Conmana (icotinib) / Betta Pharma - LARVOL DELTA

A 66-Year-Old Woman with EGFR-Mutant Lung Adenocarcinoma and Brain Metastases Achieving 96-Month Overall Survival with serially deploying three distinct third-generation EGFR-TKIs (ESMO Asia 2025) - "First-line icotinib plus paclitaxel/nedaplatin was given and achieved PR and 36-month PFS...Osimertinib 80mg qd combined with pemetrexed chemotherapy for 5 cycles, followed by osimertinib monotherapy, yielded 25-month PFS until isolated CNS progression. Despite concomitant whole-brain radiotherapy and bevacizumab with Osimertinib, intracranial lesions advanced...This exceptional survival in advanced EGFR+ NSCLC was achieved through initial chemo-TKI therapy, sequential third-generation TKIs (osi→almo→furmo) for CNS control, and furmonertinib dose escalation for late CNS progression. The persistent TP53 co-mutation suggests a resistance mechanism, while PD-L1 negativity excluded immunotherapy, demonstrating the efficacy of optimized TKI sequencing alone."

Clinical • IO biomarker • Brain Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TP53

EGFR exon 19 duplications/insertions, rare but potential therapeutic targets for NSCLC: A real-world study and pooled analysis of case series (ESMO Asia 2025) - "Stratified by treatment, mPFS1 was 15.5 months with erlotinib (IQR: 9.4-20.0), 12.3 months with afatinib (IQR 7.8-14.3), 7.8 months with osimertinib (IQR 5.6-9.4), 10.9 months with icotinib (IQR 5.9-12.6), 5.3 months with gefitinib (IQR 4.7-9.2), and 6.0 months with immuno/chemotherapy (IQR 3.9-9.0). E19dup/ins are exceedingly rare EGFR genomic alterations with 4 variants reported to date. There is a potential PFS benefit with the use of erlotinib over immuno/chemotherapy as first-line treatment for these mutations. Further data are required to confirm the role of erlotinib in this setting."

Real-world • Real-world evidence • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Befotertinib (D-0316) plus icotinib as first-line therapy for patients with EGFR-mutated advanced non-small-cell lung cancer (ESMO Asia 2025) - P=N/A | "This study demonstrates the efficacy of first-line befotertinib plus icotinib in EGFR-mutated advanced NSCLC. To our knowledge, this is the first clinical trial to adjust TKI doses based on plasma ctDNA clearance status. Results showed encouraging antitumor activity, high ctDNA clearance rates, and a manageable safety profile."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Adjuvant Icotinib in EGFR-mutated stage IB non-small cell lung cancer with high-risk factors: A retrospective case series. (PubMed, PLoS One) - "Two patients experienced disease recurrence and were successfully switched to osimertinib upon identification of an EGFR (T790M) mutation. This study suggests a potential DFS benefit and well-tolerated profile of adjuvant icotinib in patients with EGFR-mutated high-risk stage IB NSCLC. However, longer-term follow-up is necessary to assess the long-term outcomes."

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

Assessing first-line treatment for advanced EGFR-mutated NSCLC in diverse clinicopathological subgroups: a systematic review and network meta-analysis. (PubMed, BMC Cancer) - "This NMA revealed that cases with EGFR-mutated NSCLC may benefit from different first-line treatment regimens according to their clinicopathological characteristics. On the whole, osimertinib plus CT and amivantamab plus lazertinib emerged as the most noticeable treatment modalities for such cases. (PROSPERO ID: CRD42024506995)."

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

Gamma Knife consolidation therapy improves prognosis in patients with advanced epidermal growth factor receptor-mutant lung adenocarcinoma treated with first-generation epidermal growth factor receptor-tyrosine kinase inhibitors. (PubMed, Oncol Lett) - "Patients received first-generation EGFR-TKIs treatment, including gefitinib, erlotinib and icotinib, then received Gamma Knife consolidation therapy for the treatment of residual lesions in the chest, with a total of 10-17 sessions administered five times a week. In conclusion, combining first-generation EGFR-TKIs with Gamma Knife therapy can delay EGFR resistance, extend PFS and OS, and result in a low incidence of toxic and side effects. However, further prospective randomized controlled studies are required to validate the results of the present study."

