The 2026 European Society for Medical Oncology (ESMO) Annual Congress was held in Madrid, Spain from October 23 to 27. As one of the international conferences with the highest academic influence in global oncology and the strongest role as a bellwether for new drug development, ESMO serves both as a core platform for global pharmaceutical companies to present clinical data and as a preview of the cancer treatment landscape for the next three to five years.
At this year's congress, Chinese innovative drug companies delivered outstanding performances, particularly in the fields of lung cancer and colorectal cancer. Multiple companies disclosed pivotal clinical studies covering the full treatment course from first-line initial therapy, later-line resistance, and maintenance treatment, with several head-to-head studies and long-term survival benefit data reaching globally leading levels.
Sanofi and Innovent Biologics Dual Antibodies Poised to Challenge First-Line Standard of Care; Baili Tianheng Dual-Antibody ADC Delivers Impressive Data
Lung cancer is the malignant tumor with the highest incidence and mortality rates worldwide. According to IARC 2024 data, there were approximately 2.2 million new cases and 1.8 million deaths globally, with non-small cell lung cancer (NSCLC) accounting for about 85% and small cell lung cancer (SCLC) accounting for about 15%. Due to complex resistance mechanisms and strong tumor heterogeneity, lung cancer has always been the most fiercely competitive track for innovative drug development.
At this ESMO congress, Chinese pharmaceutical companies achieved breakthroughs in both NSCLC and SCLC. In first-line treatment of driver-gene-negative advanced NSCLC, PD-(L)1 inhibitors combined with platinum-based chemotherapy represent the global standard of care, but efficacy improvement has entered a bottleneck over the past decade, with median overall survival mostly in the 15-20 month range, and benefits for PD-L1 low-expression populations being very limited.
3SBio disclosed its SSGJ-707 (PD-L1/VEGF dual antibody) China randomized controlled Phase II study, which for the first time achieved clinical validation of a domestic dual antibody being superior to an imported PD-1 monoclonal antibody in a head-to-head comparison. The study enrolled 261 treatment-naive patients with non-AGA advanced NSCLC, of whom 44% were PD-L1 TPS<1% low-expression patients. Data showed that SSGJ-707 combined with chemotherapy performed better than tislelizumab combined with chemotherapy. In non-squamous patients, cORR increased from 44.7% to 75.0%, and the 12-month PFS rate increased from 43.0% to 56.0%; in squamous patients, cORR increased from 67.7% to 82.5%, and the 12-month PFS rate increased from 45.5% to 48.0%. In terms of safety, the discontinuation rate due to TRAEs in the SSGJ-707 group was only 3.2%, significantly lower than the 9.9% in the control group. Pfizer has already initiated the global Phase III registrational clinical trial Symbiotic Lung-01 for this product, which is expected to become the first domestic dual antibody to challenge the global first-line standard of care.
In later-line treatment, Hengrui Medicine's c-MET ADC SHR-1826 combined with adebrelimab and SHR-8068 dual immunotherapy regimen achieved a uORR of 42.4% and median PFS of 8.3 months in previously treated non-squamous NSCLC, providing a new treatment option for the c-MET abnormal expression immunotherapy-resistant population.
Breakthroughs were also achieved in the field of EGFR-mutant NSCLC. EGFR-mutant NSCLC is a highly prevalent subtype in Asian populations, accounting for approximately 40%-50% of NSCLC patients in China. Treatment options after third-generation EGFR-TKI resistance are limited, making it one of the areas with the most prominent unmet clinical needs.
At this ESMO congress, Baili Tianheng disclosed Phase II first-line data for its EGFR/HER3 dual-antibody ADC Iza-bren combined with osimertinib. The study enrolled 154 treatment-naive EGFR-mutant NSCLC patients. Across all dose groups, cORR reached 81.8%, DCR reached 96.8%, the 24-month PFS rate reached 70.2%, and the 24-month OS rate reached 86.6%; among them, the 2.5mg/kg dose group achieved a cORR as high as 97.5%, an 18-month PFS rate of 92.2%, with both median PFS and median DoR not reached. By comparison, the data for Iza-bren combined with osimertinib far exceeds historical data for existing third-generation TKI monotherapy in first-line treatment.
Regarding small cell lung cancer (SCLC), due to rapid proliferation, early metastasis, and strong drug resistance, SCLC is known as the "king of lung cancer." After first-line platinum-based chemotherapy combined with immunotherapy for extensive-stage SCLC, median overall survival is less than 13 months, and later-line treatment options are extremely limited, with median OS of only 6-8 months. DLL3 is a specific target highly expressed on the surface of SCLC cells and has become a core breakthrough point for SCLC research and development in recent years.
