Once again, the city of Chicago played host to the annual meeting of ASCO, the American Society of Clinical Oncology.  The ASCO meeting, which took place this year from May 30 to June 3, is an extremely important one.  Blue Matter always sends a team to meet with potential clients and colleagues, as well as perform project work on behalf of various clients.  We also take the opportunity to attend the sessions and keep up to date with the latest research in oncology.

As we do so, our various team members note the key topics, issues, data points, and themes that they think are most interesting or consequential.  In this short article, we provide a quick flyover of those items.  Let’s dive in!

Exciting developments in the fight against breast cancer

New potential paradigm in HR-positive, HER2-negative advanced breast cancer

Approximately 70% of breast cancer (BC) cases are hormone receptor-positive, HER2-negative (HR+/HER2-), making advancements in this subtype particularly impactful. While the current standard of care (SOC)—a combination of CDK4/6 inhibitors and aromatase inhibitors—has improved outcomes, up to 40% of patients eventually develop ESR1 gene mutations (ESR1m), which render them resistant to treatment. This highlights a significant unmet need for more effective, durable therapeutic options in the first-line setting.

The SERENA-6 study was designed to address this gap by evaluating whether early detection of ESR1m via circulating tumor DNA (ctDNA) could guide a timely switch to camizestrant, an oral selective estrogen receptor degrader (SERD), and improve outcomes. The results were compelling: camizestrant demonstrated a 56% reduction in the risk of disease progression compared to SOC. This suggests that ctDNA monitoring is not only a valuable prognostic tool but may also facilitate more effective intervention before clinical progression occurs.

These findings support camizestrant’s potential role in reshaping the first-line treatment paradigm for HR+/HER2- breast cancer, possibly establishing it as part of a new standard of care. However, overall survival (OS) data are still pending, and will be critical to fully confirm the clinical benefit and secure camizestrant’s place in routine practice.

A significant antibody-drug conjugate (ADC) advance in triple negative breast cancer (TNBC)?

Data from the phase 3 ASCENT-04/KEYNOTE-D19 study show that sacituzumab govitecan (Trodelvy) plus pembrolizumab (Keytruda) improved PFS over chemotherapy plus pembrolizumab in PD-L1–positive, advanced TNBC.  It showed a median PFS of 11.2 months versus 7.8 months.

The safety profile of sacituzumab govitecan plus pembrolizumab was basically as expected.  The rate of SAEs was higher compared with the chemotherapy plus pembrolizumab group, but the rate of events leading to dose reduction or treatment discontinuation was lower.

According to Sara Tolaney, MD, MPH and chief of the division of Breast Oncology at Dana-Farber Cancer Institute, “Results from ASCENT-04/KEYNOTE-D19 support the use of sacituzumab govitecan plus pembrolizumab as a potential new standard of care for patients with previously untreated, PD-L1–positive, locally advanced unresectable or metastatic TNBC.”

New first-line treatment option for HER2-positive breast cancer?

During ASCO, researchers presented data from the phase 3 DESTINY-Breast09 clinical trial.  The data showed that the combination of trastuzumab deruxtecan (Enhertu) with pertuzumab (Perjeta) can delay cancer growth for longer than the current SOC in HER2-positive locally advanced or metastatic breast cancer.

At a median follow-up of 29 months, the combination reduced the risk of disease progression or death by 44% for patients.  Measurement of OS is still immature, so the researchers will continue to follow the patients to gather long-term data.  This could herald the “end of an era,” as Herceptin may no longer be the clear SOC for HER2-positive patients.

Decades-long SOC in head and neck cancer challenged by new data

At this year’s meeting, multiple IO datasets signaled a major shift in the treatment paradigm for head and neck squamous cell carcinoma (HNSCC), a disease that has relied on chemoradiation as the standard of care for over two decades. The most notable data came from the Phase 3 NIVOPOSTOP trial, which evaluated the addition of adjuvant nivolumab to the standard regimen in patients with locally advanced, resectable HNSCC. The trial met its primary endpoint, demonstrating a disease-free survival (DFS) benefit with a hazard ratio of 0.76, and reported a manageable safety profile.

