Date: 2016-01-07
Type of information: Results
phase: 2
Announcement: results
Company: Bind Therapeutics (USA - MA)
Product: BIND-014 (docetaxel encapsulated in a polymeric nanoparticle)
Action
mechanism: taxane derivative. BIND-014 is a targeted biodegradable polymeric nanoparticle containing the cytotoxic agent docetaxel. BIND-014 is targeted to prostate-specific membrane antigen (PSMA), a cell surface antigen abundantly expressed on the surface of cancer cells and on new blood vessels that feed a wide array of solid tumors. In preclinical cancer models, BIND-014 was shown to deliver up to 20 times more docetaxel to tumors than an equivalent dose of Taxotere. The increased accumulation of docetaxel at the site of disease translated to marked improvements in antitumor activity and tolerability.The development of BIND-014 was funded in part by the National Cancer Institute and the U.S. National Institutes of Standards and Technology (NIST) under its Advanced Technology Program (ATP).
Disease: metastatic castrate-resistant prostate cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This open label, multicenter, phase 2 study aims to evaluate the efficacy and safety BIND-014 in patients with metastatic castration-resistant prostate cancer (mCRPC). (NCT01812746)
Latest
news: * On January 7, 2016, Bind Therapeutics announced the presentation of complete data from its phase 2 clinical trial of BIND-014, a PSMA-targeted ACCURIN containing docetaxel, in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC) who either were or were not exposed to anti-androgens (abiraterone acetate and/or enzalutamide). BIND-014 was clinically active and well-tolerated and the study met its primary endpoint with 71 percent of patients achieving rPFS of at least 6 months. The complete data are being presented on January 7, 2016 during a poster session at the 2016 Genitourinary Cancers Symposium held in San Francisco. In addition to the primary endpoint, data presented from the trial included measurements of safety and tolerability, objective response rates (ORR), prostate-specific antigen (PSA) response, changes in circulating tumor cells (CTC) and overall survival (OS). BIND-014 administered at 60 mg/m² on day 1 of a 21-day cycle was clinically active and well-tolerated when administered to patients (n=42) with chemotherapy-naive mCRPC, including the 74% of patients with prior exposure to abiraterone acetate and/or enzalutamide. * On January 7, 2015, Bind Therapeutics announced topline data from its ongoing phase 2 trial with BIND-014 in metastatic castration resistant prostate cancer (mCRPC). The primary endpoint of the study was to determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC. The trial enrolled 42 patients, 31 of whom had been treated with androgen inhibitors prior to enrolling in the study. As of December 15, 2014, BIND-014 demonstrated a median rPFS of 8.1 months with three patients currently on treatment and 60 percent of the patients enrolled attained a rPFS of 6 months or greater. Safety and tolerability were also promising, with notable reductions in adverse effects that often limit dosing of conventional docetaxel, including hematologic and non-hematologic toxicities. As of December 15, 2014, three patients continue on treatment and 24 patients continue to be followed for overall survival. Complete results of the mCPRC trial will be presented at an upcoming medical meeting. * On August 19, 2013, Bind Therapeutics announced that it has dosed the first patient in a Phase 2 clinical trial to assess the safety and efficacy of BIND-014, a PSMA-targeted Accurin containing docetaxel, as first-line therapy in patients with chemotherapy naïve metastatic castrate-resistant prostate cancer. This 40 patient, open label, single arm multi-center study is designed to determine the efficacy of BIND-014 as measured by progression-free survival in patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer.
Median rPFS of 9.9 months (95% CI, 7.1 - 12.6) was achieved (n=42 with 8 censored).
A confirmed ORR of 21% was observed in patients with measurable disease (n=19).
A 50% reduction in PSA was observed in 30% of PSA evaluable patients (n=40).
CTC conversion from ? 5 cells/7.5 mL blood at baseline to < 5 cells/7.5 mL blood was observed in 50% of patients.
Median OS was 13.4 months (95% CI, 9.9 - 18.6 months [n=42 with 10 censored]). "Although these data are encouraging, recent advances with anti-androgen therapy limit our ability to compare BIND-014 data to historical benchmarks,said Hagop Youssoufian, M.D., M.Sc., chief medical officer, BIND Therapeutics. At this time, we are not planning further development of BIND-014 in mCRPC given the evolving treatment landscape. We anticipate additional BIND-014 data from both the iNSITE 1 trial in squamous histology non-small cell lung cancer and the iNSITE 2 trial in multiple tumor types during the first quarter of 2016, which we expect to determine our next steps in the clinical development of BIND-014."
