Biotech Values

[DewDiligence]

IMDZ +9%/AH—gets FDA nod for CMB305 phase-3 in STS first-line “maintenance” setting:

http://ir.immunedesign.com/releasedetail.cfm?ReleaseID=1044103

The randomized Phase 3 trial will evaluate CMB305 monotherapy vs. placebo in patients with NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma, a subtype of soft tissue sarcoma, who have no evidence of progression after first-line chemotherapy.

Immune Design intends to start the study in mid-2018 and enroll 248 patients aged twelve and older. Patients will be randomized 1:1 to receive either CMB305 monotherapy or placebo. The trial will have progression free survival (PFS) followed by overall survival (OS) as co-primary endpoints. If the PFS endpoint is successful, the FDA offered that it may support full approval of CMB305. Depending on the rate of events, final PFS analysis may occur as early as 24 months from the first patient dosed.

CMB305 is a cancer vaccine expressing the NY-ESO-1 antigen.

The first-line “maintenance” setting in this trial requires only stable disease—not necessarily an objective response—following first-line chemo.

The possibility of full FDA approval (rather than merely accelerated approval) based on PFS is due to the high unmet medical need in STS, where chemotherapy is not particularly effective.

CC tomorrow at 8:30am ET.