The Society for Immunotherapy of Cancer has announced a European immuno-oncology drug development summit that will bring scientists, regulators, biotechnology executives, pharmaceutical companies and investors to Lausanne, Switzerland, on September 3 and 4, 2026. The meeting at the Agora Cancer Research Center will concentrate on the scientific and operational work required to move emerging cancer immunotherapies from experimental concepts into appropriately designed clinical trials.
The announcement is not a clinical readout, regulatory decision or product launch. Its significance lies in the structure of the programme and the groups being placed in the same room. The agenda addresses therapies beyond established PD-1 and PD-L1 checkpoint inhibitors, the overlap between oncology and autoimmunity, antibody drug conjugates, cellular therapies, radioimmunotherapy, preclinical models, global regulatory expectations and biotechnology financing.
That combination reflects a widening problem in immuno-oncology drug development. Scientific activity remains intense, but promising biology does not automatically produce a viable medicine. Developers must select the right patients, establish a dose with an acceptable benefit-risk profile, identify meaningful biomarkers, generate credible preclinical evidence and design trials capable of separating genuine therapeutic activity from noise.
The summit therefore appears designed less as a showcase of isolated discoveries and more as a translation forum. Pedro Romero of Novigenix, one of the organisers, indicated that the objective is to connect European and United States experts around development practices that can move credible therapeutic candidates toward clinical testing. The Society for Immunotherapy of Cancer is working with the Swiss Biotech Association, while the Association for Cancer Immunotherapy and Oslo Cancer Cluster are supporting the meeting as marketing partners. The Canton of Vaud’s Office for Economic Affairs and Innovation is also supporting the programme.
Why is SITC building a European summit around drug development rather than another scientific conference?
Europe does not lack immunology research, oncology expertise or early biotechnology innovation. Its harder challenge is converting those assets into programmes that are sufficiently differentiated, financed and regulator-ready to progress through clinical development.
Immuno-oncology has become a particularly unforgiving area for weak development strategies. The first wave of checkpoint inhibitors demonstrated that stimulating an antitumour immune response could produce durable benefit in selected patients. That success also encouraged a large number of companies to build programmes around additional checkpoints, immune agonists, therapeutic vaccines, cytokines, cell therapies and combinations.
Many of those programmes encountered familiar barriers. Some targets were biologically attractive but inadequately validated in humans. Others entered trials without biomarkers capable of identifying the patients most likely to respond. Combination studies sometimes added toxicity and complexity without clearly establishing the contribution of each component. Early signals observed in small, heavily selected cohorts did not always survive larger or more controlled testing.
The Lausanne programme addresses these difficulties by bringing together parties that usually view the same asset through different lenses. Academic scientists may focus on biological rationale. Biotechnology companies must translate that rationale into a manufacturable product and executable trial. Regulators examine dose justification, safety monitoring, endpoint selection and the reliability of evidence. Investors ask whether the development plan can reach a value-creating milestone before capital runs short.
Placing those perspectives in one programme does not guarantee better drugs. It can, however, expose weak assumptions before they consume years of development spending. For a small biotechnology company, an early challenge to an unrealistic trial design may be more valuable than enthusiastic feedback delivered after the programme has already become expensive.
Why does the agenda move decisively beyond PD-1 and PD-L1 checkpoint inhibition?
The summit’s first scientific session is explicitly focused on development beyond PD-1. Scheduled discussions cover cancer vaccines, T-cell receptor therapies and bispecific T-cell engagers directed at PRAME-positive cancers. Later sessions extend the scope to engineered immune-cell therapies for solid tumours, antibody drug conjugates, radioimmunotherapy and approaches intended to influence immunogenic cell death.
This breadth matters because the next phase of immuno-oncology is unlikely to be defined by a single replacement for checkpoint inhibition. It is more likely to involve multiple platforms designed to solve different biological problems.
Cancer vaccines attempt to generate or strengthen immune recognition of tumour-associated targets. T-cell receptor therapies can redirect immune cells toward intracellular antigens presented on the surface of cancer cells, potentially opening targets that conventional antibodies cannot reach. Bispecific engagers bring immune cells into closer contact with tumour cells. Engineered cell therapies seek to create more potent or persistent immune responses, although solid tumours remain difficult because of trafficking barriers, antigen heterogeneity and an immunosuppressive tumour microenvironment.
