Date: 2014-05-28
Type of information: Presentation of results at a congress
phase: 1-2
Announcement: presentation of results at the 50th annual meeting of the American Society of Clinical Oncology (ASCO)
Company: Curis (USA) Debiopharm (Switzerland)
Product: Debio 0932
Action
mechanism: Debio 0932 is an oral second-generation HSP90 inhibitor, which has shown extended tumour retention, blood-brain-barrier penetration, and promising anti-tumour activity both as monotherapy and in combination against a broad range of tumours in pre-clinical models.
Debio 0932 potently inhibits tumour growth in subcutaneous xenograft models of a number of solid and haematological malignancies, including models of NSCLC which harbour mutations conferring acquired or primary erlotinib resistance. Furthermore, Debio 0932 is able to extend animal survival in models of brain metastasis due to its ability to cross the blood-brain barrier, and it enhances the activity of several standard-of-care agents in animal models of cancer.
Disease: advanced non-small cell lung cancer (NSLC)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The HALO (HSP90 inhibition And Lung cancer Outcomes) study is a Phase I-II clinical trial of the safety and efficacy of the oral HSP90 inhibitor Debio 0932 in combination with standard of care (SOC) agents in first- and second-line therapy of patients with advanced NSCLC.
Debio 0932 will be administered in this study in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients, and with docetaxel in previously treated patients.
Once a recommended Phase II dose of Debio 0932 in combination with each of the 3 chemotherapy regimens described above has been identified, the randomized, double-blind, placebo-controlled Phase II portion of this study will then begin where approximately 140 eligible patients will be randomized to receive chemotherapy with either placebo or Debio 0932. The primary objective of the Phase II study is to determine the efficacy of Debio 0932 in combination with chemotherapy. The KRAS mutation status will also be assessed and used as a stratification factor.
Latest
news: * On May 28, 2014, Debiopharm, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs as well as companion diagnostics, announced that new data on Debio 0932 (Hsp90 inhibitor) will be presented at the 50th American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 to June 3, 2014, in Chicago. Debio 0932 is a small oral molecule inhibitor of heat shock protein 90 (HSP90). Inhibition of HSP90 results in the degradation of oncoproteins that drive malignant progression and leads to cell death. Debio 0932 has shown efficacy in various mouse tumor xenografts and exhibits sustained tumor retention. Debio 0932 has been investigated in one phase I clinical study. Two phase I/II studies are ongoing in Europe in advanced non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) in combination with SOC and everolimus, respectively. Abstracts presented at ASCO: Final results from the phase I study expansion cohort of Debio 0932, an oral HSP90 inhibitor, in patients with solid tumors (#2550) and The HALO study: A phase I-II of the oral HSP90 inhibitor Debio 0932 in combination with SOC in first- and second-line therapy of advanced NSCLC (#TPS2632). * On August 15, 2012, Curis and Debiopharm have announced that Debiopharm has begun treating patients in its HALO Phase I/II clinical trial of orally-administered Heat Shock Protein 90 (HSP90) inhibitor Debio 0932 in combination with chemotherapy regimens in patients with advanced stages of non-small cell lung cancer (NSCLC). On August 10, 2012, Debiopharm initiated the Phase I portion of this clinical trial designed to determine the recommended Phase II dose of Debio 0932 in combination with various chemotherapy regimens in patients with stage IIIb or IV NSCLC with disease that is characterized as wild-type EGFR (Epidermal Growth Factor). Debio 0932 will be administered in this study in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients, and with docetaxel in previously treated patients.
