Mutual Funds Commodities Research Tax Planning IPO Our Team Contact Us  
Google
Web www.equitybulls.com
Stock Report

| More

Nidlegy™ Phase III PIVOTAL trial meets the study's primary objective

Posted On: 2023-10-17 07:14:20 (Time Zone: IST)


Philogen S.p.A. (BIT:PHIL) and Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) are pleased to announce positive results from the Phase III PIVOTAL trial in patients with locally advanced fully resectable melanoma (NCT02938299). The study compared neoadjuvant intratumoral Nidlegy™ (Daromun) followed by surgery (treatment arm) vs. surgery alone (control arm). Patients were allowed to receive approved adjuvant systemic therapies after surgery in both arms.

According to the protocol, the primary endpoint of the study was the Recurrence-Free Survival (RFS) assessed per Blinded Independent Central Review (BICR) for patients treated with Nidlegy™, compared to the control arm. At median follow-up of 27.6 months in both groups, the study met its primary endpoint with a statistically significant and clinically meaningful improvement in RFS of the treatment arm compared to the control arm. This positive outcome was consistently in line with the Investigators' Assessment: a significant reduction of the hazard risk ratio of 33% (HR = 0.67) and 37% (HR = 0.63), respectively, favoring the treatment arm, was observed both in the BICR and in the Investigators' Assessment analysis.

Treatment-related adverse events observed with Nidlegy™ were benign and manageable, consistent with the proposed mechanism of action and with the favorable safety profile previously reported in the Phase II study [Danielli et al. (2015) Cancer Immunol. Immunother., 64, 999]. Grade 3 adverse events occurred in 24.8% of the treated patients. Neither grade 4 toxicity nor treatment-related deaths were observed in the study. Nidlegy™ treatment was not associated with the induction of autoimmune conditions.

PIVOTAL enrolled 257 patients in Europe across 22 clinical centers in Germany, Italy, France and Poland. The results, including sub-group analyses, will be presented at a forthcoming medical meeting.

Nidlegy™ is also being developed in dedicated Phase II clinical trials for the treatment of aggressive forms of non-melanoma skin cancer, including high-risk locally advanced basal cell carcinoma and cutaneous squamous cell carcinoma.

Prof. Dario Neri, co-founder, CEO and CSO of Philogen, commented: "We are extremely pleased to announce positive topline data emerging from our PIVOTAL program in locally advanced resectable melanoma. The clinical data in melanoma and high-risk non melanoma skin cancers bode well for the possible adoption of intralesional Nidlegy™ in a series of Dermato-Oncology indications. Philogen is currently executing six additional advanced clinical trials with registration potential featuring either Nidlegy™ or Fibromun, the company's most advanced product candidates, as active ingredients."

Alfredo Covelli, MD, Chief Medical Officer of Philogen, commented: "Neoadjuvant cytokine therapy for the treatment of locally advanced skin cancers enables a robust expansion of tumorinfiltrating lymphocytes. By anchoring interleukin-2 and tumor necrosis factor within the tumor mass through the L19 antibody moiety, we minimize systemic side effects while mounting a systemic robust anti-cancer immune response. This Phase 3 study merged the intralesional approach with IL2, pioneered by Prof. Claus Garbe more than 20 years ago, with the concepts of antibody-based tumor targeting, and with neoadjuvant therapy in locally advanced melanoma. The approach may find a broad applicability in different types of cancer."

Hellen De Kloet, Business Head - Western Europe and ANZ, Sun Pharma, said: "We are looking forward to commercializing Nidlegy™ in Europe, Australia and New Zealand as the first neoadjuvant immunotherapy for patients with resectable advanced melanoma. Nidlegy™, as an intralesional therapeutic option, addresses the existing significant unmet need for effective and well-tolerated treatments in patients, before undergoing surgery".

Philogen and Sun Pharma announced on May 30th, 2023, to have entered into distribution, license and supply agreement for commercializing Nidlegy™ in Europe, Australia and New Zealand for the treatment of skin cancers.

Shares of Sun Pharmaceutical Industries Limited was last trading in BSE at Rs. 1134.90 as compared to the previous close of Rs. 1145.60. The total number of shares traded during the day was 28229 in over 1751 trades.

The stock hit an intraday high of Rs. 1147.25 and intraday low of 1134.00. The net turnover during the day was Rs. 32198570.00.


Click here to send ur comments or to feedback@equitybulls.com





Other Headlines:

Infosys and Linux Foundation Networking Collaborate to Strengthen Responsible AI for Global Networks

ITC announces strategic acquisition of Pulp & Paper Undertaking of Aditya Birla Real Estate Limited

AGI Greenpac Ltd approves ~ Rs. 700 crore capex

NHPC Ltd updates on 300 MW Bikaner Solar Power Project

Prashant India Ltd enters into agreement for sale with Shantilon Poly Pvt Ltd

Trent Limited crosses operating portfolio of over 1000 fashion stores

Aditya Birla Capital Limited completes amalgamation of Aditya Birla Finance Limited

Cantabil Retail India Ltd opens 13 new showrooms

Kalpataru Projects International Ltd receives orders worth Rs. 621 crores

HCLTech elevates Public Sector expertise with launch of US subsidiary

India Glycols Limited adds 200 KLPD Ethanol capacity

FY 2024-25: Despite Supply Chain Woes, HAL Registers Revenue of Rs 30,400 Crores, Builds Capacities

Loyal Textile Mills Ltd sells part of its windmill units for Rs. 73.80 crores

Aditya Birla Real Estate Ltd streamlines portfolio - Divests Century Pulp and Paper undertaking for Rs. 3498 Cr

Artefact Projects Limited awarded project worth Rs. 241.63 lakh

Gennova Advances Pathbreaking AI-Enhanced saRNA Vaccine for one of the deadliest known viruses in collaboration with CEPI

Avenue Supermarts Ltd opens 3 new stores, increases store count to 415

Coastal Biotech Pvt Ltd starts trial runs at its Ethanol Plant

Walchandnagar Industries Limited receives contract worth Rs. 30.75 crores

GRSE Records 32 % YoY growth in the FY25

AGI Greenpac Limited to set up new Container Glass Plant in Madhya Pradesh

Triton Valves Limited signs contract with Robert Bosch GmBH

Jyoti Ltd to allot 59,63,636 shares to Rare Asset Reconstruction ltd

Avantel Ltd receives order worth Rs. 11.36 crores

Kohinoor Foods Ltd to sell rice factory for Rs. 190 crores as part of OTS

Aditya Vision Limited opens 4 showrooms at Jharkhand and UP

DCM Shriram Limited commissions new caustic soda flakes plant

Asian Granito India Limited receives IT demand notice

Newgen Software Inc. inks agreement for order worth USD 1,270,000

Blue Jet Healthcare Ltd receives demand notice from IT department for Rs. 1,93,38,55,250/- including interest

LTIMindtree announces strategic partnership with Google Cloud to drive Business Transformation with Agentic AI

NHPC commissions 3 units of Parbati-II HE project

ixigo announces APRIL FULL REFUND SALE for 1st April - 100 Lucky Travellers To Win 100% Refund on Flight Bookings

Engineers India Ltd receives orders worth Rs. 245 crores

Blue Star appoints Mohit Sud as Group President, Unitary Cooling Products

Jyoti Ltd receives Rs. 108.17 crores IT demand notice for AY 2020-21

HBL Engineering Limited receives Kavach contracts worth Rs. 762.56 crores

SPARC announces submission of IND Application for SBO-154 to USFDA

Hon'ble PM Shri Narendra Modi visits Solar Defence and Aerospace Ltd's facilities

Avenue Supermarts Ltd's store count increases to 412, opens 4 new stores today

Tera Software Ltd receives LOIs worth Rs. 273.2 crores from MVVNL

JSW Steel Ltd declared successful bidder by BCCL in the auction of Dugda Coal Washery in the State of Jharkhand

IRM Energy Ltd secures 5-Year RLNG supply agreement with Gujarat State Petroleum Corporation Limited

Uno Minda Strengthens Governance, appoints Ravi Mehra as Managing Director, and Expands Board Expertise

Manoj Vaibhav Gems 'N' Jewellers Ltd opens new Jewellery store at Narsipatnam

Income Tax Authority imposes penalty of Rs. 944.20 crore on InterGlobe Aviation Limited

Tejas Networks Ltd receives Rs. 189.1657 crore under PLI scheme

Nitco Ltd expects Rs. 100 crores on receipt of property from development of Leasehold Rights

Fusion Finance Limited fixes April 4, 2025 as record date for 55:91 rights issue

JM Financial Limited invests in rights issue of JM Financial Asset Management Ltd


Website Created & Maintained by : Chennai Scripts
West Mambalam, Chennai - 600 033,
Tamil Nadu, India

disclaimer copyright © 2005 - 2020