Sun Pharmaceutical Industries Limited has received comprehensive clinical updates on two significant drug candidates in its pipeline, Fibromun and Nidlegy, through partner Philogen's latest financial results. The updates present mixed outcomes across multiple ongoing clinical trials, with some Phase II studies missing primary endpoints while others advance toward registrational phases.

Fibromun Phase II Trials Show Mixed Results

The company reported outcomes from several Phase II studies for Fibromun across different cancer indications. While primary endpoints were not met in key studies, certain patient subgroups showed encouraging signals for future development.

The Phase II FLASH study in last-line soft tissue sarcoma enrolled 94 patients randomized 1:1 to receive either Fibromun plus dacarbazine or dacarbazine alone. Despite the comprehensive study design, the trial did not meet its primary endpoint for Progression Free Survival. The company acknowledged that pretreated soft tissue sarcoma remains a highly challenging disease with significant unmet medical need.

In glioblastoma studies, the Phase II GLIOSTAR clinical trial conducted in 163 second-line patients similarly did not meet its primary endpoint. However, an improvement in survival was observed in the subgroup of patients with limited exposure to alkylating agents, providing a foundation for future study designs.

Advancing Toward Phase III Registrational Studies

Sun Pharmaceutical remains committed to advancing its oncology pipeline through strategic trial planning. The GLIOSUN clinical trial, conducted in treatment-naïve glioblastoma patients, has completed the dose escalation phase and is initiating the subsequent dose expansion phase. The GLIOSTELLA study in late-line glioblastoma patients has completed patient enrollment in the United States and is expected to report survival data in September 2026.

Following encouraging signals from the FIBROSARC study in first-line soft tissue sarcoma, particularly in patients with liposarcoma and other sarcoma types, the company has submitted a request for Parallel Scientific Advice with the FDA and EMA. This process aims to define the design of a new Phase III registrational study (FIBROSARC-2), with the conclusion expected in the second quarter of 2026.

Nidlegy Demonstrates Strong Progress in Skin Cancer

Nidlegy, a biopharmaceutical product developed for skin cancer treatment, has shown more encouraging clinical results across multiple indications and geographical regions, with significant regulatory progress in both US and EU markets.

Following the withdrawal in 2025 of the Marketing Authorization Application previously submitted to the EMA for the melanoma indication, the company is preparing a new submission in Europe during 2026. In the United States, a Phase III clinical trial in locally advanced melanoma is ongoing and currently active in Spain and Switzerland, with planned expansion to additional countries.

A significant milestone was achieved when a Type C meeting was held with the U.S. Food and Drug Administration. During this meeting, data from the European study were presented and alignment was reached on the regulatory pathway for obtaining approval in melanoma in the United States, subject to completion and positive outcome of the ongoing study.

Registrational Studies Pipeline Expansion

The non-melanoma skin cancer program has generated particularly compelling data. The Phase II Duncan study has been completed in patients with basal cell carcinoma and cutaneous squamous cell carcinoma. The excellent results in basal cell carcinoma were presented at the European Society for Medical Oncology 2025 conference, reporting complete pathological responses in 52.60% of patients.

The Phase II Intrinsic study is currently ongoing with a target of 70 patients affected by various forms of non-melanoma skin cancer. To date, 65 patients have been treated in Italy and France. The positive results from both the Duncan and Intrinsic trials have provided strong rationale for initiating three new registrational studies in basal cell carcinoma and cutaneous squamous cell carcinoma in Europe and the United States.

The company has outlined a comprehensive regulatory strategy with specific timelines for multiple programs. The design of new registrational studies has been discussed with relevant regulatory authorities, with enrollment of the first patients expected in the second quarter of 2026. Additionally, Scientific Advice with the FDA has been completed to define a fourth registrational study in first-line basal cell carcinoma, comparing Nidlegy's performance with Hedgehog pathway inhibitors, with study initiation expected in mid-2026.

Sun Pharmaceutical Industries Limited has announced the presentation of 14 abstracts at the 2026 American Academy of Dermatology (AAD) Annual Meeting, held March 27-31, 2026 in Denver, Colorado. The comprehensive data presentations underscore the company's expertise across dermatology and immunology, reinforcing its commitment to advancing patient care in psoriasis, alopecia areata, and acne.

Research Portfolio Overview

The pharmaceutical company's extensive research presentation spans three key therapeutic areas with notable clinical developments:

Key Clinical Developments

ILUMYA Research Advances

The company presented significant data for ILUMYA, including a Phase 3b study demonstrating sustained efficacy and safety over 52 weeks in moderate-to-severe psoriasis affecting the nails. Real-world evidence from the PPD™ CorEvitas™ Psoriasis Registry showed that ILUMYA delivers holistic disease management, achieving sustained disease control across diverse patient populations worldwide.

LEQSELVI Breakthrough Results

Pooled data from the pivotal THRIVE-AA1 and THRIVE-AA2 trials revealed that LEQSELVI demonstrated significant scalp hair regrowth as early as Week 8 and Week 12, with continuous improvements over time. A landmark survey highlighted meaningful gaps in perceptions of disease burden and treatment goals between patients and clinicians, emphasizing the need for better patient-centered care alignment.

WINLEVI Combination Therapy Progress

An open-label, 52-week study of WINLEVI showed significant and progressive reduction in casual facial sebum production and acne severity, reinforcing its ability to directly target the androgen-sebum pathway. Pilot combination therapies demonstrated that WINLEVI may provide benefit in multimodal acne treatments, signaling broader clinical applicability.

Strategic Research Impact

According to Ahmad Naim, MD, Senior Vice President and North American Chief Medical Officer at Sun Pharma, "The data we are presenting at AAD underscore our commitment to advancing dermatology and immunology through meaningful science – spanning not only clinical efficacy and safety, but also how these therapies perform over time and in real-world practice."

The company also offered hands-on, immersive engagement opportunities at booth #2915, providing clinicians with interactive experiences highlighting the full dermatology and immunology portfolio.

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