Antibody drug conjugates add another layer. These therapies are generally designed to deliver a cytotoxic payload to cells expressing a selected target. Their relationship with immuno-oncology becomes particularly important when tumour-cell death releases antigens, changes immune signalling or creates a rationale for combination with checkpoint inhibitors.
The scientific opportunity is considerable, but each modality brings distinct development risks. Cell therapies face manufacturing, logistics and patient-access challenges. Bispecific immune engagers may require careful management of immune-mediated toxicities. Antibody drug conjugates depend on target selection, linker stability, payload properties and the relationship between antigen expression and clinical activity. Vaccines must generate an immune response that is not merely measurable, but sufficiently strong and durable to affect tumour control.
A summit that treats these technologies as interchangeable would have limited value. The published agenda instead suggests a modality-specific approach, with speakers expected to examine development challenges as well as opportunities. That distinction is essential because the right trial design, dose strategy and biomarker plan for an antibody drug conjugate may be inappropriate for a therapeutic vaccine or engineered T-cell product.
What does the focus on autoimmunity reveal about the next safety and efficacy challenge?
E. John Wherry of the University of Pennsylvania is scheduled to deliver the keynote address on the intersection of immuno-oncology and autoimmunity, with particular attention to the molecular mechanisms of CD8 T-cell exhaustion. The programme also includes regulatory T cells, immune-cell engagers and engineered immune-cell therapies within a dedicated session connecting autoimmunity and oncology.
This theme captures one of the central tensions in cancer immunotherapy. Developers want immune cells to recognise and attack malignant tissue more effectively, but excessive or poorly controlled immune activation can injure healthy organs. The biological mechanisms that limit immune activity may help tumours escape, yet those same mechanisms can protect the body against damaging self-reactivity.
T-cell exhaustion is similarly complicated. Exhausted T cells are often described as dysfunctional, but exhaustion can also represent an adaptive state created during persistent antigen exposure. Reversing inhibitory signalling may restore useful antitumour activity in some circumstances. Pushing the immune system too aggressively, however, may increase toxicity without creating durable tumour control.
For drug developers, the practical issue is not simply whether an experimental therapy activates immune cells. They must understand which immune populations are affected, where activation occurs, how long it persists and whether pharmacodynamic changes are associated with clinically meaningful outcomes.
These questions influence starting dose, escalation rules, patient eligibility, stopping criteria and the design of combination studies. They also affect the value of biomarkers. A marker that confirms immune activation may demonstrate biological activity, but it does not independently establish tumour response, longer survival or an acceptable safety profile.
By placing autoimmunity near the beginning of the agenda, the organisers are signalling that safety biology cannot be treated as a downstream regulatory formality. It must be incorporated into target selection and therapeutic design.
How could regulatory alignment improve Europe’s ability to run complex immuno-oncology trials?
The summit includes a panel on global regulatory perspectives and clinical-trial design featuring representatives from the Paul-Ehrlich-Institut, the United States Food and Drug Administration and Swissmedic, alongside clinical investigators from European cancer centres. A separate discussion will examine preclinical models and their role in supporting development decisions.
The European Union has already attempted to simplify multinational clinical research through the Clinical Trials Regulation and the Clinical Trials Information System. Sponsors can use a single application to seek authorisation for a trial across multiple European Economic Area countries, while national authorities collaborate on the assessment. The Clinical Trials Regulation became fully applicable after the transition of ongoing studies to the new framework.
A common application system does not eliminate the scientific complexity of immuno-oncology trials. Sponsors still need to justify their preclinical package, starting dose, escalation method, combination strategy, safety controls and proposed patient population. Country-level site contracting, ethics requirements, tissue handling, biomarker testing and operational capacity can also influence whether a nominally multinational trial recruits efficiently.
The location in Switzerland adds another useful dimension. Switzerland operates through Swissmedic rather than the European Union’s Clinical Trials Information System. Developers seeking to run studies across Switzerland, European Union countries, the United Kingdom and the United States must therefore build programmes that can satisfy multiple regulatory systems without creating incompatible protocols or duplicated work.
Regulatory dialogue is especially valuable for novel immunotherapies because traditional development templates may not fit. Some treatments have delayed responses. Others can create atypical imaging patterns. Cell therapies and immune engagers may require specialised toxicity monitoring. Biomarker-defined studies can involve small populations spread across several countries. Platform and master-protocol designs may improve efficiency, but they also require careful statistical and operational planning.
