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Next-generation modalities, precision trials, and AI-driven breakthroughs in oncology

Summary of panel discussion during 2025 European Oncology Congress

Key takeaways

  • The current landscape of oncology R&D is geared toward multi-targeted, multi-modality therapeutics.
  • Next-generation precision modalities require striking a balance between investment and risk.
  •  Partnering with regulators and collaborating payers is essential for commercial success of next-gen cancer modalities.
  • AI in oncology R&D is starting to demonstrate tangible value.

Overview

Oncology remains at the forefront of therapeutic innovation, with recent advances in modalities such as antibody-drug conjugates (ADCs), cell therapies, and bispecific antibodies reshaping treatment possibilities across tumor types. These breakthroughs are increasingly supported by precision approaches—from biomarker-driven trial design to companion diagnostic integration—that enable more targeted, efficient, and patient-specific development strategies. At the same time, the integration of AI into oncology R&D is moving beyond theory, delivering measurable impact in drug discovery, patient stratification, and clinical operations.

Context

The panelists discussed promising scientific and strategic pathways in oncology, including next- generation therapeutic modalities, precision trial strategies, AI applications with demonstrated and measurable impact, regulatory and market readiness, and collaborative models for accelerating early-phase oncology programs.

The current landscape of oncology R&D is geared toward multi-targeted, multi-modality therapeutics.

Over the past 20 years, oncology R&D has experienced a remarkable journey, from the early days of HER2 targeted therapies such as trastuzumab, as an early example of precision oncology to today’s highly sophisticated molecular techniques and diagnostics, ADCs, bispecifics, and cell and gene therapies.

In the last few years, there has also been an exponential increase in pipeline diversity. Meanwhile, and more recently from an investment perspective, there has been a refocus on smart, mechanistically driven oncology development projects, Liz O’Brien, therapeutic expert oncology, global drug development solutions, ICON, said.

"ADCs, bispecifics, and cell therapies are examples of the next wave of innovation, which is multi-targeted therapeutics [with] multi-modality mechanisms in a single molecule. We’re going to see things go by leaps and bounds from here."
– Leena Gandhi, MD, PhD, NextPoint Therapeutics

The sophistication of these novel therapies is such that, thanks to their complex mechanisms of action (MOA) and engineering platforms, they are considered close to being able to treat previously incurable diseases.


“We’re now drugging the undruggable. KRAS [the most common gene mutation in pancreatic cancer] was thought to be undruggable and now almost every presentation is showing data in pancreatic cancer,” Walid Kamoun, vice president and global head of R&D Oncology at Servier, said.
 

Next-generation precision modalities require striking a balance between investment and risk.

As novel advanced modalities proliferate, biosciences companies must balance investment decisions with risk across diverse oncology platforms. This is especially relevant for lean biotechs, which do not have the resources of large pharma organizations but still need to quickly “get to a signal” (i.e., demonstrate an effective MOA) to secure continued investment and set themselves up for collaboration with clinical teams.

Efficient trial designs that invest resources and incorporate biomarkers for patient stratification that help reveal an MOA in early phases are key to addressing that challenge.

“It’s about putting as much investment and the smartest investment possible very early to know whether your molecule is active, safe, and doing what you think it should be doing. . . This also enables you to stop programs that are likely not doing what they’re supposed to do.”
– Walid Kamoun, Servier

However, demonstrating safety and efficacy alone is not sufficient for these types of modalities. Because they are highly personalized, they also need to be delivered at the right threshold for each patient. And because selecting biomarkers and endpoints is not straightforward at that level of personalization, organizations are increasingly opting for multi-modal data to point the way.

“Cancer is an incredibly complex disease, and focusing on a single genetic alteration rarely captures the full biological context. Integrating multiomics and multimodal data provides a more comprehensive view of tumor biology and helps refine patient stratification—particularly in the ADC space, where understanding the level and distribution of target expression can determine clinical success. Ultimately, it’s about starting with the end in mind and designing studies that lead to biomarkers with true translational value.”
– Marianna Zipeto, Champions Oncology

Partnering with regulators and collaborating payers is essential for commercial success of next-gen cancer modalities.

While engaging with regulators and payers is always good practice for the commercial success of new therapies, it is even more critical in the context of novel high-precision multi-modal cancer therapies.

