ASCO 2025 Breaking News

Trodelvy plus Keytruda improves PFS in first-line triple-negative breast cancer

New Phase III data from the ASCENT-04 trial unveiled at ASCO 2025 shows that Gilead Sciences’ antibody-drug conjugate Trodelvy (sacituzumab govitecan) combined with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) outperformed standard chemotherapy in first-line treatment of PD-L1–positive metastatic triple-negative breast cancer (TNBC). 

Among 612 patients enrolled, those treated with the Trodelvy-Keytruda combo achieved a median progression-free survival (PFS) of 11.2 months versus 7.8 months for those receiving Keytruda with chemotherapy. Objective response rate was also higher (56.4% vs 39.7%), with early indications of overall survival benefit. 

The regimen was generally well tolerated, with neutropenia and diarrhea as the most common grade 3+ events. Trodelvy, already approved for pretreated TNBC and hormone receptor-positive breast cancer, is now being positioned as a first-line agent. Gilead has announced plans to file for regulatory approval later this year. 

If approved, the combination would mark the first chemotherapy-free, immunotherapy-based regimen for frontline TNBC. The results are significant for a population that has few durable treatment options. ASCO discussants noted that this strategy could reshape the treatment paradigm for one of the most aggressive breast cancer subtypes.-->Read more.

Amgen’s Nplate reduces chemotherapy dose interruptions due to thrombocytopenia

Data from a multicenter Phase III trial presented at ASCO 2025 showed that Amgen’s (Nasdaq: AMGN) thrombopoietin receptor agonist Nplate (romiplostim) significantly reduces chemotherapy-induced thrombocytopenia (CIT), a common side effect that often necessitates dose reductions or delays. 

The study enrolled 169 patients with solid tumors at risk of CIT who were undergoing myelosuppressive chemotherapy. Patients receiving Nplate weekly were 2.3 times more likely to maintain relative dose intensity above 90% compared to placebo (84% vs 36%). The Nplate group also experienced fewer treatment delays and less bleeding-related complications. Importantly, no new safety signals were identified, and adverse events were consistent with known risks, including mild headache and fatigue. CIT lacks an FDA-approved therapy, and oncologists often resort to platelet transfusions or dose reductions that can compromise efficacy. 

This trial could prompt regulatory review and guideline changes, particularly in breast, lung, and GI cancers where CIT prevalence is high. Amgen, which markets Nplate for immune thrombocytopenia, may now pursue expanded indications in the supportive oncology setting. Experts at ASCO welcomed the findings, suggesting that proactive platelet support could optimize chemotherapy delivery and improve oncologic outcomes in vulnerable patients.-->Read more.

Dual-target CAR T therapy shows promise in glioblastoma

A first-in-human trial from the University of Pennsylvania presented at ASCO 2025 explored a novel dual-target CAR T cell therapy for recurrent glioblastoma, one of the most aggressive and treatment-resistant brain cancers. The therapy was engineered to recognize both EGFR and IL13Rα2 — proteins often overexpressed in glioblastoma — using a bispecific CAR construct. 

Delivered intracranially via an Ommaya reservoir, the therapy reached cerebrospinal fluid and tumor sites more directly. Of the 18 evaluable patients, 62% showed partial responses or stable disease. One patient experienced complete tumor shrinkage and remains progression-free 16 months post-treatment, while another has not seen disease progression for over 12 months. Importantly, the treatment was well-tolerated, with no dose-limiting toxicities or neuroinflammatory adverse events. 

The research marks a milestone for applying CAR T technology beyond hematologic malignancies and could pave the way for more durable treatment options in solid tumors. Investigators stressed the need for larger confirmatory trials but noted the compelling durability of responses given the historically dismal prognosis for glioblastoma. The approach also represents a significant innovation in intrathecal immunotherapy delivery and could shape future strategies for targeting brain tumors.-->Read more.

With ASCO 2025 drawing toward its final day in Chicago, Amsterdam-based biotech Avidicure is entering the spotlight with its first public data on a new class of cancer immunotherapies. The company’s lead program, AVC-S-101, is designed to target TROP2 in non-small cell lung cancer (NSCLC) and other solid tumors.

Avidicure, which emerged from stealth in April with a $50 million seed round, is presenting preclinical data that its chief executive Arthur Lahr described in an interview with The Pharma Letter as a “milestone” for the platform.-->Read the interview.

Arcus Biosciences (NYSE: RCUS) is setting the stage for a high-stakes Phase III showdown in kidney cancer, after early results showed that nearly half of patients treated with its experimental therapy had a confirmed response.

The USA-based biotech presented fresh data from its Phase I/Ib ARC-20 trial at the ASCO annual meeting, spotlighting the potential of casdatifan, an oral HIF-2α inhibitor, combined with Exelixis’ (Nasdaq: EXEL) Cabometyx (cabozantinib). The trial involved patients with metastatic clear cell renal cell carcinoma (ccRCC) who had progressed following immunotherapy.-->Read the article.

Daiichi Sankyo (TYO: 4568) and AstraZeneca (LSE: AZN) have released detailed Phase III results that could help position their HER2-targeting drug Enhertu (trastuzumab deruxtecan) as the second-line standard of care for advanced gastric cancer.

The data, presented at the American Society of Clinical Oncology meeting, came from the DESTINY-Gastric04 trial and were compelling enough to justify the study’s early unblinding. In patients with HER2-positive, inoperable or metastatic gastric or gastroesophageal junction adenocarcinoma, Enhertu significantly extended overall survival compared to the combination of Cyramza (ramucirumab) and paclitaxel.-->Read the article

AstraZeneca (LSE: AZN) has reported positive findings from its Phase III MATTERHORN trial, spotlighting the potential of its immunotherapy Imfinzi (durvalumab) to significantly delay disease progression in patients with early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers.

Presented at the American Society of Clinical Oncology meeting in Chicago and published in The New England Journal of Medicine, the interim data revealed that combining Imfinzi with standard FLOT chemotherapy before and after surgery reduced the risk of disease progression, recurrence or death by 29% compared to chemotherapy alone.-->Read the article.

IMUNON (Nasdaq: IMNN) has entered a pivotal Phase III trial for its lead candidate IMNN-001, a DNA-based IL-12 immunotherapy for advanced ovarian cancer. In an interview with The Pharma Letter, president and CEO Stacy Lindborg reflects on the company's decade-long development journey and the therapy’s potential to transform frontline treatment.-->Read the interview