2026关键数据背后的创新趋势与价值判断_19页_535kb

报告摘要

ASCO 2026 Summary: Key Trends and Insights

Heme Oncology Trends

Core Content

CAR-T vs. Bispecific Sequencing: The focus has shifted from selecting between CAR-T and bispecifics to determining the optimal sequence, especially in relapsed/refractory (r/r) multiple myeloma (MM) and B-cell lymphomas.
Sequencing Data Gaps: Most pivotal trials exclude prior same-target exposure, leading to limited direct comparisons. However, real-world registries and guidelines are starting to address this gap.

Key ASCO 2026 Data

MajesTEC-9 (7507): Tecvayli (teclistamab) showed benefit in r/r MM when used earlier than its accelerated approval setting, but the sequence against CAR-T remains untested.
CARTITUDE-4 (7536): Carvykti (cilta-cel) confirmed its early-line position in lenalidomide-refractory MM, but excluded prior CAR-T and bispecifics.
SUNMO (7007): Lunsumio (mosunetuzumab) plus Polivy (polatuzumab vedotin) moved a chemo-free bispecific combination earlier and permitted prior CAR-T, offering insight into post-CAR-T sequencing.
In Vivo CAR-T: Trials like inMMyCAR (7509) with Kelonia's KLN-1010 showed promising results with no lymphodepletion, offering a more accessible option.
CD8-tLNP (7014): A Phase I study demonstrated rapid B-cell depletion and manageable safety, though responses were partial and transient.
EVEREST-2 (8579): A2 Bio's logic-gated mesothelin Tmod CAR-T showed a complete response in NSCLC, highlighting potential for solid tumors.
LB2102 (8012): Legend's dnTGFβR2-armored DLL3 CAR-T demonstrated 28.6% ORR and 78.6% disease control in r/r SCLC, with manageable safety.

KOL Sentiment

KOLs highlighted the need for further data on washout periods, dosing strategies, and the balance between rapid disease control and long-term CAR-T benefit.
In vivo CAR-T is seen as a game-changer due to its accessibility and reduced logistical burden, though limited data remains.
There is cautious optimism about engineered architectures improving CAR-T performance in solid tumors.

Commercial Trends

In vivo CAR-T is attracting major pharmaceutical investments, including AstraZeneca/EsoBiotec (~$1B), AbbVie/Capstan ($2.1B), and others.
Logic-gated and armored solid-tumor CAR-Ts remain venture-funded, with A2 Bio securing $80M Series C.

Next Steps

Post-CAR-T bispecific trials are underway, including Columvi (GLORY), Ordspono (ELM-1), and Epkinly (EPCORE NHL-1).
The field will refine post-CAR-T strategies rather than provide a definitive head-to-head comparison.

GLP-1 Receptor Agonists and Cancer

Core Content

GLP-1 receptor agonists are increasingly used in oncology, showing potential for cancer prevention and reduced mortality risk.
The class is moving from early signals to large real-world datasets, suggesting onco-protective effects.

Key ASCO 2026 Data

Breast cancer prevention: GLP-1 use was linked to a 27% lower risk of breast cancer incidence.
Leukemia prevention: Up to 63% reduction in AML onset.
Solid tumor survival: 42% drop in risk of death.
Checkpoint inhibitor synergy: GLP-1 users showed improved survival and fewer adverse events with IO.
Paradoxical findings: Higher BMI in GI cancers was associated with reduced mortality in some cases.

Industry and KOL Sentiment

Industry sees GLP-1s as a key component of "metabolic oncology," shifting focus from safety to potential protective benefits.
KOLs view the data as hypothesis-generating, acknowledging the need for prospective trials to confirm findings.

Next Steps

Randomized prevention studies and GLP-1 × checkpoint inhibitor interaction trials are needed to solidify evidence.
The real-world use of GLP-1s may complicate trial comparisons and benchmarking.

ADCs in Gynecological Cancers

Core Content

Gynecological cancers are seeing advancements in ADCs and combinations, with new targets and mechanisms being explored.
Toxicity management and target sequencing are critical for optimizing benefit-risk.

