Advancements in Biomarker-Driven Medicines, Cancer Vaccines, and AI Applications Paving the Way for Expansion of Precision Oncology
The sessions of the American Society of Clinical Oncology (ASCO) 2024 conference focused on this year’s theme – The Art and Science of Cancer Care: From comfort to cure. A few of the interesting developments announced included the development of biomarker-driven medicines that have led the way in the therapy of lung and breast cancer, among other cancers, and the exciting future of cancer vaccines, particularly when paired with immunotherapy (immuno-oncology [I-O]).
Biomarker Driven Treatments for Lung Cancers Continue to Gain Prominence
The impetus in the field of lung cancer research is sustained by the emergence of new data, which showcased the encouraging clinical outcomes presented by major biopharmaceutical companies.
The most favorable outcomes for advanced non-small cell lung cancer (NSCLC) patients have been observed in the Phase III CROWN study, which was conducted by Pfizer and evaluated lorlatinib, an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI). The CROWN trial’s 5-year analysis showed that lorlatinib therapy had the longest progression-free survival in ALK-positive NSCLC, making it the recommended first-line treatment. Results of the LAURA study, which investigated adjuvant osimertinib (Tagrisso) in unresectable EGFRm stage III non-small cell lung cancer (NSCLC) after concurrent chemotherapy-radiation therapy, and ADRIATIC study, which evaluated durvalumab (Imfinzi) as a consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) patients who have had concomitant chemoradiation and are in stages I through III of inoperable malignancy, were presented by AstraZeneca.
Data from the LAURA study, which demonstrate that osimertinib improves progression-free survival in patients with unresectable stage III estimated glomerular filtration rate (EGFR)-mutated NSCLC, have potential to set a new standard of care for patients with EGFR mutations. Also, consolidation of durvalumab may become the standard of therapy for limited-stage (LS)-SCLC patients who did not progress following concurrent chemoradiation therapy (CCRT).
Promising Progress in the Field of Cancer Vaccines
Cancer vaccines, both prophylactic and therapeutic, are being developed for multiple cancers, with RNA vaccines gaining popularity as personalized options, while cell-based, DNA, and biomimetic nanovaccines are also being developed. Neoantigen discovery advances is one of the major drivers amongst others in immune-oncology highlighted in our recently published study, Innovation Waves in Immuno-oncology Therapy Development.
Merck and Moderna officially disclosed the three-year results from a phase IIb study of their collaborative cancer vaccine for resected melanoma in ASCO. The information is derived from KEYNOTE-942, a clinical study that evaluated the personalized neoantigen treatment (INT) in conjunction with Keytruda for 157 patients diagnosed with high-risk melanoma (stage 3/4) after full surgical removal. Preliminary clinical evidence indicates that using a customized neoantigen mRNA vaccination with the conventional adjuvant pembrolizumab may provide therapeutic advantages as compared to using pembrolizumab alone.
Recent research has shown the efficacy of human papillomavirus (HPV) vaccination in avoiding the occurrence of several types of malignancies associated with HPV, particularly in lowering the likelihood of head and neck cancer in males. Off-the-shelf vaccines, like mRNA vaccines, have been gaining clinical attention around immunotherapy. ELI-002 7P, the main candidate of Elicio Therapeutics, headquartered in Massachusetts, is an off-the-shelf cancer vaccine consisting of seven peptides. Administration of ELI-002 7P in patients during a phase I study resulted in a 71% decrease in tumor biomarkers.
Antibody-Drug Conjugate (ADC) Targets: Current and Future Targets Remains a Priority Focus
Big biopharma has embraced the trend of transitioning primary cancer treatment from chemotherapy to innovative targeted treatments since the ADC market is projected to grow at a CAGR of 25.4% between 2022-2028, as projected in the Global Antibody Drug Conjugate (ADC) Growth Opportunities, Forecast to 2028. During ASCO 2024, AbbVie unveiled new data from its ADC platform, which is now being used for the development of therapies that specifically target solid tumors. In the past, ADCs were mostly focused on targeting blood malignancies, but they are increasingly being used to treat a wide range of tumor types.
Early clinical evidence indicates that AbbVie’s ADCs, ABBV-400 and ABBV-706, have shown encouraging outcomes. Another ADC that gained significant attention was Enhertu, a collaboration between the AstraZeneca and the Daiichi Sankyo. In a clinical study, Enhertu demonstrated a 37% reduction in the likelihood of breast cancer development compared to chemotherapy. This effect was seen in patients who tested positive for human epidermal growth factor receptor 2 (HER2), as well as those with low or ultralow levels of HER2.
The conference also covered the increasing significance of real-world evidence and the use of artificial intelligence (AI) for effective clinical decision-making in the field of oncology. As highlighted in our recent study (Global Precision Oncology Market Trends and Growth Opportunities) integrated cancer data platforms is one of the key growth opportunities in oncology.
ConcertAI, a vendor of trial software, has announced a partnership with Nvidia to create advanced clinical simulations that will enhance the development of future AI solutions for clinical trials. The primary emphasis of the collaboration will be on developing extensive clinical simulations with billions of data records per patient. Large language models for precision oncology, decision-making models, trial design, and real-time clinical information retrieval models will all benefit from these to enable them to quickly anticipate outcomes and provide answers when combined with other models.
The key imperatives for oncology industry stakeholders includes:
- Collaboration between pharmaceutical companies, the government, academics, and diagnostics providers are crucial for personalized medicine adoption and development.
- Accurate identification of neoantigens and reliable clinical results are essential for enabling access to individualized treatment needs to be resolved.
- Continuous biomarker testing is necessary to assess targeted therapy effectiveness including immunohistochemistry and next-generation sequencing (NGS).
