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

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

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

Adebrelimab and famitinib alone or combined with short-course chemotherapy as the first-line treatment for PD-L1-positive advanced non-small cell lung cancer: a clinical study (ChiCTR) - P4 | N=80 | Not yet recruiting | Sponsor: Changzhou First People's Hospital; Changzhou First People's Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

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

Fluzoparib Plus Famitinib Maintenance After First-Line Platinum Response in Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=43 | Not yet recruiting | Sponsor: Jinhua Zhou

New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

A Randomized, Open-label, Double-cohort Study of Fluzoparib Combined With Famitinib Malate or SHR-1701 for Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=104 | Not yet recruiting | Sponsor: Qinglei Gao

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

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

Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Shandong Tumor Hospital

New P2 trial • Gastric 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

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

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

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