Journal • Infectious Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • CEACAM5 • EGFR

Exploration of Icotinib Combined with Chemotherapy and Bevacizumab in Perioperative Treatment of Stage Ⅱb-Ⅲb EGFR-sensitive Mutant Non-small Cell Lung Cancer (NSCLC) (ChiCTR) - P4 | N=37 | Not yet recruiting | Sponsor: Tianjin Cancer Hospital Airport Hospita; Tianjin Cancer Hospital Airport Hospita

New P4 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

LONG-TERM SURVIVAL AND CLEARANCE OF EGFR-MUTANT CELL-FREE DNA IN METASTATIC EGFR-MUTANT NON-SMALL CELL LUNG CANCER: A CASE SERIES (CHEST 2025) - "She initially received two cycles of pemetrexed/oxaliplatin before transitioning to erlotinib; then switched to osimertinib in 2018 due to adverse effects...She was initially treated with icotinib, which was discontinued in 2019 due to side effects. Brain metastases detected in 2020 led to treatment with almonertinib, followed by osimertinib in 2022... This case series highlights long-term survival with CR in metastatic EGFR-mutant NSCLC treated with osimertinib. CtDNA testing may help determine optimal treatment duration and monitoring, warranting further investigation into when EGFR TKI therapy can be safely discontinued."

Cell-free DNA • Clinical • Metastases • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and Safety of Befotertinib Plus Icotinib in Advanced NSCLC With Uncommon EGFR Mutations: A Phase II Study (Icombine) (IASLC-WCLC 2025) - P2 | "Although uncommon EGFR mutations (accounting for 10-15% of EGFR-mutant NSCLC, such as G719X, L861Q, and S768I) show partial efficacy to approved EGFR tyrosine kinase inhibitors (TKIs) like afatinib and osimertinib, the optimal therapeutic strategy for these mutations remains undetermined, with no consensus in clinical practice. Preclinical and clinical evidence has shown that combining first-/second- and third-generation EGFR-TKIs may delay resistance (e.g., osimertinib plus gefitinib demonstrated an 88.9% objective response rate [ORR] in phase I/II trials), but such strategies remain unexplored in uncommon mutations...The primary endpoint is ORR assessed by RECIST v1.1, with secondary endpoints including PFS, disease control rate (DCR), overall survival (OS), and safety evaluations (incidence and severity of adverse events). Recruitment for this trial is currently ongoing."

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • EGFR

Long Progression-Free Survival With Sunvozertinib in EGFRm NSCLC Patients After Third-Generation EGFR TKI Failure: Case Series (IASLC-WCLC 2025) - "After relapsing in Jun 2010, he received various chemotherapy regimens until Aug 2012, followed by icotinib, then osimertinib (found T790M mutation) was administered as fifth-line therapy (Dec 2017-May 2023) combined with anlotinib from 2020, and nab-paclitaxel plus sugemalimab as sixth-line (May-Oct 2023). For seventh-line treatment, sunvozertinib 150 mg QD with vinorelbine maintained for over 12 months...After relapsing in 2016, she received gefitinib...Table 1. Case summary (Data cutoff: Dec 11, 2024)"

Clinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

New molecules in the therapy of chronic graft-versus-host disease. (PubMed, Curr Opin Hematol) - "Expanding therapeutic options in cGvHD require decision-making based on organ involvement, prior therapy, and tolerability. Emerging compounds offer the potential to modulate chronic inflammation and fibrosis more precisely, supporting a move toward personalized and combinatorial approaches in advanced-line settings."

