famitinib (SHR 1020) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Non-interventional Registration Study of Monotherapy or Combination Regimens Based on Camrelizumab or Famitinib for the Treatment of Cervical Cancer (clinicaltrials.gov) - P=N/A | N=1300 | Not yet recruiting | Sponsor: Qi Zhou

Monotherapy • New trial • Cervical Cancer • Oncology • Solid Tumor

Interim analysis of adebrelimab plus famitinib as later-line treatment for extensive-stage small cell lung cancer: A phase II clinical trial (ESMO Asia 2025) - P=N/A | "Adebrelimab combined with famitinib showed promising survival benefits with manageable toxicity in relapsed ES-SCLC, particularly in heavily pretreated pts and those with prior immunotherapy exposure."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Exploring the efficacy and safety of famitinib combined with epalrestat and torivirine in the treatment of advanced and recurrent/metastatic cervical cancer (ChiCTR) - P2 | N=90 | Not yet recruiting | Sponsor: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of

New P2 trial • Cervical Cancer • Oncology • Solid Tumor • PD-L1

A prospective, multicenter, phase II study of famitinib maleate combined with camrelizumab and chemotherapy as neoadjuvant therapy for locally advanced cervical cancer. (ChiCTR) - P2 | N=60 | Not yet recruiting | Sponsor: Fujian Cancer Hospital; Fujian Cancer Hospital

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

Phase II CAPSTONE trial of first-line camrelizumab plus famitinib for locally advanced or metastatic pulmonary sarcomatoid carcinomas (ESMO 2025) - P2 | "Two pts experienced grade 5 AEs of unknown cause. Conclusions Camrelizumab plus famitinib as first-line treatment showed encouraging antitumor activity and manageable safety in pts with locally advanced or metastatic PSC, indicating a potential novel treatment option for this population."

Clinical • Metastases • P2 data • Lung Cancer • Oncology • Sarcoma • Solid Tumor

First-line adebrelimab plus anti-angiogenic therapy in PD-L1 ≥50% NSCLC with brain metastases: Updated results from the BRAIN-AF01 study (ESMO 2025) - P2 | "This study reports updated outcomes of Adebrelimab with either famitinib or bevacizumab in patients with PD-L1 ≥50% NSCLC and brain metastases. Conclusions Adebrelimab plus anti-angiogenic therapy demonstrated promising efficacy and durable intracranial control with manageable toxicity in PD-L1 high NSCLC with brain metastases. Pharmacokinetic and MRI findings support CNS activity, warranting further investigation."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

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

Camrelizumab Combo Extends Survival in Metastatic Cervical Cancer (Cure Today) - "...Data from a phase 3 trial presented during the 2025 ESMO Congress. At the June 10, 2025, data cutoff, at a median follow-up of 19.3 months, the median progression-free survival (PFS) per blinded independent central review (BICR) was 11.1 months in the combination arm (220 patients) compared with 7.5 months in the chemotherapy arm (223 patients). The median PFS values per investigator assessment were 11.3 months and 7.7 months, respectively."

P3 data • Cervical Cancer

Hengrui innovative drug carrelizumab and malic acid famitinib for cervical cancer first-line treatment application accepted [Google translation] (Jiangsu Hengrui Press Release) - "The listing is based on a randomized, open, controlled, multi-center Phase III clinical study of carerizumab and famitinib with platinum-containing chemotherapy for recurrent or metastatic cervical cancer (SHR-1210-III-329)."

China filing • Cervical Cancer

Primary analysis of efficacy and safety of adebrelimab combined with famitinib and chemotherapy as first-line therapy for ES-SCLC: A multicenter, single-arm, phase II study (ESMO 2025) - P2 | "Methods Patients (pts) with previously untreated ES-SCLC were enrolled to receive 4 cycles of adebrelimab (1200mg,IV,Q3W) combined with famitinib (20mg,P.O.,QD) and chemotherapy (etoposide + cisplatin/carboplatin, IV, Q3W) followed by maintenance therapy with adebrelimab and famitinib. Conclusions The combination therapy of adebrelimab, famitinib and chemotherapy showed an encouraging efficacy and acceptable safety profile as first-line treatment for ES-SCLC. This study is still ongoing."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • KDR • KIT

Famitinib plus adebrelimab for advanced thyroid cancer after failed frontline treatment: A single-arm, open-label phase II trial (ESMO 2025) - P2 | "Benefit was observed even in those with failed pretreatment. TLS enrichment and T-cell infiltration may predict response, warranting further validation."

