zurletrectinib (ICP-723) / InnoCare - LARVOL DELTA

Zurletrectinib in NTRK Fusion-Positive Solid Tumors: an Integrated Efficacy and Safety Analysis of Three Open-Label Single-Arm Clinical Trials (ESMO Asia 2026) - No abstract available

Clinical • Oncology • Solid Tumor • NTRK

Title: Updated efficacy and safety of zurlectrectinib in adult patients (pts) with locally advanced or metastatic NTRK fusion-positive (NTRK+) solid tumors (Abstract No.: 3112) (Businesswire) - "Latest data of InnoCare’s robust oncology pipelines presented at the 2025 ASCO Annual Meeting....As of Nov. 23, 2024, a total of 49 TRK inhibitor naïve adult patients were evaluable for efficacy representing 12 different solid tumor types. Among the efficacy population, the distribution of NTRK1, NTRK2 and NTRK3 fusions was 53.1%, 2.0% and 44.9% respectively. The confirmed ORR by IRC was 83.7%, with CR of 10.2%. Median duration of response (DOR) and median progression-free survival (PFS) by IRC were not reached. The DOR rate and PFS rate by IRC at 12 months was 92.0% and 90.5% respectively. Two of the three patients who had brain metastasis at the baseline achieved intracerebral ORR, which is consistent with the good brain penetration and strong intracranial activity of zurletrectinib."

P1/2 data • Solid Tumor

Title: Efficacy, safety and pharmacokinetics (PK) of zurletrectinib, a next-generation pan-TRK inhibitor, in pediatric and adolescent patients with NTRK fusion-positive (NTRK+) solid tumors (Abstract No.: 10048) (Businesswire) - "Latest data of InnoCare’s robust oncology pipelines presented at the 2025 ASCO Annual Meeting....As of Nov. 23, 2024, 18 patients in total were enrolled, including 8 pediatric patients and 10 adolescent patients. Among the 18 patients, 6 TRK inhibitor treatment-naïve patients with central lab confirmed NTRK+ were efficacy evaluable. The confirmed ORR assessed by IRC was 100%. All patients achieved partial response (PR) at the first tumor assessment and maintained the remission as of the cutoff date. Median time to response were 1.0 month in adolescent patients and 0.9 month in pediatric patients. It is worth noting that one pediatric patient who progressed on prior first-generation TRK inhibitor achieved complete response after receiving zurletrectinib."

P1/2 data • Solid Tumor

InnoCare Releases 2026 Q1 Results: Strong Revenue Growth and Sustained Profitability (The Manila Times) - "In the first quarter of 2026, all four approved indications of orelabrutinib were included in the updated NRDL...Additionally, both tafasitamab and zurletrectinib have been approved for marketing in 2025 and have begun to contribute to sales. Tafasitamab became the first CD19 antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in China, while the next-generation TRK inhibitor, zurletrectinib, has been prescribed in hospitals across China. As a result, drug sales increased by 44.5%, reaching RMB 450.5 million in the first quarter of 2026."

Sales • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Marginal Zone Lymphoma • Small Lymphocytic Lymphoma

Building a competitive drug portfolio for solid tumor treatment: Zurletrectinib (ICP-723) (InnoCare Pharma Press Release) - "...the registrational trial for pediatric patients (2 years < 12 years) is ongoing, with the NDA submission targeted in first half of 2026."

FDA filing • Trial status • Solid Tumor

InnoCare Pharma…announced today that its next generation TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), for the treatment of pediatric patients (aged 2 to 12) with solid tumors harboring NTRK gene fusions (GlobeNewswire) - "Zurletrectinib has also been included in the 'SPARK Program' by the CDE, a pilot initiative to encourage the development of pediatric anti-tumor drugs....The data from the Phase I/II clinical trial of zurletrectinib for the treatment of pediatric and adolescent patients...demonstrated a well-tolerated safety profile and promising antitumor activity in pediatric/adolescent patients with NTRK/ROS1-altered solid tumors."

