Positive results from a phase III trial in advanced colorectal cancer showed that Xilonix-treated patients with advanced disease and multiple symptoms known to inversely correlate with overall survival experienced a 76 percent relative increase in clinical response rate after eight weeks of therapy compared to placebo, at 33 percent vs. 19 percent, respectively (p=.0045).
Amgen and Allergan plc announced results from a phase III study evaluating efficacy and safety of biosimilar ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive early breast cancer.
Niraparib achieved its primary endpoint in a phase III ovarian cancer trial, demonstrating prolonged progression-free survival compared to placebo among patients who are germline BRCA mutation carriers; among patients who are not germline BRCA mutation carriers, but who have homologous recombination deficient tumors as determined by the Myriad myChoice HRD test; and overall in patients who are not germline BRCA mutation carriers.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.
A secondary analysis of the phase III ASPIRE trial that showed Kyprolis (carfilzomib) for Injection, in combination with lenalidomide and dexamethasone, improved progression-free survival and overall response rate, compared to lenalidomide and dexamethasone alone, in patients with relapsed multiple myeloma with early disease progression after initial therapy or transplant.
Data from a phase III trial evaluating eribulin in liposarcoma demonstrated a significant improvement in overall survival.
Novartis published data from a phase III study showing a significant survival benefit for patients with BRAF V600E/K mutation-positive advanced melanoma when treated with the first-line combination of Tafinlar (dabrafenib) and Mekinist (trametinib), compared to Tafinlar monotherapy.
FDA approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor gene mutations in non-small cell lung cancer patients.
A combination of surgery to remove the primary tumor in women diagnosed with stage IV breast cancer, followed by standard therapies, can add months to patients' lives when compared with standard therapy alone, according to an international phase III study.
AbbVie published longer-term follow-up results from three phase III studies of Imbruvica (ibrutinib) in chronic lymphocytic leukemia and small lymphocytic lymphoma: RESONATE, RESONATE-2 and HELIOS.