Onyx/Bayer: to Pursue Development of Nexavar Despite Study Failure
Posted on: Tuesday, 5 December 2006, 12:01 CST
The addition of Nexavar to the second-line chemotherapy combination of carboplatin and paclitaxel for melanoma has failed to improve progression-free survival. Given the commercial potential associated with melanoma, the companies are likely to pursue the development of Nexavar and evaluate the drug in a more treatment-naive melanoma patient population, where more encouraging data may be possible.
The international, double-blind phase III trial randomized 270 metastatic melanoma patients who had progressed after one prior chemotherapy regimen containing either the standard agent dacarbazine or Schering-Plough's Temodar (temozolomide). No specific details regarding clinical data from the trial were reported at this time, however, Bayer and Onyx Pharmaceuticals state that this will be presented at an upcoming scientific congress.
Developed via collaboration between Onyx and Bayer, Nexavar (sorafenib) is an orally available multi-kinase inhibitor that targets both RAF/MEK/ERK signaling pathway to inhibit cell proliferation and the VEGFR-2/PDGFR-beta signaling cascade to inhibit angiogenesis. This multi-targeted approach has shown promise in a range of tumor types, both as monotherapy or in combination with the traditional cytotoxic chemotherapy agents.
Melanoma is typically associated with high unmet needs, arising mainly from the poor prognosis associated with metastatic disease. While the majority of patients are diagnosed at an early stage when surgery can still result in a cure, metastatic patients are very poorly served in terms of treatment options. Due to the resistant nature of melanoma, current chemotherapy and immunotherapy approaches typically fail most patients, making ongoing research into new systemic therapy options crucial.
The failure of Nexavar to confer a progression-free survival benefit when added to second-line chemotherapy for metastatic melanoma patients is therefore a major disappointment for patients and investors alike. However, given the resistant nature of melanoma, particularly in this pretreated patient population, the option does exist for Onyx and Bayer to continue development of Nexavar in a more treatment-naive patient population, which could yield more encouraging clinical results. A phase III trial in this setting is currently ongoing.
An approval in melanoma would to boost Nexavar's sales by some margin, since the drug is currently only indicated for treatment of renal cell carcinoma. Given the high unmet needs currently surrounding systemic treatment for melanoma, it is likely that an agent capable of conferring significant clinical benefit will be well received with encouraging uptake.
Source: Datamonitor
Related Articles
- Study Supports Possible Use of Leukine(R) As a Potential Adjuvant Therapy for High-Risk Melanoma Patients
- TorreyPines Therapeutics Completes Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated With Schizophrenia
- Nutritional Supplements Safe and Beneficial for Patients Undergoing Chemotherapy and Radiation Therapy
- Affymax Presents Results From Ongoing Phase 2 Clinical Trial of Hematide(TM) in Anemic Cancer Patients Receiving Chemotherapy
- Medarex Announces Initiation of Registrational Trial for Ipilimumab (MDX-010) As Monotherapy in Previously-Treated Metastatic Melanoma Patients
- Chemotherapy Treatment Suggested for Bird Flu Patients
- Optimer's Lead Antibiotic Candidate Moves Into Phase 2B/3 Clinical Trials for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
- First Melanoma Patients Complete Treatment in Provectus Phase 1 Clinical Trial of PV-10
- Aranesp Dosed Every Three Weeks Achieved and Maintained Target Hemoglobin Levels in Patients With Chemotherapy-Induced Anemia
- ImClone Systems Commences Patient Treatment in U.S. Phase I Clinical Trial Of IMC-1121B
 |
 |
User Comments (0)
RSS Feeds