Drugs / Xevinapant
Trials 18
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2024-06-24 | EMD Serono Research & Development Institute, Inc. | Results Merck KGaA, Darmstadt, Germany, Provides Update on Xevinapant Program in Locally Advanced Head and Neck Cancer emdserono.com ↗
The decision follows a pre-planned interim analysis performed by the study’s Independent Data Monitoring Committee, which found that the trial would be unlikely to meet its primary objective of prolonging event-free survival. |
| 2024-06-24 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, Provides Update on Xevinapant Program in Locally Advanced Head and Neck Cancer emdgroup.com ↗
The decision follows a pre-planned interim analysis performed by the study’s Independent Data Monitoring Committee, which found that the trial would be unlikely to meet its primary objective of prolonging event-free survival. |
| 2024-05-23 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono to Showcase Advances in the Science of Cancer With New Data Presented at ASCO 2024 emdserono.com ↗
This post-hoc analysis showed consistent outcomes when comparing the review of selected efficacy endpoints by blinded independent review committee (BIRC) with previously reported outcomes by investigator review. |
| 2022-09-07 | EMD Serono Research & Development Institute, Inc. | Results Xevinapant Five-Year Data Show Survival Rate Nearly Doubled in Patients with Unresected LA SCCHN, When Added to Standard of Care emdserono.com ↗
The addition of xevinapant more than halved the risk of death over five years compared with placebo. |
| 2022-09-07 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients emdserono.com ↗
Patients who received xevinapant plus chemoradiotherapy (CRT) had improved efficacy outcomes compared with those who received placebo with CRT. |
| 2020-09-17 | Debiopharm International SA | Results Debiopharm to Present Late Breaking Head & Neck Cancer Abstract at the 2020 European Society Of Medical Oncology Congress debiopharm.com ↗
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 ( ). |
| 2020-08-13 | Debiopharm International SA | Results Debiopharm’s IAP Antagonist Significantly Improves Overall Survival of High-Risk Head & Neck Cancer Patients debiopharm.com ↗
This potential first-in-class inhibitor of apoptosis proteins (IAP) antagonist with CRT showed a statistically and clinically significant improvement in Overall Survival (OS) vs. the control group, suggesting a halving of the risk of mortality (p=0.0261). |
| 2020-02-27 | Debiopharm International SA | Regulatory FDA grants Breakthrough Therapy Designation for Debiopharm’s novel chemo-radio sensitizer Debio1143 for front-line treatment of Head & Neck Cancer debiopharm.com ↗ |
| 2019-09-30 | Debiopharm International SA | Results Debiopharm’s novel IAP antagonist Debio1143 achieves outstanding Phase II results for high-risk Head and Neck cancer patients debiopharm.com ↗
The primary endpoint of LRC-rate at 18 months was met. |
| 2019-09-03 | Debiopharm International SA | Results Debiopharm successfully completes randomized Phase II study for IAP antagonist Debio1143 in high risk head & neck cancer patients debiopharm.com ↗
The results support future clinical assessments of the compound in stage III-IV LA-SCCHN patients as a frontline treatment in combination with CRT. |
| 2019-04-01 | Debiopharm International SA | Results Debiopharm releases results of 3 key oncology compound programs at the 2019 American Association for Cancer Research (AACR) Conference in Atlanta, GA debiopharm.com ↗
Debiopharm announces the poster presentations of preclinical data for Debio0123 and clinical data for Debio1143 and Debio1347 |
| 2016-06-02 | Debiopharm International SA | Regulatory FDA grants Orphan Drug Designation to Debiopharm International SA’s IAP inhibitor Debio1143 in the treatment of ovarian cancer debiopharm.com ↗
Debiopharm International SA (Debiopharm), a Swiss-based company, part of Debiopharm Group™, today announced that the FDA Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to Debio1143 for treatment of Ovarian Cancer. |
| 2015-12-08 | Debiopharm International SA | Regulatory EMA grants Orphan Drug Designation to Debiopharm International SA’s IAP inhibitor Debio1143 in the treatment of Ovarian Cancer debiopharm.com ↗
Debiopharm International SA (Debiopharm), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company, today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to Debio1143 for treatment of Ovarian Cancer affecting around 154 000 people in the European Union (EU). |
| 2015-11-03 | Debiopharm International SA | Results Debiopharm International SA presents positive preliminary results from Phase 1 trials in the development of the IAP inhibitor Debio1143 at the 27th EORTC-NCI-AACR symposium in Boston debiopharm.com ↗
Furthermore, encouraging early signs of efficacy in ovarian cancer patients have been observed (Poster #C2). |
| 2014-11-18 | Debiopharm International SA | Results Debiopharm Group™ presents advances of two key oncology clinical programs at the 26th EORTC-NCI-AACR symposium in Barcelona debiopharm.com ↗
The first signs of activity that have been observed in patients with triple-negative breast cancer and platinum-refractory ovarian cancer will be reported – Abstract number 444. |
All press releases naming this drug 20 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Xevinapant | “A Study of Xevinapant With Cisplatin and Radiation Therapy After Surgery in People With Head and Neck Cancer” NCT06145412 ↗ |
| Known as | AT-406 | “compound Debio 1143 (AT-406), a small molecule second mitochondria-derived activator of caspase C (Smac) mimetic” NCT01078649 ↗ |
| Known as | D-1143 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2158051 ↗ |
| Known as | Debio 1143 | “Debio 1143 is an investigational, oral monovalent second mitochondrial-derived activator of caspases (SMAC) mimetic designed to promote programmed cell death (apoptosis) in...” NCT03871959 ↗10“PURPOSE: To assess safety/tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of DEBIO1143, an antagonist of inhibitor apoptosis proteins.” PMID 25716544 ↗ Feb 2015 “Adaptive doses of Debio1143 oral capsules, between 50 and 400 mg until the recommended dose (RD) is determined.” NCT01930292 ↗ “Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.” NCT04459715 ↗ “Xevinapant (Debio 1143)” NCT05519540 ↗ “Drug: DEBIO1143” NCT03871959 ↗ |
| Known as | IAP INHIBITOR AT-406 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2158051 ↗ |
| Known as | MSC2735845A | ChEMBL registry synonym — accepted as the source's own label CHEMBL2158051 ↗ |
| Known as | SM-406 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2158051 ↗ |
| Action | Inhibit | “inhibiting XIAP (X linked IAP)” NCT01078649 ↗ |
| Modality | Small molecule | “a small molecule second mitochondria-derived activator of caspase C (Smac) mimetic” NCT01078649 ↗ |
| Route | Oral | “when administered orally” NCT01078649 ↗ |
| Target | XIAP | “inhibiting XIAP (X linked IAP)” NCT01078649 ↗ |