China filing • Priority review • Solid Tumor

APPROVAL OF ZURLETRECTINIB FOR THE TREATMENT OF ADULT AND ADOLESCENT PATIENTS WITH SOLID TUMORS HARBORING NTRK GENE FUSIONS IN CHINA (InnoCare Pharma Press Release) - "This announcement is made by InnoCare Pharma Limited...pursuant to Rule 13.09(2)(a) of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the 'Listing Rules') and the inside information provision (as defined in the Listing Rules) under Part XIVA of the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong)...In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy and a favorable safety profile. The study results showed an objective response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively"

China approval • Solid Tumor

Zurletrectinib Generates Responses in Advanced NTRK Fusion Solid Tumors (Cancer Network) - "Data were presented at the Congress of International Society of Pediatric Oncology (SIOP) 2025....As of July 31, 2025, the objective response rate (ORR) among patients treated with zurletrectinib was 90% as assessed by an independent review committee (IRC). Additionally, among patients who completed full efficacy evaluations, those resistant to first-generation TRK inhibitors all achieved partial responses....Additionally, the recommended phase 2 dose (RP2D) was found to be 7.2 mg/m2 for pediatric patients and 8 mg/m2 for adolescent patients."

P1/2 data • Solid Tumor

SAFETY, PHARMACOKINETICS, AND EFFICACY OF ZURLETRECTINIB, A NEXT-GENERATION PAN-TRK INHIBITOR, IN PEDIATRIC AND ADOLESCENT PATIENTS WITH ADVANCED SOLID TUMOR: A PHASE I/II TRIAL (SIOP 2025) - P1/2 | "Partial responses were also observed in 1/2 NTRK amplification and 1/2 ROS1 fusion patients. Conclusions Zurletrectinib showed manageable safety and promising antitumor activity in pediatric/ adolescent patients with NTRK/ROS1-altered solid tumors, highlighting its potential as a therapy for NTRK/ROS1-driven malignancies, particularly in overcoming resistance to first-generation TRK inhibitors."

Clinical • Metastases • P1/2 data • PK/PD data • Anemia • Brain Cancer • CNS Tumor • Oncology • Pediatrics • Solid Tumor • Spindle Cell Sarcoma • NTRK • ROS1

Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial primary completion date • Brain Cancer • CNS Tumor • Solid Tumor • NTRK

ICP-CL-00501: A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=310 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Trial primary completion date: Jun 2025 ➔ Jan 2028

Trial primary completion date • Solid Tumor

Precision Medicine: Zurletrectinib (Businesswire) - "The registrational trial for pediatric patients (2 to 12 years) is ongoing, with NDA submission later 2025."

FDA filing • Trial status • Solid Tumor

Efficacy, safety and pharmacokinetics (PK) of zurletrectinib, a next-generation pan-TRK inhibitor, in pediatric and adolescent patients (pts) with NTRK fusion-positive (NTRK+) solid tumors. (ASCO 2025) - P1/2 | "The integrated analysis demonstrated that zurletrectinib had significant efficacy and good safety profile in pediatric and adolescent pts with NTRK+ solid tumors. Zurletrectinib also showed the potential to overcome the resistance to 1st generation TRK inhibitors. These findings support zurletrectinib is a better treatment option for NTRK+ pediatric and adolescent pts."

Clinical • PK/PD data • Anemia • Fibrosarcoma • Hematological Disorders • Oncology • Pediatrics • Sarcoma • Solid Tumor • NTRK

Updated efficacy and safety of zurlectrectinib in adult patients (pts) with locally advanced or metastatic NTRK fusion–positive (NTRK+) solid tumors. (ASCO 2025) - P1/2 | "In line with previously reported results, zurlectrectinib continued to demonstrate a deep and durable responses in adult pts with NTRK+ advanced solid tumors with or without brain metastasis. Zurlectrectinib was also well-tolerated and showed favorable safety profile in adult pts with various tumor types."

Clinical • Metastases • Anemia • Hematological Disorders • Oncology • Solid Tumor • NTRK • NTRK1 • NTRK2 • NTRK3

InnoCare’s Zurletrectinib Receives Priority Review from China’s NMPA (Businesswire) - "InnoCare Pharma...announced today that its new generation pan-TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted the New Drug Application (NDA) of zurletrectinib for the treatment of patients with advanced solid tumors harboring NTRK gene fusions recently....In the registrational trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile."

China filing • Evidence highlight • Priority review • Solid Tumor • NTRK

InnoCare Announces the Acceptance of New Drug Application for pan-TRK Inhibitor Zurletrectinib in China (Businesswire) - "InnoCare Pharma...announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a New Drug Application (NDA) for its new generation pan-TRK inhibitor zurletrectinib (ICP-723) for the treatment of adult and adolescent patients (12 to 18 years old) with advanced solid tumors harboring NTRK gene fusions. In the registrational trial for adult and adolescent patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile. Zurletrectinib was also shown to overcome acquired resistance to the first-generation TRK inhibitors. Meanwhile, the Company is accelerating the registrational trial for pediatric patients (2 to 12 years old)."

China filing • Trial status • Solid Tumor

Study of ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors (clinicaltrials.gov) - P1/2 | N=55 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Jun 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Oncology • Solid Tumor • NTRK

InnoCare Releases 2024 Interim Results and Business Highlights (Businesswire) - N=P1/2 | N=310 | NCT04685226 | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | "Zurletrectinib has demonstrated good efficacy and safety profile....The clinical study with zurletrectinib has covered neurotrophic tyrosine receptor kinase (NTRK) gene fusion adult patients, adolescent patients (12 to 18 years old) and pediatric patients (2 to 12 years old). The efficacy has been observed in both adolescent and pediatric patients. The dose escalation trial for pediatric patients has been completed."

P1/2 data • Oncology • Solid Tumor

British Journal of Cancer: Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation agents (Businesswire) - "InnoCare announced British Journal of Cancer...recently published a paper entitled 'Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation agents'. The journal concluded that zurletrectinib is a novel, highly potent next-generation TRK inhibitor with higher in vivo brain penetration and stronger intracranial activity than other next-generation agents....Zurletrectinib (1 mg/kg BID) inhibited tumor growth in xenograft models derived from NTRK fusion-positive cells at a dose 30 times lower when compared to selitrectinib....In an orthotopic mouse glioma xenograft model carrying the TRKA G598R/G670A resistance mutation, zurletrectinib (15 mg/kg) significantly improved the survival of mice harboring orthotopic NTRK fusion-positive, TRK-mutant gliomas (median survival = 41.5, 66.5, and 104 days for selitrectinib, repotrectinib, and zurletrectinib respectively..."

Preclinical • Glioma

Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumours with on-target resistance to first-generation agents. (PubMed, Br J Cancer) - "Our data identifies zurletrectinib as a novel, highly potent next-generation TRK inhibitor with stronger in vivo brain penetration and intracranial activity than other next-generation agents."

Journal • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor • NTRK • NTRK2 • NTRK3

InnoCare Releases 2023 Results and Business Highlights (Businesswire) - "Zurletrectinib (ICP-723): InnoCare is accelerating the registrational trial of zurletrectinib in China. The NDA is expected to be submitted by the end of 2024....The Company is conducting a clinical trial of zurletrectinib for pediatric (2 to 12 years old) and adolescent patients (12 to 18 years old). Patient enrollment of pediatric patients is ongoing, with PR observed."

Non-US regulatory • Trial status • Oncology • Solid Tumor

A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=310 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | N=42 ➔ 310

Enrollment change • Oncology • Solid Tumor

InnoCare Announces First Pediatric Patient Dosed in Clinical Trial of pan-TRK Inhibitor Zurletrectinib in China (Businesswire) - "InnoCare Pharma...announced today that the first pediatric patient has been dosed in clinical trial with its second generation pan-TRK inhibitor zurletrectinib at Sun Yat-sen University Cancer Center. This is the first time that zurletrectinib will be evaluated in a clinical study of pediatric (2 to 12 years old) patients, after demonstrating good safety and efficacy in adult and adolescent patients (12 to 18 years old)."

Trial status • Solid Tumor

Zurletrectinib, a next-generation TRK inhibitor shows strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation drugs. (AACR-NCI-EORTC 2023) - No abstract available

Oncology • NTRK

InnoCare Releases 2023 Interim Results and Business Highlights (Businesswire) - "Patient enrollment of the registrational trial of tafasitamab in combination with lenalidomide for the treatment of r/r DLBCL was completed in China. The Company expects to submit the biologics license application (BLA) in the second quarter of 2024 and anticipate BLA approval in the first half of 2025; ICP-248...The Company expects to submit an investigational new drug (IND) application in the U.S. within this year....InnoCare is accelerating the registrational trial of zurletrectinib in China and expecting to submit NDA by end of 2024."

BLA • Enrollment closed • IND • NDA • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma