tirbanibulin oral (KX-01 oral) / Athenex - LARVOL DELTA

Randomized Comparative Study of 5-Fluorouracil 4%, Tirbanibulin, and Photodynamic Therapy for Relapsing Actinic Keratoses. (PubMed, Photodiagnosis Photodyn Ther) - "Short-term efficacy of 5-FU, tirbanibulin, and PDT was comparable, while tolerability differed markedly. Tirbanibulin demonstrated the most favorable inflammatory and cosmetic profile, whereas 5-FU and PDT may be preferred when a more intense field effect is desired. RCM detected subclinical persistence in select cases and may serve as an adjunctive imaging tool for monitoring and guiding retreatment in field cancerization."

Journal • Actinic Keratosis • Dermatology • Oncology

SRC Suppression Attenuates Vascular Aging by Activating FUNDC1-Dependent Mitophagy. (PubMed, Mech Ageing Dev) - "An accelerated vascular aging model was established using a high-fat diet and streptozotocin injection in ApoE-/- mice, while senescence in mouse aortic vascular smooth muscle cells (MOVASs) was induced by doxorubicin. Moreover, FUNDC1 knockdown abolished the anti-senescence effects of KX2-391, confirming that FUNDC1 is essential for SRC-mediated regulation. Together, these findings establish the SRC-FUNDC1 axis as an important regulator of mitophagy and vascular aging, suggesting that SRC inhibition may offer therapeutic benefit against vascular senescence and atherosclerosis."

Journal • Atherosclerosis • Cardiovascular • Metabolic Disorders • APOE

Efficacy of acitretin, cryotherapy, and tirbanibulin combination therapy for recalcitrant plantar and periungual warts: a case series of 30 patients. (PubMed, Ital J Dermatol Venerol) - No abstract available

Journal • Dermatology

Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2) (clinicaltrials.gov) - P1/2 | N=600 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

IO biomarker • New P1/2 trial • Oncology • Solid Tumor

Multidisciplinary Delphi consensus between primary care and dermatology on updated management of actinic keratosis in spain. (PubMed, Actas Dermosifiliogr) - "Regarding treatment, experts recommend the use of treatments adapted to the degree and extent of the injuries, highlighting the use of molecules such as 5-fluorouracil for isolated and field of cancerization injuries, as well as tirbanibulin for grade 1 and 2 isolated and field of cancerization injuries. These consensual recommendations seek to serve as a clinical guide on the routine management of patients with actinic keratosis."

Clinical guideline • Journal • Actinic Keratosis • Dermatology • Dermatopathology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: TCRx Therapeutics Co.Ltd

New P1 trial • Solid Tumor

Monitoring the effectiveness of noninvasive or minimally invasive therapies for nonmelanocytic lesions using reflectance confocal microscopy: a systematic review. (PubMed, Actas Dermosifiliogr) - "Evaluated therapies included ablative laser, cryosurgery, photodynamic therapy, 5-fluorouracil, imiquimod, and tirbanibulin, among others. RCM allows treatment optimization and early monitoring, even when inflammation hinders clinical assessment. It is recommended that RCM evaluations be performed starting at least 1 month after treatment for squamous conditions and 3 months for BCC."

Journal • Review • Actinic Keratosis • Basal Cell Carcinoma • Dermatology • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Rare Diseases • Skin Cancer • Squamous Cell Carcinoma

Tirbanibulin 1% real-world use in 679 actinic keratoses patients during warm season (SUMM-AK study). (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Real-world evidence • Actinic Keratosis • Dermatology

Real‐world evidence of tirbanibulin in the treatment of actinic keratosis in Germany – prospective, multicenter, non‐interventional KLIR study. (PubMed, J Dtsch Dermatol Ges) - "Tirbanibulin showed high lesion clearance and a high level of acceptance in real-life conditions."

