tambotatug pelitecan (RG6919) / MediLink, Roche - LARVOL DELTA

Tam-Peli, an Anti-B7-H3 Antibody-Drug Conjugate, Versus Topotecan in Relapsed SCLC: A Randomized, Open-Label, Phase 3 Study (TAISHAN-302) (IASLC-WCLC 2026) - "Tambotatug pelitecan (Tam-Peli, YL201) is a novel anti-B7-H3 ADC with promising activity in relapsed SCLC in preclinical and phase 1/2 studies. Conclusions : TAISHAN-302 is the first phase 3 study of an ADC to demonstrate statistically significant and clinically meaningful OS, PFS and ORR improvements compared with topotecan in relapsed SCLC, regardless of baseline metastasis status or CTFI. Together with the generally favourable and manageable safety profile, these results support Tam-Peli as a potential new standard of care option for second-line SCLC and may reshape the treatment landscape for this challenging disease."

ADC • Clinical • Late-breaking abstract • P3 data • Interstitial Lung Disease • Lung Cancer • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • CD276

First-Line YL201 Plus Serplulimab in ES-SCLC and Advanced NSCLC: Phase 1 Results of a B7-H3-Directed Combination Strategy (IASLC-WCLC 2026) - P1 | "Conclusions : First-line YL201 plus serplulimab demonstrated a manageable safety profile and encouraging, durable anti-tumor activity across ES-SCLC and NSCLC cohorts. These findings support further evaluation of this B7-H3-directed combination strategy as a novel first-line strategy for lung cancers with substantial unmet need."

Clinical • IO biomarker • Metastases • P1 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Solid Tumor • CD276

Tambotatug pelitecan - a potential new second-line treatment option for SCLC. (PubMed, Nat Rev Clin Oncol) - No abstract available

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomized, open-label, phase 3 study (TAISHAN-301) (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Tambotatug Pelitecan in Small-Cell Lung Cancer after Platinum-Based Therapy. (PubMed, N Engl J Med) - P3 | "Among patients with relapsed small-cell lung cancer after platinum-based therapy, treatment with tambotatug pelitecan resulted in longer overall survival, longer progression-free survival, and a higher percentage of patients with an objective response than treatment with topotecan, with a lower incidence of adverse events of grade 3 or higher. (Funded by the Innovative Drug Research and Development National Science and Technology Major Project and MediLink Therapeutics; TAISHAN-302 ClinicalTrials.gov number, NCT06612151.)."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/1b trial. (PubMed, Nat Med) - P1, P1/2 | "YL201, a novel B7H3-targeting ADC, leverages a tumor microenvironment activable linker-payload platform, coupled with a novel topoisomerase 1 inhibitor via a protease-cleavable linker...Phase 3 clinical trials for patients with SCLC and NPC have already been initiated. ClinicalTrials.gov identifiers: NCT05434234 and NCT06057922 ."

Journal • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Lung Adenocarcinoma • Lung Cancer • Nasopharyngeal Carcinoma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • CD276

Roche…announced that its collaborator MediLink released interim results from the randomised phase III TAISHAN-302 trial evaluating Tam-Peli (tambotatug pelitecan, YL201) versus topotecan in Chinese patients with relapsed small-cell lung cancer (SCLC) who progressed after prior platinum-based chemotherapy with or without a PD-L1 inhibitor (GlobeNewswire) - "The trial met its primary endpoint of overall survival (OS) with Tam-Peli demonstrating a statistically significant and clinically meaningful OS benefit, reducing the risk of death by 54% (median OS 13.3 vs. 9.4 months; stratified HR=0.46; p<0.0001). Tam-Peli also showed robust efficacy across secondary endpoints, significantly extending progression-free survival (PFS) (median PFS 7.4 vs. 2.8 months) and response rates (59.1% vs. 9.7%) compared to standard-of-care topotecan. The trial results are being presented as a Late-Breaking Abstract during a Presidential Presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC)....Additionally, the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for filing."

