HR20013 / Jiangsu Hengrui Pharma - LARVOL DELTA

HR20013, a fixed-dose intravenous combination of fosrolapitant and palonosetron, for the prevention of cisplatin-induced nausea and vomiting: putting the PROFIT trial into perspective. (PubMed, Ann Palliat Med) - No abstract available

Journal • Chemotherapy-Induced Nausea and Vomiting

HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents (clinicaltrials.gov) - P3 | N=706 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Oncology

Pharmacokinetics, safety, and efficacy of mixed formulation of fosrolapitant and palonosetron (HR20013) in combination with dexamethasone in patients with solid tumors scheduled for highly emetogenic cisplatin-based chemotherapy: a phase I trial. (PubMed, BMC Med) - P1 | "HR20013 plus dexamethasone had a favorable PK profile, manageable safety, and durable antiemetic efficacy."

Journal • P1 data • PK/PD data • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Solid Tumor

HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents (clinicaltrials.gov) - P3 | N=706 | Active, not recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology

Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT. (PubMed, J Clin Oncol) - "HR20013 + DEX was noninferior to FAPR + PALO + DEX for preventing HEC-CINV and well tolerated, with the potential to reduce the impact of CINV on daily life."

CINV • Journal • P3 data • Chemotherapy-Induced Nausea and Vomiting

HR20013: Phase III study on the prevention of nausea and vomiting caused by cisplatin-based chemotherapy (PROFIT study) (CSCO 2024) - "Study group: [CSCO Tumor Support and Rehabilitation Treatment Expert Committee]"

P3 data • Oncology

HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents (clinicaltrials.gov) - P3 | N=700 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2025 ➔ Sep 2025

Enrollment open • Trial primary completion date • Oncology

Phase 3 Study of HR20013 For Prevention of Cisplatin-based Chemotherapy-induced Nausea and Vomiting (PROFIT Study) (IASLC-WCLC 2024) - P3 | "The study (NCT05509634) aimed to assess HR20013 versus fosaprepitant (FAPR) plus PALO (FAPR+PALO) regimen in preventing cisplatin-based HEC-CINV...All pts also received oral dexamethasone (DEX) on days 1-4...CR Cycle 1 Cycle 2 HR20013+DEX (N=373) FAPR+PALO+DEX (N=377) D P HR20013+DEX (N=314) FAPR+PALO+DEX (N=336) D P OP 290 (77.7) 295 (78.2) -0.9 (-6.7, 5.0) <0.01 * 254 (80.9) 263 (78.3) 2.4 (-3.7, 8.5) 0.44 AP 340 (91.2) 339 (89.9) 1.0 (-3.2, 5.2) 0.64 293 (93.3) 306 (91.1) 2.2 (-1.9, 6.2) 0.30 DP 298 (79.9) 304 (80.6) -1.2 (-6.8, 4.4) 0.68 255 (81.2) 267 (79.5) 1.5 (-4.5, 7.6) 0.62 BDP 337 (90.3) 326 (86.5) 3.7 (-0.9, 8.2) 0.11 291 (92.7) 295 (87.8) 4.8 (0.3, 9.2) 0.04 0-168 h 285 (76.4) 283 (75.1) 1.0 (-5.1, 7.0) 0.75 250 (79.6) 256 (76.2) 3.2 (-3.0, 9.5) 0.32 Data are n (%) or % (95% CI). * Only P for primary endpoint was 1-sided for the noninferiority test."

CINV • P3 data • Chemotherapy-Induced Nausea and Vomiting • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents (clinicaltrials.gov) - P3 | N=700 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P3 trial • Oncology

HEALTH-RELATED QUALITY OF LIFE (QOL) IN PROFIT STUDY: A PHASE 3 TRIAL OF HR20013 FOR PREVENTION OF HIGHLY EMETOGENIC CHEMO INDUCED NAUSEA AND VOMITING (MASCC-AFSOS-ISOO 2024) - P3 | "The study results demonstrated that HR20013 + dexamethasone (DEX) was non-inferior to standard triple therapy of fosaprepitant (FAPR) + PALO+DEX in complete response (no emesis/no rescue) rate during overall phase (0–120 hours) in cycle 1 in patients receiving highly emetogenic chemo (HEC), which met primary endpoint...Methods Chemo-naïve patients were randomized to receive HR20013 (N=373; IV, D1) or FAPR+PALO (N=377; IV, D1) before each cycle of cisplatin-based HEC (2 cycles in total), along with oral DEX (D1–D4)...In cycle 2, HR20013+DEX showed lower decreases from baseline in overall score during delayed phase (DP, 24–120 hours; LS mean, -3.5 vs -6.0; P=0.03), vomiting score during DP (-1.2 vs -2.4; P=0.03), and nausea score during beyond delayed phase (BDP, 120–168 hours; -1.1 vs -2.1; P=0.04) compared with FAPR+PALO+DEX, as well as greater proportions of patients reporting NIDL for overall domain at DP (93.6% vs 87.8%; P=0.01), vomiting domain at DP (95.2%..."

Clinical • HEOR • P3 data • B3GAT1

Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P3 | N=754 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P3 | N=754 | Active, not recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2022 ➔ Apr 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P3 | N=752 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P3 | N=752 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P3 trial • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor