andamertinib (PLB1004) / Avistone Biotech - LARVOL DELTA

The Study Of Andamertinib Plus Anlotinib In Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: Fudan University

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

Andamertinib: First Approval. (PubMed, Drugs) - "On 30 April 2026, andamertinib received conditional approval in China for adult patients with locally advanced or metastatic NSCLC who have experienced disease progression during or following platinum-based chemotherapy, or who are intolerant to platinum-based chemotherapy, and who have been confirmed by testing to have an EGFR exon 20 insertion mutation. This article summarizes the milestones in the development of andamertinib leading to this first approval for NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Kannon: A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC) (clinicaltrials.gov) - P2 | N=139 | Active, not recruiting | Sponsor: Avistone Biotechnology Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

KANNON-2: Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion. (clinicaltrials.gov) - P3 | N=327 | Enrolling by invitation | Sponsor: Avistone Biotechnology Co., Ltd. | Trial completion date: Dec 2026 ➔ Jun 2030 | Trial primary completion date: Jan 2026 ➔ Jun 2028

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A clinical trial of Vebreltinib plus Andamertinib in NSCLC with MET overexpression following EGFR-TKI (ChiCTR) - P2 | N=37 | Sponsor: Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University

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

KANNON-5: Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Avistone Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

An open-label, multicenter, phase Ib/II clinical study to evaluate the safety, efficacy and pharmacokinetic characteristics of PLB1004 capsules in combination with platinum-based doublet chemotherapy in subjects with EGFR mutation-positive non-small cell lung cancer. (ChiCTR) - P1/2 | N=108 | Recruiting | Sponsor: Shanghai Chest Hospital; Avistone Pharmaceutical(Ningbo)Co., LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

KANNON-5: Andamertinib as First-line Treatment for NSCLC With EGFR PACC or EGFR L861Q Mutation (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Avistone Biotechnology Co., Ltd.

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

A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=253 | Not yet recruiting | Sponsor: Beijing Pearl Biotechnology Limited Liability Company

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Integrative analysis of MET amplification or overexpression using NGS, FISH, and IHC in patients from the KYLIN-1 study (ESMO Asia 2025) - P1/2 | "For MET amplification detection, NGS has a good agreement with FISH especially in NPA, which means NGS causes little false positive results. MET overexpression represents an independent promising biomarker to guide treatment decision in EGFR-mutated NSCLC with acquired MET overexpression. IHC reported MET overexpression could be utilized to identify target patients to receive combination of Andamertinib + Vebreltinib."

Clinical • Next-generation sequencing • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Andamertinib in Advanced Non-Small-Cell Lung Cancer with EGFR Exon 20 Insertions After Platinum-Based Chemotherapy or Immunotherapy: Results from the Phase 2 KANNON Study. (PubMed, J Thorac Oncol) - P2 | "Andamertinib at 240 mg once daily demonstrated efficacy with a manageable safety profile in previously treated patients with EGFR ex20ins-mutant NSCLC."

IO biomarker • Journal • P2 data • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

Phase III clinical study of EGFR 20 exon insertion mutation in PLB1004 non-small cell lung cancer (ChiCTR) - P3 | N=327 | Recruiting | Sponsor: Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

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

PLB-1004 in advanced non-small cell lung cancer (NSCLC) with exon 20 insertion mutations (ex20ins): A multicenter, single-arm, phase II study (ESMO 2025) - P2 | "The incidence of grade ≥3 TRAEs was higher with 320 mg, but the toxicity was clinically manageable. Conclusions 240 mg PLB-1004 shows definite efficacy in patients with EGFR ex20ins-mutated advanced NSCLC who have received prior treatment with controllable toxicity, thus offering greater clinical application advantages."

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

An open-label, multicenter, phase Ib/II clinical study to evaluate the safety, efficacy and pharmacokinetic characteristics of PLB1004 capsules in combination with platinum-based doublet chemotherapy in subjects with EGFR mutation-positive non-small cell lung cancer. (ChiCTR) - P1/2 | N=108 | Not yet recruiting | Sponsor: Shanghai Chest Hospital; Avistone Pharmaceutical(Ningbo)Co., LTD.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive (clinicaltrials.gov) - P1/2 | N=108 | Not yet recruiting | Sponsor: Avistone Pharmaceutical（Ningbo）Co., LTD.

