Odomzo (sonidegib) / Sun Pharma, Novartis - LARVOL DELTA

Phase 1/1b study of azacitidine and hedgehog pathway inhibitor sonidegib in patients with myeloid neoplasms. (PubMed, Cancer) - "Our study shows that AZA + SON are a safe combination in a patient with MN. Similar to other hedgehog inhibitors, this combination yielded limited response rate in patients with myeloid neoplasms."

Journal • P1 data • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • CNS Disorders • Constipation • Cough • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Insomnia • Leukemia • Myelodysplastic Syndrome • Myelofibrosis • Oncology • Respiratory Diseases • Sleep Disorder

Welcome and latest data on Sonidegib from Germany (ADOReg, NISSO) (ADO 2026) - "Sponsored by Sun Pharmaceuticals Germany GmbH."

Real-world efficacy and safety of Sonidegib and Cemiplimab in advanced cutaneous carcinomas: a single-center observational study. (EADV 2026) - No abstract available

Clinical • Metastases • Observational data • Real-world • Real-world effectiveness • Real-world evidence • Oncology • Skin Cancer

SONI-BCC study (sonidegib in BCC) (ADO 2026) - No abstract available

Sonidegib for the treatment of multiple and locally advanced basal cell carcinomas in a case of severe Gorlin syndrome: a 3-year follow-up (EADV 2026) - No abstract available

Clinical • Metastases • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Real‑world use and safety of sonidegib in locally advanced basal cell carcinoma (laBCC) from the post-authorisation study NISSO: Cross‑country differences between Germany, Italy and Spain cohorts (EADV 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Sonidegib and Subsequent Photodynamic Therapy for Recurrent Nodular-Ulcerative Basal Cell Carcinoma of the Right Nose Post-Surgical Resection: A Case Report. (PubMed, Case Rep Dermatol) - "This sequential approach of sonidegib combined with surgery and PDT may be an effective and cosmetic-sparing option for selected patients with recurrent facial BCC who are unsuitable for or reluctant to undergo radical surgery. Further studies are warranted to validate its long-term efficacy."

Journal • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Nodular Basal Cell Carcinoma

Beyond Complete Response: Sonidegib Consolidation and Recurrence in Locally Advanced Basal Cell Carcinoma. (PubMed, Int J Dermatol) - No abstract available

Journal • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Reflectance Confocal Microscopy for Treatment Response Monitoring in Locally Advanced Basal Cell Carcinoma Treated with Sonidegib: A Prospective Observational Study. (PubMed, Cancers (Basel)) - "These findings support integrating RCM into a multimodal, response-adapted management strategy for laBCC. However, the limited sample size warrants cautious interpretation, and larger multicenter studies are required before broad clinical implementation."

Journal • Observational data • Basal Cell Carcinoma • Fibrosis • Genetic Disorders • Immunology • Non-melanoma Skin Cancer • Oncology • Skin Cancer

Control of Skin Carcinoma via Sonidegib-loaded Transbilosomes. (PubMed, J Drug Target) - "Histopathological and safety assessments confirmed the significant antiproliferative effects and the favorable preliminary safety profile of the intratumor SLT formulation. These findings suggest that the intratumor SLT formulation provides an effective option for the management of skin carcinoma."

Journal • Oncology • Skin Cancer

Use of Hedgehog Pathway Inhibitors in Combination Therapy for Basal Cell Carcinoma: A Review and Narrative Synthesis. (PubMed, J Clin Aesthet Dermatol) - "Combination strategies for HHI therapy represent a promising avenue to optimize efficacy, improve tolerability, and expand therapeutic options for patients with BCC."

Journal • Review • Basal Cell Carcinoma • Dermatology • Non-melanoma Skin Cancer • Oncology

Super giant basal cell carcinoma in the setting of neglect: A case report. (PubMed, JAAD Case Rep) - No abstract available

Journal • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Efficacy and Safety of Sonidegib in the Treatment of Multiple Facial Cutaneous Basal Cell Carcinomas with Chronic Renal Insufficiency: A Case Report. (PubMed, Clin Cosmet Investig Dermatol) - "Here, we report a case of a patient with multiple facial BCCs complicated by chronic renal insufficiency who was treated with sonidegib. This case demonstrates that sonidegib may be a safe and effective therapeutic option for inoperable cutaneous BCC in patients with chronic renal insufficiency."

Journal • Basal Cell Carcinoma • Chronic Kidney Disease • Nephrology • Non-melanoma Skin Cancer • Oncology • Renal Disease • Skin Cancer

A prospective, single-arm, multicenter, phase IV study to evaluate the efficacy and safety of sonidegib in Chinese patients with locally advanced basal cell carcinoma. (ASCO 2026) - P4 | "In Chinese patients with locally advanced BCC, sonidegib demonstrated robust efficacy, consistent with previous reports in global study populations. The safety profile of sonidegib was manageable, and no new safety signals were observed."

Clinical • Metastases • P4 data • Alopecia • Anorexia • Basal Cell Carcinoma • Immunology • Non-melanoma Skin Cancer • Oncology

SONIBEC: Tailored Sonidegib Schedule After Complete Response in BCC (clinicaltrials.gov) - P2 | N=21 | Active, not recruiting | Sponsor: Gruppo Oncologico del Nord-Ovest | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ Dec 2026

Compliance • Enrollment closed • Trial completion date • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

UF-GI-015: AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: University of Florida | Trial completion date: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Apr 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Transforming Outcomes in Advanced Basal Cell Carcinoma: The Evolving Role of Systemic Therapy. (PubMed, Am J Clin Dermatol) - "First-line therapy with the HHIs, vismodegib and sonidegib, provides effective disease control, and may enable the preservation of function in locally complex cases. To address the shortcomings of systemic therapy and improve the long-term disease control of patients with aBCC, ongoing research focuses on alternative dosing strategies, integration of combination or novel systemic agents and the development of predictive biomarkers. This review provides a comprehensive, clinically oriented overview of the evidence on systemic treatment for aBCC, emphasizing efficacy, safety, resistance mechanisms, and therapeutic strategies."

