TQB2618 / Sino Biopharm - LARVOL DELTA

TQB2618-AK105-Ib-04: A Clinical Study of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules for First-line Treatment of Advanced Hepatocellular Carcinoma (HCC). (clinicaltrials.gov) - P1 | N=29 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Jun 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns

Trial primary completion date • Trial termination • Hepatocellular Cancer • Oncology • Solid Tumor

TQB2618-AK105-Ib-03: Clinical Trial to Evaluate the Safety and Effectiveness of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=34 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=75 ➔ 34 | Trial completion date: Dec 2024 ➔ Mar 2025 | Recruiting ➔ Terminated; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Enrollment change • Trial completion date • Trial termination • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

Combination of Tim-3 blockade TQB2618 with penpulimab and chemotherapy in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): A multicenter, single-arm, two-cohort, phase 2 study. (ASCO 2025) - P2 | "TQB2618 and penpulimab were administered intravenously at doses of 1200 mg and 200 mg, respectively, on the first day of a 21-day cycle until disease progression or unacceptable toxicity while gemcitabine (1000 mg/m2, d1&8) and cisplatin (75mg/m2, d1) were given intravenously for the first 4–6 cycles. To our knowledge, this is the first study to evaluate the addition of Tim-3 blockade to the standard first-line treatment of R/M NPC. The results demonstrated that this combination therapy provided clinical benefits comparable to those observed in the historical cohort treated with PD-1 blockade plus chemotherapy, while maintaining a manageable safety profile."

Clinical • IO biomarker • Metastases • P2 data • Anemia • Hematological Disorders • Leukopenia • Nasopharyngeal Carcinoma • Neutropenia • Oncology • Solid Tumor • HAVCR2 • PD-L1

Combination of Tim-3 blockade TQB2618 with PD-1 blockade for patients with immunotherapy-resistant recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): Preliminary results from a phase II study (ESMO-IO 2024) - P2 | "This single-arm, two-cohort, phase 2 study (NCT05563480) aimed to explore the efficacy and safety of TQB2618, a novel monoclonal antibody agent blockading Tim-3, plus PD-1 blockade penpulimab in subsequent-line treatment (cohort 1) of immunotherapy-resistant R/M NPC or in the first line by incorporating into chemotherapy (cohort 2) in treatment-naïve R/M NPC. The median PFS was 1.6 mo (95% CI, 0.0–3.2); 3 mo- and 6 mo-PFS was 27.3% and 18.2%, respectively. One pt was still on treatment after a follow-up for 14 months.Conclusions This novel dual-drug immunotherapy showed favorable safety profile, but the activity was limited in immunotherapy-resistant R/M NPC."

Clinical • IO biomarker • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • HAVCR2

TQB2618-AK105-Ib-03: Clinical Trial to Evaluate the Safety and Effectiveness of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=75 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2024 ➔ Dec 2024

Enrollment open • Metastases • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

A Phase Ib Study of TQB2618 (Anti-TIM-3) in Combination with Penpulimab and Chemotherapy in Patients with Non-small Cell Lung Cancer (CSCO 2024) - No abstract available

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

A Phase Ib Study of TQB2618 (Anti-TIM-3) in Combination with Penpulimab and Chemotherapy in Patients with Non-Small Cell Lung Cancer (IASLC-WCLC 2024) - "Methods : This is an open-label, multicenter, phase Ib study.Inclusion criteria included: age between 18-75 years, pathologically confirmed diagnosis of advanced/metastatic NSCLC(squamous or non-squamous),absence of EGFR, ALK or ROS-1 mutations.Study was divided into two parts: dose-escalation and cohort expansion(cohort A-C).All patients(pts) in cohort A were PD-L1 TPS≥1% and received TQB2618 (1200/1500mg i.v.), Penpulimab (200mg i.v.) Q3W.Pts in cohort B were all squamous and were treated with TQB2618(1500mg i.v.),penpulimab(200mg i.v.), paclitaxel(175mg/m 2 i.v.), carboplatin(AUC 5) Q3W. TEAEs were common but primarily low-grade events in cohort A. Grade≥3 TEAEs(≥10%) were neutropenia(49.1%), leukopenia(29.8%) and anemia(21.1%) in cohort B and C.Serious adverse events(SAEs) related to study treatment(≥5%) was infectious pneumonia(5.6%) in cohort A,and neutropenia(10.5%), leukopenia(8.8%), infectious pneumonia(5.3%), anemia(5.3%) in cohort B and C. Conclusions :..."

