Latest New Medical Therapy Trial Results
Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results
are also searchable by therapeutic area beginning with the most recent updates.
Week of March 20, 2017
Advaxis reported results of a phase II trial of axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC). GOG-0265 is an open-label, single-arm, two-stage study. Patients who progressed on or after at least one prior line of systemic-dose chemotherapy receive one cycle (three doses) of axalimogene filolisbac at 1 x 109 CFU every 28 days. The final efficacy results of GOG-0265 demonstrated that 38% of patients (n=19/50) with heavily pretreated PRmCC were alive 12 months following treatment with axalimogene filolisbac. The GOG-0265 study protocol used a logistic model-based calculation to establish the expected 12-month survival rate. The model identified the key prognostic factors of age, race and performance status significantly related to survival from a database of approximately 500 patients with PRmCC who participated in 17 previous phase II studies conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology. Using this model, the expected 12-month survival rate of patients enrolled in the study was calculated to be 24.5%. As a result, the 38% 12-month survival rate of patients treated with axalimogene filolisbac represents a 52% improvement over the expected survival rate and is the highest 12-month survival rate achieved to date in this setting. The probability of this survival improvement being detected by chance versus a true treatment effect was calculated to be 0.02. A compelling and ongoing complete response of 18.5 months was observed and the longest ongoing survival is 40.6 months. Advaxis plans to initiate a global, phase III, randomized registration study in patients with metastatic cervical cancer later this year.
Amgen announced four-year follow-up results of Repatha (evolocumab) for treatment of low-density lipoprotein cholesterol (LDL-C) reductions. The OSLER-1 open-label extension (OLE) study enrolled 1,324 of the 1,650 (80.2%) eligible patients who completed a phase II parent study. OSLER-1 evaluated the durability of LDL-C reduction and incidence of adverse events (AE) with long-term therapy with Repatha. Once therapy was initiated, 79% of patients persisted with Repatha treatment with average exposure duration of 44 months. Patients who reached four years of follow-up achieved a median LDL-C of 60 mg/dL. The analysis found no new safety concerns with prolonged observation and reported that AEs occurred in 52.6% of patients treated with Repatha and standard of care (SOC) during year four compared to 79.3% during year one. The annualized AE rates in the Repatha and SOC group versus SOC alone were 2.8% versus 4% for new onset diabetes, 0.4% versus 0% for neurocognitive events, and 4.7% versus 8.5% for muscle-related events. The percentage of patients who discontinued Repatha due to AEs was 0.5% in year four and 2.8% in year one. Additionally, no neutralizing antibodies and only four transient binding antibody cases were observed.
AstraZeneca released results of a phase III trial of Lynparza (olaparib) tablets (300mg twice daily), compared with placebo in the maintenance setting for germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer. The trial met its primary endpoint of investigator-assessed progress-free survival (PFS) (HR 0.30; 95% CI 0.22-0.41; p<0.0001; median 19.1 months vs 5.5 months). PFS as measured by Blinded Independent Central Review (BICR) evaluation, a pre-specified sensitivity analysis supporting the primary endpoint, demonstrated a median PFS of 30.2 months vs 5.5 months for placebo, representing an improvement of 24.7 months (HR 0.25; 95% CI 0.18-0.35; p<0.0001). Additionally, a statistically-significant benefit in time to second progression or death (PFS2) was also seen in patients treated with Lynparza (HR 0.50; 95% CI 0.34-0.72; p=0.0002; median not reached vs 18.4 months), compared with placebo, as well as improvements in other key secondary endpoints. The most common hematological AEs reported in the Lynparza arm versus placebo were anemia (43.6% vs 8.1%), neutropenia (19.5% vs 6.1%), and thrombocytopenia (13.8% vs 3.0%). Grade ≥3 hematological AEs reported in the Lynparza arm versus placebo were anemia (19.5% vs 2.0%), neutropenia (5.1% vs 4.0%) and thrombocytopenia (1.0% vs 1.0%).