HEOR • Journal • Real-world evidence • Actinic Keratosis • Dermatology

Modeling the Anticipated Organizational Impact on Health Service Provision of the Introduction of Tirbanibulin for the Topical Treatment of Actinic Keratosis in France: EPIKA Study (ISPOR-EU 2025) - "The modelling study incorporated data on the number of patients treated for AK by dermatologists in France, waiting time for appointments with dermatologists or General Practitioners (GPs), prescribing patterns for other simple-to-use topical treatments for acne, and historical experience with the now withdrawn ingenol mebutate. Introduction of a convenient and safe topical treatment for AK would be expected to transfer care from the specialist to the primary care sector and thus facilitate access to treatment."

Acne Vulgaris • Actinic Keratosis • Dermatology

Src and Abl as Therapeutic Targets in Lung Cancer: Opportunities for Drug Repurposing. (PubMed, Pharmaceuticals (Basel)) - "This review aims to provide a comprehensive overview of five tyrosine kinase inhibitors-saracatinib, imatinib, PP2, nilotinib and, tirbanibulin-that act on Src and/or Abl. Although clinical data for these drugs in lung cancer remain limited, preclinical and clinical studies suggest promising therapeutic potential, particularly in specific molecular subtypes. Overall, this review highlights the therapeutic potential of Src and Abl inhibitors beyond their original contexts and supports their possible role in lung cancer therapy, considering the disease's high heterogeneity and the growing applicability of personalized medicine."

Journal • Review • Lung Cancer • Oncology • Solid Tumor

Berberine: a promising strategy to combat cetuximab-resistance in colorectal cancer. (PubMed, BMC Cancer) - "Adding KX2-391 (Src inhibitor) rather than BML-277 (Chk-2 inhibitor) with cetuximab resulted in more cell death and apoptosis. Conversely, activation of Src with MLR-1023 mitigated the inhibitory effect of berberine alone or in combination with cetuximab. Additionally, the activities of downstream kinases of Src such as mTOR, STAT3 and the production of ROS were inhibited greatly by berberine plus cetuximab. Taken together, we concluded that the synergistic effects of BBR and cetuximab may be mediated by decreasing the activities of Src/mTOR/STAT3 and the production of ROS, thus inducing greater extent of apoptosis in cancer cells."

Journal • Colorectal Cancer • Oncology • Solid Tumor • EGFR • STAT3

Personalized KXV01 TCR Lentinvivo Injection as the Therapy for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: The First Hospital of Jilin University

New P1 trial • Solid Tumor

Personalized KXV01 TCR Lentinvivo Injection as the Therapy for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: TCRx Therapeutics Co.Ltd

New P1 trial • Oncology • Solid Tumor

Tirbanibulin: An effective treatment for recalcitrant plantar warts. (PubMed, Med Clin (Barc)) - No abstract available

Journal • Dermatology

Relating patient-reported treatment satisfaction and clinical outcomes in post-registration studies of tirbanibulin for actinic keratosis (EADV 2025) - P | "Results from this combined analysis of results from PROAK and TirbaSkin indicated that the high AK clearance rate achieved with tirbanibulin was associated with corresponding high scores for all domains of the TSQM-9."

Clinical • Clinical data • Actinic Keratosis • Dermatology

Clearance of actinic keratosis with tirbanibulin: Comparing results from controlled trials with real-world/low interventional clinical studies (EADV 2025) - P, P3 | "Materials & Efficacy of tirbanibulin 1% ointment in the treatment of actinic keratosis (AK) has been evaluated in three phase III clinical trials; two [NCT03285477, NCT03285490] [3] in which tirbanibulin was applied to an area of 25 cm2 and one to an area of 100 cm2 [NCT05279131] [4] (N=458 total patients). These results indicate that clearance rates and reductions in AK lesion counts achieved with tirbanibulin in RCTs approximated results achieved in an open-label phase IV study and in real-world clinical practice."

