AiBiTe (famitinib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Camrelizumab Plus Famitinib versus Camrelizumab Alone and Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer: A Randomized, Phase II Study. (PubMed, J Clin Oncol) - "Camrelizumab plus famitinib improved antitumor activity while exhibiting a manageable safety profile in patients with pretreated R/M CC, potentially offering a novel treatment option."

Journal • P2 data • Cervical Cancer • Oncology • Solid Tumor

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

Phase III study of camrelizumab plus famitinib versus platinum-based chemotherapy as first-line therapy for recurrent or metastatic cervical cancer (ESMO 2025) - P3 | "Methods In this multicenter, phase 3 study, pts were randomized (1:1) to receive either CAM (200 mg, iv, Q3W) plus FAM (20 mg, po, qd) or investigator's choice of chemo (paclitaxel + cisplatin/carboplatin, with/without bevacizumab). TRAE led to discontinuation of any treatment in 13.6% with CAM + FAM and 6.6% with chemo. Conclusions This chemo-free regimen of CAM plus FAM significantly prolongs PFS and OS compared with platinum-based chemo with/without bevacizumab as first-line treatment in pts with R/M CC, with a tolerable safety profile."

Clinical • Late-breaking abstract • Metastases • P3 data • Cervical Cancer • Gynecologic Cancers • Oncology • PD-L1

Retlirafusp Alfa Combined With Famitinib, Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Unresectable Pancreatic Cancer (clinicaltrials.gov) - P2 | N=88 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University

New P2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Adebrelimab With Famitinib and Chemotherapy as Neoadjuvant Therapy for ESCC (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: First Affiliated Hospital Xi'an Jiaotong University

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Adebrelimab Plus Famitinib and Chemotherapy for Advanced NSCLC After Progression With PD-1-based Therapy (IASLC-WCLC 2026) - P2 | "Patients will receive adebrelimab 1200 mg intravenously every 3 weeks in combination with famitinib 20 mg orally once daily and chemotherapy (nab-paclitaxel 260 mg/m2 or docetaxel 60-75 mg/m2 on day 1 every 3 weeks) for 4-6 induction cycles, followed by maintenance therapy with adebrelimab plus famitinib until disease progression, unacceptable toxicity, or withdrawal of consent. Response rates will be calculated with 95% CIs using the Clopper-Pearson method. Patient enrollment began in November 2023 and is expected to be completed in December 2026, with study completion anticipated in 2027."

IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Adebrelimab Combined With Famitinib and Chemotherapy as First-Line Treatment for ES-SCLC: A Prospective Case Series (IASLC-WCLC 2026) - "All patients received induction therapy with adebrelimab (1200 mg IV Q3W), famitinib (20 mg PO QD), and etoposide plus cisplatin or carboplatin (Q3W), followed by maintenance with adebrelimab plus famitinib. Conclusions : This case series demonstrates that the novel triple-combination of adebrelimab, famitinib, and platinum-based chemotherapy exhibits encouraging preliminary antitumor activity and a manageable safety profile as a first-line intervention for ES-SCLC. This safety run-in data supports further clinical development of this triplet regimen."

Clinical • Lung Cancer • Neutropenia • Pulmonary Embolism • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2028 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Clinical Study on the Efficacy and Safety of Fluzoparib Combined with Famitinib as Maintenance Therapy after First-Line Platinum-Based Chemotherapy in HRD-Negative Advanced Ovarian Cancer (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Yantai Yuhuangding Hospital; Yantai Yuhuangding Hospital

New P2 trial • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • BRCA1 • BRCA2 • MUC16

PD-1 Inhibition With Camrelizumab in Cervical Cancer: A Systematic Review and Meta-Analysis. (PubMed, Am J Clin Oncol) - "Camrelizumab demonstrates clinically meaningful antitumor activity in cervical cancer, particularly in combination regimens, though toxicity requires careful monitoring."

Journal • Retrospective data • Cardiovascular • Cervical Cancer • Hematological Disorders • Hypertension • Leukopenia • Neutropenia • Oncology • Solid Tumor • PD-L1

Efficacy at a cost: camrelizumab and famitinib within the expanding landscape of combination therapies. (PubMed, Gynecol Pelvic Med) - No abstract available

Journal • Cervical Cancer • Oncology • Solid Tumor

Addition of angiogenesis inhibitors to CDK4/6 inhibitors and fulvestrant in hormone receptor-positive, HER2-negative advanced breast cancer. (PubMed, Chin Med J (Engl)) - P1/2 | "Although the objective response threshold in the first stage of phase II was met, the median PFS did not demonstrate superiority over standard front-line regimens for HR+/HER2- advanced BC, and overlapping hematologic toxicities were observed."

Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • HER-2 • PIK3CA

Camrelizumab With Famitinib for Patients With Rare Head and Neck Malignancies (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

New P1/2 trial • Head and Neck Cancer • Oncology • Solid Tumor • HER-2

PD-1 inhibition with camrelizumab in cervical cancer: A systematic review and meta-analysis. (ASCO 2026) - "Randomized controlled trials, single-arm trials, prospective or retrospective cohort studies, and case-control studies with pathologically confirmed cervical cancer patients treated with Camrelizumab as monotherapy or in combination with chemotherapy or VEGFR-TKIs (Apatinib or Famitinib) were included. This systematic review and meta-analysis indicates that PD-1 inhibition with Camrelizumab demonstrates clinically meaningful antitumor activity in cervical cancer, both as monotherapy and in combination regimens, addressing a disease with limited effective therapeutic options. The consistency of efficacy signals across diverse study designs supports Camrelizumab as an active immunotherapeutic approach in this setting."

Retrospective data • Review • Cervical Cancer • Hypertension • Leukopenia • Neutropenia • Oncology • Solid Tumor • PD-L1

Camrelizumab Combined With Famitinib Malate and Chemotherapy for Treatment of Recurrent/ Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Hunan Cancer Hospital

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

Camrelizumab Plus Famitinib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Study. (PubMed, Cancer Med) - P2 | "In this single-arm phase II trial, camrelizumab plus famitinib demonstrated encouraging efficacy and a manageable safety profile in patients with refractory R/M HNSCC. These preliminary findings warrant further investigation."

Journal • P2 data • Cardiovascular • Head and Neck Cancer • Hematological Disorders • Hypertension • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study to Evaluate the Efficacy and Safety of Cadonilimab Plus Famitinib in Combination With Chemotherapy for Advanced Ovarian Cancer (ChiCTR) - P2 | N=66 | Sponsor: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of

IO biomarker • New P2 trial • Gastrointestinal Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CA 19-9 • PD-L1

An Exploratory, Single-Arm Study of Adebrelimab and Famitinib for Locally Advanced Head and Neck Squamous Cell Carcinoma (ChiCTR) - P=N/A | N=30 | Sponsor: Shandong Second Provincial General Hospital; Shandong Second Provincial General Hospital

New trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Tertiary lymphoid structures induction predicts and enhances response to famitinib plus PD-L1 blockade in advanced thyroid cancer (AACR 2026) - P2 | "Mechanistic evidence from this phase II study identifies TLS induction and maturation as key determinants of therapeutic response to famitinib plus adebrelimab. TLS enhances Tfh-B-cell interactions and cytotoxic T-cell activation, thereby increasing treatment sensitivity. TLS represents a mechanistic driver of response, a predictive biomarker, and an actionable immunologic target to sensitize advanced TC to TKI-immunotherapy combination."

IO biomarker • Metastases • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma • CD20 • CD8 • CXCR3 • CXCR5

Clinical and biomarker analyses of SHR-1701 combined with famitinib in patients with previously treated advanced biliary tract cancer or pancreatic ductal adenocarcinoma: A phase II trial (AACR 2025) - P=N/A | "SHR-1701 plus famitinib showed promising efficacy and manageable toxicity in advanced BTC and PDAC, providing proof-of-concept for targeting PD-L1, TGF-β, and angiogenesis pathways simultaneously. The I/M score may help select patients most likely to benefit from this regimen."

Biomarker • Clinical • IO biomarker • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • TGFB1

Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Shanghai Zhongshan Hospital

New P2 trial • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

FUSCC Refractory TNBC Platform Study (FUTURE2.0) (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Fudan University

Trial completion date • Trial primary completion date • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Fudan University | N=120 ➔ 160

Enrollment change • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

A Single-arm, Multicenter, Phase II Clinical Study of Camrelizumab Combined With Famitinib in Adjuvant Therapy After Radical Resection of Cervical Cancer (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Jin LI

New trial • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype (clinicaltrials.gov) - P3 | N=248 | Not yet recruiting | Sponsor: Fudan University

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR