News & Events
For the first time, Lupeng Pharma reported the results of the Phase I clinical study in patients with solid tumors treated with LP-118, a novel Bcl-2/Bcl-xL dual inhibitor of the company's small molecule innovative drug at the AACR Annual Meeting 2026. The phase 1 clinical study reported is the first human study of LP-118, led by Professor Wu Yilong and Professor Zhou Qing from Guangdong Provincial People's Hospital，China. The data showed that LP-118 is a novel Bcl-2/Bcl-xL dual inhibitor with favorable safety and PK profiles. Preliminary efficacy observed in patients with advanced SCLC is encouraging, supporting further clinical evaluations.
Bcl-2 family proteins are often overexpressed in tumors, which blocks apoptosis and promotes uncontrolled cell proliferation. LP-118 is a novel Bcl-2/Bcl-xL inhibitor with potent activity against Bcl-2 and fine-tuned activity against Bcl-xL, designed to minimize platelet toxicity while maintaining robust anti-tumor activity.
This is an open-label, phase I study of LP-118 in patients with solid tumors or hematological malignancies (NCT05025358). Eligible subjects had failed standard therapies and had measurable disease. LP-118 was administrated orally, with doses ranging from 50 to 700 mg/day using a 3+3 design. The study endpoints included safety, pharmacokinetic (PK) and preliminary efficacy.
As of July 09, 2025, a total of 52 patients with solid tumors, including 42 with small cell lung cancer (SCLC) were enrolled. PK analysis showed the mean half-life was 7.9 hours, supporting QD dosing. No dose-limiting toxicity (DLT) was reported, and the maximum tolerated dose (MTD) has not yet been reached. Most of the common treatment related adverse events were grade 1–2, with only 4 subjects experienced grade 3 - 4 events. Notably, the incidence of thrombocytopenia was 15.4%. Of 32 efficacy-evaluable SCLC subjects treated at ≥300 mg QD, partial response was observed in 5 subjects and stable disease in 18 subjects, including one subject remaining on treatment for over 22 months. The objective response rate (ORR) was 15.6%, and the disease control rate (DCR) was 71.9%. The median overall survival (OS) was 8.15 months.
In conclusion, LP-118 is a novel Bcl-2/Bcl-xL dual inhibitor with favorable safety and PK profiles. Encouraging preliminary efficacy has been observed in patients with small cell lung cancer, offering hope for bringing new treatment options to these patients.
The poster will presented from 9:00 AM to 12:00 PM on April 21, 2026, in section 50, with the number CT192/14, abstract link to
https://www.abstractsonline.com/pp8/#!/21436/presentation/12098.
Developed from our proprietary BeyondX ®Oral MedChem Platform, LP-118 represents a breakthrough in oral dual Bcl-2/Bcl-xL inhibitor. It is the first and only oral dual Bcl-2/Bcl-xL inhibitor that achieves a delicate balance between potent anti-tumor efficacy and on-target platelet toxicity. Phase I clinical study showed a favorable safety and encouraging efficacy for those treated by LP-118 and suggested a potential broad-spectrum anti-cancer effects addressing multiple types of cancer indications in which Bcl-2 and/or Bcl-xL plays an important role, such as SCLC, B-cell malignancies (CLL/SLL, DLBCL, MCL, etc.), myelofibrosis, and acute lymphoblastic leukemia.
Declaration: The clinical study data of LP-118 released here are preliminary, and the data may be updated and changed as the research progresses. This press release also contains forward-looking statements, which are based on current expectations and are subject to uncertainties and risks. Actual results may differ materially from those in the forward-looking statements. The company does not assume the obligation to update forward-looking statements.