Keryx Biopharma (KERX) Reports Strong Phase 2 Data for Perifosine w/ Sorafenib in Certain HL Patients
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Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) reports Aeterna Zentaris Inc. (Nasdaq: AEZS) presented encouraging clinical data from a Phase 2 clinical study in patients with refractory/relapsed Hodgkin's Lymphoma was presented yesterday during the Annual Meeting of the American Society of Hematology, which is currently being held in San Diego, California. In a poster presentation by Anna Guidetti, MD, Fondazione IRCCS Instituto Nazionale Tumori, Milan, Italy, preliminary response data showed that perifosine combined with sorafenib significantly increased median progression free survival (PFS) in refractory/relapsed Hodgkin's Lymphoma patients with high phosphorylation levels of Erk and Akt as compared to patients with low baseline phosphorylation levels of Erk and Akt.
The Phase 2 Study
In abstract # 3705, entitled "Phosphorylation Levels of Extracellular-Signal Regulated Kinase (Erk) and Akt in Circulating Lymphocytes Predict Response to Targeted Therapy with Perifosine and Sorafenib in Refractory/Relapsed Hodgkin Lymphoma Patients," phosphorylation levels of Erk (pErk) and Akt (pAkt) were evaluated in circulating lymphocytes from patients enrolled in two consecutive Phase 2 trials evaluating the activity and safety of sorafenib as a single agent or in combination with perifosine in relapsed/refractory Hodgkin Lymphoma patients.
Four patients were treated with sorafenib alone at a dose level of 400mg BID and twenty-one patients received a 4-week treatment with perifosine alone at a dose level of 50mg BID followed by a perifosine/sorafenib combination therapy with 50mg BID and 400mg BID, respectively. Circulated lymphocytes were evaluated for their phosphorylation levels of Erk and Akt in order to assess predictive value of the phosphokinase levels for therapy responses.
Results
Clinical response data showed that baseline pErk and pAkt levels were significantly higher in responsive patients as compared to unresponsive patients. The pErk and pAkt levels measured after 60 days of therapy with perifosine combined with sorafenib were significantly reduced in responsive patients. The median baseline value of pErk and pAkt efficiently discriminated responsive and unresponsive patients which was associated with a significantly improved median PFS for patients with baseline pErk ≥43% and/or pAkt > 23%.
Conclusions
Refractory/relapsed Hodgkin Lymphoma patients with increased baseline levels of pErk and pAkt demonstrated increased PFS when treated with perifosine in combination with sorafenib.
The Phase 2 Study
In abstract # 3705, entitled "Phosphorylation Levels of Extracellular-Signal Regulated Kinase (Erk) and Akt in Circulating Lymphocytes Predict Response to Targeted Therapy with Perifosine and Sorafenib in Refractory/Relapsed Hodgkin Lymphoma Patients," phosphorylation levels of Erk (pErk) and Akt (pAkt) were evaluated in circulating lymphocytes from patients enrolled in two consecutive Phase 2 trials evaluating the activity and safety of sorafenib as a single agent or in combination with perifosine in relapsed/refractory Hodgkin Lymphoma patients.
Four patients were treated with sorafenib alone at a dose level of 400mg BID and twenty-one patients received a 4-week treatment with perifosine alone at a dose level of 50mg BID followed by a perifosine/sorafenib combination therapy with 50mg BID and 400mg BID, respectively. Circulated lymphocytes were evaluated for their phosphorylation levels of Erk and Akt in order to assess predictive value of the phosphokinase levels for therapy responses.
Results
Clinical response data showed that baseline pErk and pAkt levels were significantly higher in responsive patients as compared to unresponsive patients. The pErk and pAkt levels measured after 60 days of therapy with perifosine combined with sorafenib were significantly reduced in responsive patients. The median baseline value of pErk and pAkt efficiently discriminated responsive and unresponsive patients which was associated with a significantly improved median PFS for patients with baseline pErk ≥43% and/or pAkt > 23%.
Conclusions
Refractory/relapsed Hodgkin Lymphoma patients with increased baseline levels of pErk and pAkt demonstrated increased PFS when treated with perifosine in combination with sorafenib.
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