Andewei (benmelstobart) / Apollomics, Sino Biopharm - LARVOL DELTA

R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy. (ASCO 2025) - P3 | "Benmelstobart, both as monotherapy and in combination with anlotinib, significantly prolonged PFS compared to placebo. Secondary endpoints also showed superiority, and the safety profile of the treatment group remained within acceptable parameters. (Funded by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; ClinicalTrials.gov number, NCT04325763)."

Clinical • Late-breaking abstract • Metastases • P3 data • Cardiovascular • Dyslipidemia • Hypertension • Hypertriglyceridemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Benmelstobart plus anlotinib versus pembrolizumab as first-line treatment for PD-L1-positive, advanced non-small-cell lung cancer (CAMPASS): a blinded, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Benmelstobart plus anlotinib showed longer progression-free survival than pembrolizumab plus placebo and no unexpected safety signals were reported, suggesting benmelstobart plus anlotinib as a potential first-line option in driver gene-negative, PD-L1-positive, advanced NSCLC. Longer term follow-up is needed to establish effects on overall survival."

Journal • P3 data • Cardiovascular • Hypertension • Infectious Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • PD-L1

CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC)—A randomized, single-blind, multicenter phase 3 study. (ASCO 2025) - P3 | "To our knowledge, this is the first phase III study to demonstrate the significant PFS benefit of a multikinase inhibitor plus an anti-PD-L1 mAb in the first-line treatment of PD-L1-positive aNSCLC compared to pembrolizumab. Tolerability is favourable with a lower incidence of treatment discontinuation due to TRAE. The data support this combination as a new option for these pts."

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

BACON: Benmelstobart in Combination With Anlotinib and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial OvariaN, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=578 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University

New P3 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • FAT1 • NOTCH3 • TP53

Anlotinib and Benmelstobart in DTC (clinicaltrials.gov) - P2 | N=23 | Not yet recruiting | Sponsor: Fudan University | Initiation date: Oct 2025 ➔ Apr 2026

Trial initiation date • Oncology • Solid Tumor • Thyroid Gland Carcinoma

…Sino Biopharmaceutical Limited…announces that a new indication of benmelstobart (Trade name: Andewei), a national Category 1 innovative drug independently developed by the Group, has been approved by the National Medical Products Administration (NMPA) of China for marketing (HKEXnews) - "It is indicated for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed after platinum-based concurrent or sequential chemoradiotherapy, and who do not carry known epidermal growth factor receptor (EGFR) sensitizing mutations or anaplastic lymphoma kinase (ALK) rearrangements. The approval was based on the positive results from the R-ALPS study..."

China approval • Non Small Cell Lung Cancer

Efficacy and Safety of Anlotinib plus Benmelstobart In Unresectable Anaplastic Thyroid Cancer: A Multicenter, Phase II, Single-arm Trial (ABATC Trial) (ChiCTR) - P2 | N=60 | Not yet recruiting | Sponsor: The First Affiliated Hospital, Sun Yat-sen University; The First Affiliated Hospital, Sun Yat-sen University

New P2 trial • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Solid Tumor

Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=412 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P3 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=266 | Recruiting | Sponsor: Beijing Tide Pharmaceutical Co., Ltd

New P1/2 trial • Platinum resistant • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Thyroid Gland Carcinoma • ALK • BRAF • EGFR • KRAS • MSI • NRAS • PD-L1 • ROS1

Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC). (ASCO 2025) - P3 | "TQB2450-III-12 is a multicenter, randomized, double-blind, parallel-controlled phase III study of benmelstobart (PD-L1 inhibitor) in combination with chemotherapy followed by sequential combination with anlotinib (multi-targeted angiogenesis inhibitor) versus tislelizumab plus chemotherapy as first-line therapy for locally advanced or metastatic sq-NSCLC...Paclitaxel (175 mg/m2, day 1) and carboplatin (area under the concentration [AUC] of 5, day 1) were given every 3 weeks... Benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib significantly improved PFS, with a manageable safety profile. It might be a new first-line treatment for sq-NSCLC."

