Airuituo (bevacizumab biosimilar) / Jiangsu Hengrui Pharma - LARVOL DELTA

SHR-8068 plus adebrelimab and bevacizumab for advanced hepatocellular carcinoma (aHCC): A phase 1b/2 study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT05444088 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Metastases • P1/2 data • Hepatocellular Cancer • Oncology • Solid Tumor

A phase II clinical study of adebrelimab and bevacizumab combined with cisplatin/carboplatin in triple-negative breast cancer patients with brain metastases. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT04303988 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Addition of SHR-1701 to first-line capecitabine and oxaliplatin (XELOX) plus bevacizumab for unresectable metastatic colorectal cancer. (PubMed, Signal Transduct Target Ther) - P2/3 | "Elevated baseline lactate dehydrogenase was linked to shorter PFS. SHR-1701 combined with XELOX and bevacizumab demonstrated a manageable safety profile and potent antitumor activity in unresectable mCRC."

IO biomarker • Journal • Metastases • Tumor mutational burden • Colorectal Adenocarcinoma • Colorectal Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • TGFB1 • TMB

SHR-8068 combined with adebrelimab and bevacizumab in the treatment of refractory advanced colorectal cancer: study protocol for a single-arm, phase Ib/II study. (PubMed, Front Immunol) - "This proof-of-concept study would provide safety and efficacy signals of this novel combination treatment for the MSS CRCs in the late-line setting. And it may offer new insights on the clinical application of dual immunotherapy combined with anti-angiogenic therapy in the MSS CRC."

Clinical protocol • IO biomarker • Journal • Metastases • P1/2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=347; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; N=439 ➔ 347

Clinical • Enrollment change • Enrollment open • IO biomarker • Mismatch repair • Monotherapy • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: National Cancer Institute (NCI); N=347 ➔ 200

Clinical • Enrollment change • IO biomarker • Mismatch repair • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=231; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Clinical • Enrollment open • IO biomarker • Mismatch repair • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=200; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended

Clinical • IO biomarker • Mismatch repair • Trial suspension • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

SHR-A1921 in platinum-resistant ovarian cancer (PROC): data from a first-in-human (FIH) phase I study (ESMO 2024) - P1 | "Most pts had received prior bevacizumab (69.6%) and PARP inhibitors (58.7%). SHR-A1921 demonstrated promising efficacy with a manageable safety profile in heavily pretreated pts with PROC. A pivotal phase 3 study is currently in preparation."

P1 data • Oncology • Ovarian Cancer • Solid Tumor • TACSTD2

A phase II trial combining SHR-1316, bevacizumab, and cisplatin/carboplatin in patients with TNBC with active brain metastases. (ASCO 2024) - P2 | "SHR-1316 plus bevacizumab and cisplatin/carboplatin achieves a significant improvement in CNS ORR and brings PFS and OS benefits in TNBC patients with active BMs. As an effective and safe treatment, this triple-combination warrants further investigation. Clinical trial information: NCT04303988."

Clinical • P2 data • Anemia • Cardiovascular • Hematological Disorders • Hypertension • Leukopenia • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

Efficacy and safety of HER2-ADC SHR-A1811 in HER2-positive breast cancer with brain metastases. (ASCO 2024) - P2 | " Patients with radiotherapy-naïve HER2-expressing BCBM, and not in need of immediate local treatment were enrolled, and they received SHR-A1811 as monotherapy (Arm 1 HER2+ and Arm 4 HER2-low) or in combination with pyrotinib or bevacizumab (Arm 2 and Arm 3 HER2+) until disease progression, unaccepted toxicity, or no further benefit. Our interim results showed an inspiring intracranial response rate and an acceptable tolerance of the novel ADC SHR-A1811 in HER2+ BCBM. The enrollment of this study is ongoing, and the long-term outcomes will be followed up. Clinical trial information: NCT05769010."

Clinical • Anemia • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Optimising first-line subtyping-based therapy in triple-negative breast cancer (FUTURE-SUPER): a multi-cohort, randomised, phase 2 trial. (PubMed, Lancet Oncol) - P2 | "These findings highlight the potential clinical benefits of using molecular subtype-based treatment optimisation in patients with triple-negative breast cancer, suggesting a path for further clinical investigation. Phase 3 randomised clinical trials assessing the efficacy of subtyping-based regimens are now underway."

Journal • P2 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • HER-2

Famitinib, a multi-targeted receptor tyrosine kinase inhibitor, combined with dalpicilib and fulvestrant in advanced HR-positive and HER2-negative breast cancer (SABCS 2023) - P1/2 | "However, the role of angiogenesis inhibitors, such as bevacizumab, in these patients (pts) is controversial...Our phase Ib/II trial (NCT05176080, ChiCTR2100053950) aims to evaluate the safety and efficacy of a novel anti-angiogenesis TKI famitinib (F) added to dalpiciclib (D) and ET in advanced HR-positive and HER2-negative BC... The anti-angiogenesis multi-targeted receptor TKI famitinib combined with CDK4/6i and fulvestrant has shown antitumor effects in advanced HR-positive and HER2-negative BC, and no new safety signals were observed."

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

Efficacy, safety and pharmacokinetics of apatinib plus etoposide versus apatinib alone for platinum-resistant recurrent ovarian cancer: protocol of a multicenter, open-label, randomized phase 2 trial. (PubMed, Transl Cancer Res) - P2 | "Currently preferred single-agent nonplatinum chemotherapy or its combination with bevacizumab results in a low response rate and modest survival benefit for platinum-resistant recurrent ovarian cancer, and thus more effective regimens are needed. ClinicalTrials.gov Identifier: NCT04383977. It was registered on May 12, 2020."

