JYP0322 / Guangzhou JOYO Pharma - LARVOL DELTA

JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs. (clinicaltrials.gov) - P3 | N=207 | Not yet recruiting | Sponsor: Guangzhou JOYO Pharma Co., Ltd

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

JYP0322-M101: Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors (clinicaltrials.gov) - P1 | N=101 | Recruiting | Sponsor: Guangzhou JOYO Pharma Co., Ltd | N=54 ➔ 101

Enrollment change • Brain Cancer • Lung Cancer • Oncology • Solid Tumor

A highly selective, brain-penetrant and overcoming G2032R resistance ROS1 inhibitor JYP0322 in NSCLC patients with ROS1 fusion (AACR 2025) - P1 | "JYP0322 had a favorable safety profile with a low incidence of neurotoxicities. It showed highly promising anti-tumor effects in patients with ROS1+NSCLC including both TKI-naïve and TKI pre-treated patients, as well as those with TKI-heavily treated, brain metastases, or harboring ROS1 G2032R mutation.Tumor response in patients with ROS1+ advanced NSCLCG2032R mutationsPrevious treatment lines≥2L and ROS1 TKI≥1ROS1 TKI naive Evaluable subjects (All dose level)All (n=7)Lorlatinib pretreated (n=3)All (n=22)CNS metastasis (n=13)All (n=14)CNS metastasis (n=1)ORR71.4%66.7%54.5%38.5%85.7%100%DCR100%100%81.8%69.2%100%100%"

Clinical • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

The latest clinical study results of Jiayue Pharmaceutical’s JYP0322 and WX390 were selected for AACR 2025 [Google translation] (bydrug.pharmcube.com) - "From April 25 to 30, 2025, the 2025 Annual Meeting of the American Association for Cancer Research (AACR) will be held in Chicago, USA. Jiayue Pharmaceutical will present the latest Phase I clinical study results of the new generation ROS1 inhibitor JYP0322 in patients with ROS1 gene fusion-positive advanced non-small cell lung cancer (NSCLC) in the form of an oral report. This is the first data publication of JYP0322 in NSCLC patients. In addition, the company will also present the latest clinical research results of the innovative drug WX390 (PI3K/mTOR dual-target inhibitor) combined with toripalimab in the treatment of patients with advanced cervical cancer through posters."

P1 data • P1/2 data • Cervical Cancer • Non Small Cell Lung Cancer • Solid Tumor

Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Guangzhou JOYO Pharma Co., Ltd | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Jun 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Brain Cancer • Lung Cancer • Oncology • Solid Tumor