In a Phase 2, multi-national study, 65 adults with Ph- ALL in second or greater relapse or who had progressed after two or more prior lines of treatment received single-agent Marqibo 2.25 mg/m2 (without dose cap) IV weekly. All subjects were ineligible for immediate HSCT due to refractoriness to prior HSCT or the most recent salvage attempt, poor performance status, and/or insufficient anticipated lifespan.
Overall response rate (physician assessment) was 35.4% with a 20% complete response (CR) plus CR with incomplete hematologic recovery (CRi) rate. VSLI, despite delivering individual (2.8-5.5 mg) and cumulative (up to 70.1 mg) dose-intense VCR, had a similar safety profile to that reported for standard VCR. VSLI enabled bridging to HSCT in 12 of 65 (18.5%) subjects. Eight of the 12 (66.7%) subjects had undergone at least one pre-VSLI HSCT. Five of the 12 subjects were in CR/CRi at the time of post-VSLI HSCT. Three of 12 subjects remain alive at greater than 28, 33, and 35 months, respectively, after post- VSLI HSCT. Five of 12 subjects relapsed and died following post-VSLI HSCT. Three of 12 subjects died of HSCT-related complications. All 12 subjects lived for greater than 100 days after post-VSLI HSCT.
VSLI produced rapid CR/CRi or disease stabilization and a meaningful "bridge" to HSCT in 12 or 65 (18.5%) heavily pre-treated near end-stage adults with ALL. Long-term survival (greater than 12 months) was achieved in 27% of those able to receive post-VSLI HSCT. These unexpected outcomes that are important to patients may reflect the effectiveness of the dose intensification facilitated by VSLI compared to that provided by standard vincristine.
Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the
Talon plans to submit to the
In addition to Marqibo, the Company has additional pipeline opportunities some of which, like Marqibo, have the potential to improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
Additional information on
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the timing of planned NDA submission and other regulatory filings relating to Marqibo, Talon's ability to obtain accelerated approval of Marqibo for the treatment of adult Ph- ALL, and the potential of Marqibo to replace existing therapies. Such statements involve risks and uncertainties that could cause Talon's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts
and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, the timing of Talon's proposed submission of an NDA seeking accelerated approval of Marqibo is subject to the
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