Author: Siobhan Davies, Research Consultant, Oncology team @ Beyond Blue
Personalized Cancer vaccines: A breakthrough brings a new learning curve
A genuinely new modality requires building confidence in the science, the workflow, and what it means for patients, not just awareness.
The positive results from INTerpath-001 mark an important milestone, representing the first positive Phase III readout for an individualized neoantigen therapy. This provides important clinical validation for the approach, with development now extending across tumor types and beginning to explore where and when individualized neoantigen therapies may have the greatest potential.
However, as a new modality, ESMO’s educational sessions highlighted just how much there is for clinicians to learn and become confident in. There is new science to understand, from different vaccine approaches to the potential immunostimulatory effects of the mRNA platform, alongside a new treatment workflow. Practical questions range from tissue availability and stewardship to whether personalized therapies can be manufactured and delivered within clinically useful timeframes and at scale. Patient conversations will also be important, particularly given wider public perceptions of mRNA vaccines. Before launch, pharma needs to identify where HCPs lack confidence, knowledge, or the practical means to deliver the treatment, and work out what they can realistically do to close those gaps.
KRAS G12C NSCLC: 2L has a new benchmark, but 1L remains up for grabs
Sometimes, competitive advantage comes with a limited window. The challenge is to maximize the opportunity today while using it to build the foundations for future success.
Divarasib has raised the bar for KRAS G12C inhibition in previously treated NSCLC. At ESMO, Phase III results from KRASCENDO-1 showed improved PFS and OS versus first-generation KRAS G12C inhibitors sotorasib and adagrasib, positioning divarasib to reshape the 2L setting.
But perhaps the more important story is the race to 1L, where the hierarchy could look very different. Of the next-gen agents, olomorasib is expected to deliver Phase III 1L data first, with other assets to follow. But getting there first may only be part of the story. Combining KRAS G12C inhibition with IO has proved challenging, particularly due to hepatotoxicity, and with triple combinations of KRAS inhibition, IO and chemotherapy potentially adding further concern. In an often older, comorbid population, tolerability, treatment discontinuation and potentially the flexibility to adjust dose or schedule could therefore become increasingly important drivers of decision-making. The 1L hierarchy may therefore depend not on efficacy and timing alone, but on how successfully each agent can be integrated into frontline treatment.
Post-TKI EGFR-mutant NSCLC: When is personalization worth the effort?
When physicians have easier resistance-agnostic approaches, make the personalized route feel worth pursuing, and make testing as easy and timely as possible.
The post-osimertinib landscape is set to become more crowded. Several emerging approaches could be used without identifying a specific resistance mechanism, including ivonescimab plus chemotherapy and HER3- or EGFR×HER3-directed ADCs. In parallel, SAFFRON showed improved PFS and OS with osimertinib plus savolitinib in patients with MET-positive acquired resistance, supporting a more selective, biology-led approach.
This creates a practical choice between acting broadly vs. testing to personalize treatment. Resistance-guided therapy will depend not only on the clinical evidence, but on whether physicians believe the additional testing, time, and effort are justified by the opportunity for a more precise treatment. That means understanding what makes personalization feel worthwhile, while addressing practical barriers around biopsy, testing access and turnaround time, and establishing a clear definition of MET positivity. For biomarker-led approaches, the challenge may therefore be not simply proving that they work, but giving clinicians enough reason to look for the patients who could benefit.
Winning in ES-SCLC: Is clinical efficacy enough?
Understanding what limits adoption in the real world can shape the evidence and solutions needed to unlock a brand’s wider potential.
DeLLphi-305 marks a major advance in ES-SCLC, where substantial improvements in survival have often remained elusive. Tarlatamab plus durvalumab extended median overall survival in the 1L maintenance setting to 21.1 months, compared with 12.7 months with durvalumab alone. Moving tarlatamab earlier could also give more patients the opportunity to benefit, given many deteriorate too quickly to reach second-line treatment
But realizing that opportunity also means tackling a known practical barrier to use.
Current monitoring recommendations can be difficult for many treatment centers to accommodate. DeLLphi-305 explored a reduced monitoring approach, with 1-2 hours of monitoring following the first two infusions in most regions, extending to 6-8 hours in Europe. This illustrates the importance of understanding barriers to treatment use and addressing these as a therapy moves into earlier treatment settings.
What does ESMO 2026 mean for pharma?
The advances presented at ESMO share the potential to change practice, but they create very different challenges for pharma. Together, they show that strong clinical evidence is only part of the equation. How do you build confidence in a new modality, maximize a competitive window, make personalization worth the effort, or overcome practical barriers to use?
A major data readout creates a moment to start answering these questions, and perhaps this is part of the beauty of the congress setting: it concentrates attention around new evidence and creates an opportunity to explore what it could mean for treatment and practice.
But making the most of that moment starts much earlier. Pharma needs to understand the market well enough to anticipate the questions the data could raise, know what evidence or solutions may be needed, and be ready to move quickly and help steer what happens next.
In oncology, the challenge isn’t simply keeping pace with the evidence. It’s understanding what it means for your market, your brand, and the decisions you need to make next.
At Beyond Blue, our oncology specialists combine deep market understanding with strategic insight to help teams make sense of complexity and make critical decisions with greater confidence.
Talk to our oncology team about the decisions you’re facing, or explore more of our latest oncology thinking.