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

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

A randomized, open-label, parallel-controlled phase 3 trial of benmelstobart plus chemotherapy and anlotinib for first-line treatment of advanced non-squamous non–small cell lung cancer. (ASCO 2026) - P3 | "Patients were stratified by PD-L1 TPS level (<1%/1-49%/≥50%) and randomized 1:1 to receive benmelstobart or tislelizumab plus platinum and pemetrexed for 4 cycles, then followed by maintenance with benmelstobart plus anlotinib and pemetrexed or tislelizumab plus pemetrexed until disease progression or unacceptable toxicities. Benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib significantly improved PFS compared to tislelizumab in combination with chemotherapy followed by sequential tislelizumab, with a manageable safety profile. It might be a new first-line treatment for nsq-NSCLC."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

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

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

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 Combined With Anlotinib as Maintenance Therapy for Small Cell Lung Cancer (SCLC): A Prospective Phase II Study [Google translation] (IFENG.COM) - "Results showed an ORR of 55.0% and a disease control rate (DCR) of 100%. The median PFS from the start of induction therapy was 8.8 months, and the median overall survival has not yet been reached. Treatment-related adverse events were generally manageable, with a grade ≥3 adverse event rate of 5.0%. No new safety signals or grade 5 adverse events were observed. Studies have shown that this treatment strategy has demonstrated good efficacy and manageable safety in both LS-SCLC and ES-SCLC patients, and long-term follow-up is still ongoing."

P2 data • Small Cell Lung Cancer

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

TQB2102, a Novel HER2 Bispecific Antibody-Drug Conjugate, Combined with Bemotrizumab with or without Capecitabine as First-Line Therapy for HER2-Positive Advanced Gastric/Gastroesophageal Junction Cancer: A Phase II Study (ESMO 2026) - No abstract available

ADC • Bispecific • Clinical • Metastases • P2 data • Oncology • Solid Tumor

Updated results of benmelstobart plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy for resectable esophageal squamous cell carcinoma: A randomized, multicenter, phase II trial (ALTER-E008) (ESMO 2026) - No abstract available

Clinical • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Integrated nal-IRI/5-FU/LV, benmelstobart, and anlotinib with or without SBRT for second-line metastatic pancreatic cancer: A phase II dual-cohort study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Oncology • Pancreatic Cancer • Solid Tumor

Efficacy and safety of first-line immunotherapy in advanced renal cell carcinoma: a systematic review and network meta-analysis. (PubMed, Transl Androl Urol) - "Notably, benmelstobart plus anlotinib achieved the highest ORR [odds ratio (OR): 7.55, 95% CI: 3.99-14.28], followed by pembrolizumab plus lenvatinib (OR: 4.18, 95% CI: 2.29-7.61). Other ICI plus tyrosine kinase inhibitor (TKI) combinations and nivolumab plus ipilimumab also significantly improved OS compared to sunitinib...However, these global rankings from pooled cohorts should not be interpreted as absolute clinical recommendations for all subgroups. Real-world treatment selection must be highly individualized and strictly tailored to the patient's specific International Metastatic RCC Database Consortium (IMDC) risk profile alongside the efficacy-safety trade-off."

Journal • Retrospective data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • IFNA1 • IL2

ABH-uHCC: Anlotinib + Benmelstobart + HAIC in Unresectable HCC: A Phase II Study (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

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

Updated results of benmelstobart plus anlotinib combined with SOX in the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with low PD-L1 expression: A single-arm, multicenter phase II clinical trial. (ASCO 2026) - P2 | "This study evaluates the efficacy and safety of benmelstobart (a PD-L1 inhibitor) combined with anlotinib and SOX (S-1 plus oxaliplatin) as first-line therapy in patients with advanced G/GEJ adenocarcinoma and low PD-L1 expression... The combination of benmelstobart, anlotinib, and SOX demonstrated promising efficacy with a manageable safety profile as first-line therapy for advanced G/GEJ adenocarcinoma with low PD-L1 expression. These findings warrant validation in larger cohorts."

Clinical • IO biomarker • Metastases • P2 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Oncology • HER-2 • PD-L1

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

Etoposide Plus Benmelstobart Followed by Benmelstobart Plus Anlotinib in First-Line Treatment of Elderly ES-SCLC Patients [Google translation] (IFENG.COM) - "Results showed that all five patients were evaluable for efficacy, with an ORR of 80% (4/5), a DCR of 100% (5/5), and median PFS not yet reached. This study suggests that this sequential treatment regimen demonstrates preliminary antitumor activity in elderly ES-SCLC patients, providing a reference for exploring individualized treatment strategies that balance efficacy and safety."

Clinical data • Small Cell Lung Cancer

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

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

Updated Results of the ALTER-PA-001 Trial: A Multicenter, Open-Label, Randomized Phase II Study of Anlotinib Plus Benmelstobart in Combination with AG Versus AG Alone as First-Line Treatment for Metastatic Pancreatic Cancer (ESMO 2026) - No abstract available

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

Benmelstobart Combined With Anlotinib as Maintenance Therapy for Small Cell Lung Cancer (SCLC): A Prospective Phase II Study (IASLC-WCLC 2026) - "Conclusions : Induction therapy with benmelstobart plus chemotherapy, followed by maintenance therapy with benmelstobart plus anlotinib, demonstrates promising efficacy and manageable safety among patients with either ES-SCLC or Stage III LS-SCLC. Long-term follow-up is ongoing."

Clinical • P2 data • Endocrine Disorders • Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

A Chemotherapy-free Adjuvant Strategy with Anlotinib Plus Benmelstobart for Resected ESCC: Phase II Results from the ALTER-E005 Study (ESMO 2026) - No abstract available

Clinical • P2 data • Esophageal Squamous Cell Carcinoma • Oncology

Prospective Phase II Single-Arm Multicenter Study of Nimotuzumab plus Benmelstobart and Platinum-Based Doublet Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma (ASTRO 2026) - No abstract available

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

First-line systemic treatment for people with extensive-stage small cell lung cancer: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "In people with extensive-stage SCLC, several ICI-based combinations with PE chemotherapy improve OS compared with PE alone (high-certainty evidence), although the magnitude of benefit varies across regimens. Some combinations probably or may have little to no effect on OS. Effects on PFS and ORR vary across treatments, and some combinations increase the risk of AEs whereas others result in little to no difference. HRQoL data were insufficient for quantitative synthesis, and so we are unable to draw conclusions about this outcome. The certainty of the evidence varies across outcomes and comparisons, reflecting differences in study design, variability in safety reporting, and limited direct head-to-head comparisons. Further RCTs directly comparing commonly used first-line regimens, with consistent reporting of AEs and patient-reported outcomes including HRQoL, are needed to reduce uncertainty and inform treatment decisions."

Clinical • IO biomarker • Journal • Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • TIGIT

Sino Biopharmaceutical…announces that Benmelstobart Injection…in combination with chemotherapy and sequentially followed by Anlotinib Hydrochloride Capsules has been granted marketing approval by the China’s National Medical Products Administration (NMPA) for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC) (HKEXnews) - "This approval is based on the positive results from a randomized, double-blind, parallel-controlled, multicenter Phase III clinical trial (ETER700)."

China approval • Lung Non-Small Cell Squamous Cancer