The Targeted Pulse: AI Cancer Diagnosis, Breast Cancer Treatment Updates, and More

T-DXd Plus Pertuzumab Improves Outcomes in HER2+ Breast Cancer

Topline findings from the DESTINY-Breast09 trial (NCT04784715), which examined the effectiveness of fam-trastuzumab deruxtecan (T-DXd; Enhertu) plus pertuzumab (Perjeta) for first-line HER2-positive metastatic breast cancer treatment, revealed that the combination significantly improved progression-free survival (PFS) compared with the standard treatment of taxane, trastuzumab (Herceptin), and pertuzumab. The observed PFS benefit was consistent across all patient subgroups.

While overall survival (OS) data was not yet mature at the time of the analysis, an early positive trend was noted in the T-DXd combination arm. The safety profile of the T-DXd/pertuzumab combination was consistent with the known profiles of each therapy alone.

Read the full story here.

Auletta on the ACCESS Trial

The ACCESS trial (NCT04904588), presented at the 2025 Transplantation & Cellular Therapy Meetings, investigated posttransplant cyclophosphamide as graft-vs-host disease prophylaxis in mismatched unrelated donor peripheral blood stem cell transplants. The trial demonstrated that this approach is safe and effective, with a 1-year OS rate of 84% in myeloablative adult patients, particularly benefiting ethnically diverse patients.

Hear more from Jeff Auletta, MD, senior vice president of health equity at the National Marrow Donor Program and chief scientific officer of the Center for International Blood and Marrow Transplant Research, here.

FDA Backs Innovative Trial Design for Uveal Melanoma Drug

IDEAYA Biosciences has planned a phase 3 clinical trial to evaluate darovasertib as a neoadjuvant therapy for primary uveal melanoma. Following a successful Type D meeting with the FDA, the design of this registrational trial has been finalized.

The phase 3 trial will be a randomized study aiming to assess the safety and efficacy of darovasertib in approximately 520 patients with primary uveal melanoma. Patients will be randomized in a 2:1 ratio to receive either darovasertib followed by the standard treatment (enucleation or plaque brachytherapy) or the standard treatment alone.

Learn more about the study here.

AI Tool for Pancreatic Cancer Detection Earns FDA Breakthrough Status

The FDA has granted breakthrough device designation to DAMO PANDA, an AI-powered tool for detecting pancreatic cancer. In a large-scale study, PANDA demonstrated high sensitivity (92.9%) and specificity (99.9%) in detecting pancreatic ductal adenocarcinoma (PDAC) lesions, outperforming radiologists. The AI tool identifies lesions on CT imagery and achieved high sensitivity and specificity in a real-world validation study.

Published in Nature Medicine, the study also showed that PANDA, when used with noncontrast CT, was as effective as radiology reports using contrast-enhanced CT, potentially reducing radiation exposure and adverse reactions. Trained on a large dataset and already in use in China, PANDA can potentially detect other cancers, including lung, breast, and liver cancers.

Find out more here.

Targeted Approach Boosts Survival in Tough-to-Treat Breast Cancer

The combination of sacituzumab govitecan-hziy (Trodelvy) plus pembrolizumab (Keytruda) has demonstrated a statistically significant and clinically meaningful improvement in PFS compared with pembrolizumab plus chemotherapy in patients with previously untreated, PD-L1-positive metastatic triple-negative breast cancer. These findings come from the topline results of the phase 3 ASCENT-04/KEYNOTE-D19 study (NCT05382286).

While OS, a key secondary end point, was not yet mature at the time of this primary PFS analysis, an early trend towards improvement with the combination was seen, and researchers will continue to monitor this outcome.

This combination represents the first antibody-drug conjugate combined with an immuno-oncology agent to show such potential in the early treatment lines of metastatic breast cancer.

Catch the full story here.

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