Journal • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Inflammation • Transplantation

Efficacy and safety of EGFR-TKI for EGFR-mutated NSCLC: systematic review and network meta-analysis. (PubMed, Int J Clin Exp Pathol) - "This network meta-analysis reveals that in first-line treatment, the third-generation EGFR-TKI Furmonertinib has exceptional advantages in mPFS and safety and is suited for patients with long-term disease control needs. Although second-generation Afatinib has the highest objective remission rate, it also increases the possibility of grade ≥3 AEs. Clinically, personalized programs should be devised based on the patient's mutation type, tolerance, and other factors. More head-to-head trials will be required in the future to validate the findings and optimize treatment techniques."

Journal • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pharmacologic inhibition of CSF-1R suppresses intrinsic tumor cell growth in osteosarcoma with CSF-1R overexpression. (PubMed, J Transl Med) - "These findings conclusively demonstrated that pharmacological inhibition of CSF-1R activity by ABSK021 resulted in significant anti-tumor effects in preclinical osteosarcoma models with CSF-1R overexpression. The high prevalence of CSF-1R expression observed in osteosarcoma patient samples highlights the potential clinical use of ABSK021, either as a monotherapy or in combination with chemotherapy, as a promising therapeutic strategy for osteosarcoma patients with CSF-1R as a potential predictive biomarker."

Journal • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • CASP3 • CSF1R • IL34

Adjuvant icotinib for resected EGFR-mutated stage II-IIIA non-small-cell lung cancer (ICTAN, GASTO1002): a randomized comparison study. (PubMed, Signal Transduct Target Ther) - P3 | "Rates of adverse events of grade 3 or higher were 8.3%, 6.0% and 2.4% for the 12-month icotinib, 6-month icotinib, and observation groups, respectively. Adjuvant icotinib for 12 months or 6 months following adjuvant chemotherapy improved DFS and OS compared with observation in patients with resected EGFR-mutated stage II-IIIA NSCLC with a manageable safety profile, supporting it as a potential treatment option."

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

Clinical Study on Adjuvant Targeted Therapy with EGFR Mutation after Surgery for Stage IA Non-small Cell Lung Cancer (ChiCTR) - P2 | N=128 | Not yet recruiting | Sponsor: Jining Medical University Affiliated Hospital; Jining Medical University Affiliated Hospital | N=30 ➔ 128

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

D-0316 Versus Icotinib in Patients With Locally Advanced or Metastatic EGFR Sensitising Mutation Positive NSCLC (clinicaltrials.gov) - P2/3 | N=362 | Completed | Sponsor: Betta Pharmaceuticals Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Icotinib plus chemotherapy as neoadjuvant treatment for resectable stage II-IIIB EGFR-mutant lung adenocarcinoma: a phase II study (NEOIPOWER). (PubMed, Lung Cancer) - P2 | "Neoadjuvant icotinib combined with chemotherapy did not meet its primary endpoint for MPR rate in resectable stage II-IIIB EGFRm lung adenocarcinoma, but demonstrated a manageable safety profile."

Journal • P2 data • Hematological Disorders • Leukopenia • Lung Adenocarcinoma • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Icotinib plus chemotherapy as neoadjuvant treatment for resectable stage II-IIIB EGFR-mutant lung adenocarcinoma: a phase II study (NEOIPOWER) (Lung Cancer) - P2 | N=27 | NEOIPOWER (NCT05104788) | "From October 25, 2021, to April 2, 2023, 30 patients were enrolled and completed neoadjuvant therapy. MPR was observed in 6.7 % of patients (95% CI, 0.8%–22.1%), which did not meet the primary endpoint. No patients had pCR. Twenty-eight (93.3 %) patients underwent surgery, of whom 27 (96.4 %) achieved R0 resection, and pathological downstaging was observed in 10 (35.7 %) patients. The ORR was 83.3 % (95% CI, 65.3–94.4 %) and DCR was 96.7 % (95% CI, 82.8–99.9 %) among 30 treated patients. With a median follow-up of 25.0 (range, 6.4–33.6) months, the median DFS was not reached (95% CI, 25.1-not estimable), and the 2-year DFS rate was 92.0 %."

