Date: 2014-11-19
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Company: Bind Therapeutics (USA - MA)
Product: BIND-014
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: non-small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: Russian Federation, USA
Trial
details: This open label, multicenter, phase 2 study has been designed to determine the safety and efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as second-line therapy to patients with non-small cell lung cancer (NSCLC).(NCT01792479 )
Latest
news: * On November 19, 2014, Bind Therapeutics presented results from its ongoing Phase 2 study of BIND-014 in non-small cell lung cancer (NSCLC), demonstrating it has met the primary objective in the once every three weeks (Q3W) arm as measured by overall response rate (ORR). The data demonstrate that BIND-014 is well-tolerated with clinically meaningful anti-tumor activity at a lower dose than conventional docetaxel in patients with advanced or metastatic NSCLC. BIND-014 also demonstrates promising anti-tumor activity in patients with tumors expressing KRAS mutations (mutated Kirsten ras oncogene homolog). KRAS mutations in NSCLC are generally associated with poor response to currently available drug therapy regimens, including docetaxel. An additional signal was observed in patients with squamous cell carcinomas, a major NSCLC subtype poorly served by existing available therapies. These data were presented at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain. The Q3W dosing arm of the open label, multicenter, Phase 2 study enrolled 40 patients with advanced metastatic NSCLC who were treated with 60 mg/m2 of BIND-014 on Day 1 of a 21-day cycle and achieved the following preliminary results: Five patients (13%, N=40) achieved a partial response with a median duration of response of 5.2 months and median progression free survival (PFS) of 2.7 months. There was one unconfirmed partial response that was not included in the analysis per RECIST v1.1. Bind plans to initiate global, multicenter Phase 2 studies of BIND-014 in patients with KRAS mutant NSCLC and in patients with NSCLC of squamous histology who have progressed on prior therapy. These studies aim to assess overall survival and additional endpoints to position BIND-014 for subsequent registration studies. Based on the promising results of the Q3W arm presented and the more patient-friendly once every three week dosing schedule, combined with the absence of a confirmed partial response in the first 22 patients enrolled on the Q1W schedule, the company will not continue enrollment on the weekly dosing schedule. * On October 30, 2014, Bind Therapeutics announced the online availability of an abstract providing preliminary data from the Q3W arm of its ongoing Phase 2 study of BIND-014 in non-small cell lung cancer (NSCLC). Data included in the abstract were current as of the submission deadline on June 13, 2014 and updated data will be presented in a poster presentation on November 19, 2014 at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain. * On July 29, 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 second-line therapy in patients with non-small cell lung cancer. This 40 patient, open label, single arm, multi-center study is designed to determine the efficacy of BIND-014 as measured by objective response rate in patients with Stage III/IV non-small cell lung cancer who have failed one prior platinum-containing chemotherapy regimen for advanced or metastatic disease.
Nine patients were enrolled with a confirmed KRAS mutation and two of those nine experienced an objective response (22%); median PFS in patients with KRAS mutant tumors was 2.7 months.
In patients with squamous cell carcinoma (n=9) there were no confirmed objective responses; however, median PFS in patients with squamous cell carcinoma was 2.8 months. Prolonged ( > 4 cycles) disease control was also noted in six of nine (66%) patients with squamous histology.
Preliminary median overall survival was 6.2 months for all patients treated, 9.6 months in patients with KRAS mutant tumors and 11.1 months in patients with squamous cell carcinoma.
Twenty-one of 40 patients received four or more cycles of therapy, attesting to the tolerability of BIND-014. Consistent with previous results, neutropenia, anemia, neuropathy, and alopecia, commonly observed with docetaxel, were significantly reduced with BIND-014.