Journal • P2 data • PK/PD data • Oncology • Ovarian Cancer • Solid Tumor

SHR-1701 in combination with BP102 and XELOX as first-line (1L) treatment for patients (pts) with unresectable metastatic colorectal cancer (mCRC): Data from a phase II/III study (ESMO 2023) - P2/3 | "Background The standard 1L therapies for mCRC involve a fluoropyrimidine with oxaliplatin and/or irinotecan, and a biologic agent. Median PFS was 10.3 months (95% CI, 8.3-13.7), and median OS was immature. Conclusions SHR-1701 in combination with BP102 and XELOX as 1L treatment provided a manageable safety profile and potent antitumor activity in pts with unresectable mCRC."

Clinical • Combination therapy • IO biomarker • Metastases • P2/3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • RAS • TGFB1

A phase Ib/II study of SHR-1701 (a bifunctional anti-PD-L1/TGF-βRII agent) in combination with bevacizumab (BEV) in patients with advanced solid tumors (ESMO 2023) - P1/2 | "No grade 4/5 TRAEs were reported. Table: 1026MO Efficacy outcomes Variables GC/GEJC (1L) GC/GEJC (≥2L) nsqNSCLC All (n=19) CPS≥5 (n=15) All (n=27) CPS≥5 (n=9) All (n=10) Best overall response, n (%) CR 0 0 1 (3.7) 1 (11.1) 0 PR 4 (21.1) 4 (26.7) 8 (29.6) 6 (66.7) 1 (10.0) SD 7 (36.8) 5 (33.3) 5 (18.5) 1 (11.1) 5 (50.0) PD 7 (36.8) 5 (33.3) 12 (44.4) 1 (11.1) 3 (30.0) NE 1 (5.3) 1 (6.7) 1 (3.7) 0 1 (10.0) ORR, % (95% CI) 21.1 (6.1, 45.6) 26.7 (7.8, 55.1) 33.3 (16.5, 54.0) 77.8 (40.0, 97.2) 10.0 (0.3, 44.5) DCR, % (95% CI) 57.9 (33.5-79.7) 60.0 (32.3, 83.7) 51.8 (32.0, 71.3) 88.9 (51.8, 99.7) 60.0 (26.2, 87.8) mPFS, months (95% CI) 4.1 (1.3-NR) 4.1 (1.4-NR) 4.0 (1.4-NR) 10.3 (1.3-NR) 6.2 (1.3-9.9) Conclusions SHR-1701 plus BEV showed encouraging antitumor activity with a favorable safety profile in pts with advanced GC/GEJC and nsqNSCLC."

Clinical • Combination therapy • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • PD-L1 • TGFB1

SHR-1701 in combination with platinum-based chemotherapy and BP102 (a bevacizumab biosimilar) for persistent, recurrent, or metastatic cervical cancer: Data from a phase 1b/3 study. (ASCO 2023) - P3 | "Pts were given SHR-1701 (30 mg/kg), paclitaxel (175 mg/m2), cisplatin (50 mg/m2) / carboplatin (AUC 5), and BP102 (15 mg/kg) every 3 weeks. SHR-1701 plus platinum-based doublet chemo and BP102 provided a manageable safety profile and potent antitumor activity in pts with persistent, recurrent, or metastatic cervical cancer, supporting the subsequent randomized, double-blind, placebo-controlled phase 3 part. Clinical trial information: NCT05179239. >CR, Complete response; PR, partial response; SD, stable disease; PD; progressive disease; ORR, objective response rate; DCR, disease control rate; PFS, progression-free survival; pts, patients."

Combination therapy • IO biomarker • Metastases • P1 data • Anemia • Cervical Cancer • Hematological Disorders • Oncology • Solid Tumor • Squamous Cell Carcinoma • TGFB1

FUTURE-SUPER: A randomized, subtyping-based umbrella phase II trial for first-line treatment of metastatic triple-negative breast cancer. (ASCO 2023) - P1/2, P2 | "After categorization into 5 cohorts according to TNBC subtypes and genomic biomarkers, patients were randomly assigned (in a 1:1 ratio) to receive nab-paclitaxel (control group) or nab-paclitaxel plus subtyping-based treatment (subtyping-based group): pyrotinib (LAR-HER2mut), everolimus (LAR-PI3K/AKTmut), camrelizumab and famitinib (IM), bevacizumab (BLIS/MES-PI3K/AKTWT), everolimus (MES-PI3K/AKTmut). Subtyping-based precision treatment significantly prolonged PFS versus nab-paclitaxel in the first-line treatment of advanced TNBC, with manageable toxicities. Our findings highlight the profound clinical benefits with treatment optimization according to molecular/immunological subtypes in TNBC, outlining a direction for further exploration. Clinical trial information: NCT04395989."

Clinical • Metastases • P2 data • Breast Cancer • Hematological Disorders • Immune Modulation • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR

AZD9291 (Osimertinib) With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer (clinicaltrials.gov) - P3; N=300; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

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

A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer (clinicaltrials.gov) - P3 | N=572 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

To Compare the Efficacy and Safety of BP102 vs. Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC (clinicaltrials.gov) - P3; N=520; Completed; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • Combination therapy • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer (clinicaltrials.gov) - P3; N=572; Not yet recruiting; Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Clinical • New P3 trial • Cervical Cancer • Oncology • Solid Tumor

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: OHSU Knight Cancer Institute; Trial completion date: Feb 2021 ➔ Feb 2025; Trial primary completion date: Feb 2021 ➔ Feb 2022

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Anemia • Breast Cancer • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Small Lymphocytic Lymphoma • Solid Tumor • T Acute Lymphoblastic Leukemia • Thrombocytosis

Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors (clinicaltrials.gov) - P1/2; N=113; Recruiting; Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors (clinicaltrials.gov) - P2; N=71; Not yet recruiting; Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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