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"Findings from these early phase studies are encouraging and will beintegral in informing our development strategies for the ongoing Nexavarclinical program," said Henry Fuchs, MD, executive vice president and chiefmedical officer of Onyx Pharmaceuticals. "We are committed to maximizing thepotential of Nexavar and look forward to its ongoing study with internationalstudy groups, government agencies and individual investigators in a wide rangeof cancers."
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Highlights from Nexavar data presented include:
Lung Cancer
A Randomized, Discontinuation Phase 2 Study of Sorafenib vs. Placebo inPatients with Non-Small Cell Lung Cancer (NSCLC) Who Have Failed at Least TwoPrior Chemotherapy Regimens
Preliminary findings from this randomized discontinuation Phase 2 studyshowed that treatment with Nexavar yielded encouraging results in heavilypre-treated patients with NSCLC. The study showed that patients who remainedon Nexavar experienced a longer period of disease control and diseasestabilization than patients who discontinued Nexavar after the initial run-inphase of treatment. In the study, the most common treatment-emergent adverseevents included fatigue, hand/foot syndrome and skin rash.
The lead investigator for this study is Joan Schiller, MD, professor andchief of the hematology/oncology division at the University of TexasSouthwestern and Andrea L. Simmons distinguished chair in cancer research,Dallas, TX. (abstract #8014).
Thyroid Cancer
A Phase 2 Study of Sorafenib in Metastatic Thyroid Carcinoma
Findings from this single-arm Phase 2 study showed that treatment withNexavar resulted in meaningful anti-tumor activity in the majority of patientswith encouraging overall clinical benefit (disease stabilization and partialresponses) in patients with advanced thyroid cancer. In the study, Nexavar waswell-tolerated; the most common treatment-related adverse events includedfatigue, rash, diarrhea, palmer-plantar erythema, musculoskeletal pain andweight loss. Patients enrolled in this study had been diagnosed withmetastatic, iodine-refractory, unresectable or locally-advanced thyroidcancer.
The lead investigator for this study is Marcia S. Brose, MD, PhD,assistant professor, director of cancer genetics laboratory, University ofPennsylvania Health System, Philadelphia, PA. (abstract #6026).
Gastrointestinal Stromal Tumors
Activity of Sorafenib in Patients with Imatinib and Sunitinib-ResistantGastrointestinal Stromal Tumors (GIST): A Phase 2 Trial of the University ofChicago Phase 2 Consortium
Findings from this single-arm Phase 2 study suggest that Nexavar is activeand well tolerated in patients with Gleevec or Gleevec and Sutent resistantGIST. The most common treatment-emergent adverse events included hand-footsyndrome, hypertension, rash and diarrhea.
The lead investigator for this study is Lauren Wiebe, MD, fellow,University of Chicago, Chicago, IL. (abstract #10502).
Gastric/GEJ
A Phase 2 Study: Combination of Sorafenib with Docetaxel and Cisplatin inthe Treatment of Metastatic or Advanced Unresectable Gastric andGastroesophageal Junction (GEJ) Adenocarcinoma (ECOG 5203)
Findings from this single-arm Phase 2 study provide encouraging data forthe potential use of Nexavar in combination wit