Clinical • Combination therapy • IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Benmelstobart plus carboplatin/paclitaxel with or without anlotinib, followed by maintenance benmelstobart with or without anlotinib, as first-line treatment for advanced or recurrent endometrial cancer: A randomized, open-label, phase II trial. (ASCO 2025) - P2 | "Benmelstobart combined with carboplatin/paclitaxel and anlotinib, followed by maintenance benmelstobart and anlotinib, demonstrated clinically meaningful ORR and PFS benefits in patients with previously untreated advanced or recurrent EC. The regimen was particularly helpful in improving outcomes for patients with pMMR tumors, potentially providing a new treatment option."

Clinical • Metastases • P2 data • Anemia • Endometrial Cancer • Oncology • Solid Tumor • Thrombocytopenia • PD-L1

First-line benmelstobart plus anlotinib versus sunitinib in advanced renal cell carcinoma (ETER100): a multicentre, randomised, open-label, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Benmelstobart plus anlotinib improved progression-free survival compared with sunitinib among patients with previously untreated, advanced clear-cell renal cell carcinoma. These findings suggest the potential of benmelstobart plus anlotinib as a treatment option for this population."

Clinical • Journal • P3 data • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Renal Cell Carcinoma • Renal Disease • Solid Tumor

Benmelstobart with Anlotinib plus Chemotherapy as First-line Therapy for ES-SCLC: A Randomized, Double-blind, Phase III Trial (IASLC-WCLC 2023) - "Patients were randomly assigned in a 1:1:1 ratio to receive 4 cycles (21-day cycle) of benmelstobart, anlotinib or placebo in the basis of etoposide/carboplatin (EC) (Chemotherapy remains the standard-of-care when study protocol was approved by Center for Drug Evaluation in China as well as PD-(L)1 inhibitor not received the approval), followed by benmelstobart plus anlotinib, anlotinib, or placebo as maintenance therapy until disease progression or toxicity intolerance. Benmelstobart plus anlotinib and chemotherapy reached historically longest OS in ES-SCLC, with an exceed 7.4-month survival extension over chemotherapy. The PFS of this regimen also exceeded 6 months for the first time. The safety profile is tolerable and manageable."

Clinical • P3 data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

A phase II study of anlotinib and an anti-PDL1 antibody in patients with alveolar soft part sarcoma: Results of expansion cohorts. (ASCO 2024) - "The combination of anlotinib and TQB2450 exhibits promising efficacy in ASPS patients, markedly enhancing ORR and extending PFS with favorable tolerability. Notably, TLS emerges as a potential predictive indicator of immunotherapeutic efficacy in ASPS."

Clinical • IO biomarker • P2 data • Alveolar Soft Tissue Sarcoma • Cardiovascular • Dyslipidemia • Hypertension • Hypertriglyceridemia • Oncology • Sarcoma • Solid Tumor

Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial. (PubMed, Nat Med) - P3 | "Patients randomly received benmelstobart and anlotinib plus etoposide/carboplatin (EC; n = 246), placebo and anlotinib plus EC (n = 245) or double placebo plus EC ('EC alone'; n = 247), followed by matching maintenance therapy. Our findings suggest that the addition of anti-angiogenesis therapy to immunochemotherapy may represent an efficacious and safe approach to the management of ES-SCLC. ClinicalTrials.gov identifier: NCT04234607 ."

Journal • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Anlotinib in combined with anti-PD-L1 antibody Benmelstobart(TQB2450) versus sunitinib in first-line treatment of advanced renal cell carcinoma (RCC): A randomized, open-label, phase III study (ETER100) (ESMO 2024) - P3 | "Benmelstobart plus Anlotinib provided superior PFS and ORR compared with sunitinib, and had manageable safety in pts with previously untreated advanced RCC. These results support the use of Benmelstobart plus anlotinib as a new first-line treatment for advanced RCC."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-L1

Late-Breaking Abstract: BENMELSTOBART (TQB2450) ALONE OR COMBINED WITH ANLOTINIB IN PREVIOUSLY TREATED ADVANCED ENDOMETRIAL CANCER: UPDATED RESULTS FROM A MULTICOHORT, OPEN-LABEL, MULTICENTER PHASE II CLINICAL TRIAL TQB2450-II-08 (IGCS 2024) - P2 | "The incidence of grade ≥3 TEAEs were 77.57%. Conclusion/Implications Benmelstobart plus anlotinib showed promising antitumor activity with a manageable safety profile in the treatment of recurrent or metastatic EC."