Clinical • Combination therapy • IO biomarker • P1 data • Anemia • Hematological Disorders • Infectious Disease • Leukopenia • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • ALK • EGFR • ROS1

Six innovative Chinese biopharmaceutical drugs were unveiled at the World Lung Cancer Conference to empower patients with treatment [Google translation] (Sohu.com) - "Recently, the 2024 World Lung Cancer Conference (WCLC) announced the overall data of the various research results selected for this conference. A total of 16 latest research results and progress of Sino Biopharmaceutical's Class 1 innovative drugs anlotinib, Bevacizumab...alectinib, and the research products TQB2618 (TIM-3 inhibitor) and AL2846 (small molecule multi-target receptor tyrosine kinase inhibitor) were announced. Among them, 5 were oral reports (Mini oral) and 11 were poster presentations."

Clinical data

A PHASE I STUDY OF ANTI-TIM-3 ANTIBODY TQB2618 ADDED TO HYPOMETHYLATING AGENTS (HMAS) IN ADULT PATIENTS WITH HIGHER-RISK MYELODYSPLASTIC SYNDROMES (MDS) (EHA 2024) - "Intravenous (IV) TQB2618 wereadministered on Day (D)8 every 4 weeks, azacitidineAZA; 75 mg/m2 IV ) on D1-7. TQB2618+AZA is associated with a favorable safety profile in pts with higher-risk MDS. Pts with adverse-riskdisease were able to achieve durable responses. Further exploration of the mechanism of action of TQB2618and identification of potential biomarkers to predict response is planned."

Clinical • IO biomarker • P1 data • Anemia • Bone Marrow Transplantation • Hepatology • Infectious Disease • Inflammation • Leukopenia • Myelodysplastic Syndrome • Neutropenia • Pneumonia • Respiratory Diseases • Thrombocytopenia • Transplantation • HAVCR2 • TP53

ANTI-TIM-3 ANTIBODY TQB2618 IN COMBINATION WITH PENPULIMAB IN RELAPSED OR REFRACTORY CLASSIC HODGKIN LYMPHOMA PREVIOUSLY TREATED WITH PD-1/PD-L1 THERAPY (EHA 2024) - P1/2 | "TQB2618 in combination with penpulimab were tolerated and showed promising objective response rate in ptswith prior anti-PD-1/PD-L1 failed classic Hodgkin lymphoma."

Combination therapy • Anemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • HAVCR2

A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer. (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2023 ➔ Jan 2024

Enrollment open • Metastases • Monotherapy • Trial initiation date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer. (clinicaltrials.gov) - P1 | N=75 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • Monotherapy • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

A Clinical Study of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules for First-line Treatment of Advanced Hepatocellular Carcinoma (HCC). (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Melanoma • Oncology • Solid Tumor

Clinical Trial to Evaluate the Safety and Effectiveness of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=75 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • New P1/2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • New P1/2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Clinical Trial of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=127 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

IO biomarker • New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HAVCR2 • ROS1

TQB2618 Injection Combined With Penpulimab Injection in the Treatment of Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

TQB2618 Injection Combined With Penpulimab Injection in the Treatment of Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=110 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P2 trial • Immune Modulation • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-L1

Efficacy and Safety of TQB2618 Injection Combined With Terriprizumab Injection in Patients With Advanced Melanoma (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Melanoma • Oncology • Solid Tumor

Clinical Study of TQB2618 Injection in Combination With Demethylation Drugs in Patients With Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes (clinicaltrials.gov) - P1 | N=73 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Combination therapy • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

To Evaluate the Safety and Efficacy of TQB2618 Injection Combined With Pembrolizumab in the Treatment of Patients With Relapsed and Refractory Lymphoma (clinicaltrials.gov) - P1/2 | N=92 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1/2 trial • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PD-1 • PD-L1

A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor