beruzatatug pelitecan (BNT326) / MediLink, BioNTech - LARVOL DELTA

YL202/BNT326, a HER3-targeted ADC, in patients with locally advanced or metastatic non-small cell lung cancer and breast cancer: Preliminary results from a first-in-human phase I trial. (ASCO 2024) - P1 | "YL202/BNT326 demonstrated encouraging efficacy in heavily pretreated locally advanced/ metastatic NSCLC and BC. The safety profile showed adequate safety and tolerability."

Clinical • Metastases • P1 data • Alopecia • Anemia • Breast Cancer • Dental Disorders • Fatigue • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Stomatitis • Xerostomia • EGFR • ERBB3 • HER-2

Clinical outcomes of YL202/BNT326 (HER3 ADC) in advanced/metastatic HR+/HER2-null/low breast cancer (BC) in chemotherapy (chemo)-naïve and exposed patients (pts) (ESMO 2026) - No abstract available

ADC • Clinical • Clinical data • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ERBB3 • HER-2

First disclosure of efficacy and safety data for YL202/BNT326 (HER3 ADC) from a phase II trial in patients (pts) with non-small cell lung cancer (NSCLC) (ELCC 2026) - P1/2, P2 | "Based on these results, YL202/BNT326 is being evaluated in combination with pumitamig (BNT327), an investigational anti-PD-L1xVEGF-A bispecific antibody, in NSCLC (NCT07111520). Legal entity responsible for the study MediLink Therapeutics. Funding MediLink Therapeutics."

ADC • Clinical • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ERBB3

BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=880 | Recruiting | Sponsor: BioNTech SE | N=420 ➔ 880 | Trial completion date: Jan 2030 ➔ Jun 2030

Enrollment change • Trial completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • HER-2 • KRAS • MET • NTRK • RET • ROS1

BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=1438 | Recruiting | Sponsor: BioNTech SE | N=980 ➔ 1438 | Trial completion date: Oct 2029 ➔ Mar 2030

Enrollment change • Monotherapy • Trial completion date • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • HER2 Negative Breast Cancer • Hormone Receptor Negative Breast Cancer • Lung Cancer • Melanoma • Mucosal Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • ALK • BRAF • HER-2

Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=440 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer (clinicaltrials.gov) - P3 | N=376 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumors. (ASCO 2026) - P1, P1/2, P2 | "Primary endpoints are safety, overall response rate, and pharmacokinetics for cohort 1F. Enrollment for all cohorts is ongoing globally."

ADC • Clinical • Combination therapy • Metastases • Monotherapy • P1/2 data • Breast Cancer • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB3 • HER-2

YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Trial primary completion date: Dec 2025 ➔ Dec 2026

First-in-human • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB3 • HER-2

Pumitamig + BNT326: Data from P1/2 trial (NCT07111520) for NSCLC in 2026 (BioNTech) - Q1 2026 Results

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=420 | Recruiting | Sponsor: BioNTech SE

Trial initiation date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • HER-2 • KRAS • MET • NTRK • RET • ROS1

BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=980 | Recruiting | Sponsor: BioNTech SE | N=329 ➔ 980

Enrollment change • Monotherapy • Trial initiation date • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Lung Cancer • Melanoma • Mucosal Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • ALK • BRAF • HER-2

Pivotal study to evaluate YL202 versus Docetaxel in Patients with Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (ChiCTR) - P3 | N=440 | Sponsor: Shanghai Dongfang Hospital; Shanghai Dongfang Hospital

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: BioNTech SE

Monotherapy • New P1/2 trial • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: BioNTech SE | N=172 ➔ 280

Enrollment change • Monotherapy • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

BNT326-02: A phase Ib/II trial of BNT326/YL202 (HER3 ADC) with pumitamig (PD-L1 × VEGF-A bsAb) in non-small cell lung cancer (NSCLC) (ELCC 2026) - P1/2 | "D2: PD-L1 <50%, randomized 1:1 to BNT326 (DL2) with pumitamig or pembrolizumab + chemotherapy. Enrollment is ongoing globally."

ADC • IO biomarker • P1/2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ERBB3 • PD-L1 • VEGFA

BNT326/YL202 – a HER3-targeted ADC candidate developed in collaboration with MediLink Therapeutics (Suzhou) Co., Ltd. ('MediLink') (GlobeNewswire) - "NSCLC: First clinical data from the NSCLC cohort of a Phase 2 clinical trial with BNT326/YL202 (NCT06107686) conducted in China showed antitumor activity and a favorable safety profile in patients with advanced or metastatic NSCLC who progressed after standard of care therapy. The findings support the ongoing Phase 1b/2 clinical trial (NCT07070232) evaluating the novel combination of pumitamig and BNT326/YL202."

P2 data • Trial status • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer

BNT326-02: A clinical trial to test if an investigational combination therapy with BNT326 and BNT327 is safe and potentially beneficial for people with advanced non-small cell lung cancer (NSCLC) (clinicaltrialsregister.eu) - P1/2 | N=88 | Not yet recruiting | Sponsor: BioNTech SE

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer (clinicaltrials.gov) - P3 | N=376 | Not yet recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

BNT326-01: A clinical study to test if an investigational treatment called BNT326 is safe and potentially beneficial when used alone or in combination with other investigational treatments such as BNT327, for people with advanced malignant tumors (clinicaltrialsregister.eu) - P1/2 | N=172 | Recruiting | Sponsor: BioNTech SE

Monotherapy • New P1/2 trial • Oncology • Solid Tumor

A Study of YL202 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=440 | Not yet recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First disclosure of efficacy and safety data for YL202/BNT326 (HER3 antibody-drug conjugate [ADC]) in advanced or metastatic HR+/HER2 null and HER2-low breast cancer: Phase 2 trial results (SABCS 2025) - P1/2, P2 | "The data suggest an encouraging clinical efficacy and manageable safety profile of YL202/BNT326 in BC pts with HR+ and HER2 null or HER2-low expression, with no treatment discontinuation due to TRAEs. This study continues to enroll pts with HR+ HER2-null/low BC and in addition is enrolling pts with triple-negative breast cancer. Furthermore, YL202/BNT326 is being evaluated in combination with pumitamig, an investigational anti-PD-L1 x VEGF-A bispecific antibody in pts with BC (NCT07070232)."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

In the last quarter, BioNTech initiated several signal-seeking clinical trials to evaluate pumitamig with the Company’s proprietary assets (GlobeNewswire) - "(i) In August, the first patient was dosed in a Phase 1/2 clinical trial (NCT07079631) to evaluate...BNT314/GEN1059 in combination with pumitamig and chemotherapy in patients with advanced CRC; (ii) Also in August, the first patient was dosed in a Phase 1/2 clinical trial (NCT07070232) to evaluate pumitamig in combination with...BNT326/YL202 and BNT326/YL202 as monotherapy in advanced solid tumors; (iii) In September, the first patient was dosed in a Phase 1/2 clinical trial (NCT07147348) to evaluate BNT3212...as monotherapy and in combination with pumitamig in patients with advanced solid tumors; (iv) In October, the first patient was dosed in a Phase 1/2 clinical trial (NCT07111520) to evaluate...BNT326/YL202 in combination with pumitamig in advanced NSCLC."

Trial status • Colorectal Cancer • Non Small Cell Lung Cancer

In October, the first patient was dosed in a Phase 1/2 clinical trial (NCT07111520) to evaluate BioNTech and MediLink’s BNT326/YL202 in combination with pumitamig in advanced NSCLC. (The Manila Times)

Trial status • Non Small Cell Lung Cancer