IO biomarker • Journal • Review • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Rare Diseases

Management Challenges in Gorlin Syndrome: A Case Report and Therapeutic Review (EADV-Sp 2026) - "For more advanced or numerous lesions, targeted SHH pathway inhibitors like vismodegib and sonidegib represent a paradigm shift, yet their long-term use is limited by cost, side effects, and acquired resistance, making them more suitable for advanced rather than lifelong prophylactic management. Other modalities, such as topical imiquimod or itraconazole, play ancillary roles...Effective management necessitates a personalized, multidisciplinary approach that strategically combines surgical, topical, and systemic modalities, adapting to disease progression and patient tolerance. This case reinforces the need for continued research into more sustainable targeted therapies and optimized treatment protocols to improve long-term quality of life for affected individuals."

Case report • Clinical • Review • Basal Cell Carcinoma • Rare Diseases • Skin Cancer • PTCH1

Giant basal cell carcinoma mimicking cicatricial alopecia in a 93-year-old woman: A diagnostic and therapeutic challenge (EADV-Sp 2026) - "A recent study suggested that even in >85-year-old patients, sonidegib was well tolerated, with even milder adverse effects than in younger patients. Sonidegib can be a treatment option in very elderly patients with irresectable BCC, especially in patients with symptomatic lesions, which may improve after just a few weeks of treatment."

Clinical • Alopecia • Basal Cell Carcinoma • Cardiovascular • Discoid Lupus Erythematosus • Essential Thrombocythemia • Hypertension • Immunology • Inflammatory Arthritis • Lupus • Non-melanoma Skin Cancer • Oncology • Thrombocytosis

Efficacy and Safety of Sonidegib Combined with Photodynamic Therapy in Basal Cell Carcinoma: A Retrospective Case Series of 7 Patients. (PubMed, Photodiagnosis Photodyn Ther) - "Short-course Sonidegib combined with fractional CO₂ laser-assisted ALA-PDT demonstrates high efficacy and favorable tolerability for facial BCC unsuitable for surgery, offering a durable non-surgical alternative warranting prospective validation."

Journal • Retrospective data • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Transdermal Delivery of Sonidegib via Iontophoresis from PEDOT:PSS/Gelatin Hydrogels for Basal Cell Carcinoma Skin Cancer. (PubMed, Pharmaceutics) - "Under applied electrical voltages and with PEDOT:PSS present, the amounts of Sonidegib release and release-permeation amounts increased as PEDOT:PSS assisted in providing higher electroosmosis and electrorepulsive forces. In summary, PEDOT:PSS in the BG hydrogel is demonstrated here as a potential drug carrier to improve the Sonidegib release and release-permeation iontophoretically for TDDS."

Journal • Basal Cell Carcinoma • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer

Integrative pathway analysis of I-SPY2 HER2+ breast cancers reveals drug-repurposing opportunities (AACR 2026) - "Growth-factor/RTK bypass (PI3K/AKT) and DNA repair & oxidative stress defense were strongly upregulated in non-responders within BP-HER2, revealing actionable nodes involving PI3K/AKT (alpelisib, capivasertib), IGF1R (linsitinib), MET (crizotinib, capmatinib), and DNA repair (PARP inhibitors). Notably, metabolic rewiring and lipid homeostasis—targetable by vismodegib and sonidegib—were upregulated in non-responders across both BP subtypes, reflecting a shared metabolic vulnerability. Luminal biology-linked transcriptional programs may persist within the HER2+ BP-HER2 subtype and contribute to resistance... Luminal biology-linked transcriptional programs may persist within the HER2+ BP-HER2 subtype and contribute to resistance. BP-HER2 non-responders exhibit coordinated activation of RTK-bypass and DNA repair pathways, exposing therapeutic vulnerabilities targetable by existing agents. Furthermore, targeting lipid metabolic reprogramming alongside anti-HER2 therapy..."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-world efficacy and safety of Sonidegib in Locally Advanced and Multiple Basal Cell Carcinomas: A Monocentric Prospective Observational Study. (PubMed, Clin Exp Dermatol) - "Despite the limited sample size, our findings confirm the significant efficacy of Sonidegib in a frail, pre-treated population with multiple comorbidities. This study supports its use as a valuable therapeutic strategy for complex patients with high tumor burden or those ineligible for further surgery."

Journal • Observational data • Real-world evidence • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Final analysis of the multinational, post-authorisation study (NISSO) to assess the long-term safety and effectiveness of sonidegib in patients (pts) with locally advanced basal cell carcinoma (laBCC) (EADO 2026) - P | "Most patients had the onset of the most common TEAEs after 3 months of treatment. The results of this post-authorisation study reinforce the safety and effectiveness profile observed in the pivotal BOLT trial, demonstrating that sonidegib is a well-tolerated and efficacious first-line treatment for laBCC in clinical practice, including in Gorlin's pts."

Clinical • Metastases • Alopecia • Basal Cell Carcinoma • Immunology • Non-melanoma Skin Cancer • Oncology

SATELLITE SYMPOSIUM 7: SCAR WARS: the laBCC Strikes Back – The Challenge of Recurrence in laBCC (EADO 2026) - "Sponsored by SunPharma Odomzo GOLD SPONSOR"