China filing • Late-breaking abstract • P3 data • Lung Neuroendocrine Carcinoma • Small Cell Lung Cancer

Tambotatug Pelitecan (YL201): Analyses of interstitial lung disease in patients with advanced solid tumours from Phase 1/2 studies (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor

Anti-B7-H3 ADCs Take Center Stage against SCLC at WCLC. (PubMed, Cancer Discov) - "Separate phase III trials of the anti-B7-H3 antibody-drug conjugates tambotatug pelitecan and risvutatug rezetecan significantly improved overall survival, progression-free survival, and objective response rates compared with topotecan in patients with relapsed small-cell lung cancer. In a third trial, the combination of the investigational PD-L1 x VEGF-A bispecific antibody pumitamig plus the anti-B7-H3 ADC elfetabart drozuntecan showed encouraging early efficacy in SCLC across lines of therapy and doses. The studies were presented at the 2026 World Congress on Lung Cancer in Seoul, Republic of Korea."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Phase 1/2 study of YL201, an anti-B7H3 antibody–drug conjugate (ADC), in patients with previously treated advanced pancreatic ductal adenocarcinoma (PDAC). (ASCO 2026) - P1/2 | " Patients with metastatic PDAC who had progressed on at least one prior line of systemic therapies without irinotecan were enrolled and treated with YL201 intravenously Q3W at 2.0 mg/kg or 2.4 mg/kg until disease progression or unacceptable toxicity...90.0% had received prior gemcitabine-based regimen and 46.7% had received prior fluoropyrimidine... YL201 monotherapy showed promising antitumor activity and a manageable safety profile in pretreated patients with advanced PDAC. These compelling results warrant further investigation of YL201 in a randomized controlled trial for patients with advanced PDAC in the 2L+ setting."

ADC • Clinical • Metastases • P1/2 data • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Pancreatic Ductal Adenocarcinoma • CD276

A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy (clinicaltrials.gov) - P3 | N=320 | Not yet recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

New P3 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

A Study of YL201 in Combination With Serplulimab in Participants With Treatment-nave Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=442 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Tambotatug pelitecan (YL201): Efficacy and safety in locally advanced/metastatic NSCLC from a phase 1 study (ESMO 2026) - No abstract available

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

YL201, a novel B7H3-targeting antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors: Results from a first-in-human phase I study (ESMO 2024) - P1, P1/2 | "YL201 has demonstrated encouraging efficacy in heavily pretreated advanced solid tumors with manageable safety and tolerability profile."

Clinical • Metastases • P1 data • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma(TAISHAN-301) (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • CD276

Phase 2 study of YL201, an anti-B7H3 antibody–drug conjugate (ADC), in heavily pretreated metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2026) - P2 | "YL201 showed promising antitumor activity and manageable safety profile in heavily pretreated mCRPC patients. These findings support further development of YL201 in mCRPC, especially for those who progressed after ARAT with or without taxane-based chemotherapy, and those with visceral metastases."

ADC • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pneumonia • Prostate Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • CD276

A Study of YL201 in Combination With Serplulimab in Participants With Treatment-nave Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=442 | Not yet recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Medilink Announces Formal Acceptance by NMPA of Marketing Application for Tam-Peli (YL201) for Third-Line and Beyond Treatment of Nasopharyngeal Carcinoma (Medilink Press Release) - "The application is based on the prespecified interim analysis results from a randomized, controlled, multicenter Phase III study, YL201-CN-301-01 (TAISHAN-301), comparing YL201 versus investigator's choice of chemotherapy in this patient population."

China filing • Nasopharyngeal Carcinoma

A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy (clinicaltrials.gov) - P3 | N=440 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=187 | Active, not recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

Phase 1/2 study of YL201, an anti-B7H3 antibody–drug conjugate (ADC), in patients with relapsed or refractory (R/R) Ewing sarcoma and chondrosarcoma. (ASCO 2026) - P1/2 | "YL201 showed promising antitumor activity and manageable safety profile in patients with R/R EWS and CHS, with a particularly encouraging ORR in EWS. Given the high incidence of Ewing sarcoma in adolescents, these findings support further evaluation of YL201 in pediatric populations."

ADC • Clinical • P1/2 data • Ewing Sarcoma • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Neutropenia • Osteosarcoma • Pneumonia • Pulmonary Disease • Respiratory Diseases • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Thrombocytopenia • CD276

A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=438 | Active, not recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

DeLLphi-310: Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P1 | N=29 | Active, not recruiting | Sponsor: Amgen | N=200 ➔ 29

Enrollment change • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

DeLLphi-310: Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: Amgen | Suspended ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

YL201-INT-102-02: A Study of YL201 in Combination with Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=133 | Not yet recruiting | Sponsor: Medilink Therapeutics (Suzhou) Co. Ltd. | N=51 ➔ 133

Enrollment change • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor