Debiopharm announces the presentation of the 3-year phase II follow-up data along with 2 posters for xevinapant (antagonist of IAP -Inhibitor of Apoptosis Proteins) and WEE1 inhibitor Debio 0123
LAUSANNE, Switzerland, Sept. 17, 2020 /PRNewswire/ -- Debiopharm, (www.debiopharm.com) a biopharmaceutical company based in Switzerland, today announced data releases on 2 investigational oncology programs including xevinapant (Debio 1143) and their selective WEE1 inhibitor (Debio 0123), at the European Society Of Medical Oncology (ESMO) Virtual Congress taking place virtually from September 19th – 21st. The abstract and poster presentations are a part of Debiopharm's maturing oncology portfolio which evaluates novel, first-in-class oncology and compounds that respond to high unmet needs in a wide range of cancer types.
The virtual late breaking abstract presentation of the 3-year update for the xevinapant phase II study in high-risk previously untreated locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) patients, will be given by professor Jean Bourhis, lead investigator of the study. The talk will include the statistically significant overall survival data suggesting the reduction of the risk of death by 50% with this phase III (https://patients.debiopharm.com/head-and-neck-cancer/) investigational therapy + chemoradiotherapy (CRT) vs. CRT alone.
In addition, two phase I posters will be made available for xevinapant in combination with nivolumab and for Debio 0123, the oral WEE1 inhibitor in combination with carboplatin for the treatment of solid tumors.
"We are excited to introduce first clinical data with Debio 0123 and provide a number of important updates on xevinapant during the upcoming ESMO meeting. The updated clinical data from our phase II study in Head & Neck cancer will highlight our progress towards developing a novel therapy that could significantly extend the lives of these high risk patients," expressed Angela Zubel - Chief Development Officer, R&D, Debiopharm
"The benefit to patients with xevinapant vs. chemo-radiotherapy alone at 3 years is an improvement that has not been seen in over 30 years of research, " commented Pr. Jean Bourhis, Head of the Radio-Oncology Department CHUV, Lausanne, Switzerland, and Lead Investigator of the study. "These results suggest a chemo-radio-enhancing effect, warranting further assessment during an ongoing phase III trial for LA-SCCHN patients."
ESMO 2020 Session Details
12:54 – 13:04
Proffered Paper – Head and neck cancer session 12:30 – 14:10
LBA39 – 3-years follow-up of double-blind randomized phase II comparing concurrent high-dose cisplatin chemo-radiation plus Debio-1143 (xevinapant) or placebo in high-risk patients with locally advanced squamous cell carcinoma of the head and neck
Prof. Jean Bourhis,
Head of Radio-Oncology CHUV, Lausanne, Switzerland, Lead study author
Poster Display Session
560P – Safety and efficacy of Debio 1143, an antagonist of inhibitor of apoptosis proteins (IAPs), in combination with nivolumab in a phase Ib/II trial in patients (pts) failing prior PD-1/PD-L1 treatment
Analia B. Azaro Pedrazzoli (Barcelona, Spain)
Poster Display Session
601TiP – First-in-human phase I study of a novel oral Wee1 inhibitor (Debio 0123) in combination with carboplatin in patients with advanced solid tumors
Hans Gelderblom (Leiden, Netherlands)
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Xevinapant (Debio 1143) is a potential first-in-class oral antagonist of IAPs (inhibitor of apoptosis proteins), that sensitizes tumor cells to radio-chemo-therapy by promoting programmed cell death and fostering anti-tumor immunity. The clinical benefit observed in high risk LA-SCCHN patients suggests that the addition of xevinapant into widely used CRT regimens is a promising investigational approach over a broad range of cancer types. Over 200 patients have been treated so far in various indications and lines of treatment, showing an adequate and consistent safety profile across studies.
About Debio 0123
Debio 0123 is a WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, to allow cells to repair their DNA before resuming their cycle. Inhibition of WEE1, particularly in combination with DNA damaging agents, induces an overload of DNA breaks, and in conjunction with abrogation of other checkpoints, such as G1 controlled by p53, pushes the cells through cycle without DNA repair, promotes mitotic catastrophe and induces apoptosis of cancer cells.
Debiopharm's commitment to cancer patients
Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
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