lumipodlin (ABSK043) / Abbisko - LARVOL DELTA

A Phase 2 Study of ABSK043 Combined With Osimertinib (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Abbisko Therapeutics and AstraZeneca Enter a Strategic Collaboration to Conduct the Clinical Trial of Lumipodlin (ABSK043), a First-in-Class Oral PD-L1 Inhibitor, in Combination with TAGRISSO for NSCLC (PRNewswire) - "As a multicenter, open-label Phase I/II clinical study, the combination will evaluate the safety and efficacy of Abbisko's first-in-class oral small-molecule PD-L1 inhibitor, lumipodlin (ABSK043), in combination with AstraZeneca's third-generation EGFR-TKI, TAGRISSO (osimertinib), for the treatment of patients with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC. On May 20, 2026, the investigational new drug (IND) application for the combination study was cleared by the National Medical Products Administration (NMPA). This Phase II study will be led by Abbisko, and both Abbisko and AstraZeneca will share responsibilities for the clinical trial."

Licensing / partnership • New P1/2 trial • Non Small Cell Lung Cancer

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib (clinicaltrials.gov) - P2 | N=86 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • PD-L1

Investigator-initiated phase II trial of ABSK043, an oral PD-L1 inhibitor, in patients with angiogenic sarcoma. (ASCO 2026) - P2 | "This study opened in August 2025 and is actively recruiting. Planned enrollment is 20 patients, with accrual expected to complete by June 2027."

Clinical • IO biomarker • P2 data • Angiosarcoma • Gastrointestinal Disorder • Immunology • Sarcoma • Solid Tumor

A Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: University Health Network, Toronto | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Oncology • Sarcoma • Solid Tumor

Phase II study of ABSK061 (selective FGFR2/3 inhibitor) combined with ABSK043 (oral PD-L1 inhibitor) ± CAPOX in advanced FGFR2-positive gastric cancer and gastroesophageal junction cancer (GC/GEJC): Preliminary results from ABSK061-201. (ASCO 2026) - P2 | "ABSK061 combined with ABSK043, with or without CAPOX, has demonstrated a manageable safety profile and encouraging anti-tumor activity in both 1L and 2L+ FGFR2-positive GC/GEJC. These promising results warrant further clinical development of the doublet and quadruplet regimens for GC/GEJC."

IO biomarker • Metastases • P2 data • Dental Disorders • Gastric Cancer • Oncology • Solid Tumor • Stomatitis • FGFR2 • HER-2

The FOCUS19 study: Efficacy of an oral PD-L1 inhibitor combined with an oral FGF19 in advanced hepatocellular carcinoma after 1st+ line treatment (IMMUNOLOGY 2026) - "The combination of ABSK-011 and ABSK043 showed good safety and tolerability, as well as good disease control, in patients with unresectable or metastatic hepatocellular carcinoma who have FGF19 overexpression and have previously received systemic treatment."

Clinical • IO biomarker • Metastases • Hepatocellular Cancer • Oncology • Solid Tumor • FGF19 • FGFR4

ABSK043 plus firmonertinib (Firmo) for the treatment of advanced non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations: Results from a phase II study (ESMO Asia 2025) - P1 | "The combination of ABSK043 with Firmo demonstrated a favorable safety profile, with no signals of ILD. These results support further exploration of this combination in the first-line setting, where EGFR TKIs combined with PD-(L)1 antibodies are restricted."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Abbisko Therapeutics Presents Preliminary Phase II Results of Oral PD-L1 Inhibitor ABSK043 Combined with EGFR Inhibitor Firmonertinib for the Treatment of NSCLC at ESMO Asia 2025 (HKEXnews) - "In the dose-escalation phase, a total of 21 previously treated patients with EGFR-mutated, PD-L1-positive advanced NSCLC were enrolled, among whom 17 had received prior third-generation EGFR-TKIs. The results showed that the combination of ABSK043 and firmonertinib was well-tolerated and had a manageable safety profile....The combination also demonstrated promising anti-tumor activity. Based on RECIST v1.1, the Disease Control Rate ('DCR') reached 71% with 14 patients achieving target lesion regression. Among the 5 patients who achieved Partial Response ('PR'), 4 had received a prior third-generation EGFR-TKI. As of data cutoff, median Duration of Response ('DOR') was not reached."

P2 data • Non Small Cell Lung Cancer

ABBISKO THERAPEUTICS COMPLETES FIRST PATIENT DOSING IN A PHASE II STUDY OF ABSK043, AN ORAL SMALL-MOLECULE PD-L1 INHIBITOR, IN COMBINATION WITH GLECIRASIB FOR THE TREATMENT OF NSCLC (HKEXnews)

Trial status • Non Small Cell Lung Cancer

A Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: University Health Network, Toronto | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Sarcoma • Solid Tumor

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib (clinicaltrials.gov) - P2 | N=86 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IND CLEARANCE FROM THE CDE FOR ABBISKO THERAPEUTICS’ ORAL PD-L1 INHIBITOR ABSK043 IN COMBINATION WITH KRAS G12C INHIBITOR GLECIRASIB FROM ALLIST, FOR THE TREATMENT OF NSCLC (HKEXnews)

