famitinib (SHR 1020) / 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

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

Efficacy and safety of famitinib in the treatment of unresectable advanced desmoid tumors: a prospective, single-arm clinical study (ChiCTR) - P2 | N=42 | Recruiting | Sponsor: Peking University Cancer Hospital; Peking University Cancer Hospital

New P2 trial • Desmoid Tumors • Oncology • Sarcoma

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

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

Famitinib plus camrelizumab in patients with advanced colorectal cancer: Data from a multicenter, basket study. (PubMed, Innovation (Camb)) - P2 | "In conclusion, the combination of famitinib and camrelizumab demonstrates promising antitumor activity with a manageable safety profile in metastatic colorectal cancer patients. Further research is warranted to confirm and extend these findings."

IO biomarker • Journal • Cardiovascular • Colorectal Cancer • Hypertension • Oncology • Renal Disease • Solid Tumor • PD-1

Adebrelimab combined with famitinib as third-line or beyond treatment for soft tissue sarcoma: a multicenter, parallel cohort, phase Ⅱ clinical study (ChiCTR) - P4 | N=54 | Sponsor: Jiangsu Cancer Hospital; Jiangsu Cancer Hospital

New P4 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • 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. | Enrolling by invitation ➔ Active, not recruiting | Trial completion date: May 2023 ➔ Apr 2025 | Trial primary completion date: Dec 2022 ➔ Apr 2025

Enrollment closed • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • 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 primary completion date: Sep 2024 ➔ Dec 2024

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

Precision medicine based on similarity network fusion (SNF) subtypes of multi-omics in CDK4/6 inhibitor failed HR+/ HER2- advanced breast cancer: the Linux trial (SABCS 2024) - P2 | "The subtyping-based precision therapies included: everolimus (10 mg orally daily) + fulvestrant for SNF1, camrelizumab (200 mg intravenously on days 1 and 15) and famitinib (10 mg orally daily) + TPC for SNF2, fuzuloparib (100 mg orally bid) + TPC for SNF3, and apatinib (250mg orally daily) + TPC for SNF4. Our findings highlight the potential clinical benefits of SNF subtyping guided precision medicine in patients with HR+/HER2- breast cancer, suggesting a direction for further clinical investigation. Phase III randomized clinical trials for SNF2 and SNF4 assessing the efficacy of SNF subtyping-based strategies are now underway. (Linux)"

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • SMARCA2

Hengrui's innovative drug Relafupu-α combined with Famitinib for the treatment of advanced biliary and pancreatic tumors was published in the Nature journal STTT [Google translation] (Jiangsu Hengrui Press Release) - P2 | N=51 | ChiCTR2000037927 | "A total of 27 BTC patients and 24 PDAC patients were included between September 2020 and April 2023. BTC cohort: The ORR was 28% (95%CI: 12.1-49.4) among 25 evaluable patients, including 2 complete responses (CR) and 5 partial responses (PR); the DCR was 80% (95%CI: 59.3-93.2). PDAC cohort: The ORR was 15% (95%CI: 3.2-37.9) among 20 evaluable patients, including 2 CRs and 1 PR; the DCR was 60.0% (95%CI: 36.1-80.9). As of May 1, 2024, the median follow-up time was 26.4 months (95% CI 19.6-33.2). The median PFS of the BTC cohort was 5.1 months (95% CI: 2.6-7.6), and the median OS reached 16 months (95% CI: 6.1-NE). The median PFS of the PDAC cohort was 2.1 months (95% CI: 0.7-3.5), and the median OS was 5.3 months (95% CI: 4.0-6.5)."

P2 data • Biliary Cancer • Pancreatic Cancer

Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - P1/2 | N=46 | Terminated | Sponsor: Henan Cancer Hospital | Trial completion date: Jan 2026 ➔ Jul 2024 | Active, not recruiting ➔ Terminated; Investigators' decision

Metastases • Trial completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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. (PubMed, Signal Transduct Target Ther) - P=N/A | "An immune/metabolism score integrating the features of six genes was developed as a predictive biomarker for immunotherapy response in multiple cohorts, allowing for the selection of patients most likely to experience positive outcomes from this therapy regimen. In conclusion, our study provides proof-of-concept data supporting the potential of SHR-1701 plus famitinib as an effective and safe subsequent-line therapy for refractory BTC and PDAC, highlighting the promise of targeting PD-L1, TGF-β, and angiogenesis pathways simultaneously."

