HER3-expressing advanced NSCLC — BioNTech / Sichuan Kelun-Biotech — Investigational HER3-directed antibody-drug conjugate (ADC)
Visit Interactive Trial Page →
Top tweets by impressions — click to view on X
🆙 #ELCC26 @myESMO 🇩🇰 🔥Mini Oral session 2 ☑️YL202/BNT326: HER3 ADC 🎯ORR across doses: 22.7-55.6% 🎯mPFS across doses: 2.8-10.0m 🎙️Dr. Haifeng Liu 🎙️Chair: Dr. Kersti Oselin...
Great EGFR-mutant NSCLC session. Impressed by the Sac-TMT results (anti-TROP2 ADC), which show the most positive outcomes across two Chinese studies. Other ADCs are also in the pipeline, things are...
🔥 HER3 ADC enters the NSCLC space #ELCC26 First efficacy data of YL202/BNT326 in heavily pretreated NSCLC 👇 🧬 Study population • ≥3L NSCLC post TKI + platinum • EGFRm (n=96) | AGA–...
✨ Mini oral session 2 at #ELCC26: SHR-A2009 (HER3 ADC) + aumolertinib in EGFRm NSCLC (Ph1b/2) 🎯 ORR: 72.1% (1L) | 42.9% (≥2L) 📈 Durable responses (DoR up to 15.7 mo) ⚠️ TRAE G≥3:...
✨ Mini oral session 2 at #ELCC26: YL202/BNT326 (HER3 ADC) in NSCLC with EGFRm (cohort A2) and squamous NSCLC (cohort E1) (Ph2) 🎯 ORR 34.4%/mPFS 7.5-8.1 mo (EGFRm >=3L) 👍...
🆙 #ELCC26 @myESMO @IASLC 🇩🇰 🔥Mini Oral session 2 ☑️YL202/BNT326: HER3 ADC 🎯ORR across doses: 22.7-55.6% 🎯mPFS across doses: 2.8-10.0m 🎙️Dr. Haifeng Liu 🎙️Chair: Dr....
YL202/BNT326 (pumitamig) is an investigational HER3-directed antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload (drug-to-antibody ratio of 8), jointly developed by BioNTech and Sichuan Kelun-Biotech. The phase 2 study YL202-CN-201-01 (NCT06107686) evaluates the efficacy, safety, and pharmacokinetics of YL202/BNT326 across multiple NSCLC subgroups, including EGFR-mutant patients who progressed on prior TKI and platinum-based chemotherapy, squamous NSCLC, and non-squamous AGA-negative NSCLC. First efficacy results were presented at ELCC 2026, showing clinical activity across all evaluated cohorts and dose levels.
Multicenter, open-label, Phase 2 study (YL202-CN-201-01, NCT06107686) evaluating YL202/BNT326 IV Q3W at doses of 2.0, 2.5, and 3.0 mg/kg across multiple NSCLC cohorts. Data cutoff: January 27, 2026.
152 patients with advanced NSCLC: Cohort A2 (n=102, EGFRm post-TKI + platinum), Cohort E1 (n=23, squamous, 1-2 prior lines including PD-(L)1 + chemo), Cohort E2 (n=27, non-squamous AGA-negative, 1-2 prior lines).
YL202/BNT326 administered intravenously every 3 weeks at 2.0, 2.5, or 3.0 mg/kg until disease progression, intolerable toxicity, or withdrawal of consent.
Investigator-assessed ORR per RECIST v1.1 and recommended dose for the pivotal study. Secondary endpoints include PFS, DCR, DoR, and safety.
In 96 evaluable patients with EGFR-mutant NSCLC who had progressed on prior TKI and platinum-based chemotherapy, confirmed ORR was 34.4% (95% CI: 25.0-44.8%) across all dose levels. Median PFS was 7.5 months (95% CI: 5.91-8.84) with a 6-month PFS rate of 59.6%. Median duration of response was 6.8 months. At the 3.0 mg/kg dose, confirmed ORR reached 48.5% with median PFS of 8.2 months.
In 22 patients with squamous NSCLC (2.0 mg/kg), confirmed ORR was 9.1% with DCR of 81.8% and median PFS of 5.5 months. In 27 patients with non-squamous, AGA-negative NSCLC, confirmed ORR was 37.0% (95% CI: 19.4-57.6%) with median PFS of 5.6 months and median DoR of 7.0 months, demonstrating activity across histologic subtypes.
Based on related SHR-A2009 (HER3 ADC) combination data presented at ELCC 2026: Grade 3+ TRAEs occurred in 59.5% (2L+) and 31.1% (1L) of patients. The most common TRAEs included anemia, neutrophil count decrease, nausea, and decreased appetite. ILD was reported in 7.6% (2L+) and 4.9% (1L), with grade 3+ ILD in 3.8% and 1.6%, respectively. Dose discontinuation rates were 7.6% (2L+) and 14.8% (1L).
YL202/BNT326 demonstrates meaningful clinical activity as a HER3-directed ADC across multiple NSCLC subgroups, including heavily pretreated EGFR-mutant patients (3L+). The confirmed ORR of 34.4% and median PFS of 7.5 months in the post-TKI/platinum setting positions it among an emerging class of ADCs targeting the post-osimertinib treatment landscape. Notably, this is an investigational agent and no regulatory approvals have been granted. The broad activity across EGFRm, squamous, and AGA-negative NSCLC cohorts suggests potential utility beyond driver-mutation-selected populations.
