October is a pivotal month for the oncology community, with ESMO and other key oncology medical congresses poised to deliver defining moments for the field. As Astellas prepares to share new insights from across its oncology portfolio and pipeline, Chief R&D Officer, Tadaaki Taniguchi, reflects, “This is a seminal moment for Astellas. Cancer remains one of the world’s biggest healthcare challenges and we’re targeting some of the hardest-to-treat cancers with a sense of urgency to bring innovative medicines to the people who need them most.”
Astellas’ journey: Shaping cancer care with purpose and precision
Building on Astellas’ first major entry into the oncology space in 2012 with the launch of enzalutamide for prostate cancer, the company has expanded its portfolio across genitourinary, gastrointestinal and hematological cancers – always guided by the outcomes that matter to patients, caregivers and clinicians. Taniguchi notes, “By tapping into the deep well of expertise that already existed in our company in urology and immunology, and building the right R&D and commercialization capabilities, we’ve made important progress in a relatively short period of time.”
Guiding this evolution is a sophisticated understanding of biology, deep understanding of patient unmet needs, disease expertise and a focus on advancing cutting-edge modalities in potentially breakthrough areas of R&D.
Advancing the next generation of cancer therapies
Antibody-drug conjugates
Back in 2023, thousands of delegates at ESMO witnessed a pivotal moment for patients when the combination of an antibody-drug conjugate (enfortumab vedotin) and a checkpoint inhibitor (pembrolizumab) showed significant survival benefits in advanced urothelial cancer compared to chemotherapy – a milestone nearly a decade in the making. Today, this combination has become a new standard-of-care as a first-line therapy for patients who previously had limited options in advanced or metastatic disease.
New investigational data at ESMO will showcase the potential of this combination therapy in an earlier stage of disease for muscle-invasive bladder cancer (MIBC). MIBC represents approximately 30% of all bladder cancers.
Targeted protein degraders
Another key area of scientific innovation for Astellas is targeted protein degradation (TPD). TPDs have the potential to bind to and degrade so-called ‘undruggable’ targets and could change treatment expectations for a range of cancers and potentially in other disease areas.
The company’s lead investigational TPD candidate, ASP3082, is a KRAS G12D degrader being evaluated in clinical studies. KRAS mutations are known to be drivers of multiple aggressive cancers and while therapies exist for some forms of KRAS-positive cancers, there are currently no approved options for those with KRAS G12D mutations.
Early data from these studies have reported promising efficacy signals and a safety profile that support further investigation in pancreatic cancer. Additional clinical evaluation is underway to assess ASP3082 in other KRAS G12D-positive solid tumors, including lung cancer.
Precision-driven innovation
Precision approaches underpin Astellas’ oncology strategy, driving more than two-thirds of the company’s pipeline. This is evident in its leadership of CLDN18.2 targeting therapies, a biomarker found in notoriously difficult-to-treat gastric, gastroesophageal and pancreatic cancers.
Astellas’ monoclonal antibody, zolbetuximab, was approved as the first and only treatment targeting CLDN18.2 in gastric and gastroesophageal junction adenocarcinoma. Building on this foundation, Astellas is advancing a pipeline of next-generation CLDN18.2 targeting therapies to address unmet patient needs uncovered during zolbetuximab’s development. This includes new data to be presented at ESMO for ASP2138, an investigational, next-generation bispecific T-cell engager designed to help the immune system recognize and attack cancer cells more effectively.
As Astellas’ Head of Oncology Development, Moitreyee Chatterjee-Kishore explains, “Precision medicine is a key pillar of our R&D strategy. By combining a biomarker-driven approach with cutting-edge modalities, we have the opportunity to bring potentially transformative new medicines to patients.”
A long-term commitment to access and equality
While rapid innovation has transformed cancer care, the true promise of scientific innovation and precision medicine remains ahead – there is a need to ensure adequate reimbursement for diagnostics while simultaneously improving infrastructure to ensure patients have better access to advanced diagnostics and biomarker testing.
“A more unified strategy is needed to accelerate clinical development, drive more equitable outcomes, lower overall costs to healthcare systems and ensure patients receive the right treatment at the right time, no matter where they are in the world,” says Claus Zieler, Astellas’ Chief Commercial and Medical Affairs Officer.
That’s why Astellas is working closely with regulators, payers and advocacy groups to ensure that there is recognition from health systems that precision treatments are a better use of resources, ultimately helping to bring transformative therapies to more people who need them.
As the global oncology community gathers this October, Astellas stands ready to once again join the conversation, bringing new science and possibilities to the forefront of cancer care.
To learn more about Astellas’ science, visit https://www.astellas.com/en/science