, as well as CD-3 in multiple myeloma, combining mechanisms of current bisoecific therapies with the potential for less toxicity (NCT05652335).