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Clinical Trial Protocol

FORWARD I: A Phase III Study of Mirvetuximab Soravtansine Versus Chemotherapy in Platinum-Resistant Ovarian Cancer

, , , , , , , & show all
Pages 1669-1678 | Received 20 Nov 2017, Accepted 25 Jan 2018, Published online: 09 Feb 2018

Figures & data

Infographic: A PDF version of this infographic is available as supplemental material.

Infographic: A PDF version of this infographic is available as supplemental material.
Figure 1. Mirvetuximab soravtansine mechanism of action.

Mirvetuximab soravtansine binds with high affinity to folate receptor-α expressed on the tumor cell surface, prompting internalization of the antibody–drug conjugate/receptor complex via antigen-mediated endocytosis. Lysosomal processing releases active DM4 catabolites – these maytansinoid derivatives inhibit tubulin polymerization and microtubule assembly, inducing potent antimitotic effects that result in cell-cycle arrest and apoptosis. The active metabolites may also diffuse into neighboring cells and induce further cell death (termed ‘bystander killing’).

Reproduced with permission from [Citation30].

Figure 1. Mirvetuximab soravtansine mechanism of action.Mirvetuximab soravtansine binds with high affinity to folate receptor-α expressed on the tumor cell surface, prompting internalization of the antibody–drug conjugate/receptor complex via antigen-mediated endocytosis. Lysosomal processing releases active DM4 catabolites – these maytansinoid derivatives inhibit tubulin polymerization and microtubule assembly, inducing potent antimitotic effects that result in cell-cycle arrest and apoptosis. The active metabolites may also diffuse into neighboring cells and induce further cell death (termed ‘bystander killing’).Reproduced with permission from [Citation30].
Figure 2. FORWARD I trial study design.

AIBW: Adjusted ideal body weight; OS: Overall survival; PLD: Pegylated liposomal doxorubicin.

Figure 2. FORWARD I trial study design.AIBW: Adjusted ideal body weight; OS: Overall survival; PLD: Pegylated liposomal doxorubicin.
Figure 3. Participating countries in the FORWARD I trial.

Countries with active sites are shown in green, those with pending sites are shown in yellow (as of January 2018).

Figure 3. Participating countries in the FORWARD I trial.Countries with active sites are shown in green, those with pending sites are shown in yellow (as of January 2018).

Table 1. Doses and dosing schedule.

Supplemental material