Clinical • Late-breaking abstract • Metastases • P2 data • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Preliminary results of ALTER-PA-001 trial: A multicenter, open-label, randomized, phase II trial of anlotinib and benmelstobart in combination with AG versus AG as first-line treatment for metastatic pancreatic cancer. (ASCO-GI 2026) - P2 | "While nab-paclitaxel and gemcitabine (AG) are still current standard first-line therapy with limited anti-tumor effect, new treatment options are needed to be explored. The preliminary results had demonstrated a potent efficacy of anlotnib plus benmelstobart and AG as first-line treatment for mPC patients, with a manageable safety profile."

Clinical • Combination therapy • Metastases • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • FGFR • KIT

Preliminary results of benmelstobart (BEN) combined with concurrent chemoradiotherapy (cCRT) versus cCRT alone as neoadjuvant therapy for esophageal squamous cell carcinoma (ESCC): A multicentre, randomised study. (ASCO-GI 2026) - P2 | "Participants were randomized 1:1 to receive either anti-PD-L1 antibody benmelstobart (1200mg, D1 and 22) + cCRT (paclitaxel 50 mg/m² + carboplatin AUC2, weekly with radiotherapy 41.4 Gy/23 fractions) or cCRT alone, stratified by cT stage (T1-2 vs T3). Neoadjuvant benmelstobart combined with cCRT shows encouraging preliminary efficacy, including high pCR and MPR rates, and a manageable safety profile in resectable ESCC. Continued enrollment and follow-up will further elucidate the regimen's clinical benefits."

Clinical • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology

TQB2450-II-14: Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus. (clinicaltrials.gov) - P2 | N=71 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Trial completion date: Dec 2024 ➔ Nov 2025 | Recruiting ➔ Terminated; Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.

dMMR • IO biomarker • pMMR • Trial completion date • Trial termination • Endometrial Cancer • Oncology • Sarcoma • Solid Tumor

Serum BDNF helps identify favorable subgroups in HCC patients treated with PD-L1 inhibitors and anti-angiogenic TKIs. (PubMed, Ther Adv Med Oncol) - P1/2 | "We aimed to assess the efficacy, safety, and potential biomarkers of anlotinib plus TQB2450 in patients with advanced HCC. Elevated serum BDNF levels might serve as a potential positive prognostic marker and, together with ECOG score, may help complement the CRAFITY score in identifying subgroups that could benefit from ICIs and antiangiogenic therapy. This study was registered on ClinicalTrials.gov (NCT03825705, registered January 31, 2019)."

IO biomarker • Journal • Hepatocellular Cancer • Oncology • Solid Tumor • AFP • BDNF • CRP

First line PD-L1/1 inhibition based therapies in elderly patients with ES-SCLC: a Systematic Literature Review and Network Meta-Analysis (ESMO-IO 2025) - "Currently, PD-1/PD-L1 inhibitors with platinum and etoposide (EP) have been adopted as standard first-line therapy and idemonstrated survival benefits in the overall population, while the magnitude of benefit and optimal agent in elderly patients remain unclear.Methods Following PRISMA-NMA guidelines, PubMed and ClinicalTrials.gov were searched up to 29 August 2025. Eligible RCTs compared first-line PD-L1 or PD-1 inhibitors—atezolizumab, durvalumab, serplulimab, adebrelimab, tislelizumab, pembrolizumab, socazolimab, benmelstobart(+anlotinib), nivolumab, or toripalimab with or without EP in ES-SCLC...Atezolizumab-EP ranked highest for OS (SUCRA=0.88), followed by Benmelstobart + anlotinib -EP (SUCRA = 0.86) and serplulimab-EP (SUCRA = 0.77), whereas durvalumab-EP (SUCRA = 0.36) and socazolimab-EP (SUCRA = 0.29) showed relatively modest effects.Conclusions First-line PD-L1/PD-1 inhibition plus EP confers a clinically meaningful survival advantage in elderly patients with..."

Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC (clinicaltrials.gov) - P2 | N=69 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS