Schering-Plough Presents Positive Results From Phase III Melanoma Trial
Posted on: Monday, 14 July 2008, 09:01 CDT
Schering-Plough and the European Organization for the Research and Treatment of Cancer have announced positive results from a randomized Phase III melanoma trial which showed that long-term treatment with pegylated interferon alfa-2b in stage III melanoma patients had a significant and sustained impact on relapse-free survival.
The Phase III study was designed to assess the efficacy and safety of long-term pegylated interferon alfa-2b versus observation. Researchers randomized patients to either peginterferon alfa-2b adjuvant treatment (n=627) or observation only (n=629) within 70 days of regional lymph node dissection (intent-to-treat population). The endpoint was relapse-free survival (RFS).
Participants randomized to pegylated interferon alfa-2b were to receive a dose of six micrograms/kg/week for an eight-week induction phase followed by three micrograms/kg/wk (maintenance phase), for an intended total treatment duration of five years. Patients randomized to observation received no study treatment.
The study results show that at 3.8 years median follow up, the risk of recurrence or death was reduced by 18% in the pegylated interferon alfa-2b arm compared with observation. The four-year RFS rate was 46% versus 39% in the observation arm.
Median RFS was 34.8 months and 25.6 months in the peginterferon alfa-2b and observation alfa-2b arms, respectively. The improvement in RFS was more pronounced in patients with a lower tumor burden in the lymph nodes based on predefined subgroups.
For the subgroup of patients with clinically non-palpable (microscopic) lymph node disease, the hazard ratio (HR) for RFS was 0.73 in favor of peginterferon alfa-2b treatment, as compared to 0.86 in patients with clinically palpable nodes.
Peginterferon alfa-2b adjuvant treatment was not associated with a benefit on overall survival, a secondary endpoint, with an HR of 0.98.
Source: Datamonitor
Related Articles
- Curemark Enrolls First Patients in Phase III Clinical Trials for Autism Treatment
- Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival
- Obecure Completes Treatment of Patients in Phase II Obesity Trial
- Idenix Announces New 24-Week Data From A Phase IIb Clinical Trial Of Valopicitabine Plus Pegylated Interferon in Treatment Naive Genotype-1 Hepatitis C Patients
- ViroPharma Announces Positive Data From Phase 1b Combination Study of HCV-796 and Pegylated Interferon in Hepatitis C Patients
- Favorable Antiviral Activity and Improved Tolerability Demonstrated By Valopicitabine 200 Mg/Day in Combination With Pegylated Interferon in an Ongoing Phase IIb Trial in Treatment-Naive Genotype 1 Patients
- Idenix Pharmaceuticals Reports Positive 4-Week Data From A Phase IIb Clinical Trial Evaluating Valopicitabine (NM283) Combined With Pegylated Interferon in Treatment-Naive Hepatitis C Patients
- Valopicitabine (NM283) Combined With Pegylated Interferon Demonstrated Significantly Greater Suppression of Hepatitis C Virus (HCV) Replication in Treatment-Refractory Patients Compared to Retreatment With Ribavirin Plus Pegylated Interferon
- Results of Phase IIa Study Show That Reverset Has Potential to Reduce HIV Viral Load in Treatment-Experienced Patients
 |
 |
User Comments (0)
RSS Feeds