On November 19, 2014 BIND Therapeutics reported positive 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) (Press release BIND Therapeutics, NOV 19, 2014, View Source [SID:1234500985]). 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 (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain.

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"We believe the activity and tolerability of BIND-014 demonstrated in this study suggest meaningful differentiation from the historical docetaxel experience, in both the broader NSCLC patient population and in two important groups of patients with high unmet medical need," said Hagop Youssoufian, M.D., M.Sc., Chief Medical Officer, BIND Therapeutics. "Furthermore, as the first product candidate from our Medicinal Nanoengineering platform to enter the clinic, we believe that the increased efficacy and reduced toxicity at a lower dose compared to historical docetaxel experience suggests that Accurins are successful in targeting the therapeutic payload to the tumor. Based on these positive results, we plan to conduct additional global, multicenter Phase 2 studies to confirm and expand the dataset on BIND-014 and to define an expeditious regulatory path for BIND-014."

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.
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.

"Data from this open label study suggest the potential for BIND-014 superiority over docetaxel in the treatment of NSCLC patients," said Ronald B. Natale, M.D., Medical Director of the Clinical Lung Cancer Program at the Women’s Guild Lung Institute and investigator for the Phase 2 trial of BIND-014 in NSCLC. "Furthermore, BIND-014 demonstrated intriguing activity in patients with KRAS mutated lung cancers, a group of patients who have historically been unresponsive to standard treatment with docetaxel. This initial experience with BIND-014 provides a glimpse into a new way to selectively target NSCLC tumors, an area of cancer with high unmet need."

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 today 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.

Data from the Phase 2 study will be included in a presentation by BIND CEO Scott Minick at the Stifel Nicolaus Weisel Healthcare Conference in New York at 8:35 a.m. EST today. Interested parties may access a live webcast of the presentation by visiting the BIND Therapeutics website at www.bindtherapeutics.com. The webcast will be archived on the BIND Therapeutics website following the event for one week.