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CRC's rising global burden, driven by aging and westernized lifestyles, meets precision oncology advances in MSI-H, BRAF, and KRAS G12C subgroups, but equity gaps and MSS resistance persist.
TNBC disproportionately affects women of African ancestry and younger patients, with aggressive biology and global treatment inequities limiting progress despite immunotherapy and ADC advances.
Gastric cancer's global burden is concentrated in East Asia and projected to nearly double by 2050, with molecular classification enabling biomarker-driven precision therapies, yet screening and equity gaps persist.
Multiple myeloma's global burden is rising fastest in aging and middle-income populations, but therapeutic breakthroughs remain unequally distributed, with profound survival disparities across income, race, and geography.
NSCLC remains a global health emergency, with precision oncology transforming care through molecular profiling, yet unmet needs in screening access, resistance, and global equity persist.
Pharma deployed $22B+ into AI drug discovery in 2025–2026, driven by patent cliffs and R&D productivity failures, but clinical validation remains unproven.
AI-driven oncology biomarker discovery advances from exploratory research to early clinical implementation, but prospective validation and interpretability remain critical gaps before routine clinical adoption.
AI accelerates clinical trial recruitment and protocol design with up to 95% efficiency gains, but governance, bias, and evolving FDA/EMA/NMPA regulatory frameworks remain critical implementation challenges.
AI-designed drugs reach Phase 3 trials (rentosertib, zovegalisib, GB-0895) but none yet approved; Phase 2 success matches industry norms, and regulatory frameworks are rapidly evolving.
AI-discovered drugs reach Phase III (rentosertib) but none yet approved; Phase II success matches industry norms, and target biology remains the primary bottleneck.
First-wave CD47 blockade failed in AML/MDS due to toxicity and Fc design flaws, but tumor-selective bispecifics and RBC-sparing antibodies sustain therapeutic promise.
TIGIT blockade failed Phase 3 in NSCLC and SCLC with IgG1 antibodies, but Fc-silent domvanalimab and bispecific rilvegostomig sustain signals in biomarker-selected and gastrointestinal cancers.
Tarlatamab's regulatory approval and phase III OS benefit anchor DLL3-directed SCLC therapy, with next-generation ADCs and bispecific platforms driving the expanding therapeutic pipeline.
CLDN18.2-targeted therapies — from approved zolbetuximab to ADCs, CAR-T, and bispecifics — are reshaping gastrointestinal oncology, with biomarker harmonization remaining the critical unresolved challenge.
KRAS G12C inhibitors evolved from first-in-class approval to Phase III superiority and first-line immunotherapy combinations, with resistance-informed strategies shaping next-generation targeted therapy.
CD3 bispecific antibodies redirect T cells against hematologic and solid tumors, with nine approved agents and maturing safety management enabling earlier-line and outpatient use through 2026.
PD-1 bispecifics combine checkpoint blockade with VEGF or CTLA-4 targeting, demonstrating PFS superiority in NSCLC niches; global replacement awaits FDA/EMA decisions and guideline integration.
Bispecific antibodies redirect T cells, block dual checkpoints, and combine angiogenic-immune targeting, with thirteen approved agents transforming hematologic and solid tumor care through 2026.
CAR-T therapy achieves drug-free immune reset in refractory autoimmune diseases, with high remission rates across SLE, myositis, sclerosis, and myasthenia; randomized evidence remains limited.
Allogeneic CAR-T delivers off-the-shelf cell therapy with manageable safety, rapid access, and pivotal trials nearing registrational readouts by 2026–2028.