Additional immunotherapy (IO) studies presented at ASCO—including the Phase 3 KEYNOTE-689 trial—further reinforced the potential of integrating IO into both the resectable and unresectable HNSCC treatment landscapes. KEYNOTE-689 assessed perioperative pembrolizumab in combination with standard therapy in patients with locally advanced, resectable disease, adding momentum to the growing body of evidence that IO may improve outcomes beyond what chemoradiation alone can achieve.

Together, these findings represent a potential inflection point in HNSCC management, with immune checkpoint inhibitors like nivolumab and pembrolizumab poised to challenge and possibly replace longstanding treatment norms. Ongoing maturation of these studies and future survival data will be key to confirming whether IO-based regimens become the new standard.

Surrogate endpoints, such as PFS, often do not predict Overall Survival (OS) or improved Quality of Life (QOL)

A meta-analysis presented at ASCO 2025 critically examined the clinical relevance of cancer trials that use surrogate endpoints—such as progression-free survival (PFS) or objective response rate (ORR)—instead of direct measures like overall survival (OS) or quality of life (QoL). In reviewing 180 randomized controlled trials with positive outcomes based on surrogate endpoints, researchers found that fewer than 20% ultimately demonstrated a statistically significant improvement in OS or QoL. Even among trials that led to regulatory approval, less than half confirmed long-term benefits in these patient-centered outcomes.

The findings call into question the reliability of surrogate endpoints as a basis for practice-changing decisions in oncology. While surrogate markers can expedite trial timelines and drug approval, they often fail to translate into meaningful clinical benefits for patients. This disconnect suggests that many treatments may be adopted prematurely or without sufficient evidence of real-world value, potentially exposing patients to toxicity and cost without clear benefit.

These insights have important implications for the practice of oncology care. They underscore the need for greater scrutiny in interpreting trial results and a more cautious approach to integrating new therapies into standard practice. The researchers who conducted the assessment concluded: “To increase the meaningfulness of late-phase research, future trial designs and regulatory processes should be re-focused towards OS and methodologically rigorous QOL improvements.” Ultimately, the oncology community may need to shift toward more rigorous post-marketing validation and prioritize trials that measure true survival and quality-of-life outcomes to ensure patient-centered, evidence-based care.

Sanofi and Bristol Myers Squibb make important acquisitions

Two announcements came out during the ASCO time frame that highlighted some important strategic moves for two biopharma leaders: Sanofi and BMS.

Sanofi’s purchase of Blueprint Medicines for up to $9.5 billion is a big step forward for the company in the immunology and rare disease space.  The acquisition centers around Ayvakit (avapritinib), which is the only approved medicine for advanced and indolent systemic mastocytosis (ASM and ISM), a rare immunological condition that involves the abnormal accumulation of mast cells throughout the body.  The transaction is expected to close in Q3 of this year.

BMS Bristol Myers Squibb has inked a deal with BioNTech to collaborate on bringing a PD-1/L1xVEGF-A bi-specific to the market.  As part of the deal, BMS will make a $1.5 billion up-front payment, as well as another $2 billion in non-contingent anniversary payments through 2028.  BMS has further committed to an additional $7.6 billion in payments tied to various development, regulatory and commercial milestones.  In return, BMS will get a 50% stake in an extremely “hot” and promising area of IO.

An interesting side-note regarding China

One of our team members noted that there seemed to be a very strong Chinese biotech presence in the abstracts and presentations, as well as a strong Chinese corporate presence.  This raised a question in our minds:  Could this be a real manifestation of a new model where early development happens in China and deals are struck to bring these molecules for later development and commercialization in the US?  Time will tell.

Stay tuned…

Throughout the year, our team will continue to publish resources that provide information and insights regarding the oncology market (and others).  To stay up to date, follow us on LinkedIn or check our Insights page regularly.  If you’d like to discuss a specific business challenge and explore how Blue Matter might be able to help, then please Contact Us via our website.  Until next time…