Debiopharm's novel IAP antagonist Debio 1143 achieves outstanding Phase II results for high-risk Head and Neck cancer patients

Lausanne (ots) -

Late breaking abstract results presented today at ESMO with
chemo-radio sensitizer Debio 1143 present a promising breakthrough
strategy to improve the front-line treatment of H&N cancer patients

Debiopharm, a Swiss-based global biopharmaceutical company,
presented today, at the ESMO Congress (European Society for Medical
Oncology), compelling results from a robust, randomized, Phase II
study of Debio 1143 for the treatment of high-risk, locally advanced
squamous cell carcinoma of the head and neck (LA-SCCHN) patients in
combination with current standard of care, chemo-radiotherapy (CRT).
Clinical results with Debio 1143, the most clinically advanced IAP
antagonist, revealed a statistically significant improvement of the
primary endpoint locoregional control rate (LRC - 21% improvement at
18 months after CRT vs. control arm) and a striking progression-free
survival (PFS) benefit vs. the control arm after a 2-year follow-up
period.

This double-blind, randomized, control group study, combined Debio
1143 with CRT in patients with previously untreated stage III, IVA or
IVB SCCHN. The majority of patients enrolled were considered
high-risk, facing a poor prognosis, including HPV-negative
oropharyngeal cancer (OPC) patients and heavy smokers (>10
pack-years). Ninety-six patients were enrolled at 19 centers across
France and Switzerland. The study explored whether the addition of
Debio 1143 at 200 mg/d to standard CRT could increase treatment
efficacy compared to CRT and placebo. The primary endpoint of
LRC-rate at 18 months was met. For key secondary endpoints,
clinically compelling and statistically significant outcomes in
Progression-Free survival (PFS) at 24-months were observed along with
positive trends for overall survival (OS) and complete response (CR)
rates in the active treatment group vs. CRT+placebo, although these
parameters have not yet reached statistical maturity.

"Combined with the standard of care, Debio 1143 has demonstrated
significant efficacy - especially in locoregional control rate and
progression free survival - in high-risk previously untreated
LA-SCCHN patients", commented Pr. Jean Bourhis, Head of the
Radio-Oncology Department CHUV, Lausanne, Switzerland, and Lead
Investigator of the study. "The chemo-radio-sensitizing effect of
Debio 1143 constitutes a highly promising strategy to ultimately
allow high-risk head and neck patients to achieve better control over
their disease for longer."

"The positive topline results are very encouraging and support our
efforts to provide head and neck cancer patients and clinicians with
this potential new treatment option", said Bertrand Ducrey, CEO of
Debiopharm International. "This data demonstrates proof of concept
for the potential use of Debio 1143 in other CRT applications,
potentially expanding therapeutic reach and making a difference in a
wide range of indications."

In addition, Debio 1143 showed a predictable and manageable safety
profile, without substantial additional toxicity to standard CRT.

ESMO 2019 Abstract Presenting
Session Details investigator
Sept. 30th ,
10:15am LBA65 - Double-blind Prof. Jean Bourhis
Cordoba Auditorium Randomized Phase 2 Results Head of the
(Hall 7) Comparing Concurrent Radio-Oncology
Preferred Paper - Highdose Cisplatin Department CHUV,
Head and neck cancer Chemorradiation (CRT) Lausanne,
plus Debio 1143 or Placebo Switzerland,
In High-risk Patients with Lead study author
Locally Advanced Squamous
Cell Carcinoma of the Head
and Neck (SCCHN):
A GORTEC Study

About Debio 1143

Debio 1143 is an antagonist of IAPs (inhibitor of apoptosis
proteins), acting as chemo-radio-sensitizer to enhance treatment
efficacy with a dual mode of action, promoting programmed cell death
and fostering anti-tumor immunity. Currently in clinical development
in a broad range of cancer types, the compound is being developed in
combination with chemo-radiotherapy or with ICIs (PD-1/PD-L1), with
reported data consistently showing a favorable safety profile. Over
200 patients have been treated so far with Debio 1143 in various
indications and lines of treatment.

Ongoing trials for Debio 1143:

- Head & neck cancers:
patients.debiopharm.com/head-and-neck-cancer/

- Small cell lung cancers:
patients.debiopharm.com/small-cell-lung-cancer-sclc/

- Gastrointestinal cancers:
patients.debiopharm.com/gastrointestinal-cancers/

- Gynecologic cancers: patients.debiopharm.com/gynecologic-cancer/

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.

Visit us www.debiopharm.com/

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Contact:
Debiopharm Contact
Dawn Haughton
Communication Manager
dawn.haughton@debiopharm.com
Tel: +41 (0)21 321 01 11

Original-Content von: Debiopharm International SA, übermittelt durch news aktuell