P2 data • Non Small Cell Lung Cancer

Bevacizumab Combined With Double Dose Icotinib in Patients With EGFR Exon 21-L858R Mutation (clinicaltrials.gov) - P2 | N=35 | Completed | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Recruiting ➔ Completed

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

Modeling exposure-driven adverse events of EGFR TKIs in the treatment of patients with non-small cell lung cancer. (PubMed, Acta Pharmacol Sin) - "Data were collected from 277 patients treated with gefitinib, icotinib, afatinib or osimertinib. Model simulations revealed substantial interindividual variability in drug exposure and the probability of different grades of MDRAE for the same treatment regimen. This study quantitatively elucidates the influences of drug exposure and other critical factors on safety, thereby contributing to the formulation of individualized treatment strategies to prevent and promptly address drug safety-related issues."

Adverse events • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pimicotinib in tenosynovial giant cell tumor (TGCT): Efficacy, safety and patient-reported outcomes of phase 3 MANEUVER study. (ASCO 2025) - P3 | "MANEUVER is the first randomized pivotal study in TGCT to demonstrate > 50% ORR by RECIST v1.1 at Week 25 in a diverse, global patient population. Pimi produced statistically significant and clinically meaningful improvements in physical function and symptoms, representing an effective, well-tolerated and convenient daily treatment for patients with TGCT and addressing a critical unmet need."

Clinical • P3 data • Patient reported outcomes • Giant Cell Tumor of Bone • Hepatology • Liver Failure • Musculoskeletal Diseases • Musculoskeletal Pain • Oncology • Orthopedics • Pain • Tenosynovial Giant Cell Tumor

Adjuvant icotinib of 12 months versus observation as adjuvant therapy for completely resected EGFR-mutated stage IB non-small-cell lung cancer: 5-year update from CORIN (GASTO1003). (ASCO 2025) - P2 | "In this 5-year update analysis from CORIN, adjuvant icotinib continues to demonstrate durable DFS benefit versus observation in resected EGFR-mutated stage IB NSCLC, with a manageable safety profile. Icotinib sustained OS separation versus observation over time and demonstrated a marginal OS benefit, which is limited by the small sample size and wide CIs. Adjuvant icotinib for 1 year provides a treatment option for these patients."

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

Identification and characterization of halotolerant multifunctional GH6 endoglucanases ZFEG1605 and ZFEG1663 from Mt. Everest soil metagenome. (PubMed, Carbohydr Res) - "Both enzymes exhibited high activity on konjac glucommanan (KG) and sodium carboxymethylcellulose (CMC), while ZFEG1605 also exhibited activity towards guar gum (GG)...The endoglucanases exhibited remarkable salt tolerance, retaining over 70 % of their enzymatic activity in the presence of 2.5 M NaCl. The purified enzymes hydrolyzed alkali-pretreated rice straw to release reducing sugars, demonstrating their potential usage for biomass saccharification."

Journal

Medical Management of Tenosynovial Giant Cell Tumor. (PubMed, Curr Oncol Rep) - "For an alternative to surgery, the CSF1R inhibitors pexidartinib and vimseltinib are approved in the United States for TGCT, and other CSF1R inhibitors are in clinical development...The potential risks and benefits of available treatments should be carefully considered in collaboration with a bone tumor-experienced, multidisciplinary team to determine the best course of care. Increased D-TGCT awareness and support through patient advocacy groups have helped to reshape the patient journey."

Journal • Review • Giant Cell Tumor of Bone • Oncology • Osteosarcoma • Solid Tumor • Tenosynovial Giant Cell Tumor

Effective neoadjuvant aumolertinib therapy facilitates transformation of unresectable to resectable advanced non‑small cell lung: A case report. (PubMed, Oncol Lett) - "The patient received icotinib followed by neoadjuvant aumolertinib, resulting in significant tumor shrinkage and downstaging to meet resectability criteria. The present findings provide novel insights into potential treatment choices for patients with inoperable stage IIIC NSCLC, emphasizing the possibility of achieving PR and undergoing surgery despite drug resistance. However, individual variations in such cases necessitate further research and validation before this approach can be widely implemented."

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