In recent years, regulators have sought to shake off the perception of being distant by becoming more involved in pre-clinical discussions with drug developers. What’s more, regulators are increasingly committed to ensuring that clinical trial protocols reflect the patient voice, preferences, experiences, and insights. They want to see patient quality-of-life data monitored and integrated into the totality of the evidence that companies submit when they file an investigational new drug (IND) application or a new drug application (NDA).

“Regulators absolutely need to be seen as a partner. They’re not some shadowy cabal that you can’t engage with. They’re deeply engaged and have a vested interest in ensuring that optimal treatments get to patients because they are patient-centric.”
– Liz O’Brien, ICON

To help drug manufacturers with trial design and data collection strategy, regulators must make themselves available for early consultation and iterative discussions. “In my experience in the last 10 years, they’ve been partners in sitting down across the table. After every meeting, I walk away feeling they’re in it for the patients, they’re always willing to provide guidance and give certain parameters where you can come up with certain study design,” Mahadi Baig, vice president & head of medical affairs, solid tumor, at Johnson & Johnson, said.

“[Regulators] have seen it all, and they’ve seen a lot of different things. They often have very innovative ideas, because they’ve seen things being done in a variety of different ways. So [it’s important to] think regulators are your partners, and it’s been often really meaningful to have those interactions.
– Leena Gandhi, MD, PhD, NextPoint Therapeutics

The other key stakeholder and partner for developers of novel cancer therapies is payers. With the expanding use of value-based care contracts, where determining reimbursement rates for new therapies is at least partially based on outcomes, many payers are eager to partner with drug developers to ensure that trial protocols are set up optimally to collect evidence on clinical benefit.

“Demonstrating transformative clinical benefit is crucial to reinforce our constructive partnership with payers. If payers play different roles across the globe, we all work for the benefit of patients.”
– Walid Kamoun, Servier

AI in oncology R&D is starting to demonstrate tangible value.

One well-established example of AI’s tangible impact on operational efficiency is leveraging the technology to identify sites with the highest likelihood of recruiting patients that fit a trial’s inclusion criteria/exclusion criteria. As a result of using such technology, J&J can get from protocol design to trial delivery within months to a year, depending on the size and scale of the trial.

“We have data to show that sites picked by using the tool have almost a three times higher chance of enrolling than any other traditional models we’ve used,” Baig said, adding that J&J also uses AI to predict certain mutations based on scans of pathology slides.

Another example is medical writing, which can include protocol writing, clinical study report (CSR) generation, and investigator’s brochure (IB) writing, as well as processing and pattern-finding in pharmacovigilance (PV) data. Not only can AI accelerate those processes, but it can also produce outputs of higher quality, Kamoun noted.

Conclusion

The next era of oncology R&D will be shaped by the convergence between new-generation therapy modalities, AI technologies, precision approaches, and increasingly complex and voluminous datasets.

Some of the most transformative developments shaping that convergence will come from the integration between datasets. This is because data is ultimately what fuels target discovery, pattern- finding, hypothesis drawing, and matching the right target with the right modality to induce the right mechanism of action for the right group of patients, Kamoun said.

Another major development that’s expected is the evolution and scaling of adaptive trial designs to large trials. This would allow researchers to evaluate patient response and progression in real time and adjust trials individually for each patient as needed, at scale.

And then there is ensuring patient access to novel treatments. Although that is not an innovation in and of itself, without effective access via payer coverage, much of the scientific know-how, investment, and innovation in developing these new therapies lose their meaning.

“All of these therapies, as good as they are, will be meaningless if they don’t reach the masses.”
– Mahadi Baig, Johnson & Johnson

 

Panelists:

  • Mahadi Baig, Vice President & Head of Medical Affairs, Solid Tumor, Johnson & Johnson
  • Leena Gandhi, MD, PhD, Chief Medical Officer, NextPoint Therapeutics
  • Walid Kamoun, Vice President, Global Head of R&D Oncology, Servier
  • Liz O’Brien, Therapeutic Expert Oncology, Global Drug Development Solutions, ICON
  • Marianna Zipeto, Executive Vice President, Translational Oncology, Champions Oncology
  • Moderator: Izabela Chmielewska, Editor in Chief, Custom Content, Citeline
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