Key ASCO 2026 Data

BLUESTAR study (5515): Puxi-Sam targeting B7-H4 showed impressive ORR in endometrial cancer.
Telisotuzumab adizutecan (5514): Demonstrated efficacy and safety in ovarian cancers with poor outcomes.
CRB-701 (5508): Nectin-4-targeting ADC showed promise in cervical cancer.

Trials to Watch

BLUESTAR-Endometrial01, TroFuse-020, ASCENT-GYN-01, RAINFOL-03

Next Steps

Further trials are needed to validate biomarker expression cutoffs and optimize combinations.
Ongoing trials like MIROVA (5506) and CHIPRO (LBA5504) explore ADCs in combination with chemotherapy or other agents.

ADCs in HER2+ Breast Cancer

Core Content

Trastuzumab deruxtecan (T-DXd) has become the standard in HER2+ breast cancer, with new approvals in neoadjuvant and adjuvant settings.
Real-world data and depth-of-response analyses are expanding the understanding of T-DXd's role.

Key ASCO 2026 Data

DB-09 (T-DXd + pertuzumab): 15.4% CR, 71.1% PR, with durable responses.
DB-05: T-DXd showed higher ILD risk than T-DM1, especially in Japanese and renal-impaired patients.
OptiTROP-Lung05: Sac-TMT + Keytruda demonstrated significant PFS benefit over Keytruda monotherapy in PD-L1+ NSCLC.

Trials to Watch

EmpowHER-303, HORIZON-Breast01, TQB2102, DESTINY-Breast07

Next Steps

EmpowHER-303 will test the post-T-DXd landscape.
New ADCs and bispecifics are positioning themselves in post-T-DXd patients, with competition likely to depend on global trials and combination strategies.

PD-(L)1×VEGF Bispecifics & ADCs in NSCLC

Core Content

PD-(L)1×VEGF bispecifics and TROP2-targeted ADCs are challenging Keytruda's dominance in first-line NSCLC.
These agents are primarily developed in China, using local comparators.

Key ASCO 2026 Data

HARMONi-6 (LBA4): Ivonescimab + chemo reduced mortality by 34% vs Tevimbra + chemo.
OptiTROP-Lung05 (Abs:8504): Sac-TMT + Keytruda showed 65% PFS improvement over Keytruda alone.
ROSETTA Lung-02 (Abs:8513): Pumitamig + chemo delivered 70% uORR and 62.5% cORR, comparable to ivonescimab.

KOL Sentiment

KOLs view the data as compelling but not yet practice-changing in Western markets.
The bispecific class may fragment its own opportunity, depending on trial outcomes.

Next Steps

HARMONi-3 and TroFuse-007 are critical global trials to watch.
ROSETTA Lung-202 is a head-to-head trial between pumitamig and Keytruda.

HNSCC in a Targeted Therapy Era

Core Content

HNSCC is witnessing a surge in targeted therapies and combinations, especially in post-IO and post-platinum settings.
Bispecifics and ADCs are emerging as key options for improving outcomes.

Key ASCO 2026 Data

OrigAMI-4 (Abs-6008): Amivantamab showed 42% ORR in HPV-unrelated R/M HNSCC post-ICI/chemo.
Izalontamab (Abs-6019): Combined with paclitaxel, showed 52.9% ORR, suggesting dual-receptor blockade efficacy.
Ipatasertib + pembrolizumab (Abs-6006): AKT inhibition with IO showed 2.4× ORR improvement.
Tosposertib + pembrolizumab (Abs-2635): 75% ORR in 1L, 42.9% in 2L, with activity across PD-L1 subgroups.

Trials to Watch

OrigAMI-5, TroFuse-007, ROSETTA Lung-202, Neoadjuvant ivonescimab + AP

Next Steps

Further trials are needed to validate the efficacy of combinations and to confirm the role of bispecifics and ADCs in the first-line setting.
The HPV-unrelated biomarker is gaining attention, with EGFR/MET co-expression as a key feature.

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