Pharmacy Times

Clinical Trials

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Lymphoma Patients Remained Free of Disease Progression with Rituximab

The results of a phase 3 study showed that patients with follicular lymphoma who continued receiving rituximab (Rituxan) alone after responding to rituximab and chemotherapy lived longer without their disease worsening (progression-free survival) than those who did not continue to receive rituximab. The study, known as PRIMA, is an international, multicenter, randomized, phase 3 clinical study that included 1200 patients with previously untreated advanced follicular lymphoma. PRIMA assessed the efficacy and safety profile of rituximab as maintenance therapy in patients who responded to initial treatment with rituximab plus chemotherapy (induction treatment). The primary end point was defined as the time from randomization to disease progression or death as assessed by the treating physicians and an independent review committee. Secondary end points included objective response rate, time to next treatment, eventfree survival, overall survival, and safety.

Anticancer Vaccine Shows Promise in Phase 3 Study

A randomized, multicenter, doubleblind, controlled phase 3 clinical study, carried out over 8 years in 177 patients, has shown that BiovaxID (personalized therapeutic anticancer vaccine) significantly prolonged disease-free survival in follicular non- Hodgkin’s lymphoma. Patients who received BiovaxID experienced a median disease-free survival of 44.2 months, compared with 30.6 months for those who received a control vaccine, which is a clinically and statistically significant difference (P = .045). During the median follow-up of 4.7 years, researchers also found that patients receiving BiovaxID experienced a 38% lower risk of disease recurrence. BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own tumor and selectively targets only the cancerous B-cells, while sparing healthy cells.

Treatment for Postmenopausal Vulvovaginal Atrophy Holds Promise

Ospemifene tablets (Ophena), an investigational compound, recently showed positive results for the treatment of postmenopausal vulvovaginal atrophy (VVA) in a second phase 3 clinical study. VVA is a chronic and progressive condition characterized by symptoms including vaginal dryness, sexual pain (dyspareunia), and irritation. The results of the study show positive efficacy in all 4 coprimary end points among patients with dyspareunia; the coprimary end points included decrease in parabasal and superficial cells from vaginal smear, decrease in vaginal pH, and improvement in the patient’s most bothersome moderate-to-severe symptom of dyspareunia. This randomized, double-blind, placebo-controlled phase 3 study enrolled 919 women with VVA. Ospemifene, a new SERM (selective estrogen receptor modulator), is the only nonestrogen therapy currently in late-stage development for the treatment of vaginal symptoms associated with menopause. The results showed highly statistically significant changes from baseline to week 12, compared with placebo in all 4 coprimary end points (P <.0001).

RA Treatment Demonstrates Positive Long-Term Efficacy

Patients with active rheumatoid arthritis (RA) receiving golimumab (Simponi) every 4 weeks achieved sustained improvements in signs and symptoms and physical function through 1 year, according to new long-term data from 2 phase 3 clinical trials. The data were presented at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting.

Data from the placebo-controlled, double-blind phase 3 clinical trial, Golimumab After Former Anti-TNF Therapy Evaluated in RA (GO-AFTER) study, showed that patients with RA who were previously treated with adalimumab, etanercept, or infliximab responded to, and maintained response to, golimumab through 1 year. Nearly two thirds (63%) of patients who received golimumab 50 mg achieved at least a 20% improvement in arthritis signs and symptoms by week 52 as measured by ACR 20 response, and 41% achieved a 50% improvement in arthritis signs and symptoms as measured by ACR 50 response.

Data from the multicenter clinical trial, Golimumab for Subjects with Active RA Despite Methotrexate (GO-FORWARD) study, demonstrated the efficacy of golimumab in patients with active RA and more than 4 tender and swollen joints, despite methotrexate therapy. Patients were randomized to receive either golimumab (50 or 100 mg) plus methotrexate, golimumab 100 mg plus placebo, or placebo plus methotrexate. In patients taking golimumab 50 mg plus methotrexate, 64% achieved ACR 20 response at week 52, and 25% achieved a 70% improvement in arthritis signs and symptoms as measured by ACR 70 response. Researchers also found that 48% of patients receiving golimumab 50 mg plus methotrexate achieved a low level of disease activity.