New P1/2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion. (clinicaltrials.gov) - P3 | N=327 | Enrolling by invitation | Sponsor: Avistone Biotechnology Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Vebreltinib plus PLB1004 in EGFR-mutated NSCLC with acquired MET amplification or overexpression after failure on EGFR-TKI treatment: A phase Ib/II study. (ASCO 2025) - P1/2 | "Vebreltinib and PLB1004 at RP2D demonstrates notable efficacy and manageable safety in EGFR-mutated NSCLC with METamp or METov after EGFR-TKIs failure. Findings from our phase Ib+II data suggest that NGS reported METamp+ could be utilized to identify target patients to receive combination of PLB1004 + Vebreltinib. Further studies are warranted to confirm these findings."

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

Avistone Announces Encouraging Results for Vebreltinib plus Andamertinib (PLB1004) in EGFR-mutated NSCLC with MET Amplification or Overexpression at ASCO Annual Meeting 2025 (Businesswire) - P1b/2 | N=156 | KYLIN-1 (NCT06343064) | Sponsor: Avistone Biotechnology Co., Ltd. | "The results from Phase Ib/II KYLIN-1 study (NCT06343064) showed that Vebreltinib plus Andamertinib demonstrated notable efficacy and manageable safety in EGFR-mutated NSCLC patients with MET amplification or overexpression after EGFR-TKIs failure. Among the 56 patients enrolled at a dose of Vebreltinib 150mg BID plus Andamertinib 80mg QD (RP2D), the confirmed overall response rate (ORR) was 50.0%, and the median progression-free survival (mPFS) was 9.9 months. In 19 patients with brain metastases, ORR was 42.1% and mPFS was 9.5 months. Grade 3 or higher treatment related adverse events (TRAEs) occurred in 19.6% of the patients. None discontinued treatment or died due to TRAEs. No new safety signal was observed."

P1/2 data • Non Small Cell Lung Cancer

Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI (clinicaltrials.gov) - P1/2 | N=156 | Recruiting | Sponsor: Avistone Biotechnology Co., Ltd. | Trial completion date: Jun 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure (clinicaltrials.gov) - P3 | N=278 | Not yet recruiting | Sponsor: Avistone Biotechnology Co., Ltd.

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

Kannon: A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC) (clinicaltrials.gov) - P2 | N=157 | Recruiting | Sponsor: Avistone Biotechnology Co., Ltd. | Trial completion date: Sep 2026 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Pharmacokinetics, mass balance, and metabolism of [14C]PLB1004, a selective and irreversible EGFR-TKI in humans. (PubMed, Cancer Chemother Pharmacol) - "Fecal excretion emerged as PLB1004 excretion route, while urinary excretion via the kidneys served as the secondary route. The primarily metabolic pathways are oxidation, demethylation, dehydrogenation, and cysteine conjugation in humans."

Journal • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Kannon: A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR Ex20ins Mutation Patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC) (clinicaltrials.gov) - P2 | N=157 | Recruiting | Sponsor: Avistone Biotechnology Co., Ltd. | Trial primary completion date: Apr 2024 ➔ Oct 2024

EGFR exon 20 • Metastases • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Vebreltinib Plus PLB1004 In EGFR-Mutated, NSCLC with MET Amplification or MET Overexpression Following EGFR-TKI (IASLC-WCLC 2024) - P1/2 | "No patients discontinued treatment due to TRAEs. Conclusions : Vebreltinib plus PLB1004 showed promising antitumor activity and a manageable safety profile in patients with EGFRm NSCLC with MET amplification or MET overexpression who have experienced disease progression after prior EGFR-TKI therapy, especially in those bearing brain metastases and treated with third-generation EGFR-TKI."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Avistone Announces Results from a Sponsored Clinical Research Program Studying the Combination of Two Small-Molecule c-MET and EGFR Inhibitors in NSCLC Patients at the 2024 World Conference on Lung Cancer (WCLC) (Businesswire) - P1b/2 | N=156 | NCT06343064 | Sponsor: Avistone Biotechnology Co., Ltd. | "Forty-four patients received Vebreltinib 100mg plus PLB1004 160mg (n=15), Vebreltinib 150mg plus PLB1004 160mg (n=13), Vebreltinib 200mg plus PLB1004 80mg (n=3), or Vebreltinib 150mg plus PLB1004 80mg (n=13) and were included in the overall safety analysis. Among the 44 patients evaluated, 36.4% of patients had brain metastases and 86.4% of patients had previously received a third-generation EGFR-TKI, respectively. Objective responses occurred across all Vebreltinib and PLB1004 dose levels tested, with partial responses (PRs) observed in 19/32 (59.4%) response-evaluable patients. Among patients with brain metastases, the ORR was 75.0% (9/12). The ORR was 58.6% (17/29) in patients who received prior third-generation EGFR-TKI."

P1/2 data • Non Small Cell Lung Cancer