News - EGFR L858R - LARVOL VERI

Adjuvant epidermal growth factor receptor tyrosine kinase inhibitor in resected stage N2 non-small cell lung cancer harboring EGFR mutation. (PubMed, Transl Lung Cancer Res)

Our study found that EGFR-TKI monotherapy and combination therapy demonstrated no significant differences in terms of DFS or OS in patients with completely resected stage N2 EGFR-mutant NSCLC. Adjuvant treatment with third-generation EGFR-TKIs and prolonged treatment duration may offer enhanced survival benefits.

2 days ago

Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion

Mechanism of afatinib resistance in non-small cell lung cancer patients with nonclassical EGFR mutations: A multicenter, retrospective study. (PubMed, Medicine (Baltimore))

This study represents the latest investigation of resistance mechanisms to afatinib in NSCLC patients with nonclassical mutations. The mechanism of resistance to EGFR-TKI in this study was discovered different from that of patients with classical mutations.

2 days ago

Retrospective data • Journal

EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • MET (MET proto-oncogene, receptor tyrosine kinase) • NF1 (Neurofibromin 1) • CDK4 (Cyclin-dependent kinase 4)

TP53 mutation • EGFR mutation • EGFR L858R • MET amplification • EGFR T790M

Gilotrif (afatinib)

Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)

P3, N=440, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting

3 days ago

Enrollment open

EGFR mutation • EGFR L858R • EGFR exon 19 deletion

docetaxel • BNT326

Lung cancer with EGFR PACC mutations: a practical review of available treatment options and novel therapies on the horizon. (PubMed, Transl Lung Cancer Res)

In this review, we highlight a case example that illustrates key treatment considerations, including balancing efficacy, toxicity, and patient preferences when selecting the optimal palliative therapy. We discuss key treatment considerations for EGFR PACC mutated NSCLC to inform the use of afatinib (the only approved therapy with an indication that includes two EGFR PACC mutations, G719X and S768I), osimertinib, or combination therapies in the upfront setting; limitations of the available data; and ongoing clinical trials specific to the EGFR PACC mutation subgroup that may further refine our understanding of treatment for patients with these tumors.

3 days ago

Review • Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR G719X • EGFR S768I

Tagrisso (osimertinib) • Gilotrif (afatinib)

Efficacy and safety of first-line oral vinorelbine plus firmonertinib in refractory EGFR-mutated non-small cell lung cancer: study protocol of a multicenter, non-randomized, two-cohort study. (PubMed, Ther Adv Med Oncol)

To the best of our knowledge, this study represents the first evaluation of vinorelbine plus firmonertinib in EGFR-mutated locally advanced or metastatic NSCLC with M1c2 disease or elevated PD-L1 expression, aiming to provide an effective, tolerable, and convenient all-oral treatment option for this refractory population. The study protocol (version 1.2; July 18, 2025) was registered on October 24, 2025, at the Chinese Clinical Trial Registry (ChiCTR2500111096).

3 days ago

Journal • PD(L)-1 Biomarker • IO biomarker

EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)

PD-L1 expression • EGFR mutation • EGFR L858R • EGFR exon 19 deletion

Rybrevant (amivantamab-vmjw) • Ivesa (firmonertinib) • Navelbine oral (vinorelbine tartrate oral)

Safety and efficacy of concurrent radiation therapy with amivantamab in patients with advanced EGFR- or MET-altered non-small cell lung cancer. (PubMed, Eur J Cancer)

Concurrent palliative RT and amivantamab appears feasible and well tolerated. Further validation is warranted.

3 days ago

Journal

EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • MET exon 14 mutation

Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer (clinicaltrials.gov)

P1, N=36, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Feb 2027 | Trial primary completion date: Jun 2026 --> Feb 2027

7 days ago

Trial completion date • Trial primary completion date

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M

Tagrisso (osimertinib) • sapanisertib (CB-228)

Efficacy and Safety of Induction Benmelstobart Plus Anlotinib and Chemotherapy Followed by Concurrent Chemoradiotherapy and Benmelstobart Maintenance Versus Concurrent Chemoradiotherapy Followed by Benmelstobart Maintenance in Patients With Unresectable Stage III NSCLC (clinicaltrials.gov)

P2, N=152, Not yet recruiting, The Third Xiangya Hospital of Central South University

7 days ago

New P2 trial

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)

PD-L1 expression • BRAF V600E • BRAF V600 • EGFR L858R • HER-2 mutation • RET fusion • MET exon 14 mutation • ALK fusion • RET mutation • ROS1 fusion • HER-2 exon 20 mutation • NTRK fusion

Focus V (anlotinib) • Andewei (benmelstobart)

Dual actionability of BMI1 activation and mitotic vulnerability defines adaptive Osimertinib resistance in EGFR-mutant NSCLC. (PubMed, Cell Death Dis)

Exploiting these vulnerabilities, Unesbulin (PTC596), a tubulin-binding agent with BMI1 inhibitory activity, triggers mitotic catastrophe, mechanistically induces apoptosis in vitro and drives regression of resistant xenografts in vivo. Our findings establish BMI1 as a key mediator of Osimertinib resistance and aggressiveness, uncovering a mutation-context-dependent mitotic vulnerability that can be therapeutically exploited, providing a rationale for targeting BMI1 and mitotic abnormalities to overcome resistance in T790M/L858R backgrounds.

8 days ago

Journal

EGFR (Epidermal growth factor receptor) • BMI1 (BMI1 proto-oncogene, polycomb ring finger)

EGFR mutation • EGFR L858R • EGFR T790M

Tagrisso (osimertinib) • unesbulin (BMIi-1)

SANOVO: Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)

P3, N=412, Active, not recruiting, Hutchison Medipharma Limited | Trial completion date: Aug 2026 --> May 2028 | Trial primary completion date: Aug 2026 --> May 2028

8 days ago

Trial completion date • Trial primary completion date

MET (MET proto-oncogene, receptor tyrosine kinase)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • MET overexpression

Tagrisso (osimertinib) • Orpathys (savolitinib)

EGFR-TKIs Plus PD-1 in EGFR-Mutant Advanced NSCLC (clinicaltrials.gov)

P2, N=32, Recruiting, Nanfang Hospital, Southern Medical University

9 days ago

New P2 trial • IO biomarker

EGFR mutation • EGFR L858R • EGFR exon 19 deletion

Tagrisso (osimertinib) • Tyvyt (sintilimab)

10d

A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations (clinicaltrials.gov)

P1/2, N=67, Recruiting, D3 Bio (Wuxi) Co., Ltd | Active, not recruiting --> Recruiting | Trial completion date: Apr 2028 --> Aug 2028 | Trial primary completion date: Apr 2028 --> Aug 2028

10 days ago

Enrollment open • Trial completion date • Trial primary completion date • First-in-human

EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)

BRAF V600E • EGFR mutation • KRAS G12C • BRAF V600 • EGFR L858R • EGFR T790M • KRAS G12D • ALK rearrangement • MET exon 14 mutation • EGFR L861Q • ROS1 fusion • EGFR G719X • MET mutation • EGFR S768I • RET rearrangement • KRAS G12 • KRAS G12S • KRAS Q61

D3S-002 • elisrasib (D3S-001)