Clinical • Metastases • P2 data • Oncology • Solid Tumor • Thyroid Gland Carcinoma

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 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

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

Famitinib: First Approval. (PubMed, Drugs) - "In May 2025, famitinib was granted conditional approval for use in combination with camrelizumab for the treatment of patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy and have not received prior bevacizumab in China. This article summarizes the milestones in the development of famitinib leading to this first approval for the treatment of recurrent or metastatic cervical cancer."

Journal • Cervical Cancer • Oncology • Solid Tumor

A Study to Evaluate SHR-1210 in Combination With Famitinib Plus Chemotherapy in Subjects With NSCLC. (clinicaltrials.gov) - P3 | N=48 | Terminated | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=560 ➔ 48 | Trial completion date: Oct 2023 ➔ Aug 2025 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Aug 2025; Terminated by Sponsor

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

A Study of SHR-1802 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P2 | N=25 | Terminated | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=124 ➔ 25 | Recruiting ➔ Terminated; Adjustment of R&D strategy

Enrollment change • Trial termination • Solid Tumor

Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=443 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Apr 2025 ➔ May 2027

Trial completion date • Cervical Cancer • Oncology • Solid Tumor

Tyrosine Kinase Inhibitors for Gastrointestinal Stromal Tumor After Imatinib Resistance. (PubMed, Pharmaceutics) - "Sunitinib, regorafenib, and ripretinib are currently approved as standard second-, third-, and fourth-line therapies, each demonstrating efficacy against distinct mutational profiles. Avapritinib, notably effective against PDGFRA D842V mutations, represents a milestone for previously untreatable subgroups. Several alternative agents-such as nilotinib, masitinib, sorafenib, dovitinib, pazopanib, and ponatinib-have shown varying degrees of success in refractory cases or specific genotypes. Investigational compounds, including crenolanib, bezuclastinib, famitinib, motesanib, midostaurin, IDRX-42, and olverembatinib, are under development to address resistant or wild-type GISTs...Future strategies include precision medicine approaches such as ctDNA-guided therapy, rational drug combinations, and novel drug delivery systems to optimize bioavailability and reduce toxicity. Ongoing research will be crucial for refining treatment sequencing and expanding therapeutic options,..."

Journal • Review • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Oncology • Sarcoma • KIT • PDGFRA

A Prospective, Randomized, Parallel Trial of Famitinib Malate at Different Doses Combined With Camrelizumab for the Treatment of Recurrent and Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

CASTLE-ZS-03: Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma. (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=194 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Jul 2025 | Trial primary completion date: Dec 2022 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor • PD-L1

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

Neoadjuvant SNF Precision Therapy Phase III (clinicaltrials.gov) - P3 | N=404 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Famitinib for familial adenomatous polyposis-associated aggressive desmoid tumors: 32-month follow-up from a single-center exploratory study. (ASCO 2025) - P=N/A | "Famitinib demonstrated sustained clinical efficacy and meaningful survival benefits in pts with FAP-associated aggressive DTs after a median follow-up of 32 months. Given the unique characteristics, careful monitoring for intestinal perforation and the risk of second primary tumors is crucial during treatment."

Clinical • Dermatology • Desmoid Tumors • Gastrointestinal Disorder • Genetic Disorders • Hypertension • Infectious Disease • Leukopenia • Neutropenia • Oncology • Renal Disease • Sarcoma • Small Intestinal Carcinoma • APC • FGFR • KDR • KIT

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKEXnews) - "Recently, Suzhou Suncadia Biopharmaceuticals Co., Ltd...received a notice from the National Medical Products Administration (NMPA). The NMPA conditionally approves the Company’s self-developed Class 1 innovative drug, Famitinib Malate Capsules, for marketing, to be used in combination with Camrelizumab for Injection is indicated for patients with recurrent or metastatic cervical cancer who have previously failed platinum-based chemotherapy but have not received bevacizumab treatment."

China approval • Cervical Cancer

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