New trial • Non Small Cell Lung Cancer

A Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: University Health Network, Toronto

New P2 trial • Oncology • Sarcoma • Solid Tumor

FOCUS-19: FGF19 Overexpression Combination Unified Study in HCC-19 (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: RenJi Hospital

IO biomarker • New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

ABBISKO THERAPEUTICS AND ALLIST ENTER INTO A COOPERATION AGREEMENT TO EXPLORE ABSK043 IN COMBINATION GLECIRASIB FOR THE TREATMENT OF NSCLC (HKEXnews) - "...Abbisko Therapeutics...announced that it has entered into a cooperation agreement with Shanghai Allist Pharmaceuticals...to explore the combination of Abbisko Therapeutics’ investigational oral PD-L1 inhibitor, ABSK043, with Allist’s KRAS-G12C inhibitor, glecirasib, for the treatment of non-small cell lung cancer patients with KRAS-G12C mutation."

Licensing / partnership • Non Small Cell Lung Cancer

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2025 ➔ Nov 2024 | Trial primary completion date: Jun 2027 ➔ Dec 2027

Combination therapy • Enrollment open • Metastases • Trial initiation date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Updated results of oral PD-L1 inhibitor ABSK043 in advanced solid tumor patients (pts) from a phase I study (ESMO Asia 2024) - P1 | "Conclusions ABSK043 demonstrated a favorable safety profile and impressive anti-tumor activity as a single agent, especially in EGFR-mutated lung cancers with high PD-L1 expression, where monotherapies of ICI antibodies were shown to be ineffective in the past. These findings support a continuing investigation of ABSK043, in EGFR-mutated lung cancers and various other solid tumors."

Clinical • IO biomarker • Metastases • P1 data • Breast Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Gastric Cancer • Lung Cancer • Melanoma • Microsatellite Instability • Oncology • Solid Tumor • Squamous Cell Carcinoma • Vaginal Cancer • KRAS • MSI

Phase II clinical trial of oral PD-L1 small molecule inhibitor ABSK043 combined with FGFR2/3 small molecule inhibitor ABSK061 for the treatment of solid tumors completed and the first gastric cancer patient was dosed [Google translation] (pharnexcloud.com) - "Heyu Pharmaceuticals...announced that it had completed the dosing of the first gastric cancer patient in an open-label multicenter Phase II clinical study evaluating the safety and efficacy of ABSK061 and ABSK043 with or without chemotherapy in patients with metastatic/unresectable solid tumors with FGFR2/3 alterations (Protocol number: ABSK061-201)....The dose escalation will evaluate the safety, tolerability, preliminary efficacy and PK characteristics of ABSK061+ABSK043 in patients with metastatic/unresectable advanced solid tumors with FGFR2/3 activation changes or overexpression, and recommend the dosage for the expansion phase."

Trial status • Gastric Cancer • Solid Tumor

A Phase 2 Clinical Study of ABSK061 and ABSK043 (clinicaltrials.gov) - P2 | N=202 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR2 • FGFR3 • HER-2

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

Combination therapy • Metastases • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 2 Clinical Study of ABSK061 and ABSK043 (clinicaltrials.gov) - P2 | N=202 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

Metastases • New P2 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR2 • FGFR3 • HER-2

First-in-human dose-escalating study of ABSK043, a novel and oral small-molecule inhibitor of PD-L1, in patients with advanced solid tumors (ESMO 2023) - P1 | "On-target PD effects were consistent with PD-L1 inhibition and data reported by anti-PD-(L)1 mAbs. Preliminary anti-tumor activity was observed, and further studies are warranted to explore the efficacy in a larger number of patients."

Clinical • Metastases • P1 data • Breast Cancer • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • CXCL9 • IFNG • IL2 • MSI

Abbisko will debut two blockbuster clinical research results at the 2023 European Society for Medical Oncology (ESMO)1 (PRNewswire) - P1 | N=60 | NCT04964375 | Sponsor: Abbisko Therapeutics Co, Ltd | "Abbisko Therapeutics...announced that...the clinical results of first-in-human dose-escalating of PD-L1 inhibitor ABSK043 with advanced solid tumors will be presented at the 2023 European Society for Medical Oncology (ESMO) annual meeting....ABSK043 was well tolerated up to 1000 mg BID with no DLT reported and has a safety profile consistent with monoclonal antibody immune checkpoint inhibitors. On-target PD effects were consistent with PD-L1 inhibition and data reported by anti-PD-(L)1 mAbs. Preliminary anti-tumor activity was observed, and further investigation is warranted to explore the efficacy in a larger number of patients."

P1 data • Solid Tumor

Broad anti-tumor activity of a potent and selective small molecule antagonist of PD-L1 ABSK043 in combination with other agents in preclinical models (SITC 2022) - "Results ABSK043 demonstrated strong in vivo synergy with several therapeutic agents such as carboplatin, a key component of the widely used CRC standard-of care chemotherapy treatment regimen, as well as other target therapy or immune-oncology agents. Conclusions Taken together, these data for the first time demonstrated broad combination synergy of a small molecule PD-L1 antagonist with other agents and provided basis for potential clinical evaluation of these combination treatment for cancer patients."

Combination therapy • Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • PD-L1