On April 23, 2024 Medivir AB (NASDAQ: MVIR) (STO: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported an update from a Type C meeting with the FDA, regarding the company’s plans for a global phase 2b study and opening of an IND for fostroxacitabine bralpamide (fostrox) in the US (Press release, Medivir, APR 23, 2024, View Source;lenvima-continue-302124266.html [SID1234642257]).
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The key outcome of the Type C meeting was that Medivir’s preparations for the randomized phase 2b study, comparing fostrox + Lenvima with Lenvima alone, continues with two key adjustments to the study design.
Firstly, as Medivir plans to use the improved capsule formulation of fostrox in the upcoming phase 2b study, an initial dose run-in as the first part of the study will be added. This means including 20-25 additional patients in an arm with a lower dose, in addition to the 30 mg dose used in the currently ongoing phase 1b/2a study. This change will also further strengthen the study design in relation to FDA’s Project Optimus.
Secondly, Objective Response Rate (ORR) is a validated surrogate endpoint for Overall Survival. In prior HCC studies, ORR has supported accelerated approvals. Therefore, the primary endpoint in the enhanced study design will be changed to ORR with key secondary endpoints, including duration of response, progression free survival and overall survival.
The aim of the study, as well as size and study length, remain similar as previously planned and communicated phase 2b design.
The FDA guidance has been discussed with Scientific Advisory Council members and regulatory experts. The next step is to finalize the study design and study protocol before submitting an IND in the US to enable study start in the beginning of 2025.
– "With the outcome of the Type C meeting, we are confidently moving forward with the enhanced phase 2b study design, including the adjustments informed by the discussion with FDA. Our current phase 1b/2a study, in a similar patient population, is still ongoing and patients are staying on treatment longer than expected. With the planned phase 2b study, we are excited to move forward with the development of a promising treatment alternative to second line HCC patients," says Pia Baumann, CMO at Medivir.
– "We continue to accelerate the development plan for fostrox. Engaging with FDA, to ensure best possible study design for the next phase, is critical for the program and is an important element in partnering discussions. Clarity on study design for phase 2b also allows us to move forward and perform study feasibility with speed as well as finalize CMC preparations," says Jens Lindberg, CEO at Medivir.
Medivir will provide additional details regarding the updated study design at the Quarterly Results webcast on April 30.