The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which took place in Chicago from May 30 to June 3, focused on how I-O is changing the way solid and hematologic cancers are treated.
Some of the most important I-O themes were off-the-shelf chimeric antigen receptor (CAR)-T in solid tumors, new combinations of checkpoint inhibitors, techniques for modulating the tumor microenvironment (TME), and the emergence of bispecific. These clinical advances are reflected in market momentum as the Frost & Sullivan upcoming market study “Growth Opportunities in Immuno-oncology (I-O) Therapeutics Market, 2024–2030,” the global I-O market is projected to reach $174.41 billion by 2030.
- Immunotherapy Combination Progress in Triple-negative Breast Cancer (TNBC)
Key Development: Gilead’s sacituzumab govitecan (Trodelvy) and Merck’s pembrolizumab (Keytruda) together dramatically lowered the risk of disease progression in PD-L1–positive TNBC.
Example: The Phase III EVOKE-02 study PFS increased from 7.8 to 11.2 months. Trodelvy and Keytruda are both approved by the US Food and Drug Administration (FDA), with expanding frontline and adjuvant applications.
Growth Opportunities:
- Increase the use of combination I-O treatments in TNBC populations chosen based on biomarkers.
- Shift towards chemotherapy-sparing protocols in PD-L1+ early-stage illness.
- Checkpoint Inhibitors Move Upstream in Resectable Disease
Key Development: The MATTERHORN study demonstrated that the addition of durvalumab (Imfinzi, AstraZeneca) to chemotherapy markedly decreased recurrence in resectable gastric/ gastroesophageal junction (GEJ) cancers.
Example: Event-free survival improved significantly, reinforcing the trend of checkpoint inhibitors expanding into curative-intent regimens.
Growth Opportunities:
- Use checkpoint inhibitors in neoadjuvant and adjuvant contexts.
- Create biomarkers to predict the likelihood of recurrence and response.
- Bispecific Antibodies (BsAbs) Enter I-O-Resistant Indications
Key Development: IBI363, a PD-1/IL-2a-biased bispecific fusion created by Innovent Biologics, showed that it could suppress tumors in microsatellite stable (MSS)/proficient mismatch repair (pMMR) colorectal cancer, an I-O-resistant condition.
Examples: The combination with bevacizumab (Avastin) offered new hope in cold tumor settings in Phase I/II trials. BsAbs are central to I-O pipeline investment, owing to their dual-targeting ability and success in converting immune-desert tumors into inflamed microenvironments.
Growth Opportunities:
- Expansion of BsAbs into pancreatic, prostate, and ovarian cancers.
- Advance personalized I-O by leveraging patient-specific TME features.
- Localized CAR-T Delivery Expands I-O into CNS
Key Development: The Phase I trials of intracerebroventricular infusion of CART-EGFR-IL13Ra2 demonstrated early efficacy in recurrent glioblastoma (rGBM).
Example: Developed by UPenn and Kite/Gilead, this approach showed tumor shrinkage and long-term CAR-T persistence in CSF. CAR-T sector is undergoing a pivotal shift, from autologous hematologic use toward off-the-shelf allogeneic platforms for solid tumors, leveraging improved persistence, scalability, and flexibility.
Growth Opportunities:
- Utilize multi-antigen CARs to overcome tumor heterogeneity.
- Integrate new central nervous system (CNS) biomarkers with new imaging techniques.
- Label Expansion of Flagship I-O Products in Late-stage Trials
At ASCO 2025, multiple mature I-O therapies revealed breakthrough potential in new indications and combinations:
- Nivolumab (Opdivo, BMS): The Phase 3 NIVOPOSTOP study showed that using it as an adjuvant treatment for resected high-risk head and neck squamous cell carcinoma (HNSCC) enhanced relapse-free survival.
- Pembrolizumab (Keytruda, Merck): Data from recent long-term adjuvant research in human papillomavirus (HPV)-negative HNSCC and early-stage NSCLC indicate sustained recurrence prevention, facilitating its advancement into earlier treatment contexts.
- Durvalumab (Imfinzi, AstraZeneca): In addition to gastrointestinal malignancies, late-phase trials demonstrated enhanced disease control when used in conjunction with new transforming growth factor (TGF)-beta inhibitors and bispecific antibodies in cold tumors.
- AI and Diagnostic Technology Elevate I-O Precision
ASCO 2025 highlighted the increasing utilization of AI and digital pathology to enhance immuno-oncology medication discovery and precision therapy.
Illustrations:
- AI-assisted HER2 scoring enhanced accuracy from 66.7% to 88.5% in breast cancer, facilitating the optimal use of targeted medicines such as Enhertu (Daiichi Sankyo/AstraZeneca).
- Circulating tumor DNA (ctDNA) monitoring instruments and liquid biopsies are progressively utilized to inform therapy escalation or de-escalation in early-stage illness.
- Spatial transcriptomics and high-plex imaging are facilitating the identification of new immunological markers.
Growth Opportunities:
- Radiomics and digital pathology for I-O eligibility and monitoring.
- Combining I-O and AI-informed diagnostics for adaptive trial designs.
- Combining real-world evidence platforms to improve label extensions and regulatory processes.
Looking Ahead: I-O Shifts from Palliative to Potentially Curative
ASCO 2025 reinforced a clear direction: I-O is transitioning from advanced-line palliation to early-line, biomarker-driven curative strategies — powered by new modalities and technology. This clinical evolution aligns directly with forecasted commercial growth, where innovations in antibody-drug conjugates (ADCs), BsAbs, and scalable CAR-T platforms are expected to drive significant investment and expansion through 2030.
Want to Learn More?
To explore therapeutic landscapes, pipeline analysis, market sizing, and innovation ecosystems shaping the $174 billion I-O market, connect with our team at [email protected].
Appendix:
Explore Frost & Sullivan’s latest analyses on oncology innovation:
- Immunomodulator Therapeutics Market, Global, 2024–2030
- Innovation Waves in Immuno-oncology Therapy Development
- Global Precision Oncology Market Trends and Growth Opportunities
- Engineered Antibody Therapeutics for Cancer
- Global Oncology Diagnostics in IVD Growth Opportunities
- CGT Research Outlook and Technology Growth Opportunities
- Technological Advances in Cancer Biologics and Precision Medicine Strategies