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

Efficacy and Safety of Camrelizumab Combination Therapy in Triple-Negative Breast Cancer: A Systematic Review and Meta-Analysis (SABCS 2024) - "Camrelizumab was combined with Nab-paclitaxel, Apatinib, and Famitinib in 4, 3, and 2 studies, respectively. Our meta-analysis affirms that Camrelizumab combination therapy has shown promising results in terms of overall response rate and the one-year survival rate. Further research with large-scale randomized clinical trials is warranted to generate robust results."

Combination therapy • Retrospective data • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib ± Camrelizumab (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2024 ➔ Sep 2024

Enrollment open • IO biomarker • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • BRCA

Liposomal irinotecan (Lipo-IRI) alone or in combination with famitinib or platinum for patients with extensive-stage small cell lung cancer (ES-SCLC) after failure of first-line immunotherapy: A multicenter, randomized, open-label, multicohort phase II trial (ESMO Asia 2024) - P2 | "This study aims to investigate the efficacy and safety of Lipo-IRI alone or in combination with famitinib (a structural analog of sunitinib) or platinum in patients with ES-SCLC after failure of first-line immunotherapy. Secondary endpoints include objective response rate, 6-month PFS rate, overall survival, duration of response, disease control rate, and safety. The study is registered with ChiCTR.org.cn, ChiCTR2400083693."

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

2024 SABCS Outlook | Hengrui Medicine’s 26 breast cancer research projects on innovative drugs will shine at the international academic event [Google translation] (Jiangsu Hengrui Press Release) - "At this conference, Hengrui Medicine had 26 studies of eight innovative drugs shortlisted, including the human epidermal growth factor 1/2/4 (HER1/HER2/HER4) targeted drug pyrotinib, the CDK4/6 inhibitor Dalpiciclib , the PD-1 inhibitor carrelizumab, the multi-target receptor tyrosine kinase inhibitor famitinib among which three were oral presentations, three were poster spotlights, and 20 were poster presentations."

Clinical data • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

SHR-1701 combined with famitinib for patients with previously treated advanced biliary tract or pancreatic ductal adenocarcinoma: A phase II open-label, single-arm study (EORTC-NCI-AACR 2024) - "The combination of SHR-1701 and famitinib showed promising antitumor activity with manageable toxicity in advanced BTC and PDAC."

Clinical • IO biomarker • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • TGFB1

BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov) - P2 | N=620 | Recruiting | Sponsor: Fudan University | N=140 ➔ 620

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

CAPSTONE: Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Qian Chu | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor

Phase II clinical trial of camrelizumab combined with famitinib for immunotherapy-treated advanced acral and mucosal melanoma (CSCO 2024) - "Study group: [CSCO Malignant Melanoma Expert Committee]"

Clinical • Metastases • P2 data • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

Adebrelimab Combined with Famitinib and Chemotherapy as First-Line Therapy for ES-SCLC: A Phase II, Single-Arm Exploratory Research (IASLC-WCLC 2024) - "Patients will be dosed adebrelimab (1200 mg, iv, q3w) in combination with etoposide/platinum drugs (cisplatin 75 mg/m 2 or carboplatin AUC 5, iv, q3w, 4 cycles). The primary endpoint is 6-month progress-free survival (6-month PFS) rate, and the secondary endpoints are objective response rate, disease control rate, 12-month PFS, PFS, overall survival, safety and quality of life. The study is actively recruiting."

Clinical • P2 data • Cardiovascular • Endocrine Cancer • Hypertension • Infectious Disease • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • FGFR • KDR • KIT

Preliminary Efficacy and Safety of Adebrelimab Plus Famitinib as Later-line Treatment for Extensive-Stage Small Cell Lung Cancer: A Phase 2 Trial (IASLC-WCLC 2024) - "A Simon two-stage design was applied. If there were more than 1 patient achieved response within the first 13 pts, the cohort would expand to 34 pts."

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