Breast, Rectal, Kidney and Brain Cancer Phase 3 Trials Headline Dana-Farber Research at ASCO Annual Meeting

Patrick Wen, MD

Several phase 3 studies conducted by researchers from Dana-Farber Cancer Institute show promising results for patients with rectal, brain, and kidney cancers. The results of these studies, along with dozens of others led by Dana-Farber researchers, will be presented at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. The studies will be presented both in-person and online, June 2-6, 2023. ASCO is the world’s largest clinical cancer research meeting, attracting more than 30,000 oncology professionals from around the world.

Dana-Farber’s Patrick Wen, MD, is the senior author on a global, randomized, double-blinded, phase 3 study in patients with glioma. The INDIGO trial (LBA 1) studied vorasidenib, a first-in-class, brain-penetrant, dual inhibitor of the mutant IDH1 and mutand IDH2 enzymes versus placebo in patients with residual or recurrant grade 2 glioma with an IDH1/2 mutation.

Dana-Farber Brigham Cancer Center’s Harvey Mamon, MD, PhD, is the senior author on a randomized phase 3 study in patients with locally advanced rectal cancer. The PROSPECT trial (LBA 2) studied neoadjuvant chemoradiation versus neadjuvant FOLFOX chemotherapy with selective use of chemoradiation, followed by total mesorectal excision.

Findings from both the PROSPECT and INDIGO trials will be presented during ASCO’s Plenary Session on Sunday, June 4, 2023, 2:00pm-5:00pm ET. The plenary session features four studies deemed to have the greatest potential impact on patient care.

Dana-Farber’s Toni K. Choueiri, MD, is presenting findings on a phase 3 study in metastatic kidney cancer. Late-breaking efficacy and safety data from the CONTACT-03 study which looked at atezolizumab plus cabozantinib versus cabozantinib alone after progression with prior immune checkpoint inhibitor treatment in metastatic kidney cancer (Abstract LBA4500) will be presented during the Genitourinary Cancer – Kidney and Bladder Oral Abstract Session on Monday, June 5, 2023, 12:30pm ET. The study results will publish concurrently in The Lancet.

Also included in the press program is a study presented by Dana-Farber’s Jennifer Ligibel, MD. Data highlighting results from the Breast Cancer Weight Loss (BWEL) trial will be presented during the Symptoms and Survivorship Oral Abstract Session on Monday, June 5, 2023, 9:12am ET (Abstract 12001).

Other key research from Dana-Farber faculty shows new treatments and diagnostic advances in breast cancer, prostate cancer, and many others. Key studies also look at health equity research.

Antibody-drug conjugate offers significant survival benefit for patients with HR-positive/HER2-negative metastatic breast cancer, final results of trial show

In patients with hormone receptor (HR)-positive, HER2-negative breast cancer who are resistant to hormone-blocking therapy, the antibody-drug conjugate sacituzumab govitecan provides greater survival benefit than chemotherapy treatment, final results of a phase 3 clinical trial show. The trial, dubbed TROPiCS-02, enrolled nearly 550 patients with HR-positive/HER2-negative breast cancer – by far the most common form of the disease – that had recurred or become metastatic after treatment with hormone-blocking drugs. Half the participants received sacituzumab govitecan, which fuses a tumor cell-seeking antibody to a targeted chemotherapy, and half received their physician's choice of one of four chemotherapy drugs. At a median follow-up of 13 months, patients in the sacituzumab group had a significantly longer overall survival and progression-free survival – the amount of time before the disease worsened – than patients receiving chemotherapy.

Dana-Farber’s Sara Tolaney, MD, MPH, will present final overall survival analysis from the phase 3 TROPiCS-02 study during the Oral Abstract Session on Breast Cancer – Metastatic (Abstract 1003) during ASCO on June 5, 2023 at 1:30pm ET.

PSA level below 0.1 after radiation and androgen deprivation therapy associated with improved survival, clinical trial data analysis shows

Patients with localized prostate cancer whose prostate-specific antigen (PSA) level drops below 0.1 ng/mL within six months of completing radiation with or without androgen deprivation therapy are likely to survive longer overall, survive longer while free of metastasis, and survive the disease itself longer than patients with higher PSA levels, a study by Dana-Farber researchers shows. The findings are based on data pooled from 16 clinical trials in which nearly 10,500 patients with prostate cancer were treated with radiation therapy alone or with androgen deprivation therapy (ICECAP collaborative). The results suggest that a PSA level of less than 0.1 ng/mL could provide an early signal of patients' prognosis and be used in future trials of radiation and androgen deprivation therapies combined with other treatments to identify patients who most benefit from these regimens, investigators say.

Dana-Farber’s Praful Ravi, MRCP, MBBChir, will present analysis on randomized trials from the ICECAP collaborative (Abstract 5002) during the Oral Abstract Session on Genitourinary Cancer – Prostate, Testicular, and Penile, at ASCO on June 4, 2023 at 9:24am ET.

Information from parents can help identify opportunities for interventions to reduce survival disparities among children in cancer clinical trials

Even when receiving uniform cancer treatment on clinical trials, children living in poverty and those who are Black or Hispanic are more likely to relapse and die when compared with others. Researchers have historically been unable to test interventions to try and improve these disparities because the data collected in clinical trials—race, ethnicity, ZIP code, and health insurance—are simply proxies for adverse social determinants of health (conditions in which children live or play that impact health) and cannot be modified. In a new study researchers showed that it is highly feasible to collect parent-reported data on modifiable social determinants (for example, household material hardship which includes food, housing, utility or transportation insecurity). For the first time ever, researchers allowed parents of children enrolling on a large clinical trial run by the Children’s Oncology Group for children with neuroblastoma—a common childhood solid tumor—to participate in an optional survey study collecting these data. While the trial is ongoing, more than 87% of 413 parents have agreed to participate in the survey study at more than 100 participating pediatric oncology centers. Further, more than 99% of parents completing surveys have provided complete information about household material hardship. The findings show this kind of information can and should be collected into future pediatric oncology clinical trials. This essential next step will allow researchers to identify children who may benefit from supportive care interventions (for example to reduce food insecurity during cancer treatment), and test whether such interventions can improve both survival and health equity in clinical trials for children.

Dana-Farber/Boston Children’s Cancer and Blood Disorder’s Center’s Emily Jones, BS, will present these findings during the Oral Abstract Session on Pediatric Oncology II, at ASCO on June 5, 2023, at 9:12am ET. Kira Bona, MD, MPH, Dana-Farber/Boston Children’s Cancer and Blood Disorder Center, is the senior author.

Each year ASCO also recognizes members with the Fellow of the American Society of Clinical Oncology (FASCO) distinction. This year Jennifer Mack, MD, MPH, FASCO, Erica L. Mayer, MD, MPH, FASCO, Larissa Nekhlyudoz, MD, MPH, FASCO, and Matthew B. Yurgelun, MD, FASCO, are among the recipients recognized for their extraordinary volunteer service, dedication, and commitment to ASCO.