IAP inhibitor Debio 1143 combined chemotherapy first-line treatment of head and neck cancer significantly extended survival.

In addition, the three-year follow-up results of 96 LA-SCCHN patients confirmed the continuity of the two-year expected results recently published in The Lancet, with significant statistical improvements at all other key endpoints, including doubling progression survival and longer duration of remission.
the predictable and manageable security observed by the Debio 1143-CRT scheme over a two-year period remained essentially unchanged in year 3.
note that the study was conducted at the beginning of the study over a period of 3 cycles (3 weeks each).
Debio 1143 Chemical Structure (Photo: medchemexpress.cn) Debio 1143 is a potentially pioneering (first-in-class) oral IAP (apoptosis inhibitor) inhibitor that makes tumor cells sensitive to chemotherapy by promoting programmed cell death and enhancing anti-tumor immunity.
Debio 1143 has immunomodulation properties and is a natural candidate for use in a joint application with immuno-checkpoint inhibitors.
addition, like other members of the IAP antagonist class, Debio 1143 promotes the apoptosis of cancer cells by simulating the activity of natural SMAC (a second mitochondrial-derived cysteine activator).
this dual-acting model, Debio 1143 has the potential to combine immunotherapy, chemotherapy and/or radiotherapy to improve the effectiveness of treatment in patients with multiple types of cancer.
clinical benefits observed in patients with LA-SCCHN suggest that integrating Debio 1143 into a widely used CRT solution is a promising treatment for multiple cancer types.
February, the FDA granted Debio 1143 Breakthrough Drug Qualification (BTD), combined with current standard treatment, cisplatin-based radiotherapy (CRT), to treat patients with previously untreated, non-excisive LA-SCCHN.
in the past 25 years, there has been no newly approved treatment for LA-SCCHN patients.
this BTD qualification reflects the potential for Debio 1143, combined with current standard care at LA-SCCHN, to deliver significant benefits that can be used to address the high level of unsequal needs present in this cancer.
squamous cell carcinoma (SCCHN) is the sixth most common type of cancer in the world, with more than half of patients diagnosed with localized advanced (LA) disease.
patients with high-risk LA-SCCHN, including those with HPV-negative oral pharyngophage cancer (OPC) and severe smokers, have poor prognosis even under current standards of care (SOCs), as more than half of patients relapse.
of LA-SCCHN severely affect the quality of life and social interaction of patients, affecting their expressions, speech, diet and breathing.
urgent need for additional therapies in this area to ensure better prognostication for patients facing this devastating disease.
Debio1143 represents one of the few clinical advances in head and neck cancer, where no new therapies have been approved in the past 25 years.
Debiopharm will launch a key Phase III trial in September to evaluate Debio 1143 in the treatment of head and neck cancer patients.
the company is also evaluating Debio 1143 in combination with immunosuppressants (PD-1/PD-L1) to treat multiple solid tumors.
, more than 200 patients have been treated with Debio 1143 in different tumor adaptations and treatment routes, and good and consistent safety has been shown in these studies. Angela Zubel, chief development officer at
Debiopharm, said: "This is an important step forward for head and neck cancer patients and the research community, as this potential first-line therapy could change the way these patients are treated from the start.
I am very encouraged by the long-term prognosmical improvement observed in the study.
results show that Debio 1143, in combined with CRT, has the potential to prolong patients' lives and better control their disease. Professor Jean Bourhis, lead investigator on the
study and head of the Department of Radiation Oncology at the University Hospital of Lausanne, said: "These three-year follow-up results may be important for patients with high-risk head and neck cancer, especially those with the worst prognosis for HPV-negative conditions.
As Debio 1143 enters Phase III clinical trials, we will be able to gather further evidence of this radiochemically enhanced IAP antagonist, which has the potential to become a standard care therapy for radiation oncology.
" original source: Debiopharm's IAP Antagonist Great Improves Overall Survival of High-Risk Head and Neck Cancer Patients.