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

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(GPs), prescribing patterns for other simple-to-use topical treatments for acne, and historical experience with the now withdrawn ingenol mebutate.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

Unraveling the Complexities in TNBC Gene Interaction Networks Towards Better Therapeutics. (PubMed, Biotechnol Appl Biochem) - "We hypothesize that tirbanibulin interacts either with the regulatory regions of EP300 through allosteric inhibition or indirectly by altering upstream signaling pathways. Given the vital role of drug repurposing, experimental investigations on tirbanibulin unanticipated effects against EP300 are an interesting future direction."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AKT1 • CDC37 • EGFR • EP300 • HSP90AA1 • MAPK3 • SMAD3 • TP53

Effects of tirbanibulin on cutaneous squamous cell carcinoma cells (ADO 2025) - No abstract available

Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Local Chemotherapy of Skin Pre-Neoplastic Lesions and Malignancies from the Perspective of Current Pharmaceutics. (PubMed, Pharmaceutics) - "At present, 5-Fluorouracil, imiquimod, and tirbanibulin creams and ointments have established their place in practice, while several other active pharmaceutical ingredients (APIs) (e.g., calcipotriol, tretinoin, diclofenac) have been repurposed, used off-label, or are currently being investigated in mono- or combined chemotherapies of skin cancers. A variety of prodrug and nanotechnological approaches, including vesicular systems, micro- and nanoemulsions, solid lipid nanoparticles, nanostructured lipid carriers, polymeric nanoparticles, and others, offer versatile solutions for overcoming the biophysical barrier function of the skin and the undesirable physicochemical nature of some drug molecules. This review aims to present the most significant aspects and latest achievements on the subject."

Journal • Review • Actinic Keratosis • Basal Cell Carcinoma • Dermatology • Genetic Disorders • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Field Therapy for Actinic Keratosis: One Nurse Practitioner's Perspective on Evolving Approaches and Patient-centered Care. (PubMed, J Clin Aesthet Dermatol) - "APPs are uniquely positioned to lead in early AK treatment and prevention. Combining clinical expertise with patient education and empathy enhances the impact of field therapy. The author's dual perspective as a provider and patient offers valuable insight into the real-world application of evidence-based dermatologic care."

Journal • Actinic Keratosis • Dermatology • Genetic Disorders • Oncology • Skin Cancer • Squamous Cell Carcinoma

Efficacy and safety of sequential treatment with cryotherapy followed by 1% topical tirbanibulin for actinic keratoses in organ transplant recipients: a randomized clinical trial. (PubMed, J Am Acad Dermatol) - "Sequential cryotherapy and tirbanibulin appears effective and safe for AK in SOTRs, improving lesion clearance and reducing new AK development."

Clinical • Journal • Actinic Keratosis • Dermatology • Solid Organ Transplantation • Transplantation