The 2026 ASCO Annual Meeting marked a clear inflection point in oncology drug development. Across multiple tumor types and modalities, one message came through consistently: The future of oncology lies in delivering meaningful impact earlier in the disease course - not incremental gains in late line settings.

At the European Hematology Association (EHA) Congress, that message was reinforced and extended. The conversation has moved beyond whether innovation works to how quickly it can move earlier, scale and reach patients.

ASCO 2026: Raising the Bar for Clinical Impact

Three key themes defined ASCO this year, alongside strong validation of the FDA’s Project FrontRunner initiative.

1. Transformational biology sets a new bar for innovation
   The Phase 3 RASolute-302 study of daraxonrasib delivered one of the most striking outcomes of the meeting, achieving a ~60% reduction in risk of death in metastatic pancreatic cancer. This represents the first major breakthrough in “un-druggable” KRAS-driven pancreatic cancer and represents a step change in expected effect size for novel therapeutics. Statistically significant is no longer enough. Development strategies must prioritize a clear biological differentiation and magnitude of benefit, setting internal “go/no-go” thresholds based on clinical relevance not marginal improvement.
2. Bispecifics challenge established immunotherapy paradigms
   The HARMONi-6 study demonstrated that ivonescimab (PD-1/VEGF bispecific) outperformed standard chemo immunotherapy in non-small cell lung cancer (NSCLC), delivering a meaningful overall survival benefit. This validates a broader trend moving beyond single target PD-(L)1 inhibition and toward multi mechanism immune modulation. Sponsors must anticipate a rapid evolution of comparator arms (PD-1 monotherapy is no longer sufficient) and combination strategies (additive vs mechanistically integrated approaches), treatment sequences and regimens and should continuously reassess the landscape with emerging new standard of care treatments to ensure trials remain relevant at readout.
3. Precision medicine now removes treatment
   The OPTIMA study demonstrated that genomic profiling can identify early breast cancer patients who can safely avoid chemotherapy altogether, sparing unnecessary toxicity, signalling that precision medicine is no longer just about selecting therapy but can also be about withholding ineffective treatment if the relevant tests are appropriately available for patients. Successful development strategies must therefore integrate biomarker strategies, treatment decision frameworks and value propositions beyond efficacy alone.

The FDA’s Project FrontRunner encourages sponsors to develop therapies directly in earlier disease settings rather than starting in refractory populations. The data presented at ASCO provided compelling validation of this approach, showing how it is being operationalized across the industry, and confirming that therapies are more effective when deployed earlier – biologically, clinically and commercially.

For biotechs, this reinforces the need for early-line expansion strategies as soon as proof-of-concept is established.

• Targeted therapies deliver greater impact in early disease
  The LIBRETTO-432 trial (selpercatinib) moved a RET inhibitor from metastatic NSCLC into the adjuvant setting with an 83% reduction in risk of recurrence or death (HR ~0.17) and ~91% event free survival at two years vs ~61% control. This demonstrates that the same drug that controls advanced disease can prevent recurrence when used earlier, delivering far greater clinical value.
• Systemic therapy is moving into curative intent pathways
  The PROTEUS trial evaluated perioperative apalutamide in high risk localized prostate cancer, showing ~20% reduction in metastasis or death, and significant improvements in metastasis free survival and pathological response. The data highlights how intervening before micrometastatic disease emerges can meaningfully alter long-term outcomes.

EHA 2026: Scaling Innovation Becomes the Differentiator

At EHA, I was looking to see how these trends would evolve. The answer: the industry is moving faster, but success increasingly depends on scalability, access and speed.

• Bispecifics are moving into frontline settings
  Trials such as MonumenTAL-3, EPCORE NHL, and SOUNDTRACK-F1 show bispecifics being positioned directly against standard of care in Phase 3 frontline settings.
• CAR-T exposes the access gap
  Studies like CARTITUDE-4 and LATE-R continue to demonstrate strong and durable benefit. But only a minority of eligible patients are receiving CAR-T in Europe due to referral delays, manufacturing constraints, or site and logistical complexity.
• MRD is accelerating development timelines
  Minimal residual disease (MRD) is increasingly being used in trials such as MonumenTAL-3 and BOVen ΔMRD400. While not yet universally validated as a surrogate endpoint, MRD is enabling, smaller, faster trials, earlier decision points, and adaptive and fixed-duration strategies.

What This Means for Biotech Sponsors

Across ASCO and EHA, the strategic bar has shifted. I see three priorities for biotech companies:

1. Design for earlier lines from the outset

In line with Project FrontRunner, the critical question is whether your asset can compete in:

• First- or second-line settings
• Combination regimens
• Rapidly evolving standards of care

2. Build speed into development

Incorporating MRD and other innovative endpoints can:

• Shorten trial timelines
• Enable adaptive designs
• Accelerate value creation

3. Make access and scalability core to strategy

The CAR-T experience underscores an important reality: success is not defined by efficacy alone.

Competitive advantage will depend on:

• Manufacturing scalability
• Site enablement
• Referral pathways
• Operational simplicity

The Bottom Line

Data from ASCO and EHA signals a decisive shift in oncology development:

• From late-line salvage to early intervention
• From incremental gains to transformational outcomes
• From drug-centric to biomarker- and system-enabled strategies

But just as importantly, the question for biotech is evolving. It is no longer: Does it work? It is now: Can it scale, can it combine, and can it be used early enough to truly matter?

At IQVIA Biotech, we partner with biotech and emerging biopharma sponsors to design and deliver clinical programs aligned to this new reality, helping bring the right therapies to the right patients, at the right time, and at the scale required to make an impact.

Learn how IQVIA Biotech can support your oncology drug development journey from strategy through execution.