Clinical • Real-world • Real-world evidence • Actinic Keratosis • Dermatology

Safety and tolerability of tirbanibulin for the treatment of actinic keratosis: Results from clinical trials and post-registration (EADV 2025) - P, P3 | "Materials & Information regarding safety and tolerability of tirbanibulin 1% ointment has been obtained in (i) three phase III trials, in two tirbanibulin was applied to an area of 25 cm2 (NCT03285477, NCT03285490) [3] and in one, to an area of 100 cm2 (NCT05279131) [4] (N=458 total patients), (ii) one open phase IV multicenter, single-cohort, low-interventional study (TirbaSkin [EU2022-001251-16] [5], N=334) and (iii) two real-world/low interventional studies, KLIR (DRKS00027120) [6] (N=543) and PROAK (NCT05260073) [7] (N=300), in which tirbanibulin was applied to an area of 25 cm2. These combined results indicate that tirbanibulin has low occurrence for serious or severe AEs, and severe LSRs were uncommon. The safety/tolerability profile for tirbanibulin in real-world clinical practice was comparable to the one reported in clinical trials."

Clinical • Actinic Keratosis • Dermatology • Pruritus

Sun exposure monitoring by ultraviolet sensor in patients with actinic keratosis treated with tirbanibulin 10 mg/g ointment or diclofenac sodium 3% gel: a Phase IV randomized study (EADV 2025) - "UV sensor might be a potential tool to visualize the risks associated with sun overexposure. In spring the UVI average was higher than in summer. Moreover, patients were exposed to UVI higher than recommended but improving habits from one year to another."

Clinical • P4 data • Actinic Keratosis • Dermatology • Squamous Cell Carcinoma

Tirbanibulin treatment for Actinic Keratosis: LC-OCT with AI-based algorithm evaluation (EADV 2025) - "The integration of advanced imaging techniques with targeted topical therapies marks a significant step forward in the personalized management of actinic keratosis, improving precision in diagnosis, treatment planning, and non-invasive follow-up care."

Actinic Keratosis • Dermatology • Squamous Cell Carcinoma

Topical treatment of actinic cheilitis with Tirbanibulin: Results of a monocentric phase II study to investigate efficacy and tolerability (EADV 2025) - "Introduction & Objectives: Tirbanibulin 1% ointment is licensed for treatment of actinic keratoses. These results suggest, that treatment of actinic cheilitis with Tirbanibulin appeared to be safe and effective."

Clinical • P2 data • Actinic Keratosis • Dermatology

Eficacia de la tirbanibulina al 1% en el tratamiento de la queratosis actínica pigmentada: un estudio ambispectivo en la vida real (EADV 2025) - "Tirbanibulin 1% ointment is an approved topical treatment for grade I AK, with proven efficacy and a favorable tolerability profile. In conclusion, 1% tirbanibulin appears to be an effective and safe therapeutic option for pAKs, with additional benefits in pigmentation and overall skin appearance. Further studies are needed to better understand the role of pigmentation in treatment response."

Actinic Keratosis • Aesthetic Medicine • Dermatology

Assessing The Holistic Value Of Tirbanibulin For Treating Actinic Keratosis Using Multi-Criteria Decision Analysis (MCDA) In Three European Countries (EADV 2025) - "The comparator selected for the comparative criteria was 5-fluorouracil 4% (5FU 4%), an antimetabolite chemotherapy widely used for AK treatment and approved for the target population of tirbanibulin. The findings will provide insights into the key value drivers of tirbanibulin to help inform decision making."

Actinic Keratosis • Dermatology • Skin Cancer • Squamous Cell Carcinoma

Efficacy, safety and patients satisfaction of Tirbanibulin in the treatment of actinic keratosis in sensitive facial areas: A prospective observational study (EADV 2025) - "Tirbanibulin is an effective and safe treatment for actinic keratosis in sensitive locations, demonstrating high satisfaction rates compared to other topical treatments and cryotherapy."

Clinical • Observational data • Actinic Keratosis • Dermatology • Squamous Cell Carcinoma

Real-World Efficacy of Tirbanibulin in Actinic Keratosis Treatment: Expert Consensus and Clinical Insights. (PubMed, Dermatol Pract Concept) - "Tirbanibulin should be considered as a first-line option for most patients with AK owing to its proven efficacy, good local and systemic tolerability, and a short treatment regimen of five days. All these factors encourage patient acceptability and treatment compliance. The favorable safety profile and tolerability of tirbanibulin also enable flexible therapeutic schedules, including repeated treatment cycles, if needed."

Journal • Real-world evidence • Review • Actinic Keratosis • Dermatology