Debiopharm International is conducting a randomized, double-blind, placebo-controlled Phase III trial in male and female patients with previously untreated, locally advanced, squamous cell cancer of the head and neck (oropharynx, hypopharynx and larynx).

Debio 1143 is a small molecule that neutralizes inhibitors of proteins that are involved in cell death by mimicking the activity of the natural second mitochondrial-derived activator of caspases. Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors.

The purpose of this trial is to evaluate the antitumor activity of Debio 1143, an investigational medicinal product, compared with placebo when added to the standard concurrent cisplatin and radiation therapy. Definition Clinical Guidelines on esmo.org and nccn.org

The patients will undergo three 21-day cycles of combination therapy (cisplatin and radiotherapy combined with Debio 1143 or placebo) followed by three 21-day cycles of monotherapy (only Debio 1143 or placebo). Patients will take placebo or Debio 1143 orally or via feeding tube for the first 14 days of each cycle.

Debiopharm International is conducting an open-label two-part Phase 1b/2 trial in male and female patients with either small cell lung cancer, squamous cell carcinoma of the head and neck, selected gastrointestinal or gynecologic cancers with specific genetic alterations. Tumors with these genetic alterations may respond better to this study treatment. To be eligible, patients must have received at least one prior standard chemotherapy or have no established standard therapeutic alternatives. In addition, patients must have progressed during prior immuno-oncology treatment.

The purpose of Part B is to evaluate whether Debio 1143 combined with nivolumab leads to efficient shrinkage of the tumor in patients with different types of cancer and to determine how safe it is.

Debio 1143 is an investigational medicinal product. Nivolumab is a monoclonal antibody that specifically blocks a target in the body called PD-1 and stimulates the immune system to fight cancer cells.

Debio 1143 is administered orally once daily for 10 consecutive days every 2 weeks. Nivolumab is administered by infusion every 2 weeks.

Debiopharm International is conducting a randomized, double-blind and placebo-controlled Definition This trial is randomized, double-blind and placebo-controlled. Practically, this means that all patients receive carboplatin and paclitaxel but are assigned to Debio 1143 or placebo in a random fashion which means by chance, like tossing a coin, only that a computer system does the tossing according to a mathematical method known as ‘randomization’. Placebo instead of Debio 1143 is given to half of the patients to be able to identify the real effects observed with Debio 1143. As the study is double-blind, neither the patient, nor the investigator and his study team know whether the patient is receiving Debio 1143 or placebo. This is done to ensure that those involved in the management of the trial remain objective in their observations throughout the trial. Phase I/II trial in male and female patients with previously untreated locally advanced squamous cell cancer of the head and neck (oral cavity, oropharynx, hypopharynx and larynx).

The purpose of the Phase II part of this trial is to evaluate the antitumour activity of Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK – an investigational medicinal product –  in comparison with placebo when added to standard concurrent treatments cisplatin and radiotherapy ¹.

The patients undergo three 21-day cycles of cisplatin and radiotherapy combined with Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK or placebo (a substance having no pharmacological effect). Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK or placebo is administered as an oral solution on Days 1 to 14 of every cycle in combination with cisplatin administered by infusion on the second day of every cycle and radiotherapy 5 days per week.

In the first part of this trial (Phase I), the highest dose of Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK that could be safely administered in combination with cisplatin and radiotherapy Definition the standard therapy for this type of cancer was determined. This information was needed to start the Phase II part described above.

¹ Clinical Guidelines on esmo.org and nccn.org

Debiopharm International is conducting a pre-operative, open-label Definition An open-label trial means that no placebo is administered and that patients know what treatment they are given. , non-randomized “window-of-opportunity” trial in male and female patients with resectable squamous cell cancer of the head and neck (oral cavity, oropharynx, hypopharynx and larynx). A “window-of-opportunity” trial is a trial in which patients receive one or more new compounds between their cancer diagnosis and standard treatment (mainly surgery) to obtain knowledge about the anti-tumor activity of the new agent in a disease state that is not disturbed by previous or simultaneous treatments.

The purpose of this trial is to evaluate the effects of Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK administered alone or combined with cisplatin Definition the standard therapy for this type of cancer or cisplatin Definition the standard therapy for this type of cancer alone in the above disease in a pre-operative setting. Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK is an investigational medicinal product. Cisplatin is a drug approved for the treatment of this disease.

A first group patients has already been treated with Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK alone. A second group of patients will be treated shortly with Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK combined with cisplatin Definition the standard therapy for this type of cancer or cisplatin Definition the standard therapy for this type of cancer alone until surgery. Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of proteins that induce the cell death by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK is administered orally once daily for 15 days prior to surgery. Cisplatin is administered by infusion on once weekly over 15 days.