At this ESMO congress, CSPC Pharmaceutical Group announced two Phase III studies of tarlatamab (DLL3/CD3 TCE). Tarlatamab in second-line treatment of ES-SCLC achieved a median OS of 13.6 months, extending survival by 5.2 months compared to the chemotherapy group and reducing the risk of death by 38%. The more milestone-worthy DeLLphi-305 study explored the value of tarlatamab combined with durvalumab maintenance therapy after first-line chemoimmunotherapy induction. Results showed that the combination group achieved a median OS of 21.1 months, extending survival by 8.4 months compared to single-agent immunotherapy maintenance, with a 58% reduction in the risk of death; median PFS increased dramatically from 1.9 months to 7.4 months, with a 66% reduction in the risk of disease progression; ORR reached 26.4%, which is 6.4 times that of the monotherapy group.
The DLL3 ADC route has also progressed rapidly. Zai Lab's ZL-1310 (zoci) combined with atezolizumab showed impressive first-line treatment data, with the 1.6mg/kg dose group achieving a cORR of 80.0% in first-line ES-SCLC patients, and the dual-drug regimen having a ≥Grade 3 TEAE incidence of only 26.7%, showing significantly better tolerability than the three-drug regimen combined with chemotherapy, providing a chemotherapy-free treatment possibility for patients who cannot tolerate chemotherapy.
New Hope for Later-Line Colorectal Cancer Treatment; Keymed Biosciences CDH17 ADC Worth Anticipating
Colorectal cancer is the third most common malignant tumor worldwide. In 2024, there were approximately 2.04 million new cases and 918,000 deaths globally, with about 25% of patients already having metastases at initial diagnosis, and approximately 50% of the remaining early-stage patients eventually developing metastatic colorectal cancer (mCRC). After first-line and second-line chemotherapy combined with targeted therapy, treatment options for third-line and later mCRC patients are very limited, with standard regimen ORR of only about 6% and median OS of less than 11 months, representing an extremely urgent clinical need.
At this ESMO congress, ADC drugs achieved precise stratification breakthroughs through target specificity, while multi-mechanism immunotherapy innovative regimens brought new hope for the larger MSS/pMMR population, jointly driving the upgrade of the later-line mCRC treatment landscape.
CEACAM5 (also known as CEA) is one of the most clinically valuable targets in colorectal cancer, highly expressed in approximately 80% of colorectal cancers and closely associated with tumor invasion and metastasis. Merck's CEACAM5 ADC Precem-TcT disclosed global Phase I study data for later-line mCRC at this ESMO congress, becoming the biggest highlight of later-line treatment. The study enrolled 60 patients with third-line and later mCRC who had previously received oxaliplatin, irinotecan, and fluoropyrimidine treatment, randomized 1:1 to receive 2.8mg/kg or 2.4mg/kg doses. Among enrolled patients, KRAS mutations accounted for 70%, NRAS mutations 6.7%, and BRAF mutations 8.3%, more closely reflecting real-world patient characteristics. Results showed that the 2.8mg/kg dose group achieved a median OS of 15.7 months, extending survival by nearly 5 months compared to the existing third-line standard regimen; median PFS reached 6.9 months, and cORR reached 20.7%, more than three times that of the existing standard regimen. Notably, efficacy was not significantly affected by KRAS, NRAS, BRAF mutation status or CEACAM5 expression levels, meaning the product is expected to cover a broader later-line mCRC population. In terms of safety, ≥Grade 3 TEAEs were mainly hematologic toxicities, with no interstitial lung disease, treatment-related deaths, or permanent discontinuation events, with overall tolerability being manageable. The product has already initiated a global Phase III registrational clinical trial and is expected to become the first approved CEACAM5 ADC drug.
Among domestic companies, Keymed Biosciences' independently developed CDH17 ADC CM518D1 also performed impressively. CDH17 has an expression coverage of over 90% in colorectal adenocarcinoma, with limited expression in normal tissues, making it a highly promising broad-spectrum ADC target. The China Phase I/II data disclosed at this ESMO congress showed that the study enrolled 84 patients with multi-line treated CRC, with a median of 3 prior treatment lines. Among 66 patients who completed at least one post-baseline assessment, the 4.8mg dose group achieved a uORR of 33.3%; the 5.8mg and 6.8mg dose groups achieved DCR of 88.9% and 100%, respectively, with clear tumor shrinkage observed in both. Since the CDH17 target covers a broader population and is not restricted by RAS/BRAF mutation status, CM518D1 is expected to bring treatment opportunities to more later-line mCRC patients.
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