The European Medicines Agency’s current anticancer development guidance addresses biomarker-guided development, confirmatory trial design, endpoint selection and master protocols. That framework reinforces why early regulatory engagement matters. A sophisticated mechanism does not rescue an uninformative trial.
Why are preclinical models and patient selection becoming commercial issues, not just scientific ones?
The summit’s attention to preclinical models may appear technical, but it has direct financial importance. Immuno-oncology assets frequently depend on complex interactions among tumour cells, immune cells, stromal tissue and treatment-induced signalling. Models that fail to reproduce these relationships can create false confidence.
A candidate may appear active in a simplified laboratory system because the model lacks the immune-suppressive features found in human tumours. An animal model may demonstrate tumour shrinkage without accurately predicting human dose, toxicity or durability. A combination may look synergistic under selected experimental conditions but provide little additional value in a heterogeneous patient population.
These limitations do not mean preclinical research is unhelpful. They mean that developers must define what each model can and cannot establish. Preclinical evidence should support a coherent clinical hypothesis, not serve as decorative justification for entering a trial.
Patient selection is equally consequential. As immuno-oncology becomes more fragmented across targets and modalities, broadly enrolling patients by tumour type may become inefficient. Developers increasingly need biomarkers that identify antigen expression, immune context, molecular alterations or other characteristics linked to the therapy’s mechanism.
A biomarker strategy can reduce the eligible population, complicate recruitment and require validated testing. It may also materially improve the probability of detecting activity. For investors and potential pharmaceutical partners, a smaller but biologically coherent population can be more valuable than a large theoretical market supported by weak patient selection.
The commercial question is therefore not how many patients have a particular cancer. It is how many can be reliably identified, enrolled, treated and shown to benefit under a development plan that regulators and payers will accept.
What does the investment panel say about Europe’s dependence on transatlantic capital and partnerships?
The final summit session will examine European biotechnology innovation and partnerships with the United States. Participants are scheduled to include representatives from Novo Holdings, Forbion, Medicxi, Sofinnova Partners, Yosemite and other investment organisations.
Its placement at the end of the programme is revealing. Scientific and regulatory quality ultimately determine whether an immuno-oncology programme deserves to advance, but capital determines whether it can.
Early immuno-oncology studies can require specialised clinical sites, intensive safety monitoring, biomarker testing and expensive manufacturing. Cell therapies and other complex biologics may demand substantial process-development spending before a meaningful clinical signal is available. Small European developers can therefore reach financing pressure well before their science has been adequately tested.
United States partnerships can provide capital, development infrastructure and access to larger clinical networks. They can also shift control over European-originated assets to better-funded partners. The challenge for European biotechnology companies is to form collaborations at a point where the programme has enough validation to command attractive economics, but before financing constraints force a defensive transaction.
Investors at the summit are likely to examine the same evidence gaps as regulators, although through a different lens. They will want to know whether the target is differentiated, whether the development path is credible, whether manufacturing can scale and whether the next clinical milestone can materially change the asset’s value.
That is why the investment discussion belongs beside sessions on preclinical models and regulatory design. Better financing cannot repair poor science, but good science can still fail when its development plan requires more time and capital than the sponsor can secure.
How should the industry judge whether the Lausanne summit produces meaningful results?
The meeting should not be judged by the number of speakers, companies or therapeutic platforms represented. Its value will depend on whether the discussions produce clearer development decisions.
Useful outcomes could include earlier regulatory engagement, improved trial concepts, more realistic preclinical expectations, stronger biomarker strategies and collaborations that allow promising European programmes to access clinical and financial resources. The announcement does not identify a planned consensus statement, formal guidance document or publication, so the immediate output may be relationship-building rather than a public development framework.
That would still be relevant. Drug development often fails at the boundaries between disciplines. A preclinical team may not understand what regulators require. A biotechnology company may underestimate site complexity. An investor may support an attractive mechanism without adequately testing whether the proposed trial can produce a decisive result.
The Society for Immunotherapy of Cancer’s Lausanne summit is attempting to narrow those gaps at a time when the immuno-oncology sector is moving beyond its first generation of commercial successes. The agenda recognises that the next wave will depend not only on discovering new immune targets, but on selecting therapies that can be tested rigorously, financed responsibly and advanced without confusing biological activity with established patient benefit.
The summit’s real test will come after September. Strong presentations may generate attention for two days. Meaningful progress will require participants to convert the discussions into better-designed studies, credible regulatory plans and partnerships capable of carrying Europe’s most promising immuno-oncology science into clinical development.
